Document and Entity Information
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6 Months Ended | |
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Jun. 30, 2015
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Jul. 24, 2015
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Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2015 | |
Document Fiscal Year Focus | 2015 | |
Document Fiscal Period Focus | Q2 | |
Trading Symbol | MNOV | |
Entity Registrant Name | MEDICINOVA INC | |
Entity Central Index Key | 0001226616 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Smaller Reporting Company | |
Entity Common Stock, Shares Outstanding | 24,893,221 |
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Indicate whether the registrant is one of the following: (1) Large Accelerated Filer, (2) Accelerated Filer, (3) Non-accelerated Filer, (4) Smaller Reporting Company (Non-accelerated) or (5) Smaller Reporting Accelerated Filer. Definitions of these categories are stated in Rule 12b-2 of the Exchange Act. This information should be based on the registrant's current or most recent filing containing the related disclosure. No definition available.
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Consolidated Balance Sheets (Parenthetical) (USD $)
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Jun. 30, 2015
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Dec. 31, 2014
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Statement Of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 3,000,000 | 3,000,000 |
Preferred stock, shares issued | 220,000 | 220,000 |
Preferred stock, shares outstanding | 220,000 | 220,000 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares issued | 24,893,221 | 24,436,317 |
Common stock, shares outstanding | 24,893,221 | 24,436,317 |
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Consolidated Statements of Operations and Comprehensive Loss (USD $)
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3 Months Ended | 6 Months Ended | ||
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Jun. 30, 2015
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Jun. 30, 2014
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Jun. 30, 2015
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Jun. 30, 2014
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Operating expenses: | ||||
Research, development and patents | $ 797,008 | $ 835,614 | $ 1,516,735 | $ 1,583,531 |
General and administrative | 1,480,120 | 1,295,427 | 2,975,348 | 2,911,243 |
Total operating expenses | 2,277,128 | 2,131,041 | 4,492,083 | 4,494,774 |
Operating loss | (2,277,128) | (2,131,041) | (4,492,083) | (4,494,774) |
Other expense | (14,289) | (181) | (18,441) | (304) |
Other income | 6,256 | 11,001 | 13,247 | 23,935 |
Loss before income taxes | (2,285,161) | (2,120,221) | (4,497,277) | (4,471,143) |
Income taxes | (1,661) | (1,547) | (4,608) | (3,090) |
Net loss applicable to common stockholders | (2,286,822) | (2,121,768) | (4,501,885) | (4,474,233) |
Basic and diluted net loss per common share | $ (0.09) | $ (0.09) | $ (0.18) | $ (0.19) |
Shares used to compute basic and diluted net loss per common share | 24,827,878 | 24,141,485 | 24,684,008 | 23,920,782 |
Net loss applicable to common stockholders | (2,286,822) | (2,121,768) | (4,501,885) | (4,474,233) |
Other comprehensive loss, net of tax: | ||||
Foreign currency translation adjustments | (1,681) | 797 | (2,326) | 3,466 |
Comprehensive loss | $ (2,288,503) | $ (2,120,971) | $ (4,504,211) | $ (4,470,767) |
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Interim Financial Information
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6 Months Ended |
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Jun. 30, 2015
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Quarterly Financial Information Disclosure [Abstract] | |
Interim Financial Information | 1. Interim Financial Information Organization and Business MediciNova, Inc. (the “Company” or “MediciNova”) was incorporated in the state of Delaware in September 2000 and is a public company. The Company’s common stock is listed in both the U.S. and Japan and trades on The NASDAQ Global Market and the JASDAQ Market of the Tokyo Stock Exchange. MediciNova is a biopharmaceutical company focused on acquiring and developing novel, small molecule therapeutics for the treatment of serious diseases with unmet medical needs with a commercial focus on the U.S. market. The Company’s current strategy is to focus its development activities on MN-166 (ibudilast) for neurological disorders such as progressive multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS) and substance dependence (e.g., methamphetamine dependence, opioid dependence and alcohol dependence), and MN-001 (tipelukast) for fibrotic diseases such as nonalcoholic steatohepatitis (NASH) and idiopathic pulmonary fibrosis (IPF). The Company’s pipeline also includes MN-221 (bedoradrine) for the treatment of acute exacerbations of asthma and MN-029 (denibulin) for solid tumor cancers. Basis of Presentation The accompanying unaudited consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (GAAP) for interim financial information and with the instructions of the Securities and Exchange Commission (SEC) on Form 10-Q and Rule 10-01 of Regulation S-X. Accordingly, they do not include all of the information and disclosures required by GAAP for complete financial statements. In the opinion of management, the consolidated financial statements include all adjustments necessary, which are of a normal and recurring nature, for the fair presentation of the Company’s financial position and of the results of operations and cash flows for the periods presented. The accompanying unaudited consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. These financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto for the year ended December 31, 2014 included in the Company’s Annual Report on Form 10-K filed with the SEC. The results of operations for the interim period shown in this report are not necessarily indicative of the results that may be expected for any other interim period or for the full year. The balance sheet at December 31, 2014 has been derived from the audited financial statements at that date, but does not include all of the information and footnotes required by GAAP for complete financial statements. Research, Development and Patents Research and development costs are expensed in the period incurred. Research and development costs primarily consist of salaries and related expenses for personnel, facilities and depreciation, research and development supplies, licenses and outside services. Such research and development costs totaled $0.7 million for the three-months ended June 30, 2015 and 2014. Research and development costs totaled $1.3 million and $1.4 million for the six months ended June 30, 2015 and 2014, respectively. Costs related to filing and pursuing patent applications are expensed as incurred, as recoverability of such expenditures is uncertain. The Company includes all external costs related to the filing of patents on developments in Research, Development and Patents expenses. Such patent-related expenses totaled $0.1 million for the three-months ended June 30, 2015 and 2014. Patent-related expenses totaled $0.2 million for the six months ended June 30, 2015 and 2014. Use of Estimates The preparation of the consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and the accompanying notes. Actual results could differ from those estimates. Recently Issued Accounting Pronouncements In May 2014, the Financial Accounting Standards Board (“FASB”) and the International Accounting Standards Board “(IASB”) jointly issued Accounting Standards Update (“ASU”) No. 2014-09, Revenue from Contracts from Customers, which supersedes the revenue recognition requirements in ASC 605, Revenue Recognition. ASU 2014-09 is a comprehensive new revenue recognition standard that will supersede nearly all existing revenue recognition guidance under US GAAP and IFRS. The standard’s core principle is that a company will recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. In doing so, companies will need to use more judgment and make more estimates than under current authoritative guidance. These may include identifying performance obligations in the contract, estimating the amount of variable consideration to include in the transaction price and allocating the transaction price to each separate performance obligation. The standard is effective for public entities for annual and interim periods beginning after December 15, 2016. Early adoption is not permitted under US GAAP. The adoption of this guidance is not expected to have a material impact on the Company. In August 2014, the FASB issued ASU 2014-15, Presentation of Financial Statements – Going Concern, which is new guidance requiring management to evaluate whether there are conditions and events that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the financial statements are issued (or available to be issued when applicable). Management will be required to make this evaluation for both annual and interim reporting periods and will have to make certain disclosures if it concludes that substantial doubt exists or when its plans alleviate substantial doubt about the entity’s ability to continue as a going concern. The standard is effective for annual periods ending after December 15, 2016. Early adoption is permitted. The adoption of this guidance is not expected to have a material impact on the Company. Vendor Payment During the six months ended June 30, 2015, the Company received a $100,000 payment from a vendor to offset the costs of manufactured drug product that was inadvertently destroyed by the vendor. The vendor payment has been recorded as an offset to general and administrative expense. |
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Revenue Recognition
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6 Months Ended |
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Jun. 30, 2015
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Revenue Recognition [Abstract] | |
Revenue Recognition | 2. Revenue Recognition Revenue Recognition Policy Revenues consist of milestone payments and research and development services. Milestone payments are recognized as revenue upon achievement of pre-defined scientific events, which require substantive effort, and for which achievement of the milestone was not readily assured at the inception of the agreement. Milestones that do not meet the criteria for accounting under the milestone method because the payments are solely contingent upon the performance of a third party are accounted for as contingent revenue. Research and development services are recognized as research costs are incurred over the period the services are performed. For all other revenue the Company recognizes revenues when all four of the following criteria are met: (1) persuasive evidence that an arrangement exists; (2) delivery of the products and/or services has occurred; (3) the selling price is fixed or determinable; and (4) collectability is reasonably assured. Kissei Pharmaceutical Co., Ltd In October 2011, the Company entered into an agreement with Kissei Pharmaceutical Co., Ltd., or Kissei, to perform research and development services relating to MN-221 in exchange for a non-refundable upfront payment of $2.5 million. Under the terms of the agreement, the Company is responsible for all costs to be incurred in the performance of these services. Certain of these research and development services were completed in 2013 and 2012, and the remaining services are expected to be delivered and completed at a future date. The Company assessed the deliverables in accordance with the authoritative guidance and concluded the existence of one deliverable, research and development services. As such, revenue is being recognized as the research and development services are performed. The amount received from Kissei, net of the amount recorded as revenue, is included on the balance sheet as long-term deferred revenue and will be recognized as revenue as the remaining services are performed. No revenue was recorded in the three and six months ended June 30, 2015 and 2014. |
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Fair Value Measurements
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Jun. 30, 2015
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Fair Value Measurements | 3. Fair Value Measurements Fair value is an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, a three-tier fair value hierarchy has been established, which prioritizes the inputs used in measuring fair value as follows:
Cash and cash equivalents, including money market accounts, of $8.3 million and $11.5 million measured at fair value as of June 30, 2015 and December 31, 2014, respectively, are classified within Level 1. |
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Joint Venture
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6 Months Ended |
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Jun. 30, 2015
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Equity Method Investments And Joint Ventures [Abstract] | |
Joint Venture | 4. Joint Venture The Company entered into an agreement to form a joint venture company with Zhejiang Medicine Co., Ltd. and Beijing Medfron Medical Technologies Co., Ltd. (formerly Beijing Make-Friend Medicine Technology Co., Ltd.) effective September 27, 2011. The joint venture agreement provides for the joint venture company, Zhejiang Sunmy Bio-Medical Co., Ltd. (Zhejiang Sunmy), to develop and commercialize MN-221 in China and pursue additional compounds to develop. A sublicense agreement would be required under which Zhejiang Sunmy would license MN-221 from the Company and, as of the date of this filing, no such sublicense agreement has been entered into. In accordance with the joint venture agreement, in March 2012 the Company paid $680,000 for a 30% interest in Zhejiang Sunmy. The other parties to the joint venture agreement provided funding for their combined 70% interest. In December 2013, the Board of Directors of Zhejiang Sunmy agreed to amend the joint venture agreement to allow for the departure of Zhejiang Medicine Co., Ltd. subject to the approval of the government of the People’s Republic of China. In August 2014, the Chinese government approved the amendment to the joint venture agreement to allow for the departure of Zhejiang Medicine Co., Ltd. and for Beijing Medfron Medical Technologies Co., Ltd. and MediciNova to each have a 50% interest in Zhejiang Sunmy. No additional capital was contributed by either remaining party. Zhejiang Sunmy is a variable interest entity for which the Company is not the primary beneficiary as the Company does not have a majority of the board seats and does not have power to direct or significantly influence the actions of the entity. The activities of Zhejiang Sunmy are accounted for under the equity method whereby the Company absorbs any loss or income generated by Zhejiang Sunmy according to the Company’s percentage ownership. At June 30, 2015, the investment is reflected as a long-term asset on the Company’s consolidated balance sheet which represents the investment in Zhejiang Sunmy, net of the Company’s portion of any generated loss or income. |
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Stock-based Compensation
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Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock-based Compensation | 5. Stock-based Compensation Stock Incentive Plans In June 2013, the Company adopted the 2013 Equity Incentive Plan, or 2013 Plan, under which the Company may grant stock options, stock appreciation rights, restricted stock, restricted stock units and other awards to individuals who are then employees, officers, non-employee directors or consultants of the Company or its subsidiaries. The 2013 Plan is the successor to the Company’s Amended and Restated 2004 Stock Incentive Plan, or 2004 Plan. A total of 2,500,000 shares of common stock were initially reserved for issuance under the 2013 Plan, plus “returning shares” that may become available from time to time. “Returning shares” are shares that are subject to outstanding awards granted under the 2004 Plan that expire or terminate prior to exercise or settlement, are forfeited because of the failure to vest, are repurchased, or are withheld to satisfy tax withholding or purchase price obligations in connection with such awards. Although the Company no longer grants equity awards under the 2004 Plan, all outstanding stock awards granted under the 2004 Plan will continue to be subject to the terms and conditions as set forth in the agreements evidencing such stock awards and the terms of the 2004 Plan. As of June 30, 2015, 1,710,825 options remain available for future grant under the 2013 Plan. Stock Options Options granted under the 2013 Plan and Prior Plans have terms of ten years from the date of grant and generally vest over a three or four year period. The exercise price of all options granted was equal to the market value of the Company’s common stock on the date of grant. A summary of stock option activity and related information as of June 30, 2015 is as follows:
No options were exercised during the six months ended June 30, 2015 and 2014. Employee Stock Purchase Plan Under the Company’s 2007 Employee Stock Purchase Plan, or ESPP, 300,000 shares of common stock were originally reserved for issuance. In addition, the shares reserved automatically increase each year by a number equal to the lesser of: (i) 15,000 shares; (ii) 1% of the outstanding shares of common stock on the last day of the immediately preceding fiscal year; or (iii) such lesser amount as determined by the Board. The ESPP permits full-time employees to purchase common stock through payroll deductions (which cannot exceed 15% of each employee’s compensation) at the lower of 85% of fair market value at the beginning of the offering period or the end of each six-month offering period. For the six months ended June 30, 2015, an aggregate of 21,604 shares were issued under the ESPP. As of June 30, 2015, there are 209,349 shares available for future issuance under the ESPP. Compensation Expense During the six months ended June 30, 2015, options to purchase 649,000 shares of common stock were granted. Stock-based compensation expense for stock option awards and ESPP shares are reflected in total operating expenses for each respective year. For the three months ended June 30, 2015 and 2014, stock-based compensation related to stock options and ESPP was $546,366 and $231,321, respectively. For the six months ended June 30, 2015 and 2014, stock-based compensation expense related to stock options and the ESPP was $1,059,671 and $486,420, respectively. The Company uses the Black-Scholes valuation model for determining the estimated fair value and the stock-based compensation for stock-based awards to employees. The following table provides the assumptions used in the Black-Scholes valuation model for the three and six months ended June 30, 2015 and 2014. The ESPP assumptions for the three months ended June 30, 2015 and 2014 are actual amounts, and the assumptions for the six months ended June 30, 2015 and 2014 are weighted average amounts.
As of June 30, 2015, there was $1.3 million of unamortized compensation cost related to unvested stock option awards which is expected to be recognized over a remaining weighted-average vesting period of 1.0 years, on a straight-line basis. |
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Stockholders' Equity
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6 Months Ended |
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Jun. 30, 2015
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Equity [Abstract] | |
Stockholders' Equity | 6. Stockholders’ Equity At-The-Market Issuance Sales Agreements On October 16, 2013, the Company entered into an at-the-market equity distribution agreement with Macquarie Capital USA (MCUSA) pursuant to which the Company could sell common stock through MCUSA from time to time up to an aggregate offering price of $10.0 million. Under the terms of this agreement, unless otherwise mutually agreed, no daily sale of an amount of shares of the Company’s common stock is to exceed the lower of $50,000 or 10% of the lower of the 5-day or 3-month average daily traded value of the Company’s common stock on NASDAQ (unless 10% of the lower of the 5-day or 3-month average daily traded value of the Company’s common stock on the JASDAQ Market of the Tokyo Stock Exchange (“TSE”) is greater, in which case the value from the TSE will be used) as of the date of the applicable issuance notice. The price per share is not to be less than the greater of $1.29 or the last available closing price of a share of the Company’s common stock on NASDAQ. MCUSA agreed to use its commercially reasonable efforts consistent with its customary trading and sales practices and applicable laws, rules and regulations to sell shares of the Company’s common stock and is to sell such shares by any method permitted by law deemed to be “at the market.” The Company agreed to pay MCUSA an aggregate commission rate of 7.0% of the gross proceeds of any common stock sold under this agreement. MCUSA is under no obligation to purchase shares pursuant to this agreement and there are no assurances that MCUSA will be successful in selling shares. Proceeds from sales of common stock will depend on the number of shares of common stock sold to MCUSA and the per share purchase price of each transaction. The agreement with MCUSA provides both MCUSA and the Company the right to terminate the agreement in their discretion upon giving five business days written notice. For the six months ended June 30, 2015, the Company has generated gross and net proceeds of $0.9 million and $0.7 million, respectively, under this agreement on the sale of 225,000 shares of the Company’s common stock at prices ranging from $3.24 to $4.45 per share. The at-the-market equity distribution agreement with MCUSA was terminated on May 22, 2015, and as of such date, the Company had completed sales to MCUSA totaling 2,127,500 shares of common stock at prices ranging from $2.01 to $4.45 per shares, generating gross and net proceeds of $5.3 million and $4.5 million, respectively. Net proceeds are calculated as gross proceeds less commissions and other issuance costs. On May 22, 2015, the Company entered into an at-the-market issuance sales agreement with MLV & Co. LLC (MLV) pursuant to which the Company may sell common stock through MLV from time to time up to an aggregate offering price of $30.0 million. Sales of the Company’s common stock through MLV, if any, will be made by any method that is deemed to be an “at-the-market” equity offering as defined in Rule 415 promulgated under the Securities Act of 1933, as amended, including sales made directly on NASDAQ, on any other existing trading market for the common stock or to or through a market maker. MLV may also sell the common stock in privately negotiated transactions, subject to the Company’s prior approval. The Company agreed to pay MLV an aggregate commission rate of up to 4.0% of the gross proceeds of any common stock sold under this agreement. Proceeds from sales of common stock will depend on the number of shares of common stock sold to MLV and the per share purchase price of each transaction. The Company is not obligated to make any sales of common stock under the sales agreement and may terminate the sales agreement at any time upon written notice. For the three and six months ended June 30, 2015, the Company has generated gross and net proceeds of $32,700 and $31,600, respectively (excluding $101,800 in issuance costs incurred), under this agreement on sales of 7,800 shares of the Company’s common stock at prices ranging from $4.16 to $4.23 per share. Common Stock Warrants In 2011, the Company consummated a firm-commitment underwritten public offering of 2,800,666 units at a price to the public of $3.00 per unit for gross proceeds of $8.25 million. Each unit consists of one share of common stock and a warrant to purchase one share of common stock. The shares of common stock and warrants are immediately separable and were issued separately. The warrants are exercisable immediately upon issuance, have a five-year term and an exercise price of $3.56 per share. During the six months ended June 30, 2015 and 2014, 187,500 and 85,500 of these warrants were exercised for gross proceeds of $0.7 million and $0.3 million, respectively. As of June 30, 2015, 2,389,000 of these warrants remain outstanding and exercisable. In August 2012, the Company issued a warrant in exchange for investor relations services to purchase up to 130,000 of common stock of the Company at a price of $1.88 per share, the closing price of the Company’s common stock on that date. As of June 30, 2014, the warrant was exercisable for 15,000 shares, and no further shares will vest. During the six months ended June 30, 2015, all 15,000 of these warrants were exercised for gross proceeds of $28,200. In May 2013, the Company entered into a securities purchase agreement with certain accredited investors pursuant to which the Company agreed to sell to investors 1,158,730 shares of the Company’s common stock at a price of $3.15 per share and warrants to purchase an aggregate of 869,047 shares of the Company’s common stock with an exercise price of $3.15 per share. On May 29, 2013, 119,047 of the warrants were amended to reflect an exercise price of $3.38 per share. The warrants will expire on May 9, 2018. As of June 30, 2015, 869,047 of these warrants remain outstanding and exercisable. |
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Net Loss Per Share
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6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2015
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Earnings Per Share [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Net Loss Per Share | 7. Net Loss Per Share The Company computes basic net loss per share using the weighted average number of common shares outstanding during the period. Diluted net income per share is based upon the weighted average number of common shares and potentially dilutive securities (common share equivalents) outstanding during the period. Common share equivalents outstanding, determined using the treasury stock method, are comprised of shares that may be issued under the Company’s stock option agreements and warrants. Common share equivalents are excluded from the diluted net loss per share calculation because of their anti-dilutive effect. Potentially dilutive outstanding securities excluded from diluted net loss per common share because of their anti-dilutive effect:
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Related Party Transactions
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6 Months Ended |
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Jun. 30, 2015
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Related Party Transactions [Abstract] | |
Related Party Transactions | 8. Related Party Transactions On October 13, 2011, the Company entered into a services agreement with Kissei to perform two separate studies relating to MN-221 in exchange for $2.5 million paid to the Company in October 2011. The Company is responsible for all costs to be incurred in the performance of these studies. The amount received from Kissei, net of the amount recorded as revenue through June 30, 2015, is included on the balance sheet at June 30, 2015 as long-term deferred revenue and will be recognized as revenue in future periods upon the Company’s performance of the remaining services. |
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Subsequent Events
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6 Months Ended |
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Jun. 30, 2015
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Subsequent Events [Abstract] | |
Subsequent Events | 9. Subsequent Events The Company has evaluated all subsequent events that have occurred after the date of the accompanying financial statements and determined that there were no events or transactions occurring during the subsequent event reporting period which require recognition or disclosure in the Company’s consolidated financial statements. |
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Interim Financial Information (Policies)
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6 Months Ended |
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Jun. 30, 2015
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Quarterly Financial Information Disclosure [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying unaudited consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (GAAP) for interim financial information and with the instructions of the Securities and Exchange Commission (SEC) on Form 10-Q and Rule 10-01 of Regulation S-X. Accordingly, they do not include all of the information and disclosures required by GAAP for complete financial statements. In the opinion of management, the consolidated financial statements include all adjustments necessary, which are of a normal and recurring nature, for the fair presentation of the Company’s financial position and of the results of operations and cash flows for the periods presented. The accompanying unaudited consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. These financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto for the year ended December 31, 2014 included in the Company’s Annual Report on Form 10-K filed with the SEC. The results of operations for the interim period shown in this report are not necessarily indicative of the results that may be expected for any other interim period or for the full year. The balance sheet at December 31, 2014 has been derived from the audited financial statements at that date, but does not include all of the information and footnotes required by GAAP for complete financial statements. |
Research, Development and Patents | Research, Development and Patents Research and development costs are expensed in the period incurred. Research and development costs primarily consist of salaries and related expenses for personnel, facilities and depreciation, research and development supplies, licenses and outside services. Such research and development costs totaled $0.7 million for the three-months ended June 30, 2015 and 2014. Research and development costs totaled $1.3 million and $1.4 million for the six months ended June 30, 2015 and 2014, respectively. Costs related to filing and pursuing patent applications are expensed as incurred, as recoverability of such expenditures is uncertain. The Company includes all external costs related to the filing of patents on developments in Research, Development and Patents expenses. Such patent-related expenses totaled $0.1 million for the three-months ended June 30, 2015 and 2014. Patent-related expenses totaled $0.2 million for the six months ended June 30, 2015 and 2014. |
Use of Estimates | Use of Estimates The preparation of the consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and the accompanying notes. Actual results could differ from those estimates. |
Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements In May 2014, the Financial Accounting Standards Board (“FASB”) and the International Accounting Standards Board “(IASB”) jointly issued Accounting Standards Update (“ASU”) No. 2014-09, Revenue from Contracts from Customers, which supersedes the revenue recognition requirements in ASC 605, Revenue Recognition. ASU 2014-09 is a comprehensive new revenue recognition standard that will supersede nearly all existing revenue recognition guidance under US GAAP and IFRS. The standard’s core principle is that a company will recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. In doing so, companies will need to use more judgment and make more estimates than under current authoritative guidance. These may include identifying performance obligations in the contract, estimating the amount of variable consideration to include in the transaction price and allocating the transaction price to each separate performance obligation. The standard is effective for public entities for annual and interim periods beginning after December 15, 2016. Early adoption is not permitted under US GAAP. The adoption of this guidance is not expected to have a material impact on the Company. In August 2014, the FASB issued ASU 2014-15, Presentation of Financial Statements – Going Concern, which is new guidance requiring management to evaluate whether there are conditions and events that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the financial statements are issued (or available to be issued when applicable). Management will be required to make this evaluation for both annual and interim reporting periods and will have to make certain disclosures if it concludes that substantial doubt exists or when its plans alleviate substantial doubt about the entity’s ability to continue as a going concern. The standard is effective for annual periods ending after December 15, 2016. Early adoption is permitted. The adoption of this guidance is not expected to have a material impact on the Company. |
Vendor Payment | Vendor Payment During the six months ended June 30, 2015, the Company received a $100,000 payment from a vendor to offset the costs of manufactured drug product that was inadvertently destroyed by the vendor. The vendor payment has been recorded as an offset to general and administrative expense. |
Revenue Recognition Policy | Revenue Recognition Policy Revenues consist of milestone payments and research and development services. Milestone payments are recognized as revenue upon achievement of pre-defined scientific events, which require substantive effort, and for which achievement of the milestone was not readily assured at the inception of the agreement. Milestones that do not meet the criteria for accounting under the milestone method because the payments are solely contingent upon the performance of a third party are accounted for as contingent revenue. Research and development services are recognized as research costs are incurred over the period the services are performed. For all other revenue the Company recognizes revenues when all four of the following criteria are met: (1) persuasive evidence that an arrangement exists; (2) delivery of the products and/or services has occurred; (3) the selling price is fixed or determinable; and (4) collectability is reasonably assured. |
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Research development and patents expense. No definition available.
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Vendor payment policy. No definition available.
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Stock-based Compensation (Tables)
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6 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2015
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Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Stock Option Activity and Related Information | A summary of stock option activity and related information as of June 30, 2015 is as follows:
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Weighted-Average Assumptions for Stock Option | The following table provides the assumptions used in the Black-Scholes valuation model for the three and six months ended June 30, 2015 and 2014. The ESPP assumptions for the three months ended June 30, 2015 and 2014 are actual amounts, and the assumptions for the six months ended June 30, 2015 and 2014 are weighted average amounts.
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Net Loss Per Share (Tables)
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6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2015
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Earnings Per Share [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Securities Excluded from Diluted Net Loss Per Common Share | Potentially dilutive outstanding securities excluded from diluted net loss per common share because of their anti-dilutive effect:
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Interim Financial Information - Additional Information (Detail) (USD $)
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3 Months Ended | 6 Months Ended | ||
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Jun. 30, 2015
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Jun. 30, 2014
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Jun. 30, 2015
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Jun. 30, 2014
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Quarterly Financial Information Disclosure [Abstract] | ||||
Research and development | $ 700,000 | $ 700,000 | $ 1,300,000 | $ 1,400,000 |
Patent-related expenses | 100,000 | 100,000 | 200,000 | 200,000 |
Payment received from vendor | $ 100,000 |
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Revenue Recognition - Additional Information (Detail) (USD $)
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1 Months Ended | 3 Months Ended | 6 Months Ended | ||
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Oct. 31, 2011
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Jun. 30, 2015
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Jun. 30, 2014
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Jun. 30, 2015
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Jun. 30, 2014
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Accounting Policies [Abstract] | |||||
Deferred revenue related to research and development services | $ 2,500,000 | ||||
Revenue relating to research and development services | $ 2,500,000 | $ 0 | $ 0 | $ 0 | $ 0 |
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Fair Value Measurements - Additional Information (Detail) (Fair Value Measurements Using Level 1, USD $)
In Millions, unless otherwise specified |
Jun. 30, 2015
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Dec. 31, 2014
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Fair Value Measurements Using Level 1
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Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents, including money market accounts | $ 8.3 | $ 11.5 |
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Joint Venture - Additional Information (Detail) (USD $)
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1 Months Ended | |
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Mar. 31, 2012
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Aug. 31, 2014
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Equity Method Investments And Joint Ventures [Abstract] | ||
Investment in China joint venture | $ 680,000 | |
Investment in China joint venture, percentage | 30.00% | 50.00% |
Other parties investment in China joint venture, percentage | 70.00% |
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Equity method investment third party percentage. No definition available.
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Stock-Based Compensation - Additional Information (Detail) (USD $)
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3 Months Ended | 6 Months Ended | 6 Months Ended | |||||||
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Jun. 30, 2015
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Jun. 30, 2014
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Jun. 30, 2015
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Jun. 30, 2014
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Jun. 30, 2015
Employee Stock Purchase Plan
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Dec. 31, 2007
Employee Stock Purchase Plan
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Jun. 30, 2015
2013 Plan
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Jun. 30, 2013
2013 Plan
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Jun. 30, 2015
2013 Plan
Minimum
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Jun. 30, 2015
2013 Plan
Maximum
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Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||||
Common Stock reserved for future issuance | 209,349 | 300,000 | 2,500,000 | |||||||
Stock option available for future grant | 1,710,825 | |||||||||
Options granted expiration term | 10 years | |||||||||
Stock option, vesting period | 3 years | 4 years | ||||||||
Stock options exercised | 0 | 0 | ||||||||
Shares reserved, description | Shares reserved automatically increase each year by a number equal to the lesser of: (i) 15,000 shares; (ii) 1% of the outstanding shares of common stock on the last day of the immediately preceding fiscal year; or (iii) such lesser amount as determined by the Board. | |||||||||
Percentage of employee compensation for purchase of common stock under ESPP | Cannot exceed 15% | |||||||||
Common stock fair market value, percentage | 85.00% | |||||||||
Employee stock purchase plan offering period | 6 months | |||||||||
Shares issued under ESPP | 21,604 | |||||||||
Stock Options, Granted | 649,000 | |||||||||
Stock-based compensation expense | $ 546,366 | $ 231,321 | $ 1,059,671 | $ 486,420 | ||||||
Unamortized compensation cost | $ 1,300,000 | $ 1,300,000 | ||||||||
Unamortized compensation cost, vesting period | 1 year |
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Common stock fair market value percentage. No definition available.
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Employee stock purchase plan offering period. No definition available.
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Percentage of employee compensation for purchase of common stock under espp. No definition available.
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Stock issuance limit under employee stock purchase plan description. No definition available.
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Changes in Stock Options Outstanding (Detail) (USD $)
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6 Months Ended | |
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Jun. 30, 2015
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Jun. 30, 2014
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Number of Option Shares | ||
Stock Options, Beginning Balance | 3,447,969 | |
Stock Options, Granted | 649,000 | |
Stock Options, Exercised | 0 | 0 |
Stock Options, Ending Balance | 4,096,969 | |
Stock Options, Exercisable at June 30, 2015 | 3,147,731 | |
Weighted Average Exercise Price | ||
Weighted Average Exercise Price, Beginning Balance | $ 5.00 | |
Weighted Average Exercise Price, Granted | $ 3.09 | |
Weighted Average Exercise Price, Ending Balance | $ 4.70 | |
Weighted Average Exercise Price, Exercisable at June 30, 2015 | $ 5.16 | |
Weighted Average Contractual Life | ||
Weighted Average Contractual Life, Ending balance | 6 years 2 months 19 days | |
Weighted Average Contractual Life, Exercisable at June 30, 2015 | 5 years 3 months 22 days | |
Aggregate Intrinsic Value | ||
Aggregate Intrinsic Value, Option Outstanding | $ 2,876,323 | |
Aggregate Intrinsic Value, Option Exercisable | $ 2,122,856 |
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Weighted-Average Assumptions for Stock Option (Detail)
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3 Months Ended | 6 Months Ended | ||
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Jun. 30, 2015
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Jun. 30, 2014
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Jun. 30, 2015
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Jun. 30, 2014
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Stock Option
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Weighted-average assumptions for stock options and ESPP | ||||
Risk-free interest rate | 0.21% | 1.47% | 0.21% | |
Expected volatility of common stock | 63.46% | 79.24% | 63.46% | |
Dividend yield | 0.00% | 0.00% | 0.00% | |
Expected term (in years) | 0 years | 1 year 5 months 27 days | 5 years 6 months | 1 year 5 months 27 days |
Employee Stock Purchase Plan
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Weighted-average assumptions for stock options and ESPP | ||||
Risk-free interest rate | 0.12% | 0.06% | 0.12% | 0.06% |
Expected volatility of common stock | 82.30% | 67.60% | 82.30% | 67.60% |
Dividend yield | 0.00% | 0.00% | 0.00% | 0.00% |
Expected term (in years) | 6 months | 6 months | 6 months | 6 months |
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Stockholders Equity - Additional Information (Detail) (USD $)
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6 Months Ended | 12 Months Ended | 1 Months Ended | 6 Months Ended | 0 Months Ended | 6 Months Ended | 0 Months Ended | 1 Months Ended | 6 Months Ended | ||||||||||||||
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Jun. 30, 2015
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Dec. 31, 2011
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Dec. 31, 2014
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Jun. 30, 2014
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Aug. 31, 2012
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May 31, 2013
Purchase Agreement
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Jun. 30, 2015
Purchase Agreement
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May 29, 2013
Purchase Agreement
Investor
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May 22, 2015
MCUSA
October 16, 2013 At Market Sales Agreement
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Oct. 16, 2013
MCUSA
October 16, 2013 At Market Sales Agreement
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Jun. 30, 2015
MCUSA
October 16, 2013 At Market Sales Agreement
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May 22, 2015
MLV
May 22, 2015 At Market Sales Agreement
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May 31, 2013
Common Stock
Purchase Agreement
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Jun. 30, 2015
Common Stock
MCUSA
Minimum
October 16, 2013 At Market Sales Agreement
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May 22, 2015
Common Stock
MCUSA
Minimum
October 16, 2013 At Market Sales Agreement
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Oct. 16, 2013
Common Stock
MCUSA
Minimum
October 16, 2013 At Market Sales Agreement
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Jun. 30, 2015
Common Stock
MCUSA
Maximum
October 16, 2013 At Market Sales Agreement
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May 22, 2015
Common Stock
MCUSA
Maximum
October 16, 2013 At Market Sales Agreement
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May 22, 2015
Common Stock
MLV
Minimum
May 22, 2015 At Market Sales Agreement
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May 22, 2015
Common Stock
MLV
Maximum
May 22, 2015 At Market Sales Agreement
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Jun. 30, 2015
Common Stock Warrants
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Jun. 30, 2014
Common Stock Warrants
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Dec. 31, 2011
Common Stock Warrants
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Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||||||||
Stock purchase agreement, aggregate amount of common stock agreed to be purchased | $ 10,000,000 | $ 30,000,000 | |||||||||||||||||||||
Stock Purchase Agreement, maximum amount of sale | 50,000 | ||||||||||||||||||||||
Stock Purchase Agreement, maximum amount of sale terms | 10% of the lower of the 5-day or 3-month average daily traded value of the Company’s common stock | ||||||||||||||||||||||
Sales commission as a percentage of gross proceeds | 7.00% | 4.00% | |||||||||||||||||||||
Shares purchase & equity issuance, per share amount | $ 3.24 | $ 2.01 | $ 1.29 | $ 4.45 | $ 4.45 | $ 4.16 | $ 4.23 | ||||||||||||||||
Equity distribution agreement termination date | May 22, 2015 | ||||||||||||||||||||||
Issuance of common stock under securities purchase agreements | 24,893,221 | 24,436,317 | 2,127,500 | 225,000 | 7,800 | ||||||||||||||||||
Stock purchase agreement, gross proceeds | 5,300,000 | 900,000 | 32,700 | ||||||||||||||||||||
Stock purchase agreement, net proceeds | 4,500,000 | 700,000 | 31,600 | ||||||||||||||||||||
Payments of Stock Issuance Costs | 101,800 | ||||||||||||||||||||||
Public Offering | 2,800,666 | ||||||||||||||||||||||
Public Offering per unit | $ 3.00 | ||||||||||||||||||||||
Public Offering proceeds | 8,250,000 | ||||||||||||||||||||||
Warrant, exercisable period | 5 years | ||||||||||||||||||||||
Common share exercise price | $ 1.88 | $ 3.15 | $ 3.38 | $ 3.56 | |||||||||||||||||||
Warrant exercised | 187,500 | 85,500 | |||||||||||||||||||||
Warrants, exercisable value | $ 28,200 | $ 700,000 | $ 300,000 | ||||||||||||||||||||
Warrants, Outstanding | 869,047 | 2,389,000 | |||||||||||||||||||||
Warrant issued to purchase Common shares | 130,000 | 869,047 | 119,047 | ||||||||||||||||||||
Warrant, exercisable shares | 15,000 | ||||||||||||||||||||||
Warrant, vested shares | 0 | ||||||||||||||||||||||
Issuance of common stock under securities purchase agreements | 1,158,730 | ||||||||||||||||||||||
Shares purchase & equity issuance, per share amount | $ 3.15 | ||||||||||||||||||||||
Warrant termination date | May 09, 2018 |
X | ||||||||||
- Definition
Agreement termination date. No definition available.
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X | ||||||||||
- Definition
Class of warrant or right, exercisable. No definition available.
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X | ||||||||||
- Definition
Class of warrant or right, exercised in period. No definition available.
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X | ||||||||||
- Definition
Class of warrant or rights exercisable period from date of issuance. No definition available.
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X | ||||||||||
- Definition
Class of warrant or right vested. No definition available.
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X | ||||||||||
- Definition
Common shares in underwritten public offering. No definition available.
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X | ||||||||||
- Definition
Common stock issued under underwritten public offering price per share. No definition available.
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X | ||||||||||
- Definition
Common stock maximum sale amount under purchase agreement. No definition available.
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X | ||||||||||
- Definition
Equity issuance per share amount. No definition available.
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X | ||||||||||
- Definition
Proceeds from issuance of common stock net. No definition available.
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X | ||||||||||
- Definition
Sales commission. No definition available.
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X | ||||||||||
- Definition
Stock issued during period shares issued for cash. No definition available.
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X | ||||||||||
- Definition
Underwritten public offering price value. No definition available.
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X | ||||||||||
- Definition
Warrants expiration date. No definition available.
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X | ||||||||||
- Definition
No authoritative reference available. No definition available.
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X | ||||||||||
- Definition
No authoritative reference available. No definition available.
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X | ||||||||||
- Definition
No authoritative reference available. No definition available.
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X | ||||||||||
- Definition
No authoritative reference available. No definition available.
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X | ||||||||||
- Definition
No authoritative reference available. No definition available.
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X | ||||||||||
- Definition
No authoritative reference available. No definition available.
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X | ||||||||||
- Definition
No authoritative reference available. No definition available.
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X | ||||||||||
- Definition
No authoritative reference available. No definition available.
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X | ||||||||||
- Definition
No authoritative reference available. No definition available.
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X | ||||||||||
- Details
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X | ||||||||||
- Definition
No authoritative reference available. No definition available.
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Securities Excluded from Diluted Net Loss Per Common Share (Detail)
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6 Months Ended | |
---|---|---|
Jun. 30, 2015
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Jun. 30, 2014
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Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 9,753,036 | 9,141,034 |
Convertible preferred stock, as converted
|
||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 2,200,000 | 2,200,000 |
Stock options
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||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 4,096,969 | 3,265,467 |
Warrants
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Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 3,456,067 | 3,675,567 |
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
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X | ||||||||||
- Details
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Related Party Transactions - Additional Information (Detail) (USD $)
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1 Months Ended | 3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|---|
Oct. 31, 2011
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Jun. 30, 2015
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Jun. 30, 2014
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Jun. 30, 2015
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Jun. 30, 2014
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Related Party Transactions [Abstract] | |||||
Revenue relating to research and development services | $ 2,500,000 | $ 0 | $ 0 | $ 0 | $ 0 |
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- Details
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X | ||||||||||
- Definition
No authoritative reference available. No definition available.
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