Document_and_Entity_Informatio
Document and Entity Information | 3 Months Ended | |
Mar. 31, 2015 | 11-May-15 | |
Document and Entity Information | ||
Entity Registrant Name | AGILE THERAPEUTICS INC | |
Entity Central Index Key | 1261249 | |
Document Type | 10-Q | |
Document Period End Date | 31-Mar-15 | |
Amendment Flag | FALSE | |
Current Fiscal Year End Date | -19 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Common Stock, Shares Outstanding | 22,202,637 | |
Document Fiscal Year Focus | 2015 | |
Document Fiscal Period Focus | Q1 |
Balance_Sheets
Balance Sheets (USD $) | Mar. 31, 2015 | Dec. 31, 2014 |
Current assets: | ||
Cash and cash equivalents | $53,865,380 | $40,182,141 |
Prepaid expenses | 495,221 | 803,775 |
Total current assets | 54,360,601 | 40,985,916 |
Property and equipment, net of accumulated depreciation of $290,669 in 2015 and $285,643 in 2014 | 12,229,840 | 12,046,267 |
Prepaid expenses, long-term | 1,677,434 | 1,677,434 |
Deferred financing costs, net | 410,069 | 98,401 |
Other assets | 18,208 | 18,208 |
Total assets | 68,696,152 | 54,826,226 |
Current liabilities: | ||
Accounts payable | 3,309,188 | 2,631,217 |
Accrued expenses | 1,108,412 | 1,062,113 |
Loan payable, current portion | 5,003,143 | |
Warrant liability | 396,892 | 296,048 |
Total current liabilities | 4,814,492 | 8,992,521 |
Loan payable, long-term | 15,124,990 | 9,827,758 |
Commitment and contingencies | ||
Stockholders' equity: | ||
Common stock, $.0001 par value, authorized 150,000,000 shares; 22,160,233 shares issued and outstanding as of March 31, 2015 and 18,634,872 shares issued and outstanding as of December 31, 2014 | 2,217 | 1,864 |
Additional paid-in capital | 191,684,665 | 170,395,934 |
Accumulated deficit | -142,930,212 | -134,391,851 |
Total stockholders' equity | 48,756,670 | 36,005,947 |
Total liabilities and stockholders' equity | $68,696,152 | $54,826,226 |
Balance_Sheets_Parenthetical
Balance Sheets (Parenthetical) (USD $) | Mar. 31, 2015 | Dec. 31, 2014 |
Balance Sheets | ||
Accumulated depreciation | $290,669 | $285,643 |
Common stock, par value (in dollars per share) | $0.00 | $0.00 |
Common stock, authorized | 150,000,000 | 150,000,000 |
Common stock, issued | 22,160,233 | 18,634,872 |
Common stock, outstanding | 22,160,233 | 18,634,872 |
Statements_of_Operations
Statements of Operations (USD $) | 3 Months Ended | |
Mar. 31, 2015 | Mar. 31, 2014 | |
Operating expenses: | ||
Research and development | $5,378,148 | $1,394,322 |
General and administrative | 1,598,726 | 1,053,304 |
Total operating expenses | 6,976,874 | 2,447,626 |
Loss from operations | -6,976,874 | -2,447,626 |
Other income (expense) | ||
Interest expense | -425,834 | -378,228 |
Interest income | 1,172 | 56 |
Change in fair value of warrants | -100,844 | 12,606 |
Loss on extinguishment of debt | 1,035,981 | |
Loss before benefit from income taxes | -8,538,361 | -2,813,192 |
Benefit from income taxes | 3,652,485 | |
Net loss (income) | ($8,538,361) | $839,293 |
Net (loss) income per share (basic) | ($0.40) | $0.10 |
Net (loss) income per share (diluted) | ($0.40) | $0.01 |
Weighted-average shares outstanding (basic) | 21,282,692 | 106,309 |
Weighted-average shares outstanding (diluted) | 21,282,692 | 822,178 |
Statements_of_Cash_Flows
Statements of Cash Flows (USD $) | 3 Months Ended | |
Mar. 31, 2015 | Mar. 31, 2014 | |
Cash flows from operating activities | ||
Net loss (income) | ($8,538,361) | $839,293 |
Adjustments to reconcile net (loss) income to net cash (used in) provided by operating activities: | ||
Depreciation | 5,026 | 2,587 |
Noncash stock bonus | 80,000 | |
Noncash stock based compensation | 644,721 | 228,106 |
Noncash interest | 73,074 | 33,228 |
Loss on extinguishment of debt | -1,035,981 | |
Change in fair value of warrants | 100,844 | -12,606 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | 308,554 | 51,430 |
Accounts payable and accrued expenses | 724,269 | -290,451 |
Net cash (used in) provided by operating activities | -5,645,892 | 931,587 |
Cash flows from investing activities | ||
Acquisition of property and equipment | -188,599 | -1,070 |
Net cash used in investing activities | -188,599 | -1,070 |
Cash flows from financing activities | ||
Cash paid for offering costs | -40,160 | |
Proceeds from issuance of long-term debt, net | 16,265,000 | |
Repayment of long-term debt | -15,784,150 | |
Cash paid for financing costs | -423,256 | |
Proceeds from the issuance of common stock, net | 19,330,613 | |
Proceeds from exercise of stock options | 129,523 | |
Net cash provided by (used in) financing activities | 19,517,730 | -40,160 |
Net increase in cash and cash equivalents | 13,683,239 | 890,357 |
Cash and cash equivalents, beginning of period | 40,182,141 | 2,119,646 |
Cash and cash equivalents, end of period | 53,865,380 | 3,010,003 |
Supplemental cash flow information | ||
Interest paid | 339,261 | 345,000 |
Fair value of common stock warrants | $1,184,228 |
Organization_and_Basis_of_Pres
Organization and Basis of Presentation | 3 Months Ended |
Mar. 31, 2015 | |
Organization and Basis of Presentation | |
Organization and Basis of Presentation | |
1. Organization and Basis of Presentation | |
Nature of Operations | |
Agile Therapeutics, Inc. (the “Company”) was incorporated in Delaware on December 22, 1997. The Company is engaged in research and development of transdermal patch technology for use in contraception. The Company’s activities since inception have consisted principally of raising capital, and performing research and development. The Company is headquartered in Princeton, New Jersey. | |
The Company is devoting substantially all of its efforts toward research and development of its transdermal patch for use in contraception, and raising capital. The Company has not generated product revenue to date and is subject to a number of risks similar to those of other early stage companies, including dependence on key individuals, the difficulties inherent in the development of commercially usable products, the potential need to obtain additional capital necessary to fund the development of its products, and competition from larger companies. The Company has incurred losses each year since inception. As of March 31 2015, the Company had an accumulated deficit of approximately $142.9 million. | |
The Company has financed its operations to date primarily through the issuance and sale of its common stock in its initial public offering (see Note 7), private placements of its common stock and convertible preferred stock, venture loans, and non-dilutive grant funding. The Company expects to continue to incur net losses into the foreseeable future. | |
Basis of Presentation | |
The accompanying unaudited interim condensed financial statements have been prepared by the Company, without audit, in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) for interim information and pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”) for reporting on Form 10-Q. Accordingly, certain information and footnote disclosure normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations. These interim condensed financial statements should be read in conjunction with the audited financial statements and related notes included in the Company’s annual report on Form 10-K for the year ended December 31, 2014 filed with the SEC. | |
In the opinion of management, the unaudited interim condensed financial statements reflects all adjustments, which are normal recurring adjustments, necessary for the fair presentation of the financial information for the interim periods have been made. The results of operations for the three months ended March 31, 2015 are not necessarily indicative of the operating results for the full fiscal year or any future period. | |
Summary_of_Significant_Account
Summary of Significant Accounting Polices | 3 Months Ended | |||||||
Mar. 31, 2015 | ||||||||
Summary of Significant Accounting Polices | ||||||||
Summary of Significant Accounting Polices | ||||||||
2. Summary of Significant Accounting Polices | ||||||||
The Company’s complete listing of significant accounting policies are described in Note 2 to the Company’s audited financial statements as of December 31, 2014 included in its annual report on Form 10-K filed with the SEC. | ||||||||
Use of Estimates | ||||||||
The preparation of the Company’s financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. The Company bases its estimates and judgments on historical experience and various other assumptions that it believes are reasonable under the circumstances. The amounts of assets and liabilities reported in the Company’s balance sheets and the amounts of expenses reported for each of the periods presented are affected by estimates and assumptions, which are used for, but not limited to, the accounting for common stock warrants, stock-based compensation, income taxes, and accounting for research and development costs. Actual results could differ from those estimates. | ||||||||
Fair Value of Financial Instruments | ||||||||
In accordance with ASC 825, Financial Instruments, disclosures of fair value information about financial instruments are required, whether or not recognized in the balance sheet, for which it is practicable to estimate that value. Cash and cash equivalents are carried at fair value (see Note 3). | ||||||||
Financial instruments, including accounts payable and accrued liabilities, are carried at cost, which approximates fair value given their short-term nature. | ||||||||
Warrants | ||||||||
The Company accounts for its warrants to purchase redeemable convertible stock in accordance with ASC 480, Distinguishing Liabilities from Equity. ASC 480 requires that a financial instrument, other than outstanding share, that, at inception, is indexed to an obligation to repurchase the issuer’s equity shares, regardless of the timing or the probability of the redemption feature, and may require the issuer to settle the obligation by transferring assets be classified as a liability. The Company measures the fair value of its warrant liability using an option pricing model with changes in fair value recognized as increases or reductions to other income (expense) in the statement of operations. | ||||||||
In connection with the completion of the Company’s initial public offering in May 2014, the warrants to purchase shares of Series A-1 and Series A-2 preferred stock expired unexercised and the warrants to purchase shares of Series C preferred stock automatically converted into warrants to purchase shares of common stock. Warrants with non-standard anti-dilution provisions (referred to as down round protection) are classified as liabilities and re-measured each reporting period. | ||||||||
The warrants issued in connection with the Company’s debt financing completed in February 2015 (see Note 6) are classified as a component of stockholders’ equity. The value of such warrants was determined using the Black-Scholes option-pricing model. | ||||||||
Stock-Based Compensation | ||||||||
The Company accounts for stock-based compensation in accordance with ASC 718, Compensation-Stock Compensation. The Company grants stock options for a fixed number of shares to employees and non-employees with an exercise price equal to the fair value of the shares at grant date. Compensation cost is recognized for all share-based payments granted and is based on the grant- date fair value estimated using the weighted-average assumption of the Black- Scholes option pricing model based on key assumptions such as stock price, expected volatility and expected term. The equity instrument is not considered to be issued until the instrument vests. As a result, compensation cost is recognized over the requisite service period with an offsetting credit to additional paid-in capital. | ||||||||
Awards for consultants are accounted for under ASC 505-50, Equity Based Payments to Non-Employees. Any compensation expense related to consultants is marked-to-market over the applicable vesting period as they vest. | ||||||||
Net (Loss) Income Per Share | ||||||||
Basic net (loss) income per share is calculated by dividing the net (loss) income attributable to common stockholders by the weighted average number of common shares outstanding for the period, without consideration for common stock equivalents. Diluted net (loss) income per share is calculated by dividing the net (loss) income attributable to common stockholders by the weighted-average number of common shares outstanding plus the effect of dilutive potential common shares outstanding during the period determined using the treasury-stock and if-converted methods. Dilutive potential common shares are comprised of convertible preferred stock, convertible preferred stock warrants and options outstanding under the Company’s equity incentive plan. | ||||||||
Prior to their conversion in connection with the Company’s initial public offering, the Company’s Series A-1, Series A-2, Series B and Series C convertible preferred stock were entitles to participate in earnings of the Company based upon dividend rights. Accordingly, prior to the initial public offering, the Company measured net income per share based upon the two-class method. Net income attributable to common stockholders excludes $829,285 for the three months ended March 31, 2014 for net income attributable to participating securities. | ||||||||
Potentially dilutive securities that have been excluded from the calculation of diluted net loss per share for the three months ended March 31, 2015, because to do so would be anti-dilutive, are as follows (in common equivalent shares): | ||||||||
March 31, 2015 | ||||||||
Common stock warrants | 242,779 | |||||||
Common stock options | 2,234,191 | |||||||
Total | 2,476,970 | |||||||
The following table summarizes the Company’s computation of basic and diluted net (loss) income per share for common stockholders: | ||||||||
Three Months Ended | ||||||||
March 31 | ||||||||
2015 | 2014 | |||||||
Numerator | ||||||||
Net (loss) income | (8,538,361 | ) | $ | 839,293 | ||||
Less net income attributable to participating preferred stock | — | (829,180 | ) | |||||
Net (loss) income attributable to common stockholders | (8,538,361 | ) | $ | 10,113 | ||||
Denominator | ||||||||
Denominator for basic and diluted net loss per share | 21,282,692 | 106,309 | ||||||
Effect of dilutive securities: | ||||||||
Stock options | — | 715,869 | ||||||
Denominator for diluted net (loss) income per share | 21,282,692 | 822,178 | ||||||
Net (loss) income per share, basic | $ | (0.40 | ) | $ | 0.1 | |||
Net (loss) income per share, diluted | $ | (0.40 | ) | $ | 0.01 | |||
Recent Accounting Pronouncements | ||||||||
In April 2015, the Financial Accounting Standards Board (FASB) issued an amendment to U.S. GAAP to simplify the balance sheet presentation of the costs for issuing debt. The changes were adopted in Accounting Standards Update (ASU) No. 2015-03, Interest — Imputation of Interest (Subtopic 835-30): Simplifying the Presentation of Debt Issue Costs. Public companies will have to apply the amendments for reporting periods that begin after December 15, 2015. This amendment requires adoption by revising the balance sheets for periods prior to the effective date. The Company is currently evaluating the impact of this ASU and does not believe the adoption of this ASU will have a material impact on the Company’s financial position or results of operations. | ||||||||
Fair_Value_Measurements
Fair Value Measurements | 3 Months Ended | ||||||||||
Mar. 31, 2015 | |||||||||||
Fair Value Measurements | |||||||||||
Fair Value Measurements | |||||||||||
3. Fair Value Measurements | |||||||||||
ASC 820, 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. | |||||||||||
Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants at the measurement date. Assets and liabilities that are measured at fair value are reported using a three-level fair value hierarchy that prioritizes the inputs used to measure fair value. This hierarchy maximizes the use of observable inputs and minimizes the use of unobservable inputs. The three levels of inputs used to measure fair value are as follows: | |||||||||||
· | Level 1 — Quotes prices in active markets for identical assets and liabilities. The Company’s Level 1 assets and liabilities consist of cash and cash equivalents. | ||||||||||
· | Level 2 — Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted market prices for similar assets or liabilities in active markets or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets and liabilities. The Company has no Level 2 assets or liabilities. | ||||||||||
· | Level 3 — Unobservable inputs that are supported by little or no market data and which require internal development of assumptions about how market participant price the fair value of the assets or liabilities. The Company’s Level 3 liabilities consist of the warrant liability. | ||||||||||
The Company is required to mark the value of its warrant liability to market and recognize the change in valuation in its statements of operations each reporting period. | |||||||||||
The following table sets forth the Company’s financial instruments measured at fair value by level within the fair value hierarchy as of March 31, 2015 and December 31, 2014. | |||||||||||
Level 1 | Level 2 | Level 3 | |||||||||
March 31, 2015 | |||||||||||
Assets: | |||||||||||
Cash and cash equivalents | $ | 53,807,863 | $ | — | $ | — | |||||
Total assets at fair value | $ | 53,807,863 | $ | — | $ | — | |||||
Liabilities: | |||||||||||
Common stock warrants | $ | — | $ | — | $ | 396,892 | |||||
Total liabilities at fair value | $ | — | $ | — | $ | 396,892 | |||||
The significant assumptions used in preparing the option pricing model for valuing the Company’s warrants as of March 31, 2015 include (i) volatility (75.0%), (ii) risk free interest rate of 1.41% (estimated using treasury bonds with a 4.75 year life), (iii) strike price ($6.00) for the common stock warrants, (iv) fair value of common stock ($9.27) and (v) expected life (4.75 years). | |||||||||||
The following is a rollforward of the fair value of Level 3 warrants: | |||||||||||
Beginning balance at December 31, 2014 | $ | 296,048 | |||||||||
Change in fair value | 100,844 | ||||||||||
Ending balance at March 31, 2015 | $ | 396,892 | |||||||||
Level 1 | Level 2 | Level 3 | |||||||||
December 31, 2014 | |||||||||||
Assets: | |||||||||||
Cash and cash equivalents | $ | 40,135,102 | $ | — | $ | — | |||||
Total assets at fair value | $ | 40,135,102 | $ | — | $ | — | |||||
Liabilities: | |||||||||||
Common stock warrants | — | — | 296,048 | ||||||||
Total liabilities at fair value | $ | — | $ | — | $ | 296,048 | |||||
The significant assumptions used in preparing the option pricing model for valuing the Company’s warrants as of December 31, 2014 include (i) volatility (104.8%), (ii) risk free interest rate of 1.68% (estimated using treasury bonds with a 5 year life), (iii) strike price ($6.00) for the common stock warrants, (iv) fair value of common stock ($6.14) and (v) expected life (five years). | |||||||||||
There were no transfers between Level 1, 2 or 3 during 2013 or 2014. If the Company’s estimates regarding the fair value of its warrants are inaccurate, a future adjustment to these estimated fair values may be required. Additionally, these estimated fair values could change significantly. | |||||||||||
Prepaid_Expenses
Prepaid Expenses | 3 Months Ended | |||||||
Mar. 31, 2015 | ||||||||
Prepaid Expenses | ||||||||
Prepaid Expenses | ||||||||
4. Prepaid Expenses | ||||||||
Prepaid expenses consist of the following: | ||||||||
March 31, 2015 | December 31, | |||||||
2014 | ||||||||
Prepaid clinical trial expense | $ | 1,677,434 | $ | 1,677,434 | ||||
Prepaid insurance | 427,494 | 761,842 | ||||||
Other | 67,727 | 41,933 | ||||||
Total prepaid expenses | $ | 2,172,655 | $ | 2,481,209 | ||||
Prepaid expenses, short-term | $ | 495,221 | $ | 803,775 | ||||
Prepaid expenses, long-term | 1,677,434 | 1,677,434 | ||||||
Total prepaid expenses | $ | 2,172,655 | $ | 2,481,209 | ||||
Prepaid expenses, long-term represents non-refundable advances to the Company’s clinical research organization which will be applied against final invoices in accordance with the contractual terms of the arrangement. | ||||||||
Accrued_Liabilities
Accrued Liabilities | 3 Months Ended | |||||||
Mar. 31, 2015 | ||||||||
Accrued Liabilities | ||||||||
Accrued Liabilities | ||||||||
5. Accrued Liabilities | ||||||||
Accrued liabilities consist of the following: | ||||||||
March 31, 2015 | December 31, | |||||||
2014 | ||||||||
Employee bonuses | $ | 211,297 | $ | 665,050 | ||||
Accrued clinical trial costs | 770,897 | 254,333 | ||||||
Other | 126,218 | 142,730 | ||||||
Total accrued liabilities | $ | 1,108,412 | $ | 1,062,113 | ||||
Loan_and_Security_Agreements
Loan and Security Agreements | 3 Months Ended |
Mar. 31, 2015 | |
Loan and Security Agreements | |
Loan and Security Agreements | |
6. Loan and Security Agreements | |
Oxford Finance LLC | |
In December 2012, the Company entered into a Loan and Security Agreement (the “Oxford Loan”) with Oxford Finance LLC (“Oxford”) pursuant to which the Company borrowed a total of $15.0 million from Oxford. The Oxford Loan accrued interest at a fixed annual rate equal to 9.20% (three-month U.S. Libor rate of 0.47% plus 8.73%). | |
Interest on the Oxford Loan was payable monthly and principal was due in 30 equal consecutive monthly installments beginning on February 1, 2015 and ending on July 1, 2017. In addition, the Company was required to make a final payment of $675,000 on the maturity date of the Oxford Loan (July 1, 2017). | |
In February 2015, the Company terminated and repaid all amounts outstanding under the Oxford Loan and recorded a loss on the extinguishment of the Oxford Loan (see further discussion below). | |
Hercules Technology Growth Capital, Inc. | |
In February 2015, the Company entered into a loan and security agreement (the “Hercules Loan”) with Hercules Technology Growth Capital, Inc. (“Hercules”) for a term loan of up to $25.0 million. A first tranche of $16.5 million was funded upon execution of the loan agreement, approximately $15.5 million of which was used to repay the Company’s existing term loan with Oxford. The Company is scheduled to make interest only payments on the loan until July 1, 2016, which period may be extended under certain circumstances. Under the terms of the loan and security agreement, the Company may, but is not obligated to, draw an additional tranche of up to $8.5 million prior to July 1, 2016, subject to the achievement of certain clinical milestones, which may be extended to December 31, 2016 under certain circumstances. | |
The Hercules Loan accrues interest at a rate of the greater of 9.0% or 9.0% plus Prime minus 4.25% and is payable monthly. Principal is due in 30 equal consecutive monthly installments beginning on July 1, 2016 and ending on December 1, 2018. In addition, the Company is required to make a final payment of $610,500 on the maturity date of the Hercules Loan (December 1, 2018). | |
The Company may prepay all, but not less than all, of the Hercules Loan subject to a prepayment premium of 3.0% of the outstanding principal if prepaid during the first year, 2.0% of the outstanding principal if prepaid during the second year and 1.0% of the outstanding principal if prepaid after the second year. The obligations of the Company under the Hercules Loan are secured by a perfected first position lien on all of the assets of the Company, excluding intellectual property assets. | |
In connection with the loan agreement, the Company issued Hercules a warrant to purchase 180,274 shares of the Company’s common stock at an exercise price of $5.89 per share and granted Hercules the right to participate in future equity financings in an amount up to $2.0 million while the loan and warrant are outstanding. | |
The Company allocated the proceeds of $16.5 million in accordance with ASC 470 based on the relative fair values. The relative fair value of the warrants of approximately $1.2 million at the time of issuance, which was determined using the Black-Scholes option-pricing model, was recorded as additional paid-in capital and reduced the carrying value of the debt. The discount on the debt is being amortized to interest expense over the term of the debt. | |
As a result of the repayment of the Oxford Loan, the Company recorded a loss on the extinguishment of debt of approximately $1.0 million on the Company’s statement of operations for the three months ended March 31, 2015, representing a prepayment premium, the unamortized discount of the Oxford Loan and the write off of deferred financing costs. | |
Stockholders_Equity
Stockholders' Equity | 3 Months Ended | |||||||
Mar. 31, 2015 | ||||||||
Stockholders' Equity | ||||||||
Stockholders' Equity | ||||||||
7. Stockholders’ Equity | ||||||||
Initial Public Offering and Related Transactions | ||||||||
On May 29, 2014, the Company completed its initial public offering selling 9,166,667 shares of common stock at $6.00 per share. Proceeds from the Company’s initial public offering, net of underwriting discounts and commissions and other offering costs, were $49.7 million. | ||||||||
In addition, each of the following occurred in connection with the completion of the Company’s IPO on May 29, 2014: | ||||||||
· | the conversion of all outstanding shares of convertible preferred stock into 8,809,325 shares of common stock | |||||||
· | the conversion of the aggregate principal amount of $3.0 million and accrued interest under the Company’s outstanding convertible subordinated promissory notes into 503,450 shares of common stock. | |||||||
Private Placement | ||||||||
In January 2015, the Company completed a private placement of approximately 3.4 million shares of common stock at $5.85 per share. Proceeds from the Company’s private placement, net of commissions and other offering costs, were approximately $19.3 million. | ||||||||
Stock-Based Compensation Expense | ||||||||
Stock-based compensation expense related to stock options was allocated as follows: | ||||||||
Three Months Ended | ||||||||
March 31 | ||||||||
2015 | 2014 | |||||||
Research and development | $ | 315,907 | $ | 126,525 | ||||
General and administrative | 328,814 | 101,581 | ||||||
Total stock-based compensation expense | $ | 644,721 | $ | 228,106 | ||||
Income_Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2015 | |
Income Taxes | |
Income Taxes | |
8. Income Taxes | |
Sale of New Jersey Net Operating Losses | |
The Company received approval to sell a portion of the Company’s New Jersey net operating losses (NOLs) as part of the Technology Business Tax Certificate Program sponsored by The New Jersey Economic Development Authority. Under the program, emerging biotechnology companies with unused NOLs and unused research and development credits are allowed to sell these benefits to other companies. On February 27, 2014, the Company completed the sale of NOLs totaling approximately $39.1 million for net proceeds of approximately $3.6 million. Such proceeds are reflected as a tax benefit for three months ended March 31, 2014. | |
Related_Party_Transactions
Related Party Transactions | 3 Months Ended |
Mar. 31, 2015 | |
Related Party Transactions | |
Related Party Transactions | |
9. Related Party Transactions | |
Effective March 17, 2014, one of the Managing Partners of SmartPharma LLC or SmartPharma, an entity which provides commercial and business development consulting services to the Company was appointed Chief Commercial Officer. In connection with the appointment of this individual as Chief Commercial Officer, the Company amended its consulting agreement with SmartPharma to remove this individual from the list of persons providing service under the consulting agreement. SmartPharma invoiced the Company $26,100 and $71,050 of fees for the three months ended March 31, 2015 and 2014, respectively. | |
Summary_of_Significant_Account1
Summary of Significant Accounting Polices (Polices) | 3 Months Ended | |||||||
Mar. 31, 2015 | ||||||||
Summary of Significant Accounting Polices | ||||||||
Use of Estimates | ||||||||
Use of Estimates | ||||||||
The preparation of the Company’s financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. The Company bases its estimates and judgments on historical experience and various other assumptions that it believes are reasonable under the circumstances. The amounts of assets and liabilities reported in the Company’s balance sheets and the amounts of expenses reported for each of the periods presented are affected by estimates and assumptions, which are used for, but not limited to, the accounting for common stock warrants, stock-based compensation, income taxes, and accounting for research and development costs. Actual results could differ from those estimates. | ||||||||
Fair Value of Financial Instruments | ||||||||
Fair Value of Financial Instruments | ||||||||
In accordance with ASC 825, Financial Instruments, disclosures of fair value information about financial instruments are required, whether or not recognized in the balance sheet, for which it is practicable to estimate that value. Cash and cash equivalents are carried at fair value (see Note 3). | ||||||||
Financial instruments, including accounts payable and accrued liabilities, are carried at cost, which approximates fair value given their short-term nature. | ||||||||
Warrants | ||||||||
Warrants | ||||||||
The Company accounts for its warrants to purchase redeemable convertible stock in accordance with ASC 480, Distinguishing Liabilities from Equity. ASC 480 requires that a financial instrument, other than outstanding share, that, at inception, is indexed to an obligation to repurchase the issuer’s equity shares, regardless of the timing or the probability of the redemption feature, and may require the issuer to settle the obligation by transferring assets be classified as a liability. The Company measures the fair value of its warrant liability using an option pricing model with changes in fair value recognized as increases or reductions to other income (expense) in the statement of operations. | ||||||||
In connection with the completion of the Company’s initial public offering in May 2014, the warrants to purchase shares of Series A-1 and Series A-2 preferred stock expired unexercised and the warrants to purchase shares of Series C preferred stock automatically converted into warrants to purchase shares of common stock. Warrants with non-standard anti-dilution provisions (referred to as down round protection) are classified as liabilities and re-measured each reporting period. | ||||||||
The warrants issued in connection with the Company’s debt financing completed in February 2015 (see Note 6) are classified as a component of stockholders’ equity. The value of such warrants was determined using the Black-Scholes option-pricing model. | ||||||||
Stock-Based Compensation | ||||||||
Stock-Based Compensation | ||||||||
The Company accounts for stock-based compensation in accordance with ASC 718, Compensation-Stock Compensation. The Company grants stock options for a fixed number of shares to employees and non-employees with an exercise price equal to the fair value of the shares at grant date. Compensation cost is recognized for all share-based payments granted and is based on the grant- date fair value estimated using the weighted-average assumption of the Black- Scholes option pricing model based on key assumptions such as stock price, expected volatility and expected term. The equity instrument is not considered to be issued until the instrument vests. As a result, compensation cost is recognized over the requisite service period with an offsetting credit to additional paid-in capital. | ||||||||
Awards for consultants are accounted for under ASC 505-50, Equity Based Payments to Non-Employees. Any compensation expense related to consultants is marked-to-market over the applicable vesting period as they vest. | ||||||||
Net (Loss) Income Per Share | ||||||||
Net (Loss) Income Per Share | ||||||||
Basic net (loss) income per share is calculated by dividing the net (loss) income attributable to common stockholders by the weighted average number of common shares outstanding for the period, without consideration for common stock equivalents. Diluted net (loss) income per share is calculated by dividing the net (loss) income attributable to common stockholders by the weighted-average number of common shares outstanding plus the effect of dilutive potential common shares outstanding during the period determined using the treasury-stock and if-converted methods. Dilutive potential common shares are comprised of convertible preferred stock, convertible preferred stock warrants and options outstanding under the Company’s equity incentive plan. | ||||||||
Prior to their conversion in connection with the Company’s initial public offering, the Company’s Series A-1, Series A-2, Series B and Series C convertible preferred stock were entitles to participate in earnings of the Company based upon dividend rights. Accordingly, prior to the initial public offering, the Company measured net income per share based upon the two-class method. Net income attributable to common stockholders excludes $829,285 for the three months ended March 31, 2014 for net income attributable to participating securities. | ||||||||
Potentially dilutive securities that have been excluded from the calculation of diluted net loss per share for the three months ended March 31, 2015, because to do so would be anti-dilutive, are as follows (in common equivalent shares): | ||||||||
March 31, 2015 | ||||||||
Common stock warrants | 242,779 | |||||||
Common stock options | 2,234,191 | |||||||
Total | 2,476,970 | |||||||
The following table summarizes the Company’s computation of basic and diluted net (loss) income per share for common stockholders: | ||||||||
Three Months Ended | ||||||||
March 31 | ||||||||
2015 | 2014 | |||||||
Numerator | ||||||||
Net (loss) income | (8,538,361 | ) | $ | 839,293 | ||||
Less net income attributable to participating preferred stock | — | (829,180 | ) | |||||
Net (loss) income attributable to common stockholders | (8,538,361 | ) | $ | 10,113 | ||||
Denominator | ||||||||
Denominator for basic and diluted net loss per share | 21,282,692 | 106,309 | ||||||
Effect of dilutive securities: | ||||||||
Stock options | — | 715,869 | ||||||
Denominator for diluted net (loss) income per share | 21,282,692 | 822,178 | ||||||
Net (loss) income per share, basic | $ | (0.40 | ) | $ | 0.1 | |||
Net (loss) income per share, diluted | $ | (0.40 | ) | $ | 0.01 | |||
Recent Accounting Pronouncements | ||||||||
Recent Accounting Pronouncements | ||||||||
In April 2015, the Financial Accounting Standards Board (FASB) issued an amendment to U.S. GAAP to simplify the balance sheet presentation of the costs for issuing debt. The changes were adopted in Accounting Standards Update (ASU) No. 2015-03, Interest — Imputation of Interest (Subtopic 835-30): Simplifying the Presentation of Debt Issue Costs. Public companies will have to apply the amendments for reporting periods that begin after December 15, 2015. This amendment requires adoption by revising the balance sheets for periods prior to the effective date. The Company is currently evaluating the impact of this ASU and does not believe the adoption of this ASU will have a material impact on the Company’s financial position or results of operations. | ||||||||
Summary_of_Significant_Account2
Summary of Significant Accounting Polices (Tables) | 3 Months Ended | |||||||
Mar. 31, 2015 | ||||||||
Summary of Significant Accounting Polices | ||||||||
Schedule of potentially dilutive securities excluded from calculation of diluted net loss per share | ||||||||
Potentially dilutive securities that have been excluded from the calculation of diluted net loss per share for the three months ended March 31, 2015, because to do so would be anti-dilutive, are as follows (in common equivalent shares): | ||||||||
March 31, 2015 | ||||||||
Common stock warrants | 242,779 | |||||||
Common stock options | 2,234,191 | |||||||
Total | 2,476,970 | |||||||
Summary of computation of basic and diluted net (loss) income per share | ||||||||
Three Months Ended | ||||||||
March 31 | ||||||||
2015 | 2014 | |||||||
Numerator | ||||||||
Net (loss) income | (8,538,361 | ) | $ | 839,293 | ||||
Less net income attributable to participating preferred stock | — | (829,180 | ) | |||||
Net (loss) income attributable to common stockholders | (8,538,361 | ) | $ | 10,113 | ||||
Denominator | ||||||||
Denominator for basic and diluted net loss per share | 21,282,692 | 106,309 | ||||||
Effect of dilutive securities: | ||||||||
Stock options | — | 715,869 | ||||||
Denominator for diluted net (loss) income per share | 21,282,692 | 822,178 | ||||||
Net (loss) income per share, basic | $ | (0.40 | ) | $ | 0.1 | |||
Net (loss) income per share, diluted | $ | (0.40 | ) | $ | 0.01 | |||
Fair_Value_Measurements_Tables
Fair Value Measurements (Tables) | 3 Months Ended | ||||||||||
Mar. 31, 2015 | |||||||||||
Fair Value Measurements | |||||||||||
Schedule of financial instruments measured at fair value by level within fair value hierarchy | Level 1 | Level 2 | Level 3 | ||||||||
March 31, 2015 | |||||||||||
Assets: | |||||||||||
Cash and cash equivalents | $ | 53,807,863 | $ | — | $ | — | |||||
Total assets at fair value | $ | 53,807,863 | $ | — | $ | — | |||||
Liabilities: | |||||||||||
Common stock warrants | $ | — | $ | — | $ | 396,892 | |||||
Total liabilities at fair value | $ | — | $ | — | $ | 396,892 | |||||
Level 1 | Level 2 | Level 3 | |||||||||
December 31, 2014 | |||||||||||
Assets: | |||||||||||
Cash and cash equivalents | $ | 40,135,102 | $ | — | $ | — | |||||
Total assets at fair value | $ | 40,135,102 | $ | — | $ | — | |||||
Liabilities: | |||||||||||
Common stock warrants | — | — | 296,048 | ||||||||
Total liabilities at fair value | $ | — | $ | — | $ | 296,048 | |||||
Schedule of rollforward of fair value of Level 3 warrants | Beginning balance at December 31, 2014 | $ | 296,048 | ||||||||
Change in fair value | 100,844 | ||||||||||
Ending balance at March 31, 2015 | $ | 396,892 | |||||||||
Prepaid_Expenses_Tables
Prepaid Expenses (Tables) | 3 Months Ended | |||||||
Mar. 31, 2015 | ||||||||
Prepaid Expenses | ||||||||
Schedule of prepaid expenses by component and classification | March 31, 2015 | December 31, | ||||||
2014 | ||||||||
Prepaid clinical trial expense | $ | 1,677,434 | $ | 1,677,434 | ||||
Prepaid insurance | 427,494 | 761,842 | ||||||
Other | 67,727 | 41,933 | ||||||
Total prepaid expenses | $ | 2,172,655 | $ | 2,481,209 | ||||
Prepaid expenses, short-term | $ | 495,221 | $ | 803,775 | ||||
Prepaid expenses, long-term | 1,677,434 | 1,677,434 | ||||||
Total prepaid expenses | $ | 2,172,655 | $ | 2,481,209 | ||||
Accrued_Liabilities_Tables
Accrued Liabilities (Tables) | 3 Months Ended | |||||||
Mar. 31, 2015 | ||||||||
Accrued Liabilities | ||||||||
Schedule of components of accrued liabilities | March 31, 2015 | December 31, | ||||||
2014 | ||||||||
Employee bonuses | $ | 211,297 | $ | 665,050 | ||||
Accrued clinical trial costs | 770,897 | 254,333 | ||||||
Other | 126,218 | 142,730 | ||||||
Total accrued liabilities | $ | 1,108,412 | $ | 1,062,113 | ||||
Stockholders_Equity_Tables
Stockholders' Equity (Tables) | 3 Months Ended | |||||||
Mar. 31, 2015 | ||||||||
Stockholders' Equity | ||||||||
Schedule of stock-based compensation expense related to stock options | Three Months Ended | |||||||
March 31 | ||||||||
2015 | 2014 | |||||||
Research and development | $ | 315,907 | $ | 126,525 | ||||
General and administrative | 328,814 | 101,581 | ||||||
Total stock-based compensation expense | $ | 644,721 | $ | 228,106 | ||||
Organization_and_Basis_of_Pres1
Organization and Basis of Presentation (Details) (USD $) | Mar. 31, 2015 | Dec. 31, 2014 |
Organization and Basis of Presentation | ||
Accumulated deficit | $142,930,212 | $134,391,851 |
Summary_of_Significant_Account3
Summary of Significant Accounting Polices (Details) (USD $) | 3 Months Ended |
Mar. 31, 2014 | |
Net income per share measured based upon the two-class method | |
Net income attributable to participating securities excluded from net income attributable to common stockholders | $829,285 |
Summary_of_Significant_Account4
Summary of Significant Accounting Polices (Details 2) | 3 Months Ended |
Mar. 31, 2015 | |
Anti-dilutive securities | |
Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares) | 2,476,970 |
Warrants | |
Anti-dilutive securities | |
Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares) | 242,779 |
Stock options | |
Anti-dilutive securities | |
Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares) | 2,234,191 |
Summary_of_Significant_Account5
Summary of Significant Accounting Polices (Details 3) (USD $) | 3 Months Ended | |
Mar. 31, 2015 | Mar. 31, 2014 | |
Numerator | ||
Net loss (income) | ($8,538,361) | $839,293 |
Less net income attributable to participating preferred stock | -829,180 | |
Net (loss) income | ($8,538,361) | $10,113 |
Denominator | ||
Denominator for basic and diluted net loss per share (in shares) | 21,282,692 | 106,309 |
Effect of dilutive securities: Stock options (in shares) | 715,869 | |
Denominator for diluted net (loss) income per share (in shares) | 21,282,692 | 822,178 |
Net (loss) income per share, basic (in dollars per share) | ($0.40) | $0.10 |
Net (loss) income per share, diluted (in dollars per share) | ($0.40) | $0.01 |
Fair_Value_Measurements_Detail
Fair Value Measurements (Details) (USD $) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2015 | Dec. 31, 2014 | |
Liabilities: | ||
Liability | $396,892 | $296,048 |
Recurring | Level 3 | Warrants | Liabilities | Option pricing model | ||
Significant assumptions used in preparing the option pricing model for valuing the Company's warrants | ||
Volatility (as a percent) | 75.00% | 104.80% |
Risk free interest rate (as a percent) | 1.41% | 1.68% |
Life of treasury bonds | 4 years 9 months | 5 years |
Strike price (in dollars per share) | $6 | $6 |
Fair value of stock (in dollars per share) | $9.27 | $6.14 |
Expected life | 4 years 9 months | 5 years |
Recurring | Measured at fair value | Level 1 | ||
Assets: | ||
Cash and cash equivalents | 53,807,863 | 40,135,102 |
Total assets at fair value | 53,807,863 | 40,135,102 |
Recurring | Measured at fair value | Level 3 | ||
Liabilities: | ||
Total liabilities at fair value | 396,892 | 296,048 |
Recurring | Measured at fair value | Level 3 | Warrants | ||
Liabilities: | ||
Liability | $396,892 | $296,048 |
Fair_Value_Measurements_Detail1
Fair Value Measurements (Details 2) (USD $) | 3 Months Ended | 12 Months Ended |
Mar. 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 |
Liability transfers out of Level 1 into Level 2 | 0 | 0 |
Liability transfers out of Level 2 into Level 1 | 0 | 0 |
Liability transfers into (out of) Level 3 | 0 | 0 |
Liabilities | Warrants | ||
Rollforward of the fair value of Level 3 warrants | ||
Beginning balance | 296,048 | |
Change in fair value | 100,844 | |
Ending balance | $396,892 |
Prepaid_Expenses_Details
Prepaid Expenses (Details) (USD $) | Mar. 31, 2015 | Dec. 31, 2014 |
Prepaid Expenses | ||
Prepaid clinical trial expense | $1,677,434 | $1,677,434 |
Prepaid insurance | 427,494 | 761,842 |
Other | 67,727 | 41,933 |
Total prepaid expenses | 2,172,655 | 2,481,209 |
Prepaid expenses, short-term and long-term | ||
Prepaid expenses, short-term | 495,221 | 803,775 |
Prepaid expenses, long-term | 1,677,434 | 1,677,434 |
Total prepaid expenses | $2,172,655 | $2,481,209 |
Accrued_Liabilities_Details
Accrued Liabilities (Details) (USD $) | Mar. 31, 2015 | Dec. 31, 2014 |
Accrued Liabilities | ||
Employee bonuses | $211,297 | $665,050 |
Accrued clinical trial costs | 770,897 | 254,333 |
Other | 126,218 | 142,730 |
Total accrued liabilities | $1,108,412 | $1,062,113 |
Loan_and_Security_Agreements_D
Loan and Security Agreements (Details) (USD $) | 3 Months Ended | 1 Months Ended | 12 Months Ended | ||
Mar. 31, 2015 | Mar. 31, 2014 | Feb. 28, 2015 | Dec. 31, 2012 | Dec. 31, 2014 | |
installment | |||||
Loan and Security Agreements | |||||
Repayment of existing term loan | $15,784,150 | ||||
Value of warrants | 1,184,228 | ||||
Interest expense, including accretion of the value of the related warrants and amortization of deferred financing costs | 425,834 | 378,228 | |||
Loss on extinguishment of debt | 1,035,981 | ||||
Secured debt | Oxford Loan | |||||
Loan and Security Agreements | |||||
Loss on extinguishment of debt | 1,000,000 | ||||
Secured debt | Oxford Loan | |||||
Loan and Security Agreements | |||||
Amount borrowed | 15,000,000 | ||||
Repayment of existing term loan | 15,500,000 | ||||
Fixed interest rate (as a percent) | 9.20% | ||||
Number of consecutive monthly principal installments | 30 | ||||
Final payment | 675,000 | ||||
Secured debt | February 2015 Loan and Security Agreement | |||||
Loan and Security Agreements | |||||
Maximum borrowing capacity | 25,000,000 | ||||
Amount borrowed | 16,500,000 | ||||
Additional amount available | 8,500,000 | ||||
Number of consecutive monthly principal installments | 30 | ||||
Final payment | 610,500 | ||||
Secured debt | February 2015 Loan and Security Agreement | Minimum | |||||
Loan and Security Agreements | |||||
Fixed interest rate (as a percent) | 9.00% | ||||
Secured debt | February 2015 Loan and Security Agreement | Hercules | |||||
Loan and Security Agreements | |||||
Number of warrants (in shares) | 180,274 | ||||
Exercise price of warrants (in dollars per share) | $5.89 | ||||
Value of warrants | 1,200,000 | ||||
Secured debt | February 2015 Loan and Security Agreement | Equity financings | Hercules | Right to participate in future equity financings | Maximum | |||||
Loan and Security Agreements | |||||
Equity financings amount | $2,000,000 | ||||
Secured debt | LIBOR | Oxford Loan | |||||
Loan and Security Agreements | |||||
Variable rate basis | three-month U.S. Libor rate | ||||
Variable interest rate margin (as a percent) | 8.73% | ||||
Secured debt | LIBOR | Oxford Loan | Minimum | |||||
Loan and Security Agreements | |||||
Variable rate base (as a percent) | 0.47% | ||||
Secured debt | Prime | February 2015 Loan and Security Agreement | |||||
Loan and Security Agreements | |||||
Variable rate basis | Prime minus 4.25% | ||||
Variable interest rate margin (as a percent) | 9.00% | ||||
Variable rate adjustment (as a percent) | 4.25% | ||||
Secured debt | First year | February 2015 Loan and Security Agreement | |||||
Loan and Security Agreements | |||||
Prepayment premium as percentage of outstanding principal | 3.00% | ||||
Secured debt | Second year | February 2015 Loan and Security Agreement | |||||
Loan and Security Agreements | |||||
Prepayment premium as percentage of outstanding principal | 2.00% | ||||
Secured debt | After the second year | February 2015 Loan and Security Agreement | |||||
Loan and Security Agreements | |||||
Prepayment premium as percentage of outstanding principal | 1.00% |
Stockholders_Equity_Details
Stockholders' Equity (Details) (USD $) | 0 Months Ended |
29-May-14 | |
Convertible Promissory Notes, April 2014 | |
Stockholders' equity | |
Aggregate principal amount converted | $3,000,000 |
Convertible Promissory Notes, April 2014 | Common stock | |
Stockholders' equity | |
Number of common shares into which convertible subordinated promissory notes were converted (in shares) | 503,450 |
Redeemable Convertible Preferred Stock | Common stock | |
Stockholders' equity | |
Number of common shares into which convertible preferred stock was converted | 8,809,325 |
Initial public offering | |
Stockholders' equity | |
Proceeds from offering, net of underwriting discounts and commissions and other offering costs | $49,700,000 |
Initial public offering | Common stock | |
Stockholders' equity | |
Common stock issued (in shares) | 9,166,667 |
Share price (in dollars per share) | $6 |
Stockholders_Equity_Details_2
Stockholders' Equity (Details 2) (Private Placement, USD $) | 1 Months Ended |
In Millions, except Share data, unless otherwise specified | Jan. 31, 2015 |
Stockholders' equity | |
Proceeds from sale of stock, net of commissions and other offering costs | $19.30 |
Common stock | |
Stockholders' equity | |
Issuance of stock (in shares) | 3,400,000 |
Share price (in dollars per share) | $5.85 |
Stockholders_Equity_Details_3
Stockholders' Equity (Details 3) (Stock options, USD $) | 3 Months Ended | |
Mar. 31, 2015 | Mar. 31, 2014 | |
Stock-Based Compensation Expense | ||
Total stock-based compensation expense | $644,721 | $228,106 |
Research and development | ||
Stock-Based Compensation Expense | ||
Total stock-based compensation expense | 315,907 | 126,525 |
General and administrative | ||
Stock-Based Compensation Expense | ||
Total stock-based compensation expense | $328,814 | $101,581 |
Income_Taxes_Details
Income Taxes (Details) (State, New Jersey, Sale of NOLs and research and development credits, USD $) | 0 Months Ended | |
In Millions, unless otherwise specified | Feb. 27, 2014 | Feb. 27, 2014 |
State | New Jersey | Sale of NOLs and research and development credits | ||
Sale of New Jersey Net Operating Losses | ||
NOLs | $39.10 | $39.10 |
Net proceeds from sale | $3.60 |
Related_Party_Transactions_Det
Related Party Transactions (Details) (SmartPharma, Commercial and business development consulting services, USD $) | 3 Months Ended | |
Mar. 31, 2015 | Mar. 31, 2014 | |
SmartPharma | Commercial and business development consulting services | ||
Related party transactions | ||
Fees invoiced by the related party | $26,100 | $71,050 |