Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2015 | Mar. 04, 2016 | Jun. 30, 2015 | |
Document and Entity Information | |||
Entity Registrant Name | COLLEGIUM PHARMACEUTICAL, INC | ||
Entity Central Index Key | 1,267,565 | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2015 | ||
Amendment Flag | false | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Public Float | $ 189 | ||
Entity Common Stock, Shares Outstanding | 23,507,347 | ||
Document Fiscal Year Focus | 2,015 | ||
Document Fiscal Period Focus | FY |
BALANCE SHEETS
BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Current assets: | ||
Cash and cash equivalents | $ 95,697 | $ 1,634 |
Refundable PDUFA fee | 2,335 | |
Prepaid expenses and other current assets | 1,186 | 527 |
Total current assets | 96,883 | 4,496 |
Property and equipment, net | 738 | 514 |
Restricted cash | 97 | 80 |
Total assets | 97,718 | 5,090 |
Current liabilities: | ||
Accounts payable | 3,537 | 2,208 |
Accrued expenses | 2,228 | 1,956 |
Current portion of deferred rent and lease note payable | 59 | |
Current portion of term loan payable | 2,667 | 1,194 |
Convertible bridge notes with related parties | 5,000 | |
Total current liabilities | 8,432 | 10,417 |
Lease incentive obligation | 68 | 101 |
Term loan payable, long-term | 4,146 | 6,813 |
Total liabilities | $ 12,646 | $ 17,331 |
Commitments and contingencies (See Note 7) | ||
Shareholders’ equity (deficit): | ||
Common stock, $0.001 par value; authorized shares - 100,000,000 at December 31, 2015 and 72,000,000 at December 31, 2014; issued and outstanding shares - 20,739,351 at December 31, 2015 and 1,006,219 at December 31, 2014 | $ 21 | $ 1 |
Additional paid-in capital | 214,062 | 12,407 |
Accumulated deficit | (129,008) | (101,753) |
Treasury stock | (3) | (3) |
Total shareholders' equity (deficit) | 85,072 | (89,348) |
Total liabilities, convertible redeemable preferred stock and shareholders' equity (deficit) | $ 97,718 | 5,090 |
Series A convertible redeemable preferred stock | ||
Convertible redeemable preferred stock | ||
Convertible redeemable preferred stock | 12,781 | |
Series B convertible redeemable preferred stock | ||
Convertible redeemable preferred stock | ||
Convertible redeemable preferred stock | 51,212 | |
Series C convertible redeemable preferred stock | ||
Convertible redeemable preferred stock | ||
Convertible redeemable preferred stock | $ 13,114 |
BALANCE SHEETS (Parenthetical)
BALANCE SHEETS (Parenthetical) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Convertible redeemable preferred stock, authorized shares | 5,000,000 | 54,481,000 |
Convertible redeemable preferred stock, issued shares | 0 | |
Convertible redeemable preferred stock, outstanding shares | 0 | |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, authorized shares | 100,000,000 | 72,000,000 |
Common stock, issued shares | 20,739,351 | 1,006,219 |
Common stock, outstanding shares | 20,739,351 | 1,006,219 |
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, authorized shares | 5,000,000 | 0 |
Preferred stock, issued shares | 0 | 0 |
Preferred stock, outstanding shares | 0 | 0 |
Liquidation preference | $ 0 | $ 0 |
Series A convertible redeemable preferred stock | ||
Convertible redeemable preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Convertible redeemable preferred stock, authorized shares | 0 | 18,498,419 |
Convertible redeemable preferred stock, issued shares | 0 | 9,232,334 |
Convertible redeemable preferred stock, outstanding shares | 0 | 9,232,334 |
Convertible redeemable preferred stock, liquidation preference | $ 0 | $ 12,781 |
Series B convertible redeemable preferred stock | ||
Convertible redeemable preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Convertible redeemable preferred stock, authorized shares | 0 | 27,324,237 |
Convertible redeemable preferred stock, issued shares | 0 | 27,324,237 |
Convertible redeemable preferred stock, outstanding shares | 0 | 27,324,237 |
Convertible redeemable preferred stock, liquidation preference | $ 0 | $ 51,212 |
Series C convertible redeemable preferred stock | ||
Convertible redeemable preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Convertible redeemable preferred stock, authorized shares | 0 | 8,658,344 |
Convertible redeemable preferred stock, issued shares | 0 | 8,658,008 |
Convertible redeemable preferred stock, outstanding shares | 0 | 8,658,008 |
Convertible redeemable preferred stock, liquidation preference | $ 0 | $ 13,114 |
STATEMENTS OF OPERATIONS
STATEMENTS OF OPERATIONS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Operating expenses: | |||
Research and development | $ 7,975 | $ 14,959 | $ 14,157 |
General and administrative | 18,932 | 2,706 | 1,885 |
Total operating expenses | 26,907 | 17,665 | 16,042 |
Loss from operations | (26,907) | (17,665) | (16,042) |
Other expense (income): | |||
Interest expense, net | 439 | 252 | 76 |
Gain (loss) on extinguishment of debt | (91) | 79 | |
Change in fair value of derivative liability | 79 | ||
Total other expense, net | 348 | 252 | 155 |
Net loss | $ (27,255) | $ (17,917) | $ (16,197) |
Net loss per share - basic and diluted (in dollars per share) | $ (1.48) | $ (22.72) | $ (4.06) |
Weighted-average number of common shares used in net loss per share-basic and diluted (in shares) | 13,542,282 | 933,997 | 1,697,044 |
CONVERTIBLE REDEEMABLE PREFERRE
CONVERTIBLE REDEEMABLE PREFERRED STOCK - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Increase (decrease) in convertible redeemable preferred stock | |||
Accruals of dividends and accretion to redemption value | $ 31,184 | ||
Conversion of preferred stock to common stock | $ 119,250 | ||
Balance at end of year (in shares) | 0 | ||
Series A convertible redeemable preferred stock | |||
Increase (decrease) in convertible redeemable preferred stock | |||
Balance at beginning of year | $ 12,781 | $ 12,277 | $ 23,546 |
Balance at beginning of year (in shares) | 9,232,334 | 9,232,334 | 18,464,674 |
Accruals of dividends and accretion to redemption value | $ 2,297 | $ 504 | $ 970 |
Conversion of preferred stock to common stock | $ (11,345) | ||
Conversion of preferred stock to common stock (in shares) | (9,232,334) | ||
Extinguishment of prior preferred stock dividends | $ (3,733) | ||
Performance Adjustment | $ (12,239) | ||
Performance Adjustment of (in shares) | (9,232,340) | ||
Balance at end of year | $ 12,781 | $ 12,277 | |
Balance at end of year (in shares) | 0 | 9,232,334 | 9,232,334 |
Series B convertible redeemable preferred stock | |||
Increase (decrease) in convertible redeemable preferred stock | |||
Balance at beginning of year | $ 51,212 | $ 49,376 | $ 47,540 |
Balance at beginning of year (in shares) | 27,324,237 | 27,324,237 | 27,324,237 |
Accruals of dividends and accretion to redemption value | $ 18,034 | $ 1,836 | $ 1,836 |
Conversion of preferred stock to common stock | $ (45,905) | ||
Conversion of preferred stock to common stock (in shares) | (27,324,237) | ||
Extinguishment of prior preferred stock dividends | $ (23,341) | ||
Balance at end of year | $ 51,212 | $ 49,376 | |
Balance at end of year (in shares) | 0 | 27,324,237 | 27,324,237 |
Series C convertible redeemable preferred stock | |||
Increase (decrease) in convertible redeemable preferred stock | |||
Balance at beginning of year | $ 13,114 | ||
Balance at beginning of year (in shares) | 8,658,008 | 8,658,008 | |
Issuance of new convertible redeemable preferred stock, net of issuance costs | $ 12,034 | ||
Issuance of new redeemable preferred stock (in shares) | 12,154,000 | ||
Accruals of dividends and accretion to redemption value | $ 2,996 | $ 960 | $ 120 |
Conversion of preferred stock to common stock | $ (12,000) | ||
Conversion of preferred stock to common stock (in shares) | (8,658,008) | ||
Extinguishment of prior preferred stock dividends | $ (4,110) | ||
Balance at end of year | $ 13,114 | ||
Balance at end of year (in shares) | 0 | 8,658,008 | 8,658,008 |
Series D convertible redeemable preferred stock | |||
Increase (decrease) in convertible redeemable preferred stock | |||
Issuance of new convertible redeemable preferred stock, net of issuance costs | $ 44,807 | ||
Issuance of new redeemable preferred stock (in shares) | 37,500,000 | ||
Accruals of dividends and accretion to redemption value | $ 1,245 | ||
Conversion of notes to preferred stock | $ 5,000 | ||
Conversion of notes to preferred stock (in shares) | 4,166,667 | ||
Conversion of preferred stock to common stock | $ (50,000) | ||
Conversion of preferred stock to common stock (in shares) | (41,666,667) | ||
Extinguishment of prior preferred stock dividends | $ (1,052) |
CONVERTIBLE REDEEMABLE PREFERR6
CONVERTIBLE REDEEMABLE PREFERRED STOCK (Parenthetical) $ in Thousands | 12 Months Ended |
Dec. 31, 2015USD ($) | |
Common stock | Initial public offering | |
Sale of stock | |
Issuance costs | $ 2,408 |
Series D convertible redeemable preferred stock | |
Sale of stock | |
Issuance costs | $ 193 |
SHAREHOLDERS_ DEFICIT
SHAREHOLDERS’ DEFICIT - USD ($) $ in Thousands | Series D convertible redeemable preferred stock | Initial public offeringCommon Stock | Initial public offeringAdditional Paid-In Capital | Initial public offering | Common Stock | Additional Paid-In Capital | Treasury Stock, at cost | Accumulated Deficit | Total |
Balance at beginning of year at Dec. 31, 2012 | $ 2 | $ 11 | $ (3) | $ (61,414) | $ (61,404) | ||||
Balance at beginning of year (in shares) at Dec. 31, 2012 | 1,924,845 | ||||||||
Increase (decrease) in stockholders' equity (deficit) | |||||||||
Accruals of dividends and accretion to redemption value | (1) | (2,925) | (2,926) | ||||||
Performance Adjustment of Series A | $ (1) | 12,240 | 12,239 | ||||||
Performance Adjustment of Series A (in shares) | (962,962) | ||||||||
Stock-based compensation expense | 62 | 62 | |||||||
Exercise of common stock options | 1 | 1 | |||||||
Exercise of common stock options (in shares) | 1,077 | ||||||||
Net loss | (16,197) | (16,197) | |||||||
Balance at end of year at Dec. 31, 2013 | $ 1 | 12,313 | (3) | (80,536) | (68,225) | ||||
Balance at end of year (in shares) at Dec. 31, 2013 | 962,960 | ||||||||
Increase (decrease) in stockholders' equity (deficit) | |||||||||
Accruals of dividends and accretion to redemption value | (3,300) | (3,300) | |||||||
Issuance of restricted stock awards to employees (in shares) | 10,869 | ||||||||
Stock-based compensation expense | 22 | 22 | |||||||
Exercise of common stock options | 72 | 72 | |||||||
Exercise of common stock options (in shares) | 32,390 | ||||||||
Net loss | (17,917) | (17,917) | |||||||
Balance at end of year at Dec. 31, 2014 | $ 1 | 12,407 | (3) | (101,753) | (89,348) | ||||
Balance at end of year (in shares) at Dec. 31, 2014 | 1,006,219 | ||||||||
Increase (decrease) in stockholders' equity (deficit) | |||||||||
Accruals of dividends and accretion to redemption value | (24,572) | (24,572) | |||||||
Conversion of preferred stock to common stock | $ (50,000) | $ 13 | 119,237 | 119,250 | |||||
Conversion of preferred stock to common stock (in shares) | (41,666,667) | 12,591,463 | |||||||
Issuance of stock, net of issuance costs | $ 7 | $ 72,022 | $ 72,029 | 1,052 | 1,052 | ||||
Issuance of stock (in shares) | 6,670,000 | 87,662 | |||||||
Extinguishment of prior preferred stock dividends | 31,184 | 31,184 | |||||||
Issuance of restricted stock awards to employees (in shares) | 194,694 | ||||||||
Stock-based compensation expense | 2,209 | 2,209 | |||||||
Exercise of common stock options | 517 | 517 | |||||||
Exercise of common stock options (in shares) | 173,251 | ||||||||
Exercise of warrants | 6 | 6 | |||||||
Exercise of warrants (in shares) | 16,062 | ||||||||
Net loss | (27,255) | (27,255) | |||||||
Balance at end of year at Dec. 31, 2015 | $ 21 | $ 214,062 | $ (3) | $ (129,008) | $ 85,072 | ||||
Balance at end of year (in shares) at Dec. 31, 2015 | 20,739,351 |
STATEMENTS OF CASH FLOWS
STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Operating activities | |||
Net loss | $ (27,255) | $ (17,917) | $ (16,197) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation and amortization | 171 | 187 | 169 |
Lease incentive | (34) | (34) | (34) |
Stock-based compensation expense | 2,209 | 22 | 62 |
Non cash interest expense | 6 | 7 | 12 |
Accrual of back end fees related to note payable | 7 | 13 | |
Change in fair value of derivative liability | 79 | ||
Changes in operating assets and liabilities: | |||
Prepaid expenses and other current assets | (659) | 183 | (11) |
Refundable PDUFA fee | 2,335 | (2,335) | |
Accounts payable | 1,298 | 990 | (822) |
Accrued expenses | 362 | 943 | 199 |
Net cash used in operating activities | (21,567) | (17,947) | (16,530) |
Investing activities | |||
Purchases of property and equipment | (362) | (8) | (206) |
Net cash used in investing activities | (362) | (8) | (206) |
Financing activities | |||
Proceeds from issuance of convertible bridge note | 5,000 | ||
Proceeds from notes payable, net of original note payoff | 7,056 | 500 | |
Repayment of term note | (1,286) | (28) | (43) |
Repayment of lease note payable | (59) | (62) | (62) |
Restricted cash | (16) | ||
Proceeds from the exercise of stock options | 517 | 72 | 1 |
Net cash provided by financing activities | 115,992 | 12,038 | 12,351 |
Net increase (decrease) in cash and cash equivalents | 94,063 | (5,917) | (4,385) |
Cash and cash equivalents at beginning of period | 1,634 | 7,551 | 11,936 |
Cash and cash equivalents at end of period | 95,697 | 1,634 | 7,551 |
Supplemental disclosure of cash flow information | |||
Cash paid for interest | 353 | 181 | 73 |
Supplemental disclosure of noncash activities | |||
Preferred stock conversion to common stock | 944 | ||
Extinguishment of Preferred Stock | 120,302 | ||
Accruals of dividends and accretion to redemption value | 31,184 | ||
Conversion of bridge note to preferred stock | 24,572 | 3,300 | 2,926 |
Repayment of term note with proceeds of notes payable | 5,000 | ||
Performance Adjustment to Series A and common shares | 12,239 | ||
Series C convertible redeemable preferred stock | |||
Financing activities | |||
Proceeds from issuance of stock, net of issuance costs | 11,955 | ||
Supplemental disclosure of noncash activities | |||
Accruals of dividends and accretion to redemption value | 2,996 | $ 960 | $ 120 |
Series D convertible redeemable preferred stock | |||
Financing activities | |||
Proceeds from issuance of stock, net of issuance costs | 44,807 | ||
Supplemental disclosure of noncash activities | |||
Accruals of dividends and accretion to redemption value | 1,245 | ||
Initial public offering | Common stock | |||
Financing activities | |||
Proceeds from issuance of stock, net of issuance costs | $ 72,029 |
STATEMENTS OF CASH FLOWS (Paren
STATEMENTS OF CASH FLOWS (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2013 | |
Series C convertible redeemable preferred stock | ||
Preferred stock | ||
Stock issuance costs | $ 45 | |
Series D convertible redeemable preferred stock | ||
Preferred stock | ||
Stock issuance costs | $ 193 | |
Initial public offering | Common stock | ||
Preferred stock | ||
Stock issuance costs | $ 2,408 |
NATURE OF BUSINESS
NATURE OF BUSINESS | 12 Months Ended |
Dec. 31, 2015 | |
NATURE OF BUSINESS | |
NATURE OF BUSINESS | 1. NATURE OF BUSINESS Organization Collegium Pharmaceutical, Inc. (the “Company”) was incorporated in Delaware in April 2002 and then reincorporated in Virginia in July 2014. The Company has its principal operations in Canton, Massachusetts. The Company is a specialty pharmaceutical company developing and planning to commercialize next ‑generation abuse ‑deterrent products that incorporate the Company’s patented DETERx ® platform technology for the treatment of chronic pain and other diseases. The Company’s lead product candidate, Xtampza ER™, or Xtampza, is an abuse ‑deterrent, extended ‑release, oral formulation of oxycodone, a widely prescribed opioid medication. Xtampza has received Fast Track status from the U.S. Food and Drug Administration (“FDA”). The Company’s new drug application (“NDA”) filing for Xtampza was accepted by the FDA on February 10, 2015. On November 6, 2015, the FDA granted tentative approval to the Xtampza NDA for the management of pain severe enough to require daily around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. With tentative approval, the FDA has determined that Xtampza meets the required quality, safety and efficacy standards for approval but that it was subject to an automatic stay of up to 30 months as a result of patent litigation filed by Purdue Pharma, L.P. (Purdue) in March 2015. In February 2016, the District Court of Massachusetts entered a judgment in the Company’s favor related to Purdue’s three Orange Book-listed patents that were the cause of the 30 month stay. The Company submitted its request for final approval of the Xtampza NDA to the FDA on February 26, 2016. The FDA has set a Prescription Drug User Fee Act, or PDUFA, goal date of April 26, 2016. The Company’s operations are subject to certain risks and uncertainties. The risks include negative outcome of clinical trials, inability or delay in completing clinical trials or obtaining regulatory approvals, the rate and degree of market acceptance of our product candidates, changing market conditions for products being developed by the Company, the need to retain key personnel and protect intellectual property, patent infringement litigation and the availability of additional capital financing on terms acceptable to the Company. Initial Public Offering In May 2015, the Company closed an initial public offering (“IPO ” ) of its common stock, which resulted in the sale of 6,670,000 shares of its common stock at a public offering price of $12.00 per share, including 870,000 shares of common stock upon the exercise by the underwriters of their option to purchase additional shares at the public offering price. The Company received proceeds from the IPO of approximately $72,029 after deducting underwriting discounts, commissions and expenses payable by the Company. In April 2015, in connection with preparing for the IPO, the Company’s board of directors and shareholders approved a one ‑for ‑6.9 reverse split of the Company’s common stock. All common stock share and per share amounts in the financial statements have been retroactively adjusted for all periods presented to give effect to the reverse split of our common stock, including reclassifying an amount equal to the reduction in par value to additional paid ‑in capital In connection with the closing of the IPO, all of the Company’s outstanding convertible preferred stock and accrued dividends automatically converted to common stock in May 2015, resulting in an additional 12,591,463 shares of common stock of the Company becoming outstanding. The significant increase in common stock outstanding in May 2015 is expected to impact the year-over-year comparability of the Company’s net loss per share calculations in future periods. Basis of Accounting The consolidated financial statements include the accounts of Collegium Pharmaceutical, Inc. (a Virginia corporation) as well as the accounts of Collegium Securities Corp. (a Massachusetts corporation), incorporated in December 2015, a wholly-owned subsidiary requiring consolida tion, and are prepared in conformity with accounting principles generally accepted in the United States of America. All significant intercompany balances and transactions have been eliminated in consolidation. Liquidity The Company has experienced net losses and negative cash flows from operating activities since its inception, and as of December 31, 2015 and December 31, 2014, had an accumulated deficit of $ 129,008 and $101,753 , respectively. The Company expects to continue to incur net losses in the foreseeable future. A successful transition to attaining profitable operations is dependent upon achieving a level of revenues adequate to support the Company’s cost structure. The Company may never achieve profitability, and unless and until it does, the Company will continue to need to raise additional cash. Management intends to fund future operations through additional private or public debt or equity offerings, and may seek additional capital through arrangements with strategic partners or from other sources. The Company believes that its existing cash and cash equivalents, including the net proceeds from its January 2016 follow-on offering, will be sufficient to fund operations and future growth initiatives for at least the next twelve months ; however, there can be no assurance that the Company will be successful in achieving its projections, reducing costs, or raising additional funds with terms acceptable to the Company. If the Company is unable to obtain financing or increase profitability, the related lack of liquidity will have a material adverse effect on the Company’s operations and future prospects. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2015 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Use of Estimates The preparation of the Company’s financial statements requires it to make estimates and assumptions that impact the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in the Company’s financial statements and accompanying notes. The most significant estimates in the Company’s financial statements relate to the valuation of equity awards, fair value estimates of warrants, estimated useful lives of fixed assets and accruals related to clinical trials. The Company bases estimates and assumptions on historical experience when available and on various factors that it believes to be reasonable under the circumstances. The Company evaluates its estimates and assumptions on an ongoing basis. The Company’s actual results may differ from these estimates under different assumptions or conditions. Fair Value Measurements Disclosures of fair value information about financial instruments are required, whether or not recognized in the balance sheet, for financial instruments with respect to which it is practicable to estimate that value. The carrying amounts reported in the Company’s financial statements for cash and cash equivalents, accounts payable , loan payable and accrued liabilities approximate their respective fair values because of the short ‑term nature of these accounts. Fair value measurements and disclosures describes the fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value, as follows: Level 1 Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities. The Company’s Level 1 assets and liabilities consist of money market investments. Level 2 Quoted prices for similar assets, or inputs that are observable, either directly or indirectly, for substantially the full term through corroboration with observable market data. Level 2 includes investments valued at quoted prices adjusted for legal or contractual restrictions specific to the security. The Company does not have Level 2 assets or liabilities. Level 3 Pricing inputs are unobservable for the assets or liabilities, that is, inputs that reflect the reporting entity’s own assumptions about the assumptions market participants would use in pricing the assets. Level 3 includes private investments that are supported by little or no market activity. The Company does not have Level 3 assets or liabilities. Transfers are calculated on values as of the transfer date. There were no transfers between Levels 1 , 2 and 3 during the years ended December 31, 2015 and 2014. The following tables present the Company’s financial instruments carried at fair value using the lowest level input applicable to each financial instrument at December 31, 2015 and 2014. Significant Quoted Prices other Significant in active observable unobservable markets inputs inputs Description Total (Level 1) (Level 2) (Level 3) December 31, 2015 Money market funds, included in cash equivalents $ $ $ — $ — December 31, 2014 Money market funds, included in cash equivalents $ $ $ — $ — Concentration of Credit Risk Financial instruments, which potentially subject the Company to significant concentration of credit risk, consist primarily of cash and cash equivalents. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits. The Company has not experienced any losses in such accounts and management believes that the Company is not exposed to significant credit risk due to the financial position of the financial institutions in which those deposits are held. The Company has no financial instruments with off ‑balance sheet risk of loss. Cash and Cash Equivalents Cash and cash equivalents include cash in readily available checking and savings accounts and money market funds. The Company considers all highly liquid investments with an original maturity of three months or less from the date of purchase to be cash equivalents. The Company’s cash equivalents, which consist of money market funds, are measured at fair value on a recurring basis. As of December 31, 2015 and 2014, the carrying amount of cash and cash equivalents was $95,697 a nd $1,634 , respectively, which approximates fair value and was determined based upon Level 1 inputs. Money market funds are valued using quoted market prices with no valuation adjustments applied. Accordingly, these securities are categorized as Level 1. Property and Equipment Property and equipment are recorded at historical cost. Maintenance and repair costs are expensed as incurred. Costs which materially improve or extend the lives of existing assets are capitalized. The Company provides for depreciation and amortization using the straight ‑line method over the estimated useful lives of the assets, which are as follows: Asset Category Estimated Useful Life Machinery and equipment years Computers and office equipment years Furniture and fixtures years Leasehold improvements the shorter of the lease term or years Upon retirement or sale, the cost of assets disposed and the related accumulated depreciation are removed from the accounts and any resulting gain or loss is recorded in the statements of operations. Impairment of Long ‑Lived Assets Long ‑lived assets consist of property and equipment. When impairment indicators exist, the Company’s management evaluates long ‑lived assets for potential impairment. An impairment loss is recorded if and when events and circumstances indicate that assets might be impaired and the undiscounted cash flows estimated to be generated by those assets are less than the carrying amount of those assets. While the Company’s current and historical operating losses and negative cash flows are indicators of impairment, management believes that future cash flows to be received support the carrying value of its long ‑lived assets and, accordingly, has not recognized any impairment losses since inception. Impairment losses, if any, are recognized in earnings. An impairment loss would be recognized in an amount equal to the excess of the carrying amount over the estimated fair value. Deferred Financing Costs The Company defers direct incremental costs attributable to public offerings of its common stock. These costs represent legal, accounting and other direct costs related to the Company’s efforts to raise capital through a public sale of its common stock. Costs will be deferred until the completion of the public offering, at which time they will be reclassified to additional paid ‑in capital as a reduction of the public offering proceeds. If the Company terminates its plan for a public offering or delays such plan for more than 90 days, any costs deferred will be expensed immediately. Deferred financing costs were $353 and $233 at December 31, 2015 and 2014, respectively. Deferred financing costs are included in prepaid expenses and other assets in the balance sheet. Restricted Cash Restricted cash represents cash held in a depository account at a financial institution to collateralize a conditional stand ‑by letter of credit related to the Company’s Canton, Massachusetts facility lease agreement. Restricted cash is reported as non ‑current unless the restrictions are expected to be released in the next twelve months. Deferred Rent Deferred rent consists of the difference between cash payments and the recognition of rent expense on a straight ‑line basis for the facilities the Company occupies. The Company’s lease for its facility provides for fixed increases in minimum annual rental payments and for additional rent in the form of maintenance and operating costs during the lease term. The total amount of rental payments due over the lease term is being charged to rent expense ratably over the life of the lease. Research and Development Costs Research and development costs are charged to expense as incurred and consist of costs incurred to further the Company’s research and development activities including salaries and employee related costs, costs associated with market research and design, costs associated with conducting preclinical, clinical and regulatory activities including fees paid to third ‑party professional consultants and service providers, costs incurred under clinical trial agreements, costs for laboratory supplies and laboratory equipment, costs to acquire, develop and manufacture preclinical study and clinical trial materials, facilities, depreciation and other expenses including allocated expenses for rent and maintenance of facilities. Government grants are recognized as a reduction of the qualifying cost being reimbursed. Patent Costs Costs related to filing and pursuing patent applications are recorded as general and administrative expense as incurred since the recoverability of such expenditures is uncertain. Stock ‑Based Compensation The Company accounts for grants of stock options and restricted stock to employees, including members of the board of directors, based on their grant date fair value and recognizes compensation expense over their vesting period. The Company estimates the fair value of stock options as of the date of grant using the Black ‑Scholes option pricing model and restricted stock based on the fair value of the underlying common stock as determined by management or the value of the services provided, whichever is more readily determinable. Stock ‑based compensation expense represents the cost of the grant date fair value of employee stock option grants recognized over the requisite service period of the awards (usually the vesting period) on a straight ‑line basis, net of estimated forfeitures. The expense is adjusted for actual forfeitures at year end. Stock ‑based compensation expense recognized in the financial statements is based on awards that are ultimately expected to vest. For stock option grants with performance ‑based milestones, the expense is recorded over the remaining service period after the point when the achievement of the milestone is probable or the performance condition has been achieved. For stock option grants with both performance ‑based milestones and market conditions, expense is recorded over the derived service period after the point when the achievement of the performance ‑based milestone is probable or the performance condition has been achieved. The Company accounts for stock options and restricted stock awards to non ‑employees using the fair value approach. Stock options and restricted stock awards to non ‑employees are subject to periodic revaluation over their vesting terms. There were no non ‑employee grants in 2014. There was one non-employee grant in 2015. Income Taxes The Company accounts for income taxes under the liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements. Under this method, deferred tax assets and liabilities are determined on the basis of the differences between the financial statements and tax basis of assets and liabilities using enacted tax rates in effect for the years in which the differences are expected to reverse. The effect of a change in tax rates on deferred tax assets and liabilities is recognized in income in the period that includes the enactment date. The Company recognizes net deferred tax assets to the extent that the Company believes these assets are more likely than not to be realized. In making such a determination, management considers all available positive and negative evidence, including future reversals of existing taxable temporary differences, projected future taxable income, tax ‑planning strategies and results of recent operations. If management determines that the Company would be able to realize its deferred tax assets in the future, in excess of its net recorded amount, management would make an adjustment to the deferred tax asset valuation allowance, which would reduce the provision for income taxes. The Company records uncertain tax positions on the basis of a two ‑step process whereby (i) management determines whether it is more likely than not that the tax positions will be sustained on the basis of the technical merits of the position and (ii) for those tax positions that meet the more likely than not recognition threshold, management recognizes the largest amount of tax benefit that is more than 50 percent likely to be realized upon ultimate settlement with the related tax authority. The Company will recognize interest and penalties related to uncertain tax positions within income tax expense. Any accrued interest and penalties will be included within the related tax liability. As of December 31, 2015 and 2014, the Company had no accrued interest or penalties related to uncertain tax positions and no amounts have been recognized in the Company’s statements of operations. Net loss per Common Share Basic net loss per common share is calculated by dividing the net loss attributable to common shareholders by the weighted ‑average number of shares of common stock outstanding during the period, without consideration for potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss attributable to common shareholders by the weighted ‑average number of shares of common stock and potentially dilutive securities outstanding for the period. For purposes of the diluted net loss per share calculation, stock options, warrants, redeemable convertible preferred stock and unvested restricted stock are considered potentially dilutive securities. Because the Company has reported a net loss for the twelve months ended December 31, 2015, 2014 and 2013 , diluted net loss per common share is the same as basic net loss per common share for those periods. Diluted earnings per share is computed using the more dilutive of (i) the two ‑class method, or (ii) the if ‑converted method. The Company allocates earnings first to preferred shareholders based on dividend rights and then to common and preferred shareholders based on ownership interests. The weighted ‑average number of common shares included in the computation of diluted earnings (loss) gives effect to all potentially dilutive common equivalent shares, including outstanding stock options, warrants, convertible redeemable preferred stock and the potential issuance of stock upon the conversion of the Company’s convertible notes. Common stock equivalent shares are excluded from the computation of diluted earnings (loss) per share if their effect is antidilutive. Recently Issued Accounting Pronouncements In February 2016, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2016-02, Leases (Topic 842). The ASU requires lessees to put most leases on their balance sheets as a liability for the obligation to make lease payments and as a right-of-use asset, but recognize expenses on the income statements in a manner similar to today’s accounting. The guidance also eliminates the current real estate-specific provisions for all entities. For calendar-year public entities, the guidance becomes effective in 2019 and interim periods within that year. Early adoption is permitted for all entities. The Company has not chosen early adoption for this ASU and is currently evaluating its effect on the Company’s consolidated financial statements In November 2015, the FASB issued ASU 2015-17, Income Taxes: Balance Sheet Classification of Deferred Taxes (Topic 740) . ASU 2015-17 simplifies the presentation of deferred income taxes by eliminating the separate classification of deferred income tax assets and liabilities into current and noncurrent amounts in the consolidated balance sheet statement of financial position. The amendments in the update require that all deferred tax assets and liabilities be classified as noncurrent in the consolidated balance sheet. The amendments in this update are effective for annual periods beginning after December 15, 2017, and interim periods therein and may be applied either prospectively or retrospectively to all periods presented. Early adoption is permitted. The Company is currently evaluating its effect on the Company’s consolidated financial statements. In May 2014, the FASB issued ASU No. 2014 ‑09, Revenue from Contracts with Customers. This ASU is a comprehensive new revenue recognition model that requires a company to recognize revenue to depict the transfer of goods or services to a customer at an amount that reflects the consideration it expects to receive in exchange for those goods or services. This ASU is effective for annual reporting periods beginning after December 15, 2016 and early adoption is not permitted. Accordingly, the Company will adopt this ASU on January 1, 2017. Management does not believe the adoption of this ASU will have a material impact on the Company’s financial condition, results of operations or cash flows. In June 2014, the FASB issued ASU No. 2014 ‑12, Compensation — Stock Compensation (Topic 718): Accounting for Share ‑Based Payments When the Terms of an Award Provide That a Performance Target Could Be Achieved after the Requisite Service Period . ASU 2014 ‑12 applies to all reporting entities that grant their employees share ‑based payments in which the terms of the award provide that a performance target that affects vesting could be achieved after the requisite service period. That is the case when an employee is eligible to retire or otherwise terminate employment before the end of the period in which a performance target (for example, an initial public offering or a profitability target) could be achieved and still be eligible to vest in the award if and when the performance target is achieved. The standard is required to be adopted by public business entities in annual periods beginning on or after December 15, 2015 and interim periods within those annual periods. The Company plans to implement this standard in the first quarter of fiscal year 2016 and is currently evaluating the potential impact of this new guidance on its financial statements. In August 2014, the FASB issued ASU No. 2014 ‑15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern. ASU 2014 ‑15 requires management to evaluate, at each annual or interim reporting period, whether there are conditions or events that exist that raise substantial doubt about an entity’s ability to continue as a going concern within one year after the date the financial statements are issued and provide related disclosures. ASU 2014 ‑15 is effective for annual periods ending after December 15, 2016 and earlier application is permitted. The adoption of ASU 2014 ‑15 is not expected to have a material effect on the Company’s financial statements or disclosures. In November 2014, the FASB issued ASU No. 2014 ‑16, Derivatives and Hedging (Topic 815) — Determining Whether the Host Contract in a Hybrid Financial Instrument Issued in the Form of a Share is More Akin to Debt or to Equity . This ASU was issued to clarify how current U.S. generally accepted accounting principles should be interpreted in evaluating the economic characteristics and risk of a host contract in a hybrid financial instrument that is issued in the form of a share. In addition, this ASU was issued to clarify that in evaluating the nature of a host contract, an entity should assess the substance of the relevant terms and features (that is, the relative strength of the debt ‑like or equity ‑like terms and features given the facts and circumstances) when considering how to weight those terms and features. The effects of initially adopting this ASU should be applied on a modified retrospective basis to existing hybrid financial instruments issued in a form of a share as of the beginning of the fiscal year for which the amendments are effective. Retrospective application is permitted to all relevant prior periods. This ASU is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2015. Early adoption in an interim period is permitted. The Company is currently evaluating the impact of the adoption of this ASU on its financial statements . |
NET LOSS PER COMMON SHARE
NET LOSS PER COMMON SHARE | 12 Months Ended |
Dec. 31, 2015 | |
NET LOSS PER COMMON SHARE | |
NET LOSS PER COMMON SHARE | 3. NET LOSS PER COMMON SHARE Basic net loss per share is computed by dividing net loss by the weighted ‑average number of shares of common stock outstanding during the period. Diluted net loss per share is computed by dividing the net loss attributable to common shareholders by the weighted ‑average number of shares of common stock and potentially dilutive securities outstanding for the period. Stock options, warrants, convertible preferred stock and unvested restricted stock are considered to be potentially dilutive securities and are only included in the calculation of diluted net loss per share when their effect is dilutive. For the twelve months ended December 31, 2015, 2014 and 2013, these securities were anti ‑dilutive due to the net losses in those periods and, therefore, the number of shares used to compute basic and diluted earnings per share are the same for of those periods. The following table presents the computations of basic and dilutive net loss per share: Years Ended December 31, 2015 2014 2013 Net loss $ $ $ Extinguishment of preferred stock - see note 10 — — Accretion and dividends of prior preferred stock - see note 10 Accretion and dividends of Series D preferred stock — — Performance Adjustment of Series A — — Loss attributable to common shareholders — basic and diluted $ $ $ Weighted-average number of common shares used in net loss per share—basic and diluted Net loss per share—basic and diluted $ $ $ The following potentially dilutive securities outstanding have been excluded from the computations of diluted weighted ‑average shares outstanding because such securities have an antidilutive impact due to losses reported (in common stock equivalent shares): Years Ended December 31, 2015 2014 2013 Outstanding stock options Warrants Redeemable convertible preferred stock — Unvested restricted stock |
PREPAID EXPENSES AND OTHER CURR
PREPAID EXPENSES AND OTHER CURRENT ASSETS | 12 Months Ended |
Dec. 31, 2015 | |
PREPAID EXPENSES AND OTHER CURRENT ASSETS. | |
PREPAID EXPENSES AND OTHER CURRENT ASSETS | 4. PREPAID EXPENSES AND OTHER CURRENT ASSETS Prepaid expenses and other current assets consisted of the following: As of December 31, 2015 2014 Prepaid Insurance $ $ — Deferred financing costs Other prepaid expenses Other current assets Employee advances — Prepaid expenses and other current assets $ $ |
PROPERTY AND EQUIPMENT
PROPERTY AND EQUIPMENT | 12 Months Ended |
Dec. 31, 2015 | |
PROPERTY AND EQUIPMENT | |
PROPERTY AND EQUIPMENT | 5. PROPERTY AND EQUIPMENT Property and equipment consisted of the following: As of December 31, 2015 2014 Machinery and equipment $ $ Leasehold improvements Computers and office equipment Furniture and fixtures Total property and equipment Less: accumulated deprecation Property and equipment, net $ $ Depreciation expense related to property and equipment amounted to $171 and $ 187 for the years ended December 31, 2015 and 2014, respectively. |
ACCRUED EXPENSES
ACCRUED EXPENSES | 12 Months Ended |
Dec. 31, 2015 | |
ACCRUED EXPENSES | |
ACCRUED EXPENSES | 6. ACCRUED EXPENSES Accrued expenses consisted of the following: As of December 31, 2015 2014 Accrued compensation $ $ Accrued audit and legal Accrued other Accrued marketing — Accrued development costs Accrued interest Total accrued expenses $ $ |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Dec. 31, 2015 | |
COMMITMENTS AND CONTINGENCIES. | |
COMMITMENTS AND CONTINGENCIES | 7. COMMITMENTS AND CONTINGENCIES Legal Proceedings From time to time the Company may face legal claims or actions in the normal course of business. Except as disclosed below, t he Company is not currently a party to any litigation and, accordingly, does not have any amounts recorded for any litigation related matters. The Company’s NDA filing for Xtampza is a 505(b)(2) application, which allows the Company to reference data from an approved drug listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the “Orange Book”), in this case OxyContin OP. In connection with the 505(b)(2) process, the Company certified to the FDA and notified Purdue Pharma, L.P. (“Purdue”), as the holder of the NDA and any other Orange Book ‑listed patent owners, that the Company does not infringe any of the patents listed for OxyContin OP in the Orange Book. Under the Hatch ‑Waxman Act of 1984, Purdue had the option to sue the Company for infringement and receive a stay of up to 30 months before the FDA can issue a final regulatory approval for Xtampza, unless the stay is earlier terminated. Purdue exercised its option and elected to sue the Company for infringement in the District of Delaware in March 2015 asserting infringement of three of Purdue’s Orange Book ‑listed patents and one non-Orange Book-listed patent. Purdue filed another case in Massachusetts asserting the same four patents as in the Delaware case. In October 2015, the Delaware case was transferred to Massachusetts. In November 2015, Purdue filed suit asserting infringement of another non-Orange Book-listed patent. On November 9, 2015, the Company filed a motion for partial judgment on the pleadings in relation to three Orange Book-listed patents asserted against the Company, which had been previously invalidated by the court in the Southern District of New York in Purdue’s suit against another company. On February 1, 2016, the Court of Appeals for the Federal Circuit affirmed the New York judgment of invalidity. On February 9, 2016, the District Court of Massachusetts ordered judgment in favor of the Company on the three Orange Book-listed patents that were the basis of the 30-month stay, Patent Nos. 7,674,799, 7,674,800, and 7,683,072 and dismissed the claims asserting infringement of those patents with prejudice. Purdue continues to assert infringement of two patents against the company, neither of which is associated with any stay of FDA approval. The Company has moved for judgment of invalidity of one of those patents based on collateral estoppel and that motion remains pending. At this time the Company is unable to provide meaningful quantification of how this potential litigation may impact its future financial condition, results of operations, or cash flows. Operating Leases The Company leases its office and research facility under a non ‑cancellable operating lease. Terms of the agreement provide for an initial two ‑month rent ‑free period and future rent escalation, and provide that in addition to minimum lease rental payments, the Company is responsible for a pro ‑rata share of operating expenses and taxes. In March 2015, the Company amended its lease to include an additional 9,660 square feet of space for a total of 19,335 square feet. In addition, the lease term was extended and now terminates on August 30, 2020. At the Company’s election, the lease term may be extended for an additional 5 -year term. Aggregate minimum annual lease commitments of the Company under its non ‑cancellable operating lease as of December 31, 2015 are as follows: 2016 $ 2017 2018 2019 2020 Total minimum lease payments $ Rent expense under the operating lease agreement amounted to approximately $112 and $69 for the years ended December 31, 2015 and 2014, respectively. In addition, the Company maintained a stand ‑by letter of credit in connection with the Canton facility lease of $97 and $80 at December 31, 2015 and December 31, 2014, respectively. This amount is classified as restricted cash in the balance sheets. As an inducement to enter into its Canton facility lease, the lessor agreed to provide the Company with an improvement allowance of up to $174 towards leasehold improvements. In addition the lessor provided the Company with a reimbursable allowance of $164 which is to be amortized and repaid by the Company at an 8% interest rate over the initial term of 36 months. Amounts provided by the lessor related to tenant improvements are considered inducements to enter into the lease. The Company has recorded these costs in the balance sheet as leasehold improvements, with the corresponding liabilities as deferred lease incentive and lease note payable. These liabilities are amortized on a straight ‑line basis over the term of the lease. |
DEBT
DEBT | 12 Months Ended |
Dec. 31, 2015 | |
DEBT | |
DEBT | 8. DEBT On August 28, 2012, the Company entered into a loan agreement (“Original Term Loan”) with Silicon Valley Bank (“SVB”) to borrow up to a maximum amount of $1,000 . In August 2012, October 2012 and February 2013, the Company borrowed $250 , $250 and $500 , respectively. The Original Term Loan bore interest at a rate per annum of 2.25% above the prime rate fixed at the time of advance of the Original Term Loan ( 5.50% ) . The Original Term Loan provided for interest ‑only payments for the first 12 months based on the date of each borrowing, and, thereafter, 36 monthly payments of principal and interest. In connection with the Original Term Loan, the Company granted SVB a warrant to purchase 23,810 shares of common stock at an exercise price of $0.07 per share (See Note 9). In January 2014, the Original Term Loan was amended (“Amendment No. 1”) to provide for the following; borrowings of up to $6,000 , repayment in full of the Original Term Loan balance outstanding, and an adjustment of the variable interest rate from 2.25% above the prime rate to 1.75% above the prime rate. In February 2014, the Company borrowed $2,000 . The proceeds from the initial borrowing were used to pay down the Original Term Loan balance outstanding resulting in the Company receiving $1,056 . Borrowings under Amendment No. 1 bore interest at a rate of 5.0% . Amendment No. 1 provided for interest ‑only payments for the first 12 months based on the date of each borrowing, and thereafter, 36 monthly payments of principal and interest. In connection with Amendment No. 1, the Company granted to SVB a warrant to purchase 14,430 shares of common stock with an exercise price of $0.05 per share (See Note 9). In August 2014 the Original Term Loan was further amended (“Amendment No. 2”) to provide for total borrowings of up to $8,000 . In August 2014 and September 2014 the Company drew down $3,000 and $3,000 , respectively. Pursuant to Amendment No. 2, interest ‑only payments are to be made for the first 12 months based on the date of each borrowing; thereafter, 36 monthly payments of principal and interest are to be made. Borrowings under Amendment 2 bear interest at the rate of 5.0% . The warrant agreement contains a performance clause that the Company met, resulting in additional financing extended and issuance of a warrant to purchase 86,580 additional shares of common stock with an exercise price of $0.05 per share (See Note 9). In September 2014, the Original Term Loan was further amended (“Amendment No. 3”) to extend the loan draw period. In November and December of 2014 the Company entered into a Note Purchase Agreement (the “Bridge Notes”) allowing for the issuance of $5,000 of convertible promissory notes to a group of investors (the “Holders”) bearing interest at a rate per annum of 6.0% . The Holders are related parties of the Company. In March 2015, in connection with the Series D convertible preferred stock financing, the Bridge Notes converted into 4,166,667 shares of Series D convertible preferred stock. Upon the conversion, the Company recognized a gain on extinguishment of $91 . The accrued interest on the Bridge Notes was waived. As of December 31, 2015, future payments under the Company’s term loan are as follows: 2016 $ 2017 2018 Balance $ |
WARRANTS
WARRANTS | 12 Months Ended |
Dec. 31, 2015 | |
WARRANTS. | |
WARRANTS | 9. WARRANTS In November 2010, the Company issued a warrant to Comerica Bank. The warrant represents the right to purchase 2,445 shares of common stock with an exercise price of $12.27 . The warrant expires in October 2017. In connection with the Term Loan Financings with Silicon Valley Bank, the Company issued warrants to purchase a total of 16,357 shares of common stock. In June 2015, SVB exercised all of its warrants. |
EQUITY
EQUITY | 12 Months Ended |
Dec. 31, 2015 | |
EQUITY | |
EQUITY | 10. EQUITY As of December 31, 2013 the authorized capital stock of the Company included 72,000,000 shares of common stock, par value $0.001 per share, 962,960 of which were issued and outstanding. As of December 31, 2013, 54,481,000 shares of preferred stock were authorized, designated as Series A , Series B and Series C preferred Stock of which 9,232,334 , 27,324,237 and 8,658,008 were issued and outstanding, respectively. As of December 31, 2014, the authorized capital stock of the Company included 72,000,000 shares of common stock, par value $0.001 per share, 1,006,219 of which were issued and outstanding . As of December 31, 2014, 54,481,000 shares of preferred stock were authorized, designated as Series A , Series B and Series C Preferred Stock of which 9,232,334 , 27,324,237 and 8,658,008 were issued and outstanding, respectively. In March 2015, the Company issued and sold an aggregate of 41,666,667 shares of Series D convertible preferred stock for aggregate consideration of $50,000 , comprised of $45,000 in cash and conversion of $5,000 in Bridge Notes. As of December 31, 2015, the authorized capital stock of the Company included 100,000,000 shares of common stock, par value $0.001 per share, 20,739,351 of which were issued and outstanding . As of December 31, 2015, 5,000,000 shares of preferred stock were authorized, and none were issued and outstanding . Common Stock In May 2015, the Company closed an initial public offering (“IPO) of its common stock, which resulted in the sale of 6,670,000 shares of its common stock at a public offering price of $12.00 per share, including 870,000 shares of common stock upon the exercise by the underwriters of their option to purchase additional shares at the public offering price. The Company received proceeds from the IPO of approximately $72,029 after deducting underwriting discounts, commissions and expenses payable by the Company. In April 2015, in connection with preparing for the IPO, the Company’s board of directors and shareholders approved a one ‑for ‑6.9 reverse split of the Company’s common stock. All common stock share and per share amounts in the financial statements have been retroactively adjusted for all periods presented to give effect to the reverse split of our common stock, including reclassifying an amount equal to the reduction in par value to additional paid ‑in capital In c onnection with the closing of the IPO, all of the Company’s outstanding convertible preferred stock and accrued dividends automatically converted to common stock in May 2015, resulting in an additional 12,591,463 shares of common stock of the Company becoming outstanding. The significant increase in common stock outstanding in May 2015 is expected to impact the year-over-year comparability of the Company’s net loss per share calculations in future periods. As of December 31, 2015 and 2014, the Company had reserved the following shares of common stock for the issuance of common stock for the exercise of stock options and warrant s, the issuance of shares under the employee stock purchase plan and conversion of preferred stock (in thousands): As of December 31, 2015 2014 Options to purchase common stock Employee stock purchase plan — Warrants Conversion of Series A Preferred — Conversion of Series B Preferred — Conversion of Series C Preferred — Total Convertible Redeemable Preferred Stock Series A, B and Series C Redeemable Convertible Preferred Stock In February 2012, the Company exchanged all previously outstanding preferred stock into 18,464,674 shares of Series A Preferred Stock (“Series A”), par value $0.001 . On the same date, the Company issued 27,324,237 shares of Series B Preferred Stock (“Series B”), par value $0.001 for $0.84 per share, which resulted in gross proceeds of $20,050 . Closing costs associated with the issuance of the Series B amounted to $147 . These costs were recorded as a reduction of the carrying amount of the Series B and were accreted to the carrying value of the applicable preferred stock. During 2013, the Company issued 8,658,008 shares of Series C Preferred Stock (“Series C”) in exchange for $12,000 in a series of tranches. Costs incurred in connection with the issuance of Series C amounted to $45 and have been recorded as a reduction to the carrying amount of Series C and were accreted to the carrying value of the applicable preferred stock. In accordance with the terms of the Series C Preferred Stock Purchase Agreement, the Company authorized the sale and issuance of up to 8,658,008 shares of Series C for total gross proceeds of $12,000 . Closing costs associated with the issuance of Series C amounted to $45 . The Series C financing was structured to close in two tranches. The Company determined the right of the investors to purchase shares of Series C in a future tranche met the definition of a freestanding financial instrument and was recognized as a liability at fair value. The Company adjusted the carrying value of the tranche obligations to its estimated fair value at each reporting date and upon closing of the second tranche in December 2013. Increases or decreases in the fair value of the tranche obligations were recorded as other expense, net, in the statements of operations. The first tranche closed in August and September 2013 and resulted in the issuance of 2,886,004 shares of Series C for gross cash proceeds of $4,000 . Upon the first tranche closing, the Company recognized a liability of $266 for the fair value of the future tranche obligations. The fair value of the freestanding instrument tranche obligations was determined using Black ‑Scholes option ‑pricing models on the date of the issuance using the following assumptions: fair value of Series C of $1.30 , expected life of 0.35 to 0.43 years and expected volatility of 53% to 60% . The liability related to the tranche obligations was remeasured at fair value up to the date of the closing of the second tranche in December 2013. Upon the closing of the second tranche, the Company derecognized the tranche obligation, which resulted in a net increase in the proceeds allocated to the Series C shares of $345 . The fair value of the freestanding instrument tranche obligations was determined using Black ‑Scholes option ‑pricing models on the date of the issuance using the following assumptions: fair value of Series C of $1.27 , expected life of 0.16 years and expected volatility of 52% . The valuation of the tranche obligation liability was determined to be a Level 3 valuation based upon the use of unobservable inputs. A roll ‑ forward of the recurring fair value measurements of the tranche liability categorized with Level 3 inputs are as follows: Balance — December 31, 2013 $ — Tranche liability upon issuance Change in fair value Tranche liability upon close of tranche Balance — December 31, 2014 $ — The closing of the second tranche of Series C in December 2013 triggered a p erformance a djustment of the outstanding shares of Series A and common stock to which the Series A and common stock were subject to modification in which every two shares of issued and outstanding Series A and common shares became one share of each class respectively. In connection with the p erformance a djustment, the Company adjusted the carrying value of the outstanding shares of Series A to its redemption amount by recording a decrease of $12,239 . In March 2015, the Company sold 41,666,667 shares of Series D convertible preferred stock for aggregate consideration of $50,000, comprised of $45,000 in cash and conversion of $5,000 in convertible notes with related parties. The convertible notes converted into 4,166,667 shares of Series D convertible preferred stock. The accrued interest on the convertible notes was waived. In this financing, the mandatory conversion for all series of preferred stock was modified so as to occur upon an initial public offering with gross proceeds in excess of $50,000 . |
STOCK BASED COMPENSATION
STOCK BASED COMPENSATION | 12 Months Ended |
Dec. 31, 2015 | |
STOCK BASED COMPENSATION | |
STOCK BASED COMPENSATION | 11. STOCK ‑BASED COMPENSATION Restricted Stock Awards and Stock Options In May 2015, the Company adopted the Amended and Restated 2014 Stock Incentive Plan (the “Plan”), under which an aggregate of 2,700,000 shares of common stock are authorized for issuance to employees, officers, directors, consultants and advisors of the Company, plus an annual increase to be added on the first day of each fiscal year until the expiration of the Plan equal to 4% of the total number of outstanding shares of common stock on December 31 st of the immediately preceding calendar year (or a lower amount as otherwise determined by the board of directors prior to January 1 st ). As of December 31, 2015, 1,452,149 of the shares of common stock authorized for issuance pursuant to the Plan were outstanding. In connection with the Company’s reincorporation into Virginia in July 2014, each outstanding option to purchase shares of common stock under the 2012 Stock Incentive Plan and 2002 Stock Plan, was automatically terminated and replaced with an option to purchase shares of common stock under the Plan having the same vesting terms and exercise price as the option that was replaced. The Plan provides for granting of both Internal Revenue Service qualified incentive stock options (“ISOs”) and non ‑qualified options (“NQs”), restricted stock awards (“RSAs”) and restricted stock units (“RSUs”). Stock options generally vest over a four year period of service; however, certain options contain performance conditions. The options generally have a ten year contractual life and, upon termination, vested options are generally exercisable between one and three months following the termination date, while unvested options are forfeited immediately. Stock option activity under the Plan is summarized as follows: Weighted- Weighted- average average remaining Aggregate exercise price contractual Intrinsic Shares per share term (years) Value Outstanding at December 31, 2014 $ $ Granted Exercised Cancelled Outstanding at December 31, 2015 $ $ Exercisable at December 31, 2015 $ $ Vested and expected to vest at December 31, 2015 $ $ As of December 31, 2015, the unrecognized compensation cost related to outstanding options wa s $9,212 , and is expected to be recognized as expense over approximately 3.4 years. As of December 31, 2015, the weighted average fair value of vested options was $ 2.96. The weighted-average grant date fair value of options granted during the year ended December 31, 2015 was $7.85. The fair value of options that vested during the year ended December 31, 2015 was $3.43. Restricted stock awards under the Plan are summarized as follows: Weighted average purchase price Shares per share Unvested at December 31, 2014 Granted Vested Unvested at December 31, 2015 $ The total fair value of restricted stock vested d u ring the years ended December 31, 2015, was $692 . As of December 31, 2015, the unrecognized compensation cost related to restricted stock awards was $434 , and is expected to be recognized as expense over approximately 2.3 years . Stock ‑Based Compensation Expense The Company granted stock options to employees for the years ended December 31, 2015 , 2014 and 201 3 . The Company estimates the fair value of stock options as of the date of grant using the Black ‑Scholes option pricing model and restricted stock based on the fair value of the award. Stock options and restricted stock issued to non ‑board member, non ‑employees are accounted for using the fair value approach and are subject to periodic revaluation over their vesting terms. Stock ‑based compensation for all stock options and restricted stock awards are reported within: Years Ended December 31, 2015 2014 2013 Research and development $ $ $ General and administrative Total stock-based compensation expense $ $ $ The weighted ‑average assumptions used in the Black ‑Scholes option pricing model to determine the fair value of the employee stock option grants were as follows: Years Ended December 31, 2015 2014 2013 Risk-free interest rate 1.70 % % 1.09 - 1.22 % Volatility 77.0 % % 87.8 % Expected term (years) 6.20 6.25 Expected dividend yield — % — % — % Risk ‑free Interest Rate. The risk ‑free interest rate assumption is based on observed interest rates appropriate for the expected term of the stock option grants. Expected Volatility. Due to the Company’s limited operating history and lack of company ‑specific historical or implied volatility, the expected volatility assumption is based on historical volatilities of a peer group of similar companies whose share prices are publicly available. The peer group was developed based on com panies in the biotechnology and pharmaceutical industries. In evaluating similarity, we consider factors such as industry, stage of life cycle and size. Expected Term. The expected term represents the period of time that options are expected to be outstanding. Because the Company does not have historical exercise behavior, through December 31, 2015 it determined the expected life assumption using the simplified method, which is an average of the contractual term of the option and its vesting period. Expected Dividend Yield. The expected dividend yield assumption is based on the fact that the Company has never paid cash dividends and has no present intention to pay cash dividends. |
INCOME TAXES
INCOME TAXES | 12 Months Ended |
Dec. 31, 2015 | |
INCOME TAXES. | |
INCOME TAXES | 12. INCOME TAXES For the years ended December 31, 2015, 2014 and 2013, the Company did not record a current or deferred income tax expense or (benefit) due to current and historical losses incurred by the Company. The Company’s losses before income taxes consist solely of domestic losses. A reconciliation of income tax expense (benefit) computed at the statutory federal income tax rate to income taxes as reflected in the financial statements is as follows: As of December 31, 2015 2014 2013 Federal income tax (benefit) at statutory rate % % % (Increase) decrease income tax (benefit) resulting from: State income tax, net of federal benefit — — Expiration of state net operating losses — — Permanent items Research and development credits Change in valuation allowance Income tax expense (benefit) % % % Deferred taxes are recognized for temporary differences between the basis of assets and liabilities for financial statement and income tax purposes. The significant components of the Company’s deferred tax assets and liabilities are comprised of the following: As of December 31, 2015 2014 Deferred tax assets: Net operating loss carryforwards $ $ Research and development credits Accruals and other — Depreciation and amortization Deferred tax assets before valuation allowance Valuation allowance Net deferred tax assets $ — $ — The Company has evaluated the positive and negative evidence bearing upon the realizability of its deferred tax assets. As of December 31, 2015 and 2014, based on the Company’s history of operating losses, the Company has concluded that it is not more likely than not that the benefit of its deferred tax assets will be realized. Accordingly, the Company has provided a full valuation allowance for deferred tax assets as of December 31, 2015 and 2014. The valuation allowance increased $10,539 and $7,737 during the years ended December 31, 2015 and 2014 respectively, due primarily to net operating losses generated. As of December 31, 2015, 2014 and 2013, the Company had U.S. federal net operating loss carryforwards of $104,888 , $78,276 and $60,380 , respectively, which may be available to offset future income tax liabilities and expire at various dates through 2035. As of December 31, 2015, 201 4 and 2013, the Company also had U.S. state net operating loss carryforwards of $59,875 , $34,184 and $16,354 , respectively, which may be available to offset future income tax liabilities and expire at various dates through 2035. Included in the federal and state net operating loss carryforwards are approximately $1,064 , $0 , and $0 respectively, of deductions related to the exercise of stock options which represent an excess tax benefit which will be realized when it results in the reduction of cash income tax in accordance with ASC 718. As of December 31, 2015, 2014 and 2013, the Company had federal research and development tax credit carryforwards of approximately $3,110 , $2,868, and $2,311 , respectively, available to reduce future tax liabilities which expire at various dates through 2035. As of December 31, 2015, 2014 and 2013, the Company had state research and development tax credit carryforwards of approximately $469 , $226 , and $121 , respectively, available to reduce future tax liabilities which expire at various dates through 2030. Under the provisions of the Internal Revenue Code, the net operating loss and tax credit carryforwards are subject to review and possible adjustment by the Internal Revenue Service and state tax authorities. Net operating loss and tax credit carryforwards may become subject to an annual limitation in the event of certain cumulative changes in the ownership interest of significant shareholders over a three-year period in excess of 50 percent, as defined under Sections 382 and 383 of the Internal Revenue Code, respectively, as well as similar state provisions. This could limit the amount of tax attributes that can be utilized annually to offset future taxable income or tax liabilities. The amount of the annual limitation is determined based on the value of the Company immediately prior to the ownership change. Subsequent ownership changes may further affect the limitation in future years. The Company has completed several financings since its inception which may have resulted in a change in control as defined by Sections 382 and 383 of the Internal Revenue Code, or could result in a change in control in the future. The Company will recognize interest and penalties related to uncertain tax positions in income tax expense. As of December 31, 2015 and 2014, the Company had no accrued interest or penalties related to uncertain tax positions and no amounts have been recognized in the Company’s statements of operations and comprehensive loss. For all years through December 31, 2015, the Company generated research and development credits but has not conducted a study to document the qualified activities. This study may result in an adjustment to the Company’s research and development credit carryforwards; however, until a study is completed and any adjustment is known, no amounts are being presented as an uncertain tax position for these two years. A full valuation allowance has been provided against the Company’s research and development credits and, if an adjustment is required, this adjustment would be offset by an adjustment to the deferred tax asset established for the research and development credit carryforwards and the valuation allowance. The Company files income tax returns in the United States and Massachusetts. The federal and Massachusetts income tax returns are generally subject to tax examinations for the tax years ended December 31, 2012 through December 31, 2015. To the extent the Company has tax attribute carryforwards, the tax years in which the attribute was generated may still be adjusted upon examination by the Internal Revenue Service and state tax authorities to the extent utilized in a future period. |
EMPLOYEE BENEFITS
EMPLOYEE BENEFITS | 12 Months Ended |
Dec. 31, 2015 | |
EMPLOYEE BENEFITS | |
EMPLOYEE BENEFITS | 13. EMPLOYEE BENEFITS The Company has a retirement savings plan, which is qualified under section 401(k) of the Code, for its employees. The plan allows eligible employees to defer, at the employee’s discretion, pretax compensation up to the Internal Revenue Service annual limits. Employees become eligible to participate after completing 3 months of service. The Company is not required to contribute to this plan. Total expense for contributions made by the Company was $35 for the year ended December 31, 2014 and $44 for the year ended December 31, 2015. |
UNAUDITED QUARTERLY OPERATING R
UNAUDITED QUARTERLY OPERATING RESULTS | 12 Months Ended |
Dec. 31, 2015 | |
UNAUDITED QUARTERLY OPERATING RESULTS | |
UNAUDITED QUARTERLY OPERATING RESULTS | 14. UNAUDITED QUARTERLY OPERATING RESULTS The following is a summary of unaudited quarterly results of operations for the years ended December 31, 2015 and 2014: First Second Third Fourth Year ended December 31, 2015 Quarter Quarter Quarter Quarter Operating expenses: Research and development $ $ $ $ General and administrative Total operating expenses Loss from operations $ $ $ Other expense, net Net Loss $ $ $ $ Shares used in computing net loss per share-basic Shares used in computing net loss per share-diluted Net loss per share-basic $ $ $ $ Net loss per share-diluted $ $ $ $ First Second Third Fourth Year ended December 31, 2014 Quarter Quarter Quarter Quarter Operating expenses: Research and development $ $ $ $ General and administrative Total operating expenses Loss from operations Other expense, net Net Loss $ $ $ $ Shares used in computing net loss per share-basic and diluted Net loss per share-basic and diluted $ $ $ $ |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 12 Months Ended |
Dec. 31, 2015 | |
SUBSEQUENT EVENTS. | |
SUBSEQUENT EVENTS | 15. SUBSEQUENT EVENTS The Company has completed an evaluation of all subsequent events through March 1 8 , 2016, the date these financial statements are available to be issued. The Company has concluded that only one subsequent event that has occurred requires disclosure. In January 2016, the Company issued and sold in a public offering an aggregate of 2,750,000 shares of its common stock at $20.00 per share. This public offering resulted in approximately $51,700 of net proceeds, after deduction underwriting discounts and commissions but before deducting other offering expenses payable by the Company . At December 31, 2015 , the Company capitalized $353 of costs related to expenses incurred in this public offering. These costs were reclassified to additional paid-in capital when the offering closed in January, 2016. |
SUMMARY OF SIGNIFICANT ACCOUN25
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies). | 12 Months Ended |
Dec. 31, 2015 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Use of Estimates | Use of Estimates The preparation of the Company’s financial statements requires it to make estimates and assumptions that impact the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in the Company’s financial statements and accompanying notes. The most significant estimates in the Company’s financial statements relate to the valuation of equity awards, fair value estimates of warrants, estimated useful lives of fixed assets and accruals related to clinical trials. The Company bases estimates and assumptions on historical experience when available and on various factors that it believes to be reasonable under the circumstances. The Company evaluates its estimates and assumptions on an ongoing basis. The Company’s actual results may differ from these estimates under different assumptions or conditions. |
Fair Value Measurements | Fair Value Measurements Disclosures of fair value information about financial instruments are required, whether or not recognized in the balance sheet, for financial instruments with respect to which it is practicable to estimate that value. The carrying amounts reported in the Company’s financial statements for cash and cash equivalents, accounts payable , loan payable and accrued liabilities approximate their respective fair values because of the short ‑term nature of these accounts. Fair value measurements and disclosures describes the fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value, as follows: Level 1 Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities. The Company’s Level 1 assets and liabilities consist of money market investments. Level 2 Quoted prices for similar assets, or inputs that are observable, either directly or indirectly, for substantially the full term through corroboration with observable market data. Level 2 includes investments valued at quoted prices adjusted for legal or contractual restrictions specific to the security. The Company does not have Level 2 assets or liabilities. Level 3 Pricing inputs are unobservable for the assets or liabilities, that is, inputs that reflect the reporting entity’s own assumptions about the assumptions market participants would use in pricing the assets. Level 3 includes private investments that are supported by little or no market activity. The Company does not have Level 3 assets or liabilities. Transfers are calculated on values as of the transfer date. There were no transfers between Levels 1 , 2 and 3 during the years ended December 31, 2015 and 2014. The following tables present the Company’s financial instruments carried at fair value using the lowest level input applicable to each financial instrument at December 31, 2015 and 2014. Significant Quoted Prices other Significant in active observable unobservable markets inputs inputs Description Total (Level 1) (Level 2) (Level 3) December 31, 2015 Money market funds, included in cash equivalents $ $ $ — $ — December 31, 2014 Money market funds, included in cash equivalents $ $ $ — $ — |
Concentration of Credit Risk | Concentration of Credit Risk Financial instruments, which potentially subject the Company to significant concentration of credit risk, consist primarily of cash and cash equivalents. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits. The Company has not experienced any losses in such accounts and management believes that the Company is not exposed to significant credit risk due to the financial position of the financial institutions in which those deposits are held. The Company has no financial instruments with off ‑balance sheet risk of loss. |
Cash and Cash Equivalents | Cash and Cash Equivalents Cash and cash equivalents include cash in readily available checking and savings accounts and money market funds. The Company considers all highly liquid investments with an original maturity of three months or less from the date of purchase to be cash equivalents. The Company’s cash equivalents, which consist of money market funds, are measured at fair value on a recurring basis. As of December 31, 2015 and 2014, the carrying amount of cash and cash equivalents was $95,697 a nd $1,634 , respectively, which approximates fair value and was determined based upon Level 1 inputs. Money market funds are valued using quoted market prices with no valuation adjustments applied. Accordingly, these securities are categorized as Level 1. |
Property and Equipment | Property and Equipment Property and equipment are recorded at historical cost. Maintenance and repair costs are expensed as incurred. Costs which materially improve or extend the lives of existing assets are capitalized. The Company provides for depreciation and amortization using the straight ‑line method over the estimated useful lives of the assets, which are as follows: Asset Category Estimated Useful Life Machinery and equipment years Computers and office equipment years Furniture and fixtures years Leasehold improvements the shorter of the lease term or years Upon retirement or sale, the cost of assets disposed and the related accumulated depreciation are removed from the accounts and any resulting gain or loss is recorded in the statements of operations. |
Impairment of Long Lived Assets | Impairment of Long ‑Lived Assets Long ‑lived assets consist of property and equipment. When impairment indicators exist, the Company’s management evaluates long ‑lived assets for potential impairment. An impairment loss is recorded if and when events and circumstances indicate that assets might be impaired and the undiscounted cash flows estimated to be generated by those assets are less than the carrying amount of those assets. While the Company’s current and historical operating losses and negative cash flows are indicators of impairment, management believes that future cash flows to be received support the carrying value of its long ‑lived assets and, accordingly, has not recognized any impairment losses since inception. Impairment losses, if any, are recognized in earnings. An impairment loss would be recognized in an amount equal to the excess of the carrying amount over the estimated fair value. |
Deferred Financing Costs | Deferred Financing Costs The Company defers direct incremental costs attributable to public offerings of its common stock. These costs represent legal, accounting and other direct costs related to the Company’s efforts to raise capital through a public sale of its common stock. Costs will be deferred until the completion of the public offering, at which time they will be reclassified to additional paid ‑in capital as a reduction of the public offering proceeds. If the Company terminates its plan for a public offering or delays such plan for more than 90 days, any costs deferred will be expensed immediately. Deferred financing costs were $353 and $233 at December 31, 2015 and 2014, respectively. Deferred financing costs are included in prepaid expenses and other assets in the balance sheet. |
Restricted Cash | Restricted Cash Restricted cash represents cash held in a depository account at a financial institution to collateralize a conditional stand ‑by letter of credit related to the Company’s Canton, Massachusetts facility lease agreement. Restricted cash is reported as non ‑current unless the restrictions are expected to be released in the next twelve months. |
Deferred Rent | Deferred Rent Deferred rent consists of the difference between cash payments and the recognition of rent expense on a straight ‑line basis for the facilities the Company occupies. The Company’s lease for its facility provides for fixed increases in minimum annual rental payments and for additional rent in the form of maintenance and operating costs during the lease term. The total amount of rental payments due over the lease term is being charged to rent expense ratably over the life of the lease. |
Research and Development Costs | Research and Development Costs Research and development costs are charged to expense as incurred and consist of costs incurred to further the Company’s research and development activities including salaries and employee related costs, costs associated with market research and design, costs associated with conducting preclinical, clinical and regulatory activities including fees paid to third ‑party professional consultants and service providers, costs incurred under clinical trial agreements, costs for laboratory supplies and laboratory equipment, costs to acquire, develop and manufacture preclinical study and clinical trial materials, facilities, depreciation and other expenses including allocated expenses for rent and maintenance of facilities. Government grants are recognized as a reduction of the qualifying cost being reimbursed. |
Patent Costs | Patent Costs Costs related to filing and pursuing patent applications are recorded as general and administrative expense as incurred since the recoverability of such expenditures is uncertain. |
Stock-Based Compensation | Stock ‑Based Compensation The Company accounts for grants of stock options and restricted stock to employees, including members of the board of directors, based on their grant date fair value and recognizes compensation expense over their vesting period. The Company estimates the fair value of stock options as of the date of grant using the Black ‑Scholes option pricing model and restricted stock based on the fair value of the underlying common stock as determined by management or the value of the services provided, whichever is more readily determinable. Stock ‑based compensation expense represents the cost of the grant date fair value of employee stock option grants recognized over the requisite service period of the awards (usually the vesting period) on a straight ‑line basis, net of estimated forfeitures. The expense is adjusted for actual forfeitures at year end. Stock ‑based compensation expense recognized in the financial statements is based on awards that are ultimately expected to vest. For stock option grants with performance ‑based milestones, the expense is recorded over the remaining service period after the point when the achievement of the milestone is probable or the performance condition has been achieved. For stock option grants with both performance ‑based milestones and market conditions, expense is recorded over the derived service period after the point when the achievement of the performance ‑based milestone is probable or the performance condition has been achieved. The Company accounts for stock options and restricted stock awards to non ‑employees using the fair value approach. Stock options and restricted stock awards to non ‑employees are subject to periodic revaluation over their vesting terms. There were no non ‑employee grants in 2014. There was one non-employee grant in 2015. |
Income Taxes | Income Taxes The Company accounts for income taxes under the liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements. Under this method, deferred tax assets and liabilities are determined on the basis of the differences between the financial statements and tax basis of assets and liabilities using enacted tax rates in effect for the years in which the differences are expected to reverse. The effect of a change in tax rates on deferred tax assets and liabilities is recognized in income in the period that includes the enactment date. The Company recognizes net deferred tax assets to the extent that the Company believes these assets are more likely than not to be realized. In making such a determination, management considers all available positive and negative evidence, including future reversals of existing taxable temporary differences, projected future taxable income, tax ‑planning strategies and results of recent operations. If management determines that the Company would be able to realize its deferred tax assets in the future, in excess of its net recorded amount, management would make an adjustment to the deferred tax asset valuation allowance, which would reduce the provision for income taxes. The Company records uncertain tax positions on the basis of a two ‑step process whereby (i) management determines whether it is more likely than not that the tax positions will be sustained on the basis of the technical merits of the position and (ii) for those tax positions that meet the more likely than not recognition threshold, management recognizes the largest amount of tax benefit that is more than 50 percent likely to be realized upon ultimate settlement with the related tax authority. The Company will recognize interest and penalties related to uncertain tax positions within income tax expense. Any accrued interest and penalties will be included within the related tax liability. As of December 31, 2015 and 2014, the Company had no accrued interest or penalties related to uncertain tax positions and no amounts have been recognized in the Company’s statements of operations. |
Net loss per Common Share | Net loss per Common Share Basic net loss per common share is calculated by dividing the net loss attributable to common shareholders by the weighted ‑average number of shares of common stock outstanding during the period, without consideration for potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss attributable to common shareholders by the weighted ‑average number of shares of common stock and potentially dilutive securities outstanding for the period. For purposes of the diluted net loss per share calculation, stock options, warrants, redeemable convertible preferred stock and unvested restricted stock are considered potentially dilutive securities. Because the Company has reported a net loss for the twelve months ended December 31, 2015, 2014 and 2013 , diluted net loss per common share is the same as basic net loss per common share for those periods. Diluted earnings per share is computed using the more dilutive of (i) the two ‑class method, or (ii) the if ‑converted method. The Company allocates earnings first to preferred shareholders based on dividend rights and then to common and preferred shareholders based on ownership interests. The weighted ‑average number of common shares included in the computation of diluted earnings (loss) gives effect to all potentially dilutive common equivalent shares, including outstanding stock options, warrants, convertible redeemable preferred stock and the potential issuance of stock upon the conversion of the Company’s convertible notes. Common stock equivalent shares are excluded from the computation of diluted earnings (loss) per share if their effect is antidilutive. |
Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements In February 2016, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2016-02, Leases (Topic 842). The ASU requires lessees to put most leases on their balance sheets as a liability for the obligation to make lease payments and as a right-of-use asset, but recognize expenses on the income statements in a manner similar to today’s accounting. The guidance also eliminates the current real estate-specific provisions for all entities. For calendar-year public entities, the guidance becomes effective in 2019 and interim periods within that year. Early adoption is permitted for all entities. The Company has not chosen early adoption for this ASU and is currently evaluating its effect on the Company’s consolidated financial statements In November 2015, the FASB issued ASU 2015-17, Income Taxes: Balance Sheet Classification of Deferred Taxes (Topic 740) . ASU 2015-17 simplifies the presentation of deferred income taxes by eliminating the separate classification of deferred income tax assets and liabilities into current and noncurrent amounts in the consolidated balance sheet statement of financial position. The amendments in the update require that all deferred tax assets and liabilities be classified as noncurrent in the consolidated balance sheet. The amendments in this update are effective for annual periods beginning after December 15, 2017, and interim periods therein and may be applied either prospectively or retrospectively to all periods presented. Early adoption is permitted. The Company is currently evaluating its effect on the Company’s consolidated financial statements. In May 2014, the FASB issued ASU No. 2014 ‑09, Revenue from Contracts with Customers. This ASU is a comprehensive new revenue recognition model that requires a company to recognize revenue to depict the transfer of goods or services to a customer at an amount that reflects the consideration it expects to receive in exchange for those goods or services. This ASU is effective for annual reporting periods beginning after December 15, 2016 and early adoption is not permitted. Accordingly, the Company will adopt this ASU on January 1, 2017. Management does not believe the adoption of this ASU will have a material impact on the Company’s financial condition, results of operations or cash flows. In June 2014, the FASB issued ASU No. 2014 ‑12, Compensation — Stock Compensation (Topic 718): Accounting for Share ‑Based Payments When the Terms of an Award Provide That a Performance Target Could Be Achieved after the Requisite Service Period . ASU 2014 ‑12 applies to all reporting entities that grant their employees share ‑based payments in which the terms of the award provide that a performance target that affects vesting could be achieved after the requisite service period. That is the case when an employee is eligible to retire or otherwise terminate employment before the end of the period in which a performance target (for example, an initial public offering or a profitability target) could be achieved and still be eligible to vest in the award if and when the performance target is achieved. The standard is required to be adopted by public business entities in annual periods beginning on or after December 15, 2015 and interim periods within those annual periods. The Company plans to implement this standard in the first quarter of fiscal year 2016 and is currently evaluating the potential impact of this new guidance on its financial statements. In August 2014, the FASB issued ASU No. 2014 ‑15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern. ASU 2014 ‑15 requires management to evaluate, at each annual or interim reporting period, whether there are conditions or events that exist that raise substantial doubt about an entity’s ability to continue as a going concern within one year after the date the financial statements are issued and provide related disclosures. ASU 2014 ‑15 is effective for annual periods ending after December 15, 2016 and earlier application is permitted. The adoption of ASU 2014 ‑15 is not expected to have a material effect on the Company’s financial statements or disclosures. In November 2014, the FASB issued ASU No. 2014 ‑16, Derivatives and Hedging (Topic 815) — Determining Whether the Host Contract in a Hybrid Financial Instrument Issued in the Form of a Share is More Akin to Debt or to Equity . This ASU was issued to clarify how current U.S. generally accepted accounting principles should be interpreted in evaluating the economic characteristics and risk of a host contract in a hybrid financial instrument that is issued in the form of a share. In addition, this ASU was issued to clarify that in evaluating the nature of a host contract, an entity should assess the substance of the relevant terms and features (that is, the relative strength of the debt ‑like or equity ‑like terms and features given the facts and circumstances) when considering how to weight those terms and features. The effects of initially adopting this ASU should be applied on a modified retrospective basis to existing hybrid financial instruments issued in a form of a share as of the beginning of the fiscal year for which the amendments are effective. Retrospective application is permitted to all relevant prior periods. This ASU is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2015. Early adoption in an interim period is permitted. The Company is currently evaluating the impact of the adoption of this ASU on its financial statements |
SUMMARY OF SIGNIFICANT ACCOUN26
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Schedule of financial instruments measured at fair value by level within fair value hierarchy | Significant Quoted Prices other Significant in active observable unobservable markets inputs inputs Description Total (Level 1) (Level 2) (Level 3) December 31, 2015 Money market funds, included in cash equivalents $ $ $ — $ — December 31, 2014 Money market funds, included in cash equivalents $ $ $ — $ — |
Schedule of estimated useful lives of property and equipment | Asset Category Estimated Useful Life Machinery and equipment years Computers and office equipment years Furniture and fixtures years Leasehold improvements the shorter of the lease term or years |
NET LOSS PER COMMON SHARE (Tabl
NET LOSS PER COMMON SHARE (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
NET LOSS PER COMMON SHARE | |
Schedule of computations of basic and diluted net loss per share | Years Ended December 31, 2015 2014 2013 Net loss $ $ $ Extinguishment of preferred stock - see note 10 — — Accretion and dividends of prior preferred stock - see note 10 Accretion and dividends of Series D preferred stock — — Performance Adjustment of Series A — — Loss attributable to common shareholders — basic and diluted $ $ $ Weighted-average number of common shares used in net loss per share—basic and diluted Net loss per share—basic and diluted $ $ $ |
Schedule of potentially dilutive securities excluded from computations of diluted weighted-average shares outstanding | Years Ended December 31, 2015 2014 2013 Outstanding stock options Warrants Redeemable convertible preferred stock — Unvested restricted stock |
PREPAID EXPENSES AND OTHER CU28
PREPAID EXPENSES AND OTHER CURRENT ASSETS (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
PREPAID EXPENSES AND OTHER CURRENT ASSETS. | |
Schedule of components of prepaid expenses and other current assets | As of December 31, 2015 2014 Prepaid Insurance $ $ — Deferred financing costs Other prepaid expenses Other current assets Employee advances — Prepaid expenses and other current assets $ $ |
PROPERTY AND EQUIPMENT (Tables)
PROPERTY AND EQUIPMENT (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
PROPERTY AND EQUIPMENT | |
Schedule of components of property and equipment | As of December 31, 2015 2014 Machinery and equipment $ $ Leasehold improvements Computers and office equipment Furniture and fixtures Total property and equipment Less: accumulated deprecation Property and equipment, net $ $ |
ACCRUED EXPENSES (Tables)
ACCRUED EXPENSES (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
ACCRUED EXPENSES | |
Schedule of components of accrued expenses | As of December 31, 2015 2014 Accrued compensation $ $ Accrued audit and legal Accrued other Accrued marketing — Accrued development costs Accrued interest Total accrued expenses $ $ |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
COMMITMENTS AND CONTINGENCIES. | |
Schedule of aggregate minimum annual lease commitments under non-cancellable operating lease | 2016 $ 2017 2018 2019 2020 Total minimum lease payments $ |
DEBT (Tables)
DEBT (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
DEBT | |
Schedule of future payments under debt agreements | 2016 $ 2017 2018 Balance $ |
EQUITY (Tables)
EQUITY (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
EQUITY | |
Schedule of shares of common stock reserved for future issuance | As of December 31, 2015 2014 Options to purchase common stock Employee stock purchase plan — Warrants Conversion of Series A Preferred — Conversion of Series B Preferred — Conversion of Series C Preferred — Total |
Schedule of roll-forward of recurring fair value measurements of tranche liability categorized with Level 3 inputs | Balance — December 31, 2013 $ — Tranche liability upon issuance Change in fair value Tranche liability upon close of tranche Balance — December 31, 2014 $ — |
STOCK-BASED COMPENSATION (Table
STOCK-BASED COMPENSATION (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
STOCK BASED COMPENSATION | |
Summary of stock option activity | Weighted- Weighted- average average remaining Aggregate exercise price contractual Intrinsic Shares per share term (years) Value Outstanding at December 31, 2014 $ $ Granted Exercised Cancelled Outstanding at December 31, 2015 $ $ Exercisable at December 31, 2015 $ $ Vested and expected to vest at December 31, 2015 $ $ |
Summary of restricted stock awards | Weighted average purchase price Shares per share Unvested at December 31, 2014 Granted Vested Unvested at December 31, 2015 $ |
Schedule of stock-based compensation for all stock options and restricted stock awards | Years Ended December 31, 2015 2014 2013 Research and development $ $ $ General and administrative Total stock-based compensation expense $ $ $ |
Schedule of weighted-average assumptions used in Black-Scholes option-pricing model | Years Ended December 31, 2015 2014 2013 Risk-free interest rate 1.70 % % 1.09 - 1.22 % Volatility 77.0 % % 87.8 % Expected term (years) 6.20 6.25 Expected dividend yield — % — % — % |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
INCOME TAXES. | |
Schedule of reconciliation of income tax expense (benefit) at statutory federal income tax rate to income taxes | As of December 31, 2015 2014 2013 Federal income tax (benefit) at statutory rate % % % (Increase) decrease income tax (benefit) resulting from: State income tax, net of federal benefit — — Expiration of state net operating losses — — Permanent items Research and development credits Change in valuation allowance Income tax expense (benefit) % % % |
Schedule of significant components of deferred tax assets and liabilities | As of December 31, 2015 2014 Deferred tax assets: Net operating loss carryforwards $ $ Research and development credits Accruals and other — Depreciation and amortization Deferred tax assets before valuation allowance Valuation allowance Net deferred tax assets $ — $ — |
UNAUDITED QUARTERLY OPERATING36
UNAUDITED QUARTERLY OPERATING RESULTS (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
UNAUDITED QUARTERLY OPERATING RESULTS | |
Summary of unaudited quarterly results of operations | First Second Third Fourth Year ended December 31, 2015 Quarter Quarter Quarter Quarter Operating expenses: Research and development $ $ $ $ General and administrative Total operating expenses Loss from operations $ $ $ Other expense, net Net Loss $ $ $ $ Shares used in computing net loss per share-basic Shares used in computing net loss per share-diluted Net loss per share-basic $ $ $ $ Net loss per share-diluted $ $ $ $ First Second Third Fourth Year ended December 31, 2014 Quarter Quarter Quarter Quarter Operating expenses: Research and development $ $ $ $ General and administrative Total operating expenses Loss from operations Other expense, net Net Loss $ $ $ $ Shares used in computing net loss per share-basic and diluted Net loss per share-basic and diluted $ $ $ $ |
NATURE OF BUSINESS (Details)
NATURE OF BUSINESS (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||
May. 31, 2015USD ($)$ / sharesshares | Apr. 30, 2015shares | Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($) | |
Maximum period automatic stay in effect | 30 months | |||
Common stock split ratio | 0.1449 | |||
Accumulated deficit | ||||
Accumulated deficit | $ | $ 129,008 | $ 101,753 | ||
Initial public offering | ||||
Issuance of stock (in shares) | 6,670,000 | |||
Offering price (in dollars per share) | $ / shares | $ 12 | |||
Net proceeds from IPO | $ | $ 72,029 | |||
Common stock split ratio | 0.1449 | |||
Conversion into common stock | 12,591,463 | 12,591,463 | ||
Underwriters over-allotment option | ||||
Issuance of stock (in shares) | 870,000 |
SUMMARY OF SIGNIFICANT ACCOUN38
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | |
May. 31, 2015 | Dec. 31, 2015 | Dec. 31, 2014 | |
Fair value measurements | |||
Asset transfers out of Level 1 into Level 2 | $ 0 | $ 0 | |
Asset transfers out of Level 2 into Level 1 | 0 | 0 | |
Asset transfers into (out of) Level 3 | 0 | $ 0 | |
Financial instruments with off balance sheet risk of loss, assets | 0 | ||
Financial instruments with off balance sheet risk of loss, liabilities | $ 0 | ||
Initial public offering | |||
Common stock sold (in shares) | 6,670,000 | ||
Offering price (in dollars per share) | $ 12 | ||
Underwriters over-allotment option | |||
Common stock sold (in shares) | 870,000 |
SUMMARY OF SIGNIFICANT ACCOUN39
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Fair Value (Details) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Carrying amount | ||
Cash and Cash Equivalents | ||
Cash and cash equivalents | $ 95,697 | $ 1,634 |
Money market funds | Estimate of fair value | ||
Cash and Cash Equivalents | ||
Cash and cash equivalents | 94,912 | 457 |
Money market funds | Estimate of fair value | Quoted Prices in active markets (Level 1) | ||
Cash and Cash Equivalents | ||
Cash and cash equivalents | $ 94,912 | $ 457 |
SUMMARY OF SIGNIFICANT ACCOUN40
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Property, Plant and Equipment (Details) | 12 Months Ended |
Dec. 31, 2015 | |
Machinery and equipment | |
Property and Equipment | |
Estimate Useful Life | 5 years |
Computers and office equipment | |
Property and Equipment | |
Estimate Useful Life | 5 years |
Furniture and fixtures | |
Property and Equipment | |
Estimate Useful Life | 7 years |
Leasehold improvements | |
Property and Equipment | |
Estimate Useful Life | 5 years |
SUMMARY OF SIGNIFICANT ACCOUN41
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Deferred IPO Costs (Details) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Prepaid expenses and other current assets | ||
Sale of stock | ||
Deferred IPO costs | $ 353 | $ 233 |
SUMMARY OF SIGNIFICANT ACCOUN42
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Stock-Based Compensation (Details) - shares | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Non-employee stock options | ||
Stock-based compensation | ||
Options granted (in shares) | 0 | 0 |
Restricted stock | ||
Stock-based compensation | ||
Restricted stock granted (in shares) | 194,694 | |
Restricted stock | Non-employee | ||
Stock-based compensation | ||
Restricted stock granted (in shares) | 0 | 0 |
NET LOSS PER COMMON SHARE (Deta
NET LOSS PER COMMON SHARE (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Net loss per common share | |||||||||||
Net loss | $ (9,525) | $ (9,362) | $ (4,674) | $ (3,694) | $ (3,469) | $ (6,556) | $ (4,117) | $ (3,775) | $ (27,255) | $ (17,917) | $ (16,197) |
Extinguishment of preferred stock | 31,806 | ||||||||||
Accretion and dividends of prior preferred stock | (23,327) | (3,300) | (2,925) | ||||||||
Loss attributable to common stockholders - basic and diluted | $ (20,021) | $ (21,217) | $ (6,883) | ||||||||
Weighted-average number of common shares used in net loss per share-basic and diluted (in shares) | 955,957 | 940,621 | 926,239 | 912,616 | 13,542,282 | 933,997 | 1,697,044 | ||||
Net loss per share - basic and diluted (in dollars per share) | $ (4.50) | $ (7.85) | $ (5.33) | $ (5.03) | $ (1.48) | $ (22.72) | $ (4.06) | ||||
Earnings per share - basic | $ (0.46) | $ (0.46) | $ (0.45) | $ 0.34 | |||||||
Earnings per share - diluted | $ (0.46) | $ (0.46) | $ (0.45) | $ (0.65) | |||||||
Shares used in computing net loss per share-basic (in shares) | 20,558,205 | 20,531,406 | 11,791,546 | 1,001,704 | |||||||
Weighted-average number of common shares used in earnings per share - Diluted | 20,558,205 | 20,531,406 | 11,791,546 | 7,554,524 | |||||||
Series D convertible redeemable preferred stock | |||||||||||
Net loss per common share | |||||||||||
Accretion and dividends of prior preferred stock | $ (1,245) | ||||||||||
Series A convertible redeemable preferred stock | |||||||||||
Net loss per common share | |||||||||||
Performance Adjustment | $ 12,239 |
NET LOSS PER COMMON SHARE - Ant
NET LOSS PER COMMON SHARE - Antidilutive (Details) - shares | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Stock options | |||
Anti-dilutive securities | |||
Potentially dilutive securities outstanding excluded from the computations of diluted weighted-average shares outstanding (in shares) | 1,452,149 | 281,029 | 229,791 |
Warrants | |||
Anti-dilutive securities | |||
Potentially dilutive securities outstanding excluded from the computations of diluted weighted-average shares outstanding (in shares) | 2,445 | 18,809 | 4,170 |
All series of convertible redeemable preferred stock | |||
Anti-dilutive securities | |||
Potentially dilutive securities outstanding excluded from the computations of diluted weighted-average shares outstanding (in shares) | 6,552,820 | 6,552,820 | |
Restricted stock | |||
Anti-dilutive securities | |||
Potentially dilutive securities outstanding excluded from the computations of diluted weighted-average shares outstanding (in shares) | 75,718 | 15,387 | 55,298 |
PREPAID EXPENSES AND OTHER CU45
PREPAID EXPENSES AND OTHER CURRENT ASSETS (Details) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
PREPAID EXPENSES AND OTHER CURRENT ASSETS. | ||
Prepaid Insurance | $ 420 | |
Deferred financing costs | 353 | $ 233 |
Other prepaid expenses | 208 | 8 |
Other current assets | 205 | 253 |
Employee advances | 33 | |
Total prepaid expenses and other current assets | $ 1,186 | $ 527 |
PROPERTY AND EQUIPMENT (Details
PROPERTY AND EQUIPMENT (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Property and Equipment | |||
Total property and equipment | $ 1,812 | $ 1,417 | |
Less: accumulated deprecation | (1,074) | (903) | |
Property and equipment, net | 738 | 514 | |
Depreciation and amortization | 171 | 187 | $ 169 |
Machinery and equipment | |||
Property and Equipment | |||
Total property and equipment | 755 | 741 | |
Leasehold improvements | |||
Property and Equipment | |||
Total property and equipment | 678 | 606 | |
Computers and office equipment | |||
Property and Equipment | |||
Total property and equipment | 262 | 26 | |
Furniture and fixtures | |||
Property and Equipment | |||
Total property and equipment | $ 117 | $ 44 |
ACCRUED EXPENSES (Details)
ACCRUED EXPENSES (Details) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
ACCRUED EXPENSES | ||
Accrued compensation | $ 1,567 | $ 635 |
Accrued audit and legal | 209 | 249 |
Accrued other | 186 | 31 |
Accrued marketing | 157 | |
Accrued development costs | 80 | 970 |
Accrued interest | 29 | 71 |
Total accrued expenses | $ 2,228 | $ 1,956 |
COMMITMENTS AND CONTINGENCIES48
COMMITMENTS AND CONTINGENCIES (Details) - patent | Feb. 09, 2016 | Nov. 09, 2015 | Nov. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2015 |
Purdue Pharma, L. P. patent infringement suits | |||||
Contingencies | |||||
Total number of no stay patents asserted to have been infringed | 2 | ||||
Total number of no stay patents asserted to have been infringed moved for judgment based on collateral estoppel | 1 | ||||
Total number of Orange Book patents asserted to have been infringed previously invalidated in a suit against another company | 3 | ||||
Total number of non-Orange Book patents asserted to have been infringed | 1 | ||||
Purdue Pharma, L. P. patent infringement suit, District of Delaware | |||||
Contingencies | |||||
Total number of Orange Book patents asserted to have been infringed | 3 | ||||
Total number of non-Orange Book patents asserted to have been infringed | 1 | ||||
Purdue Pharma, L. P., patent infringement suit, District of Massachusetts | |||||
Contingencies | |||||
Total number of patents asserted to have been infringed | 4 | ||||
Total number of Orange Book patents asserted to have been infringed dismissed by judgment | 3 | ||||
Hatch-Waxman Act of 1984 election to sue for patent infringement | Purdue Pharma, L. P. patent infringement suits | Maximum | |||||
Contingencies | |||||
Stay period before FDA can issue a final approval unless it is terminated | 30 months |
COMMITMENTS AND CONTINGENCIES -
COMMITMENTS AND CONTINGENCIES - Minimum Annual Lease Commitments (Details) $ in Thousands | 1 Months Ended | 12 Months Ended | |
Mar. 31, 2015ft² | Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($) | |
Lease | |||
Rent-free term | 2 months | ||
Aggregate minimum annual lease commitments under non cancellable operating lease | |||
2,016 | $ 216 | ||
2,017 | 226 | ||
2,018 | 234 | ||
2,019 | 241 | ||
2,020 | 164 | ||
Total minimum lease payments | 1,081 | ||
Rent expense under operating lease agreement | |||
Rent expense | 112 | $ 69 | |
Guarantees | |||
Restricted cash | 97 | 80 | |
Maximum | |||
Lease inducements | |||
Leasehold improvement allowance | 174 | ||
Amendment to office and research facility operating lease | |||
Lease | |||
Square of feet of space | ft² | 9,660 | ||
Office and research facility operating lease | |||
Lease | |||
Square of feet of space | ft² | 19,335 | ||
Term of lease extension option | 5 years | ||
Canton facility lease reimbursable allowance | |||
Lease inducements | |||
Reimbursable improvement allowance | $ 164 | ||
Interest rate (as a percent) | 8.00% | ||
Term | 36 months | ||
Stand-by letter of credit | |||
Guarantees | |||
Restricted cash | $ 97 | $ 80 |
DEBT (Details)
DEBT (Details) - USD ($) $ / shares in Units, $ in Thousands | Aug. 28, 2012 | Sep. 30, 2014 | Aug. 31, 2014 | Feb. 28, 2014 | Jan. 31, 2014 | Feb. 28, 2013 | Oct. 31, 2012 | Aug. 31, 2012 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2015 |
Loan and Security Agreements | |||||||||||
Maximum borrowing capacity | $ 1,000 | ||||||||||
Proceeds from notes payable, net of original note payoff | $ 7,056 | $ 500 | |||||||||
Exercise price of warrant (in dollars per share) | $ 12.27 | ||||||||||
Common stock warrant, Silicon Valley Bank, Original Term Loan | |||||||||||
Loan and Security Agreements | |||||||||||
Common stock that may be purchased upon exercise of warrant (in shares) | 23,810 | ||||||||||
Exercise price of warrant (in dollars per share) | $ 0.07 | ||||||||||
Common stock warrant, Silicon Valley Bank, Term Loan, Amendment No. 1 | |||||||||||
Loan and Security Agreements | |||||||||||
Common stock that may be purchased upon exercise of warrant (in shares) | 14,430 | ||||||||||
Exercise price of warrant (in dollars per share) | $ 0.05 | ||||||||||
Common stock warrant, Silicon Valley Bank, Term Loan, Amendment No. 2 | |||||||||||
Loan and Security Agreements | |||||||||||
Common stock that may be purchased upon exercise of warrant (in shares) | 86,580 | ||||||||||
Exercise price of warrant (in dollars per share) | $ 0.05 | ||||||||||
Term loan | Silicon Valley Bank loan agreement | |||||||||||
Loan and Security Agreements | |||||||||||
Maximum borrowing capacity | $ 1,000 | ||||||||||
Amount borrowed | $ 500 | $ 250 | $ 250 | ||||||||
Initial period of interest only payments | 12 months | ||||||||||
Subsequent period of principal and interest payments | 36 months | ||||||||||
Term loan | Silicon Valley Bank loan agreement | Prime | |||||||||||
Loan and Security Agreements | |||||||||||
Variable interest rate margin (as a percent) | 2.25% | 2.25% | |||||||||
Interest rate (as a percent) | 5.50% | ||||||||||
Term loan | Silicon Valley Bank loan agreement, Amendment No. 1 | |||||||||||
Loan and Security Agreements | |||||||||||
Maximum borrowing capacity | $ 6,000 | ||||||||||
Amount borrowed | $ 2,000 | ||||||||||
Proceeds from notes payable, net of original note payoff | $ 1,056 | ||||||||||
Initial period of interest only payments | 12 months | ||||||||||
Subsequent period of principal and interest payments | 36 months | ||||||||||
Term loan | Silicon Valley Bank loan agreement, Amendment No. 1 | Prime | |||||||||||
Loan and Security Agreements | |||||||||||
Variable rate basis | 1.75% | ||||||||||
Interest rate (as a percent) | 5.00% | ||||||||||
Term loan | Silicon Valley Bank loan agreement Amendment No. 2 | |||||||||||
Loan and Security Agreements | |||||||||||
Maximum borrowing capacity | $ 8,000 | ||||||||||
Amount borrowed | $ 3,000 | $ 3,000 | |||||||||
Initial period of interest only payments | 12 months | ||||||||||
Subsequent period of principal and interest payments | 36 months | ||||||||||
Term loan | Silicon Valley Bank loan agreement Amendment No. 2 | Prime | |||||||||||
Loan and Security Agreements | |||||||||||
Interest rate (as a percent) | 5.00% |
DEBT - Related Party (Details)
DEBT - Related Party (Details) - USD ($) $ in Thousands | 1 Months Ended | 2 Months Ended | 12 Months Ended | |
Mar. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2015 | Dec. 31, 2013 | |
Related party transactions | ||||
Gain on extinguishment | $ 91 | $ (79) | ||
6.0% Convertible promissory notes | ||||
Related party transactions | ||||
Gain on extinguishment | $ 91 | |||
Series D convertible redeemable preferred stock | ||||
Related party transactions | ||||
Issuance of stock (in shares) | 4,166,667 | |||
Bridge Notes Purchase Agreement | Investors | 6.0% Convertible promissory notes | ||||
Related party transactions | ||||
Amount issued | $ 5,000 | |||
Stated interest rate | 6.00% |
DEBT - Future Payments (Details
DEBT - Future Payments (Details) $ in Thousands | Dec. 31, 2015USD ($) |
Future payments under term loan | |
2,016 | $ 2,667 |
2,017 | 2,667 |
2,018 | 1,479 |
Total | $ 6,813 |
WARRANTS (Details)
WARRANTS (Details) - $ / shares | Dec. 31, 2015 | Aug. 28, 2012 |
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 2,445 | |
Exercise price of warrant (in dollars per share) | $ 12.27 | |
Common stock warrant, Silicon Valley Bank, Original Term Loan | ||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 16,357 | |
Exercise price of warrant (in dollars per share) | $ 0.07 |
EQUITY (Details)
EQUITY (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||||||
May. 31, 2015USD ($)$ / sharesshares | Apr. 30, 2015shares | Mar. 31, 2015USD ($)shares | Dec. 31, 2013$ / sharesshares | Dec. 31, 2015USD ($)$ / sharesshares | Dec. 31, 2013USD ($)$ / sharesshares | Dec. 31, 2014$ / sharesshares | Dec. 31, 2012shares | |
Equity | ||||||||
Authorized common stock (in shares) | 72,000,000 | 100,000,000 | 72,000,000 | 72,000,000 | ||||
Par value of common stock (in dollars per share) | $ / shares | $ 0.001 | $ 0.001 | $ 0.001 | $ 0.001 | ||||
Common stock issued (in shares) | 962,960 | 20,739,351 | 962,960 | 1,006,219 | ||||
Common stock outstanding (in shares) | 962,960 | 20,739,351 | 962,960 | 1,006,219 | ||||
Authorized preferred stock (in shares) | 54,481,000 | 5,000,000 | 54,481,000 | 54,481,000 | ||||
Preferred stock issued (in shares) | 0 | |||||||
Preferred stock outstanding (in shares) | 0 | |||||||
Common stock split ratio | 0.1449 | |||||||
Common stock reserved for future issuance (in shares) | 2,844 | 21,930 | ||||||
Employee stock purchase plan | ||||||||
Equity | ||||||||
Common stock reserved for future issuance (in shares) | 200 | |||||||
Initial public offering | ||||||||
Equity | ||||||||
Issuance of stock (in shares) | 6,670,000 | |||||||
Issue price (in dollars per share) | $ / shares | $ 12 | |||||||
Net proceeds from IPO | $ | $ 72,029 | |||||||
Common stock split ratio | 0.1449 | |||||||
Conversion into common stock | 12,591,463 | 12,591,463 | ||||||
Underwriters over-allotment option | ||||||||
Equity | ||||||||
Issuance of stock (in shares) | 870,000 | |||||||
Employee stock options | ||||||||
Equity | ||||||||
Common stock reserved for future issuance (in shares) | 2,642 | 3,413 | ||||||
Warrants | ||||||||
Equity | ||||||||
Common stock reserved for future issuance (in shares) | 2 | 19 | ||||||
Series A convertible redeemable preferred stock | ||||||||
Equity | ||||||||
Authorized preferred stock (in shares) | 0 | 18,498,419 | ||||||
Preferred stock issued (in shares) | 9,232,334 | 0 | 9,232,334 | 9,232,334 | 18,464,674 | |||
Preferred stock outstanding (in shares) | 9,232,334 | 0 | 9,232,334 | 9,232,334 | ||||
Common stock split ratio | 0.5 | |||||||
Common stock reserved for future issuance (in shares) | 18,498 | |||||||
Series B convertible redeemable preferred stock | ||||||||
Equity | ||||||||
Authorized preferred stock (in shares) | 0 | 27,324,237 | ||||||
Preferred stock issued (in shares) | 27,324,237 | 0 | 27,324,237 | 27,324,237 | 27,324,237 | |||
Preferred stock outstanding (in shares) | 27,324,237 | 0 | 27,324,237 | 27,324,237 | ||||
Common stock reserved for future issuance (in shares) | 27,324 | |||||||
Series C convertible redeemable preferred stock | ||||||||
Equity | ||||||||
Authorized preferred stock (in shares) | 0 | 8,658,344 | ||||||
Preferred stock issued (in shares) | 8,658,008 | 0 | 8,658,008 | 8,658,008 | ||||
Preferred stock outstanding (in shares) | 8,658,008 | 0 | 8,658,008 | 8,658,008 | ||||
Aggregate consideration | $ | $ 12,034 | |||||||
Common stock reserved for future issuance (in shares) | 8,658 | |||||||
Series D convertible redeemable preferred stock | ||||||||
Equity | ||||||||
Aggregate consideration | $ | $ 50,000 | $ 44,807 | ||||||
Proceeds from Issuance of Convertible Preferred Stock | $ | $ 45,000 | |||||||
Conversion into bridge notes | 5,000,000 | |||||||
Issuance of stock (in shares) | 4,166,667 |
EQUITY - Redeemeble Preferred (
EQUITY - Redeemeble Preferred (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 2 Months Ended | 12 Months Ended | |||||
Apr. 30, 2015 | Mar. 31, 2015shares | Dec. 31, 2013USD ($)$ / shares | Feb. 29, 2012USD ($)$ / sharesshares | Sep. 30, 2013USD ($)$ / sharesshares | Dec. 31, 2015USD ($)$ / sharesshares | Dec. 31, 2014USD ($)$ / shares | Dec. 31, 2013USD ($)tranche$ / sharesshares | |
Performance Adjustment | ||||||||
Performance adjustment ratio | 0.1449 | |||||||
Common Stock | ||||||||
Performance Adjustment | ||||||||
Performance adjustment ratio | 0.5 | |||||||
Series A convertible redeemable preferred stock | ||||||||
Preferred stock | ||||||||
Convertible redeemable preferred stock, par value (in dollars per share) | $ / shares | $ 0.001 | $ 0.001 | $ 0.001 | |||||
Performance Adjustment | ||||||||
Performance adjustment ratio | 0.5 | |||||||
Performance Adjustment | $ 12,239 | $ 12,239 | ||||||
Series B convertible redeemable preferred stock | ||||||||
Preferred stock | ||||||||
Convertible redeemable preferred stock, par value (in dollars per share) | $ / shares | $ 0.001 | 0.001 | 0.001 | |||||
Series C convertible redeemable preferred stock | ||||||||
Preferred stock | ||||||||
Issuance of stock (in shares) | shares | 12,154,000 | |||||||
Convertible redeemable preferred stock, par value (in dollars per share) | $ / shares | $ 0.001 | $ 0.001 | ||||||
Closing costs | $ 45 | |||||||
Series D convertible redeemable preferred stock | ||||||||
Preferred stock | ||||||||
Issuance of stock (in shares) | shares | 41,666,667 | 37,500,000 | ||||||
Closing costs | $ 193 | |||||||
Series B Preferred Stock financing February 2012 | Series B convertible redeemable preferred stock | ||||||||
Preferred stock | ||||||||
Issuance of stock (in shares) | shares | 27,324,237 | |||||||
Issue price (in dollars per share) | $ / shares | $ 0.84 | |||||||
Gross proceeds | $ 20,050 | |||||||
Closing costs | $ 147 | |||||||
Series C Preferred Stock financing 2013 | Series C convertible redeemable preferred stock | ||||||||
Preferred stock | ||||||||
Issuance of stock (in shares) | shares | 8,658,008 | |||||||
Gross proceeds | $ 12,000 | |||||||
Closing costs | $ 45 | |||||||
Number of tranches into which financing was structured | tranche | 2 | |||||||
Series C Preferred Stock financing 2013 | Series C convertible redeemable preferred stock | Maximum | ||||||||
Preferred stock | ||||||||
Shares authorized for sale and issuance (in shares) | shares | 8,658,008 | |||||||
Amount authorized for sale and issuance | $ 12,000 | |||||||
Series C Preferred Stock financing 2013 | Series C convertible redeemable preferred stock | Stock purchase right | ||||||||
Preferred stock | ||||||||
Stock purchase right liability | $ 266 | |||||||
Series C Preferred Stock financing 2013, first tranche | Series C convertible redeemable preferred stock | ||||||||
Preferred stock | ||||||||
Issuance of stock (in shares) | shares | 2,886,004 | |||||||
Gross proceeds | $ 4,000 | |||||||
Series C Preferred Stock financing 2013, second tranche | Series C convertible redeemable preferred stock | Stock purchase right | ||||||||
Fair value assumptions | ||||||||
Fair value of stock (in dollars per share) | $ / shares | $ 1.27 | $ 1.30 | $ 1.27 | |||||
Expected life | 1 month 28 days | |||||||
Volatility (as a percent) | 52.00% | |||||||
Roll forward of the recurring fair value measurements of the tranche liability categorized with Level 3 inputs | ||||||||
Tranche liability upon issuance | $ 266 | |||||||
Change in fair value | 79 | |||||||
Tranche liability upon close of tranche | $ (345) | |||||||
Series C Preferred Stock financing 2013, second tranche | Series C convertible redeemable preferred stock | Stock purchase right | Minimum | ||||||||
Fair value assumptions | ||||||||
Expected life | 4 months 6 days | |||||||
Volatility (as a percent) | 53.00% | |||||||
Series C Preferred Stock financing 2013, second tranche | Series C convertible redeemable preferred stock | Stock purchase right | Maximum | ||||||||
Fair value assumptions | ||||||||
Expected life | 5 months 5 days | |||||||
Volatility (as a percent) | 60.00% | |||||||
Conversion of preferred stock into Series A Preferred Stock | Series A convertible redeemable preferred stock | ||||||||
Preferred stock | ||||||||
Number of shares issued in exchange for previously outstanding stock (in shares) | shares | 18,464,674 |
STOCK-BASED COMPENSATION - Rest
STOCK-BASED COMPENSATION - Restricted Stock Awards and Options (Details) | 1 Months Ended | 12 Months Ended | ||
May. 31, 2015shares | Apr. 30, 2015 | Dec. 31, 2015shares | Dec. 31, 2014shares | |
Stock-based compensation | ||||
Performance adjustment ratio | 0.1449 | |||
Stock options | ||||
Stock-based compensation | ||||
Shares of common stock authorized for issuance outstanding (in shares) | 1,452,149 | 281,029 | ||
Vesting period | 4 years | |||
Contractual life | 10 years | |||
Stock options | Minimum | ||||
Stock-based compensation | ||||
Period following termination date vested options are exercisable | 1 month | |||
Stock options | Maximum | ||||
Stock-based compensation | ||||
Period following termination date vested options are exercisable | 3 months | |||
2014 Stock Incentive Plan | ||||
Stock-based compensation | ||||
Shares of common stock authorized for issuance (in shares) | 2,700,000 | |||
Increase in number of authorized shares on the first day of each fiscal year, as a percentage of outstanding common stock (as a percent) | 4.00% |
STOCK-BASED COMPENSATION - Stoc
STOCK-BASED COMPENSATION - Stock Option Activity (Details) - Stock options - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Stock option activity | ||
Outstanding at beginning of year (in shares) | 281,029 | |
Granted (in shares) | 1,350,952 | |
Exercised (in shares) | (173,251) | |
Cancelled (in shares) | (6,581) | |
Outstanding at end of period (in shares) | 1,452,149 | 281,029 |
Exercisable at end of period (in shares) | 205,891 | |
Vested and expected to vest at end of period (in shares) | 1,436,582 | |
Weighted average exercise price per share | ||
Outstanding at beginning of year (in dollars per share) | $ 0.69 | |
Granted (in dollars per share) | 11.46 | |
Exercised (in dollars per share) | 2.99 | |
Cancelled (in dollars per share) | 14.54 | |
Outstanding at end of period (in dollars per share) | 10.37 | $ 0.69 |
Exercisable at end of period (in dollars per share) | 3.75 | |
Vested and expected to vest at end of period (in dollars per share) | $ 10.46 | |
Stock option activity, additional information | ||
Outstanding at end of period, Weighted-average remaining contractual term | 10 years 4 months 10 days | 7 years 5 months 27 days |
Exercisable at end of period, Weighted-average remaining contractual term | 7 years 10 months 24 days | |
Vested and expected to vest at end of period, weighted-average remaining contractual term | 9 years 1 month 6 days | |
Outstanding at beginning of period, Aggregate Intrinsic Value | $ 1,505 | |
Outstanding at end of period, Aggregate Intrinsic Value | 24,887 | $ 1,505 |
Exercisable at end of period, Aggregate Intrinsic Value | 4,890 | |
Vested and expected to vest at end of period, Aggregate Intrinsic Value | 26,061 | |
Unrecognized compensation cost related to outstanding options | $ 9,212 | |
Period over which unrecognized compensation cost is expected to be recognized as expense | 3 years 4 months 24 days | |
Weighted average fair value of vested options (in dollars per share) | $ 2.96 |
STOCK-BASED COMPENSATION - Re58
STOCK-BASED COMPENSATION - Restricted Award Vesting (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Share-based compensation. | |||
Total stock-based compensation expense | $ 2,209 | $ 22 | $ 62 |
Restricted stock | |||
Restricted stock awards | |||
Unvested at beginning of year (in shares) | 15,387 | ||
Granted (in shares) | 194,694 | ||
Vested (in shares) | (134,363) | ||
Unvested at end of year (in shares) | 75,718 | 15,387 | |
Weighted-average purchase price per share | |||
Unvested at beginning of year (in dollars per share) | $ 0.69 | ||
Granted (in dollars per share) | 5.73 | ||
Vested (in dollars per share) | 5.15 | ||
Unvested at end of year (in dollars per share) | $ 5.73 | $ 0.69 | |
Unrecognized compensation cost | |||
Total fair value of restricted stock units vested | $ 692 | ||
Unrecognized stock-based compensation expense | $ 434 | ||
Period over which unrecognized compensation cost is expected to be recognized as expense | 2 years 3 months 18 days | ||
Research and development | |||
Share-based compensation. | |||
Total stock-based compensation expense | $ 223 | $ 12 | 24 |
General and administrative | |||
Share-based compensation. | |||
Total stock-based compensation expense | $ 1,986 | $ 10 | $ 38 |
STOCK-BASED COMPENSATION - Valu
STOCK-BASED COMPENSATION - Valuation Assumptions (Details) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Weighted-average assumptions used in the Black-Scholes option pricing model to determine the fair value of the employee stock option grants | |||
Risk-free interest rate | 1.70% | 1.80% | |
Volatility | 77.00% | 77.10% | 87.80% |
Expected term (in years) | 6 years 2 months 12 days | 6 years 3 months | 6 years 3 months |
Minimum | |||
Weighted-average assumptions used in the Black-Scholes option pricing model to determine the fair value of the employee stock option grants | |||
Risk-free interest rate | 1.09% | ||
Maximum | |||
Weighted-average assumptions used in the Black-Scholes option pricing model to determine the fair value of the employee stock option grants | |||
Risk-free interest rate | 1.22% |
INCOME TAXES (Details)
INCOME TAXES (Details) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Reconciliation of income tax expense (benefit) computed at the statutory federal income tax rate to income taxes as reflected in the financial statements | |||
Federal income tax (benefit) at statutory rate (as a percent) | 34.00% | 34.00% | 34.00% |
State income tax, net of federal benefit | 5.29% | ||
Expiration of state net operating losses (as a percent) | (12.11%) | ||
Permanent items (as a percent) | (1.70%) | (0.17%) | (0.01%) |
Research and development credits | 0.89% | 3.74% | 4.19% |
Change in valuation allowance (as a percent) | (38.48%) | (37.57%) | (26.07%) |
Income tax expense (benefit) (as a percent) | 0.00% | 0.00% | 0.00% |
INCOME TAXES - Deferred Tax Ass
INCOME TAXES - Deferred Tax Assets and Liabilities (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Deferred tax assets: | |||
Net operating loss carryforwards | $ 38,405 | $ 28,419 | |
Research and development credits | 3,421 | 3,070 | |
Accruals and other | 144 | ||
Depreciation and amortization | 94 | 36 | |
Deferred tax assets before valuation allowance | 42,064 | 31,525 | |
Valuation allowance | (42,064) | (31,525) | |
Valuation allowance | |||
Deferred tax asset valuation allowance increase | 10,539 | 7,737 | |
Net operating loss carryforwards | |||
Operating Loss Carryforwards | 1,064,000 | 0 | $ 0 |
Interest and Penalties relating to uncertain tax positions | 0 | 0 | |
Amount recognized in statement of operations | 0 | 0 | |
U.S. federal | |||
Deferred tax assets: | |||
Research and development credits | 3,110,000 | 2,868,000 | 2,311,000 |
Net operating loss carryforwards | |||
Available net operating loss carryforwards as of the end of the year | 104,888 | 78,276 | 60,380 |
State | |||
Deferred tax assets: | |||
Research and development credits | 469 | 226 | 121 |
Net operating loss carryforwards | |||
Available net operating loss carryforwards as of the end of the year | $ 59,875 | $ 34,184 | $ 16,354 |
EMPLOYEE BENEFITS (Details)
EMPLOYEE BENEFITS (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
EMPLOYEE BENEFITS | ||
Requisite service period of employees to be eligible to participate in the 401(k) plan | 3 months | |
Total expense for contributions made to 401(k) plan | $ 44 | $ 35 |
UNAUDITED QUARTERLY OPERATING63
UNAUDITED QUARTERLY OPERATING RESULTS (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
UNAUDITED QUARTERLY OPERATING RESULTS | |||||||||||
Research and development | $ 1,531 | $ 3,358 | $ 1,641 | $ 1,445 | $ 2,307 | $ 5,818 | $ 3,565 | $ 3,269 | $ 7,975 | $ 14,959 | $ 14,157 |
General and administrative | 7,905 | 5,907 | 2,934 | 2,186 | 1,020 | 687 | 523 | 476 | 18,932 | 2,706 | 1,885 |
Total operating expenses | 9,436 | 9,265 | 4,575 | 3,631 | 3,327 | 6,505 | 4,088 | 3,745 | 26,907 | 17,665 | 16,042 |
Loss from operations | (9,436) | (9,265) | (4,575) | (3,631) | (3,327) | (6,505) | (4,088) | (3,745) | (26,907) | (17,665) | (16,042) |
Other expense, net | (89) | (97) | (99) | (63) | (142) | (51) | (29) | (30) | (348) | (252) | (155) |
Net loss | $ (9,525) | $ (9,362) | $ (4,674) | $ (3,694) | $ (3,469) | $ (6,556) | $ (4,117) | $ (3,775) | $ (27,255) | $ (17,917) | $ (16,197) |
Shares used in computing net loss per share-basic (in shares) | 20,558,205 | 20,531,406 | 11,791,546 | 1,001,704 | |||||||
Shares used in computing net loss per share-diluted (in shares) | 20,558,205 | 20,531,406 | 11,791,546 | 7,554,524 | |||||||
Net loss per share-basic (in dollars per share) | $ (0.46) | $ (0.46) | $ (0.45) | $ 0.34 | |||||||
Net loss per share-diluted (in dollars per share) | $ (0.46) | $ (0.46) | $ (0.45) | $ (0.65) | |||||||
Shares used in computing net loss per share-basic and diluted (in shares) | 955,957 | 940,621 | 926,239 | 912,616 | 13,542,282 | 933,997 | 1,697,044 | ||||
Net loss per share - basic and diluted (in dollars per share) | $ (4.50) | $ (7.85) | $ (5.33) | $ (5.03) | $ (1.48) | $ (22.72) | $ (4.06) |
SUBSEQUENT EVENTS (Details)
SUBSEQUENT EVENTS (Details) - Subsequent events $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended |
Jan. 31, 2016USD ($)$ / sharesshares | Mar. 18, 2016item | |
SUBSEQUENT EVENTS | ||
Subsequent events number | item | 1 | |
Issuance of stock (in shares) | shares | 2,750,000 | |
Issue price (in dollars per share) | $ / shares | $ 20 | |
Net proceeds after deducting underwriting discounts and commissions but before deducting other offering expenses payable | $ 51,700 | |
Deferred IPO costs | $ 353 |