Basis of Presentation and Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2014 |
Accounting Policies [Abstract] | ' |
Basis of Presentation and Significant Accounting Policies | ' |
2 | Basis of Presentation and Significant Accounting Policies. | | | | | | | | | | | | | | | |
|
| a. | INTERIM FINANCIAL STATEMENTS. The accompanying unaudited interim financial statements have been prepared in accordance with U.S. generally accepted accounting principles (U.S. GAAP), and pursuant to the rules and regulations of the SEC for reporting of interim financial information. Pursuant to such rules and regulations, certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted. The balance sheet as of December 31, 2013 included in this Form 10-Q was derived from the audited financial statements and does not include all disclosures required by U.S. GAAP. | | | | | | | | | | | | | | |
In the opinion of management, the accompanying unaudited interim financial statements of the Company contain all adjustments (consisting of only normal recurring adjustments) necessary to present fairly the financial position of the Company as of the dates and for the periods presented. Accordingly, these statements should be read in conjunction with the financial statements and notes thereto for the year ended December 31, 2013 included in the 2013 Annual Report on Form 10-K filed by the Company with the SEC. The results of operations for the three and nine months ended September 30, 2014 are not necessarily indicative of the results to be expected for any future period or for the full 2014 fiscal year. |
|
| b. | USE OF ESTIMATES. The preparation of financial statements in conformity with U.S. generally accepted accounting principles requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates. | | | | | | | | | | | | | | |
|
| c. | CASH AND CASH EQUIVALENTS. The Company considers all highly liquid instruments purchased with an original maturity of three months or less to be cash equivalents. Cash equivalents consist of money market funds. The Company has substantially all of its cash and cash equivalents deposited with one financial institution. | | | | | | | | | | | | | | |
|
| d. | CERTIFICATES OF DEPOSIT. The certificates of deposit are issued by a banking institution and are recorded at cost plus accrued interest. The original maturity is greater than three months but does not exceed one year. Interest income is recorded in the statement of operations as it is earned. Carrying value at September 30, 2014 and December 31, 2013 approximates fair value. | | | | | | | | | | | | | | |
|
| e. | SHORT-TERM INVESTMENTS. The Company invests in short-term investments in high credit-quality funds in order to obtain higher yields on its cash available for investments. As of September 30, 2014 and December 31, 2013 short-term investments consisted of a short-term bond fund. Such investments are not insured by the Federal Deposit Insurance Corporation. Short-term investments at September 30, 2014 and December 31, 2013 were considered trading securities. Trading securities are recorded at fair value based on the closing market price of the security. For trading securities, the Company recognizes realized gains and losses and unrealized gains and losses to earnings. Realized and unrealized losses for the three and nine months ended September 30, 2014 were $29,430 and $18,316, respectively. Realized and unrealized gains (losses) for the three and nine months ended September 30, 2013 were nominal. | | | | | | | | | | | | | | |
|
| f. | PREPAID EXPENSES AND OTHER CURRENT ASSETS. Prepaid expenses and other current assets consist primarily of insurance recoverable, prepaid research fees, prepaid insurance and prepaid subscription fees. Insurance recoverable relates to the securities class action lawsuit proposed settlement to be paid by the Company’s insurance carrier. Prepaid research fees consists of advances for the Company’s product development activities, including drug manufacturing, contracts for pre-clinical studies, clinical trials, regulatory affairs and consulting. Such advances are recorded as expense as the related goods are received or the related services are performed. | | | | | | | | | | | | | | |
|
| g. | FAIR VALUE OF FINANCIAL INSTRUMENTS. The Company’s financial instruments consist of cash and cash equivalents, certificates of deposit, short-term investments, accounts payables, accrued expenses and other liabilities, and warrants liability. At September 30, 2014 and December 31, 2013, the fair value of these instruments approximated their carrying value. | | | | | | | | | | | | | | |
|
| h. | FAIR VALUE MEASUREMENTS. Current Financial Accounting Standards Board (FASB) fair value guidance emphasizes that fair value is a market-based measurement, not an entity-specific measurement. Therefore, a fair value measurement should be determined based on the assumptions that market participants would use in pricing the asset or liability. As a basis for considering market participant assumptions in fair value measurements, current FASB guidance establishes a fair value hierarchy that distinguishes between market participant assumptions based on market data obtained from sources independent of the reporting entity (observable inputs that are classified within Levels 1 and 2 of the hierarchy) and the reporting entity’s own assumptions that market participants would use in pricing assets or liabilities (unobservable inputs classified within Level 3 of the hierarchy). | | | | | | | | | | | | | | |
|
Level 1 inputs utilize quoted prices (unadjusted) in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date. Level 2 inputs are inputs other than quoted prices included in Level 1 that are observable for the asset or liability, either directly or indirectly. Level 2 inputs may include quoted prices for similar assets and liabilities in active markets, as well as inputs that are observable for the asset or liability (other than quoted prices), such as interest rates, foreign exchange rates, and yield curves that are observable at commonly quoted intervals. Level 3 inputs are unobservable inputs for the asset or liability, which is typically based on an entity’s own assumptions, as there is little, if any, related market activity. In instances where the determination of the fair value measurement is based on inputs from different levels of the fair value hierarchy, the level in the fair value hierarchy within which the entire fair value measurement falls is based on the lowest level input that is significant to the fair value measurement in its entirety. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment, and considers factors specific to the asset or liability. |
|
| | | | | | | | | | | | | | | | |
| | Fair Value Measurements at Reporting Date Using | |
| | Balances as of | | | Quoted Prices in | | | Significant | | | Significant | |
September 30, | Active Markets | Other | Unobservable |
2014 | for Identical | Observable | Inputs |
| Assets/Liabilities | Inputs | (Level 3) |
| (Level 1) | (Level 2) | |
Money market funds | | $ | 10,030,873 | | | $ | 10,030,873 | | | $ | — | | | $ | — | |
| | | | | | | | | | | | | | | | |
Certificates of deposit | | $ | 3,714,634 | | | $ | — | | | $ | 3,714,634 | | | $ | — | |
| | | | | | | | | | | | | | | | |
Short-term investments | | $ | 26,468,664 | | | $ | 26,468,664 | | | $ | — | | | $ | — | |
| | | | | | | | | | | | | | | | |
Warrants liability | | $ | 3,266,917 | | | $ | — | | | $ | — | | | $ | 3,266,917 | |
| | | | | | | | | | | | | | | | |
| |
| | Fair Value Measurements at Reporting Date Using | |
| | Balances as of | | | Quoted Prices in | | | Significant | | | Significant | |
December 31, | Active Markets | Other | Unobservable |
2013 | for Identical | Observable | Inputs |
| Assets/Liabilities | Inputs | (Level 3) |
| (Level 1) | (Level 2) | |
Money market funds | | $ | 25,693 | | | $ | 25,693 | | | $ | — | | | $ | — | |
| | | | | | | | | | | | | | | | |
Certificates of deposit | | $ | 4,011,576 | | | $ | — | | | $ | 4,011,576 | | | $ | — | |
| | | | | | | | | | | | | | | | |
Short-term investments | | $ | 17,483,062 | | | $ | 17,483,062 | | | $ | — | | | $ | — | |
| | | | | | | | | | | | | | | | |
Warrants liability | | $ | 1,819,562 | | | $ | — | | | $ | — | | | $ | 1,819,562 | |
| | | | | | | | | | | | | | | | |
|
| i. | WARRANTS LIABILITY. In October 2011, the Company issued 1,523,370 warrants (the 2011 warrants) to purchase shares of the Company’s common stock in connection with a registered direct offering under the 2010 Shelf Registration Statement. The Company accounted for these warrants as a liability measured at fair value due to a provision included in the warrants agreement that provides the warrants holders with an option to require the Company (or its successor) to purchase their warrants for cash in an amount equal to their Black-Scholes Option Pricing Model (the Black-Scholes Model) value, in the event that certain fundamental transactions, as defined, occur. The fair value of the warrants liability is estimated using the Black-Scholes Model which requires inputs such as the expected term of the warrants, share price volatility and risk-free interest rate. These assumptions are reviewed on a quarterly basis and changes in the estimated fair value of the outstanding warrants are recognized each reporting period in the “Change in fair value of warrants liability” line in the statement of operations. As of September 30, 2014 and December 31, 2013, 1,242,174 and 1,254,870, respectively, of the 2011 warrants remained outstanding. | | | | | | | | | | | | | | |
|
| j. | STOCK-BASED COMPENSATION. The Company recognizes expense in the statement of operations for the fair value of all share-based payments to employees, directors, consultants and scientific advisors, including grants of stock options and other share-based awards. For stock options, the Company uses the Black-Scholes option valuation model, the single-option award approach, and the straight-line attribution method. Using this approach, compensation cost is amortized on a straight-line basis over the vesting period of each respective stock option, generally three to seven years. The Company estimates forfeitures and adjusts this estimate periodically based on actual forfeitures. | | | | | | | | | | | | | | |
As of September 30, 2014, there were outstanding stock options to purchase 4,624,610 shares of common stock, of which stock options to purchase 3,227,942 shares of common stock were exercisable as of September 30, 2014. |
For the three and nine month periods ended September 30, 2014 and 2013, the Company recorded stock-based compensation expense as follows: |
|
| | | | | | | | | | | | | | | | |
| | Three months ended | | | Nine months ended | |
September 30, | September 30, |
| | 2014 | | | 2013 | | | 2014 | | | 2013 | |
Research and development | | $ | 35,704 | | | $ | 23,133 | | | $ | 59,583 | | | $ | 63,508 | |
General and administrative | | | 408,922 | | | | 23,532 | | | | 430,743 | | | | 69,797 | |
| | | | | | | | | | | | | | | | |
Total stock-based compensation | | $ | 444,626 | | | $ | 46,665 | | | $ | 490,326 | | | $ | 133,305 | |
| | | | | | | | | | | | | | | | |
|
| k. | COMPREHENSIVE INCOME (LOSS). U.S. generally accepted accounting principles require that all components of comprehensive income (loss) be reported in the financial statements in the period in which they are recognized. Comprehensive income (loss) is net income (loss), plus certain other items that are recorded directly into stockholders’ equity. For all periods presented, the Company’s net loss equals comprehensive loss, since the Company has no items which are considered other comprehensive income (loss). | | | | | | | | | | | | | | |
|
| l. | NET LOSS PER SHARE. Basic loss per share is computed by dividing net loss for the period by the weighted average number of common shares outstanding during the period. The calculation of basic and diluted net loss per share is the same for all periods presented, as the effect of potential common stock equivalents is anti-dilutive due to the Company’s net loss position for all periods presented. The potential shares, which are excluded from the determination of basic and diluted net loss per share as their effect is anti-dilutive, are as follows: | | | | | | | | | | | | | | |
|
| | | | | | | | | | | | | | | | |
| | September 30, | | | | | | | | | |
| | 2014 | | | 2013 | | | | | | | | | |
Options to purchase common stock | | | 4,624,610 | | | | 3,488,906 | | | | | | | | | |
Warrants to purchase common stock | | | 4,835,924 | | | | 4,994,620 | | | | | | | | | |
| | | | | | | | | | | | | | | | |
Potential equivalent common stock excluded | | | 9,460,534 | | | | 8,483,526 | | | | | | | | | |
| | | | | | | | | | | | | | | | |
Potentially dilutive options to purchase common stock as of September 30, 2014 and 2013 have exercise prices per share ranging from $0.47 to $3.12 and $0.47 to $6.00, respectively. Potentially dilutive warrants to purchase common stock as of September 30, 2014 and 2013 have exercise prices ranging from $1.04 to $2.08 per share. |
|
| m. | RECENTLY ISSUED ACCOUNTING STANDARDS. In June 2014, the FASB issued ASU No. 2014-10, Development Stage Entities (Topic 915): Elimination of Certain Financial Reporting Requirements, Including an Amendment to Variable Interest Entities Guidance in Topic 810, Consolidation. The amendments in this ASU include: i) eliminating the requirement to present inception-to-date information on the statements of income, cash flows, and shareholders’ equity, ii) eliminating the need to label the financial statements as those of a development stage entity, iii) eliminating the need to disclose a description of the development stage activities in which the entity is engaged, and iv) eliminating the requirement to disclose in the first year in which the entity is no longer a development stage entity that in prior years it had been in the development stage. The amendments in ASU No. 2014-10 are effective for public companies for annual and interim reporting periods beginning after December 15, 2014. Early adoption is permitted. The Company has early adopted ASU No. 2014-10, beginning with the interim period ended June 30, 2014. | | | | | | | | | | | | | | |
In August 2014, the FASB issued ASU No. 2014-15, Presentation of Financial Statements—Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern. The amendments in this ASU, require management to assess a company’s ability to continue as a going concern and to provide related footnote disclosures in certain circumstances. The guidance will be effective for the annual period ending after December 15, 2016 and subsequent interim and annual periods thereafter. The Company is currently evaluating the impact of this accounting standard update on its financial statements. |