Agile Therapeutics (AGXRW) 10-Q 9 Nov 15 2015 Q3 Quarterly report Financial data

Document and Entity Information

Document and Entity Information - shares	9 Months Ended
	Sep. 30, 2015	Nov. 09, 2015
Document and Entity Information
Entity Registrant Name	AGILE THERAPEUTICS INC
Entity Central Index Key	1,261,249
Document Type	10-Q
Document Period End Date	Sep. 30, 2015
Amendment Flag	false
Current Fiscal Year End Date	--12-31
Entity Current Reporting Status	Yes
Entity Filer Category	Non-accelerated Filer
Entity Common Stock, Shares Outstanding		22,292,167
Document Fiscal Year Focus	2,015
Document Fiscal Period Focus	Q3

Balance Sheets

Balance Sheets - USD ($)	Sep. 30, 2015	Dec. 31, 2014
Current assets:
Cash and cash equivalents	$ 39,404,313	$ 40,182,141
Prepaid expenses	1,260,699	803,775
Total current assets	40,665,012	40,985,916
Property and equipment, net of accumulated depreciation of $299,943 in 2015 and $285,643 in 2014	12,320,365	12,046,267
Prepaid expenses, long-term	1,751,051	1,677,434
Deferred financing costs, net	330,948	98,401
Other assets	18,208	18,208
Total assets	55,085,584	54,826,226
Current liabilities:
Accounts payable	4,349,935	2,631,217
Accrued expenses	2,348,157	1,062,113
Loan payable, current portion		5,003,143
Warrant liability	251,247	296,048
Total current liabilities	6,949,339	8,992,521
Loan payable, long-term	$ 15,390,295	$ 9,827,758
Commitments and contingencies
Stockholders' equity:
Common stock, $.0001 par value, authorized 150,000,000 shares; 22,292,167 shares issued and outstanding as of September 30, 2015 and 18,634,872 shares issued and outstanding as of December 31, 2014	$ 2,230	$ 1,864
Additional paid-in capital	193,571,822	170,395,934
Accumulated deficit	(160,828,102)	(134,391,851)
Total stockholders' equity	32,745,950	36,005,947
Total liabilities and stockholders' equity	$ 55,085,584	$ 54,826,226

Balance Sheets (Parenthetical)

Balance Sheets (Parenthetical) - USD ($)	Sep. 30, 2015	Dec. 31, 2014
Balance Sheets
Accumulated depreciation	$ 299,943	$ 285,643
Common stock, par value (in dollars per share)	$ 0.0001	$ 0.0001
Common stock, authorized	150,000,000	150,000,000
Common stock, issued	22,292,167	18,634,872
Common stock, outstanding	22,292,167	18,634,872

Statements of Operations

Statements of Operations - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2015	Sep. 30, 2014	Sep. 30, 2015	Sep. 30, 2014
Operating expenses:
Research and development	$ 7,162,541	$ 4,602,513	$ 18,708,447	$ 8,387,693
General and administrative	1,802,660	1,446,371	5,215,169	3,603,528
Total operating expenses	8,965,201	6,048,884	23,923,616	11,991,221
Loss from operations	(8,965,201)	(6,048,884)	(23,923,616)	(11,991,221)
Other income (expense)
Interest expense	(551,713)	(392,009)	(1,525,136)	(1,173,723)
Interest income	1,175	1,288	3,682	1,425
Change in fair value of warrants	104,298	86,243	44,801	278,564
Loss on extinguishment of debt			1,035,981
Loss before benefit from income taxes	(9,411,441)	(6,353,362)	(26,436,250)	(12,884,955)
Benefit from income taxes				3,652,485
Net loss	$ (9,411,441)	$ (6,353,362)	$ (26,436,250)	$ (9,232,470)
Net loss per share - basic and diluted	$ (0.42)	$ (0.34)	$ (1.21)	$ (1.03)
Weighted-average shares outstanding - basic and diluted	22,272,777	18,592,968	21,923,070	8,967,324

Statements of Cash Flows

Statements of Cash Flows - USD ($)	9 Months Ended
	Sep. 30, 2015	Sep. 30, 2014
Cash flows from operating activities
Net loss	$ (26,436,250)	$ (9,232,470)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation	14,300	7,730
Noncash stock bonus		80,000
Noncash stock based compensation	2,129,172	973,354
Noncash interest	417,501	138,723
Loss on extinguishment of debt	1,035,981
Change in fair value of warrants	(44,801)	(278,564)
Changes in operating assets and liabilities:
Prepaid expenses and other current assets	(530,543)	(2,900,224)
Accounts payable and accrued expenses	3,004,762	2,220,392
Net cash used in operating activities	(20,409,878)	(8,991,059)
Cash flows from investing activities
Acquisition of property and equipment	(288,398)	(42,348)
Net cash used in investing activities	(288,398)	(42,348)
Cash flows from financing activities
Proceeds from issuance of long-term debt	16,265,000
Repayment of long-term debt	(15,784,150)
Proceeds from convertible bridge notes		3,000,000
Cash paid for debt financing costs	(423,256)	(150,000)
Proceeds from the issuance of common stock, net	19,330,613	49,743,641
Proceeds from exercise of stock options	532,241
Net cash provided by financing activities	19,920,448	52,593,641
Net (decrease) increase in cash and cash equivalents	(777,828)	43,560,234
Cash and cash equivalents, beginning of period	40,182,141	2,119,646
Cash and cash equivalents, end of period	39,404,313	45,679,880
Supplemental disclosure of noncash financing activities
Fair value of common stock warrants issued	1,184,228
Conversion of preferred stock into common stock		69,232,677
Conversion of notes payable and interest into common stock		3,020,667
Supplemental cash flow information
Interest paid	$ 1,098,261	$ 1,035,000

Organization and Basis of Prese

Organization and Basis of Presentation	9 Months Ended
	Sep. 30, 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 September 30, 2015, the Company had an accumulated deficit of approximately $160.8 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 and nine months ended September 30, 2015 are not necessarily indicative of the operating results for the full fiscal year or any future period.

Summary of Significant Accounti

Summary of Significant Accounting Polices	9 Months Ended
	Sep. 30, 2015
Summary of Significant Accounting Polices
Summary of Significant Accounting Polices	2. Summary of Significant Accounting Policies 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 Per Share Basic net loss per share is calculated by dividing the net loss 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 per share is calculated by dividing the net loss 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. For purposes of diluted net loss per share calculation, convertible preferred stock, convertible preferred stock warrants, common stock warrants and stock options are considered to be potentially dilutive securities but are excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive and therefore, basic and diluted net loss per share were the same for all periods presented. Potentially dilutive securities that have been excluded from the calculation of diluted net loss per share for the three and nine months ended September 30, 2015 and 2014 because to do so would be anti-dilutive are as follows (in common equivalent shares): September 30, 2015 2014 Common stock warrants Common stock options Total 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	9 Months Ended
	Sep. 30, 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 September 30, 2015 and December 31, 2014. Level 1 Level 2 Level 3 September 30, 2015 Assets: Cash and cash equivalents $ $ — $ — Total assets at fair value $ $ — $ — Liabilities: Common stock warrants $ — $ — $ Total liabilities at fair value $ — $ — $ The significant assumptions used in preparing the option pricing model for valuing the Company’s warrants as of September 30, 2015 include (i) volatility (75.0%), (ii) risk free interest rate of 1.15% (estimated using treasury bonds with a 4.25 year life), (iii) strike price ($6.00) for the common stock warrants, (iv) fair value of common stock ($6.74) and (v) expected life (4.25 years). The following is a rollforward of the fair value of Level 3 warrants: Beginning balance at December 31, 2014 $ Change in fair value ) Ending balance at September 30, 2015 $ Level 1 Level 2 Level 3 December 31, 2014 Assets: Cash and cash equivalents $ $ — $ — Total assets at fair value $ $ — $ — Liabilities: Common stock warrants — — Total liabilities at fair value $ — $ — $ 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 2014 or 2015. 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	9 Months Ended
	Sep. 30, 2015
Prepaid Expenses
Prepaid Expenses	4. Prepaid Expenses Prepaid expenses consist of the following: September 30, 2015 December 31, 2014 Prepaid clinical trial expense $ $ Prepaid insurance Other Total prepaid expenses $ $ Prepaid expenses, short-term $ $ Prepaid expenses, long-term Total prepaid expenses $ $ 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	9 Months Ended
	Sep. 30, 2015
Accrued Liabilities
Accrued Liabilities	5. Accrued Liabilities Accrued liabilities consist of the following: September 30, 2015 December 31, 2014 Employee bonuses $ $ Accrued clinical trial costs Other Total accrued liabilities $ $

Loan and Security Agreements

Loan and Security Agreements	9 Months Ended
	Sep. 30, 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 Hercules Loan, 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 Hercules Loan, 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 Hercules Loan, 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 nine months ended September 30, 2015, representing a prepayment premium, the unamortized discount of the Oxford Loan and the write off of deferred financing costs.

Stockholders' Equity

Stockholders' Equity	9 Months Ended
	Sep. 30, 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. Shelf Registration Statement On June 19, 2015, the Company filed a universal shelf registration statement with the SEC for the issuance of common stock, preferred stock, warrants, rights, debt securities and units up to an aggregate amount of $150.0 million (the “2015 Shelf Registration Statement”). On July 1, 2015, the 2015 Shelf Registration Statement was declared effective by the SEC. In the future, the Company may periodically offer one or more of these securities in amounts, prices and terms to be announced when and if the securities are offered. At the time any of the securities covered by the 2015 Shelf Registration Statement are offered for sale, a prospectus supplement will be prepared and filed with the SEC containing specific information about the terms of any such offering. Stock-Based Compensation Expense Stock-based compensation expense related to stock options was allocated as follows: Three Months Ended September 30, 2015 2014 Research and development $ $ General and administrative Total stock-based compensation expense $ $ Nine Months Ended September 30, 2015 2014 Research and development $ $ General and administrative Total stock-based compensation expense $ $

Income Taxes

Income Taxes	9 Months Ended
	Sep. 30, 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 nine months ended September 30, 2014.

Related Party Transactions

Related Party Transactions	9 Months Ended
	Sep. 30, 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 $17,544 and $61,694 of fees for the three and nine months ended September 30, 2015, respectively, and $26,100 and $100,400 of fees for the three and nine months ended September 30, 2014, respectively.

Summary of Significant Accoun15

Summary of Significant Accounting Polices (Polices)	9 Months Ended
	Sep. 30, 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 Per Share	Net Loss Per Share Basic net loss per share is calculated by dividing the net loss 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 per share is calculated by dividing the net loss 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. For purposes of diluted net loss per share calculation, convertible preferred stock, convertible preferred stock warrants, common stock warrants and stock options are considered to be potentially dilutive securities but are excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive and therefore, basic and diluted net loss per share were the same for all periods presented. Potentially dilutive securities that have been excluded from the calculation of diluted net loss per share for the three and nine months ended September 30, 2015 and 2014 because to do so would be anti-dilutive are as follows (in common equivalent shares): September 30, 2015 2014 Common stock warrants Common stock options Total
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 Accoun16

Summary of Significant Accounting Polices (Tables)	9 Months Ended
	Sep. 30, 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 and nine months ended September 30, 2015 and 2014 because to do so would be anti-dilutive are as follows (in common equivalent shares): September 30, 2015 2014 Common stock warrants Common stock options Total

Fair Value Measurements (Tables

Fair Value Measurements (Tables)	9 Months Ended
	Sep. 30, 2015
Fair Value Measurements
Schedule of financial instruments measured at fair value by level within fair value hierarchy	Level 1 Level 2 Level 3 September 30, 2015 Assets: Cash and cash equivalents $ $ — $ — Total assets at fair value $ $ — $ — Liabilities: Common stock warrants $ — $ — $ Total liabilities at fair value $ — $ — $ Level 1 Level 2 Level 3 December 31, 2014 Assets: Cash and cash equivalents $ $ — $ — Total assets at fair value $ $ — $ — Liabilities: Common stock warrants — — Total liabilities at fair value $ — $ — $
Rollforward of fair value of Level 3 warrants	Beginning balance at December 31, 2014 $ Change in fair value ) Ending balance at September 30, 2015 $

Prepaid Expenses (Tables)

Prepaid Expenses (Tables)	9 Months Ended
	Sep. 30, 2015
Prepaid Expenses
Schedule of prepaid expenses by component and classification	September 30, 2015 December 31, 2014 Prepaid clinical trial expense $ $ Prepaid insurance Other Total prepaid expenses $ $ Prepaid expenses, short-term $ $ Prepaid expenses, long-term Total prepaid expenses $ $

Accrued Liabilities (Tables)

Accrued Liabilities (Tables)	9 Months Ended
	Sep. 30, 2015
Accrued Liabilities
Schedule of components of accrued liabilities	September 30, 2015 December 31, 2014 Employee bonuses $ $ Accrued clinical trial costs Other Total accrued liabilities $ $

Stockholders' Equity (Tables)

Stockholders' Equity (Tables)	9 Months Ended
	Sep. 30, 2015
Stockholders' Equity
Schedule of stock-based compensation expense related to stock options	Three Months Ended September 30, 2015 2014 Research and development $ $ General and administrative Total stock-based compensation expense $ $ Nine Months Ended September 30, 2015 2014 Research and development $ $ General and administrative Total stock-based compensation expense $ $

Organization and Basis of Pre21

Organization and Basis of Presentation (Details) - USD ($)	9 Months Ended
	Sep. 30, 2015	Dec. 31, 2014
Organization and Basis of Presentation
Revenue, Net	$ 0
Accumulated deficit	$ 160,828,102	$ 134,391,851

Summary of Significant Accoun22

Summary of Significant Accounting Polices (Details) - shares	9 Months Ended
	Sep. 30, 2015	Sep. 30, 2014
Anti-dilutive securities
Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares)	2,435,437	1,812,625
Warrants
Anti-dilutive securities
Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares)	242,779	62,505
Stock options
Anti-dilutive securities
Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares)	2,192,658	1,750,120

Fair Value Measurements (Detail

Fair Value Measurements (Details) - USD ($)	9 Months Ended	12 Months Ended
	Sep. 30, 2015	Dec. 31, 2014
Liabilities:
Common stock warrants	$ 251,247	$ 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)	1.15%	1.68%
Life of treasury bonds	4 years 3 months	5 years
Strike price (in dollars per share)	$ 6	$ 6
Fair value of stock (in dollars per share)	$ 6.74	$ 6.14
Expected life	4 years 3 months	5 years
Recurring | Measured at fair value | Level 1
Assets:
Cash and cash equivalents	$ 39,359,262	$ 40,135,102
Total assets at fair value	39,359,262	40,135,102
Recurring | Measured at fair value | Level 3
Liabilities:
Total liabilities at fair value	251,247	296,048
Recurring | Measured at fair value | Level 3 | Warrants
Liabilities:
Common stock warrants	$ 251,247	$ 296,048

Fair Value Measurements (Deta24

Fair Value Measurements (Details 2) - USD ($)	9 Months Ended	12 Months Ended
	Sep. 30, 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	(44,801)
Ending balance	$ 251,247	$ 296,048

Prepaid Expenses (Details)

Prepaid Expenses (Details) - USD ($)	Sep. 30, 2015	Dec. 31, 2014
Prepaid Expenses
Prepaid clinical trial expense	$ 1,751,051	$ 1,677,434
Prepaid insurance	1,130,205	761,842
Other	130,494	41,933
Total prepaid expenses	3,011,750	2,481,209
Prepaid expenses, short-term and long-term
Prepaid expenses, short-term	1,260,699	803,775
Prepaid expenses, long-term	1,751,051	1,677,434
Total prepaid expenses	$ 3,011,750	$ 2,481,209

Accrued Liabilities (Details)

Accrued Liabilities (Details) - USD ($)	Sep. 30, 2015	Dec. 31, 2014
Accrued Liabilities
Employee bonuses	$ 640,108	$ 665,050
Accrued clinical trial costs	1,518,699	254,333
Other	189,350	142,730
Total accrued liabilities	$ 2,348,157	$ 1,062,113

Loan and Security Agreements (D

Loan and Security Agreements (Details)	1 Months Ended		9 Months Ended	12 Months Ended
	Feb. 28, 2015USD ($)$ / sharesshares	Dec. 31, 2012USD ($)	Sep. 30, 2015USD ($)installment	Dec. 31, 2014USD ($)installment
Loan and Security Agreements
Repayment of existing debt			$ 15,784,150
Value of warrants			1,184,228
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 debt	$ 15,500,000
Fixed interest rate (as a percent)				9.20%
Number of consecutive monthly principal installments | installment				30
Final payment				$ 675,000
Secured debt | Hercules Loan
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 | installment			30
Final payment			$ 610,500
Secured debt | Hercules Loan | Minimum
Loan and Security Agreements
Fixed interest rate (as a percent)			9.00%
Secured debt | Hercules Loan | Hercules
Loan and Security Agreements
Number of warrants (in shares) | shares	180,274
Exercise price of warrants (in dollars per share) | $ / shares	$ 5.89
Value of warrants	$ 1,200,000
Secured debt | Hercules Loan | 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 | Hercules Loan
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 | Hercules Loan
Loan and Security Agreements
Prepayment premium as percentage of outstanding principal			3.00%
Secured debt | Second year | Hercules Loan
Loan and Security Agreements
Prepayment premium as percentage of outstanding principal			2.00%
Secured debt | After the second year | Hercules Loan
Loan and Security Agreements
Prepayment premium as percentage of outstanding principal			1.00%

Stockholders' Equity (Details)

Stockholders' Equity (Details)	May. 29, 2014USD ($)$ / sharesshares
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) | $ / shares	$ 6

Stockholders' Equity (Details 2

Stockholders' Equity (Details 2) - USD ($) $ / shares in Units, shares in Millions	1 Months Ended
	Jan. 31, 2015	Jun. 19, 2015
Private Placement
Stockholders' equity
Proceeds from sale of stock, net of commissions and other offering costs	$ 19,300,000
Private Placement | Common stock
Stockholders' equity
Issuance of stock (in shares)	3.4
Share price (in dollars per share)	$ 5.85
2015 Shelf Registration
Stockholders' equity
Aggregate amount of securities issuable		$ 150,000,000

Stockholders' Equity (Details 3

Stockholders' Equity (Details 3) - Stock options - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2015	Sep. 30, 2014	Sep. 30, 2015	Sep. 30, 2014
Stock-Based Compensation Expense
Total stock-based compensation expense	$ 746,499	$ 381,009	$ 2,129,172	$ 973,354
Research and development
Stock-Based Compensation Expense
Total stock-based compensation expense	220,748	148,244	856,671	483,677
General and administrative
Stock-Based Compensation Expense
Total stock-based compensation expense	$ 525,751	$ 232,765	$ 1,272,501	$ 489,677

Income Taxes (Details)

Income Taxes (Details) - State - New Jersey - Sale of NOLs and research and development credits $ in Millions	Feb. 27, 2014USD ($)
Sale of New Jersey Net Operating Losses
NOLs	$ 39.1
Net proceeds from sale	$ 3.6

Related Party Transactions (Det

Related Party Transactions (Details) - SmartPharma	3 Months Ended		9 Months Ended
	Sep. 30, 2015USD ($)	Sep. 30, 2014USD ($)	Sep. 30, 2015USD ($)	Sep. 30, 2014USD ($)	Mar. 17, 2014person
Related party transactions
Number of Managing Partners appointed to Chief Commercial Officer					1
Commercial and business development consulting services
Related party transactions
Fees invoiced by the related party | $	$ 17,544	$ 26,100	$ 61,694	$ 100,400