Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2016 | Oct. 31, 2016 | |
Document and Entity Information | ||
Entity Registrant Name | TREVENA INC | |
Entity Central Index Key | 1,429,560 | |
Document Type | 10-Q | |
Document Period End Date | Sep. 30, 2016 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 52,334,987 | |
Document Fiscal Year Focus | 2,016 | |
Document Fiscal Period Focus | Q3 |
Balance Sheets
Balance Sheets - USD ($) | Sep. 30, 2016 | Dec. 31, 2015 |
Current assets: | ||
Cash and cash equivalents | $ 25,228,034 | $ 46,773,566 |
Marketable securities | 94,386,006 | 125,864,447 |
Prepaid expenses and other current assets | 1,644,792 | 1,892,217 |
Total current assets | 121,258,832 | 174,530,230 |
Property and equipment, net | 745,292 | 696,280 |
Restricted cash | 112,620 | 112,620 |
Intangible asset, net | 13,438 | 14,844 |
Total assets | 122,130,182 | 175,353,974 |
Current liabilities: | ||
Accounts payable | 6,903,250 | 6,749,625 |
Accrued expenses and other current liabilities | 3,530,702 | 3,029,782 |
Long Term Debt Current | 4,635,046 | |
Deferred revenue | 3,750,000 | |
Deferred rent | 50,175 | 43,907 |
Total current liabilities | 15,119,173 | 13,573,314 |
Loans payable, net | 13,644,787 | 18,185,898 |
Capital leases, net of current portion | 12,022 | 7,942 |
Deferred rent, net of current portion | 200,666 | 238,917 |
Warrant liability | 90,561 | 153,238 |
Other long term liabilities | 373,488 | 63,200 |
Total liabilities | 29,440,697 | 32,222,509 |
Stockholders' equity: | ||
Common stock—$0.001 par value; 100,000,000 shares authorized, 52,242,647 and 50,802,603 shares issued and outstanding at September 30, 2016 and December 31, 2015 respectively | 52,243 | 50,802 |
Preferred stock - $0.001 par value; 5,000,000 shares authorized, none issued or outstanding at September 30, 2016 and December 31, 2015, respectively | ||
Additional paid-in capital | 341,973,243 | 325,784,484 |
Accumulated deficit | (249,391,918) | (182,497,965) |
Accumulated other comprehensive loss | 55,917 | (205,856) |
Total stockholders' equity | 92,689,485 | 143,131,465 |
Total liabilities, redeemable convertible preferred stock and stockholders' equity | $ 122,130,182 | $ 175,353,974 |
Balance Sheets (Parenthetical)
Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2016 | Dec. 31, 2015 |
Balance Sheets | ||
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares issued | 52,242,647 | 50,802,603 |
Common stock, shares outstanding | 52,242,647 | 50,802,603 |
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Statements of Operations and Co
Statements of Operations and Comprehensive Income (Loss) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Revenue: | ||||
Collaboration revenue | $ 1,875,000 | $ 3,750,000 | $ 4,375,000 | |
Total revenue | 1,875,000 | 3,750,000 | 4,375,000 | |
Operating expenses: | ||||
General and administrative | $ 4,078,349 | 2,780,115 | 11,692,781 | 8,977,000 |
Research and development | 25,548,532 | 9,650,138 | 58,504,964 | 30,524,601 |
Total operating expenses | 29,626,881 | 12,430,253 | 70,197,745 | 39,501,601 |
Loss from operations | (29,626,881) | (10,555,253) | (66,447,745) | (35,126,601) |
Other income (expense): | ||||
Change in fair value of warrant liability | (7,044) | (68,037) | 62,677 | (71,102) |
Gain on asset disposal | (8,808) | (8,808) | 2,656 | |
Miscellaneous income | 731 | 221,699 | 174,266 | |
Interest income | 178,008 | 79,407 | 585,221 | 172,095 |
Interest expense | (433,931) | (72,331) | (1,306,997) | (215,293) |
Total other (expense) income | (271,775) | (60,230) | (446,208) | 62,622 |
Net loss | (29,898,656) | (10,615,483) | (66,893,953) | (35,063,979) |
Net loss attributable to common stockholders | (29,898,656) | (10,615,483) | (66,893,953) | (35,063,979) |
Other comprehensive income, net: | ||||
Unrealized gain (loss) on marketable securities | (19,200) | 32,298 | 261,773 | 61,182 |
Other comprehensive income | (19,200) | 32,298 | 261,773 | 61,182 |
Comprehensive loss | $ (29,917,856) | $ (10,583,185) | $ (66,632,180) | $ (35,002,797) |
Per share information: | ||||
Net loss per share of common stock, basic and diluted (in dollars per share) | $ (0.57) | $ (0.24) | $ (1.29) | $ (0.85) |
Weighted average common shares outstanding, basic and diluted (in shares) | 52,205,156 | 44,214,428 | 51,911,107 | 41,443,362 |
Statement of Stockholders_ Equi
Statement of Stockholders’ Equity - 9 months ended Sep. 30, 2016 - USD ($) | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Accumulated Other Comprehensive Income (Loss) | Total |
Balance at Dec. 31, 2015 | $ 50,802 | $ 325,784,484 | $ (182,497,965) | $ (205,856) | $ 143,131,465 |
Balance (in shares) at Dec. 31, 2015 | 50,802,603 | 50,802,603 | |||
Increase (Decrease) in Stockholders' Equity | |||||
Stock-based compensation expense | 4,258,418 | $ 4,258,418 | |||
Exercise of stock options | $ 89 | 139,295 | $ 139,384 | ||
Exercise of stock options (in shares) | 88,591 | 88,591 | |||
Net exercise of common stock warrant | $ 1 | (1) | |||
Net exercise of common stock warrant (in shares) | 698 | ||||
Issuance of common stock, net of issuance costs | $ 1,351 | 11,791,047 | $ 11,792,398 | ||
Issuance of common stock, net of issuance costs (in shares) | 1,350,755 | ||||
Unrealized gain (loss) on marketable securities | 261,773 | 261,773 | |||
Net loss | (66,893,953) | (66,893,953) | |||
Balance at Sep. 30, 2016 | $ 52,243 | $ 341,973,243 | $ (249,391,918) | $ 55,917 | $ 92,689,485 |
Balance (in shares) at Sep. 30, 2016 | 52,242,647 | 52,242,647 |
Statements of Cash Flows
Statements of Cash Flows - USD ($) | 9 Months Ended | |
Sep. 30, 2016 | Sep. 30, 2015 | |
Operating activities: | ||
Net loss | $ (66,893,953) | $ (35,063,979) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 180,012 | 155,257 |
Stock-based compensation | 4,258,418 | 2,348,526 |
Noncash interest expense on loans | 404,222 | 117,188 |
Loss on disposal of assets | 10,229 | |
Revaluation of warrant liability | (62,677) | 71,102 |
Amortization of bond premium on marketable securities | 1,119,730 | 758,337 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other assets | 247,425 | (317,720) |
Accounts payable and other liabilities | 620,791 | (1,917,189) |
Deferred revenue | (3,750,000) | 5,625,000 |
Net cash used in operating activities | (63,865,803) | (28,223,478) |
Investing activities: | ||
Purchases of property and equipment | (228,902) | (203,440) |
Maturities of marketable securities | 84,264,000 | 48,350,000 |
Purchases of marketable securities | (53,643,516) | (108,285,889) |
Net cash provided by investing activities | 30,391,582 | (60,139,329) |
Financing activities: | ||
Proceeds from exercise of common stock options | 139,384 | 683,053 |
Proceeds from issuance of common stock, net | 11,792,398 | 90,510,810 |
Capital lease payments | (3,093) | (1,906) |
Net cash provided by financing activities | 11,928,689 | 91,191,957 |
Net (decrease) increase in cash and cash equivalents | (21,545,532) | 2,829,150 |
Cash and cash equivalents—beginning of period | 46,773,566 | 36,205,559 |
Cash and cash equivalents—end of period | 25,228,034 | 39,034,709 |
Supplemental disclosure of cash flow information: | ||
Cash paid for interest | 902,775 | $ 65,413 |
Capital lease additions | $ 8,944 |
Organization and Description of
Organization and Description of the Business | 9 Months Ended |
Sep. 30, 2016 | |
Organization and Description of the Business | |
Organization and Description of the Business | TREVENA, INC. Notes to Unaudited Financial Statements 1. Organization and Description of the Business Trevena, Inc. (the “Company”) was incorporated in Delaware as Parallax Therapeutics, Inc. on November 9, 2007. The Company began operations in December 2007, and its name was changed to Trevena, Inc. on January 3, 2008. Trevena, Inc. is a biopharmaceutical company dedicated to discovering and developing innovative new medicines for serious unmet medical needs by utilizing novel approaches to target G protein coupled receptors. The Company operates in one segment and has its principal office in King of Prussia, Pennsylvania. Liquidity At September 30, 2016, the Company had an accumulated deficit of $249.4 million. The Company’s net loss was $66.9 million and $35.1 million for the nine months ended September 30, 2016 and 2015, respectively. The Company expects its cash and cash equivalents of $25.2 million and marketable securities of $94.4 million as of September 30, 2016, together with interest thereon, to be sufficient to fund its operating expenses and capital expenditure requirements into 2018. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2016 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The accompanying financial statements have been prepared in conformity with accounting principles generally accepted in the United States (“GAAP”) for interim financial information and are unaudited. The Company’s functional currency is the U.S. dollar. The financial statements include all normal and recurring adjustments that are considered necessary for the fair presentation of the Company’s balance sheet as of September 30, 2016, its results of operations and its comprehensive income (loss) for the three and nine months ended September 30, 2016 and 2015, its statement of stockholders’ equity for the period from January 1, 2016 to September 30, 2016 and its cash flows for the nine months ended September 30, 2016 and 2015. The information included in this Quarterly Report on Form 10-Q should be read in conjunction with the consolidated financial statements and accompanying notes included in the Company’s most recent Annual Report on Form 10-K for the year ended December 31, 2015. Since the date of those financial statements, there have been no changes to the Company’s significant accounting policies. The financial data and other information disclosed in these notes related to the three and nine months ended September 30, 2016 and 2015 are not necessarily indicative of the results to be expected for the year ending December 31, 2016, any other interim periods or any future year or period. Recent Accounting Pronouncements In August 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-15, Statement of Cash Flows (Topic 230) (“ASU 2016-15”). ASU 2016-15 was issued to clarify how certain cash receipts and payments should be presented in the statement of cash flows. The standard is effective for annual periods beginning after December 15, 2017 and interim periods within that reporting period. Early adoption is permitted. The Company is evaluating the effect this standard will have on its financial statements and related disclosures. In March 2016, the FASB issued ASU 2016-09, Compensation— Stock Compensation (“ASU 2016-09”). ASU 2016-09 was issued as part of the FASB Simplification Initiative. This update addresses the income tax effects of stock-based payments and eliminates the windfall pool concept, as all of the tax effects related to stock-based payments will now be recorded at settlement (or expiration) through the income statement. The new guidance also permits entities to make an accounting policy election for the impact of forfeitures on the recognition of expense for stock-based payment awards. Forfeitures can be estimated or recognized when they occur. The standard is effective for annual periods beginning after December 15, 2016 and interim periods within that reporting period. Early adoption is permitted in any interim or annual period, with any adjustment reflected as of the beginning of the fiscal year of adoption. The Company is evaluating the effect this standard will have on its financial statements and related disclosures. In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) (“ASU 2016-02”). ASU 2016-02 requires lessees to record most leases on their balance sheets and disclose key information about leasing arrangements in an effort to increase transparency and comparability among organizations. The standard is effective for annual periods beginning after December 15, 2018 and interim periods within that reporting period. Early adoption is permitted. The Company is evaluating the effect this standard will have on its financial statements and related disclosures. In August 2014, the FASB issued ASU 2014‑15, Presentation of Financial Statements‑Going Concern (Subtopic 205‑40): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern (“ASU 2014-15”), which defines management’s responsibility to assess an entity’s ability to continue as a going concern, and to provide related footnote disclosures if there is substantial doubt about its ability to continue as a going concern. The pronouncement is effective for annual reporting periods ending after December 15, 2016 with early adoption permitted. The Company is evaluating the effect this standard will have on its financial statements and related disclosures. In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers (“ASU 2014-09”). ASU 2014-09 is a comprehensive new revenue recognition model requiring a company to recognize revenue to depict the transfer of goods or services to a customer in an amount reflecting the consideration it expects to receive in exchange for those goods or services. Additionally, in March 2016, the FASB issued ASU 2016-08 Revenue from Contracts with Customers, Principal versus Agent Considerations (“ASU 2016-08”). ASU 2016-08 amends the principal versus agent guidance in ASU 2014-09 to clarify how an entity should identify the unit of accounting for the principal versus agent evaluation and how it should apply the control principal to certain types of arrangements. The effective date for both standards is January 1, 2018, with an option that permits companies to adopt the standard as early as January 1, 2017. Early application prior to January 1, 2017 is not permitted. The standards permit the use of either the retrospective or cumulative effect transition method. The Company is evaluating the transition method that it will elect. The adoption of these standards is not expected to have a material impact on the Company’s financial statements. |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 9 Months Ended |
Sep. 30, 2016 | |
Fair Value of Financial Instruments | |
Fair Value of Financial Instruments | 3. Fair Value of Financial Instruments Accounting Standards Codification (“ASC”) Topic 820, Fair Value Measurement (“ASC 820”), establishes a fair value hierarchy for instruments measured at fair value that distinguishes between assumptions based on market data (observable inputs) and the Company’s own assumptions (unobservable inputs). As a basis for considering market participant assumptions in fair value measurements, ASC Topic 820 establishes a three-tier fair value hierarchy that distinguishes among the following: · Level 1—Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access. · Level 2—Valuations based on quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active and models for which all significant inputs are observable, either directly or indirectly. · Level 3—Valuations based on inputs that are unobservable and significant to the overall fair value measurement. Cash, Cash Equivalents and Marketable Securities The following table presents fair value of the Company’s cash, cash equivalents and marketable securities as of September 30, 2016 and December 31, 2015: September 30, 2016 Unrealized Unrealized Cash and Cash Marketable Adjusted Cost Gains Losses Fair Value Equivalents Securities Cash $ $ — $ — $ $ $ — Level 1 (1): Money market funds — — — Level 2 (2): Cash and cash equivalents — — U.S. government agency securities — Subtotal Total $ $ $ $ $ $ December 31, 2015 Unrealized Unrealized Cash and Cash Marketable Adjusted Cost Gains Losses Fair Value Equivalents Securities Cash $ $ — $ — $ $ $ — Level 1 (1): Money market funds — — — U.S. Treasury securities — Subtotal Level 2 (2): Repurchase agreements — — — U.S. government agency securities — Subtotal Total $ $ $ $ $ $ (1) The fair value of Level 1 securities is estimated based on quoted prices in active markets for identical assets or liabilities. (2) The fair value of Level 2 securities is estimated based on observable inputs other than quoted prices in active markets for identical assets and liabilities, quoted prices for identical or similar assets or liabilities in inactive markets, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. The Company classifies investments available to fund current operations as current assets on its balance sheets. As of September 30, 2016, the Company held $1.9 million of available-for-sale investment securities with contractual maturity dates of more than one year and less than two years. The Company did not hold any investment securities exceeding a two-year maturity. Unrealized gains and losses on marketable securities are recorded as a separate component of accumulated other comprehensive income (loss) included in stockholders’ equity. The Company recorded an unrealized loss of $19,200 and an unrealized gain of $32,298 during the three months ended September 30, 2016 and 2015, respectively, and unrealized gains of $261,773 and $61,182 during the nine months ended September 30, 2016 and 2015, respectively. Realized gains (losses) are included in interest income (expense) in the statement of operations and comprehensive income (loss) on a specific identification basis. The Company did not record any realized gains or losses during the nine months ended September 30, 2016 and 2015. To date, the Company has not recorded any impairment charges on marketable securities related to other-than-temporary declines in market value. There were no transfers between Level 2 and Level 3 during the nine months ended September 30, 2016 or the year ended December 31, 2015. Warrants At September 30, 2016, there is an outstanding warrant to purchase up to 20,161 shares of the Company’s common stock with a fair value recorded as a liability of $90,561 as it contains a cash settlement feature upon certain strategic transactions. The following table sets forth a summary of changes in the fair value of this warrant liability, which represents a recurring measurement that is classified within Level 3 of the fair value hierarchy, wherein fair value is estimated using significant unobservable inputs: Warrant Liability Balance as of December 31, 2015 Amounts acquired or issued — Changes in estimated fair value Balance as of September 30, 2016 $ On each re-measurement date, the fair value of the warrant classified as a liability is estimated using the Black-Scholes option pricing model. For this liability, the Company develops its own assumptions that do not have observable inputs or available market data to support the fair value. This method of valuation involves using inputs such as the fair value of the Company’s common stock, stock price volatility, the contractual term of the warrant, risk-free interest rates and dividend yields. Due to the nature of these inputs, the valuation of the warrant is considered a Level 3 measurement. The following assumptions were used at September 30, 2016 and December 31, 2015 to determine the common stock warrant liability: September 30, 2016 December 31, 2015 Estimated remaining term years years Risk-free interest rate % % Volatility % % Dividend yield % % Fair value of underlying instrument* $ $ * The warrant liability is recorded on its own line item on the Company’s balance sheets and is marked-to-market at each reporting period with the change in fair value recorded on its own line in the statements of operations and comprehensive income (loss). In addition to the outstanding warrant to purchase 20,161 shares of common stock discussed above, the Company has outstanding warrants to purchase an aggregate of 40,689 shares of the Company’s common stock. These warrants qualify for equity classification and have been allocated upon the relative fair value of the base instrument and the warrants, according to the guidance of ASC 470-20-25-2. See Note 4 for additional information. |
Loans Payable
Loans Payable | 9 Months Ended |
Sep. 30, 2016 | |
Loans Payable. | |
Loans Payable | 4. Loans Payable In September 2014, the Company entered into a loan and security agreement with Oxford Finance LLC and Pacific Western Bank (formerly Square 1 Bank) (together, the “lenders”), pursuant to which the lenders agreed to lend the Company up to $35.0 million in a three-tranche series of term loans (Term Loans A, B, and C). Upon initially entering into the agreement, the Company borrowed $2.0 million under Term Loan A. On April 13, 2015, the Company amended the agreement with the lenders to change the draw period for Term Loan B. On December 23, 2015, the Company further amended the agreement with the lenders to, among other things, change the draw period for Term Loan C, modify the interest only period, and modify the maturity date of the loan. In December 2015, the Company borrowed the Term Loan B tranche of $16.5 million. The Company’s ability to draw an additional $16.5 million under Term Loan C was subject to the satisfaction of one or more specified triggers related to the results of the Company’s Phase 2b clinical trial of TRV027, which were announced in May 2016. Although certain of the triggers to draw on Term Loan C were not attained as of September 30, 2016, the Company is continuing to assess the remaining triggers to determine its eligibility to draw on Term Loan C. The proceeds from Term Loan A and Term Loan B may be used to satisfy the Company’s future working capital needs, potentially including the development of its clinical and preclinical product candidates. Borrowings accrue interest at a fixed rate of 6.50% per annum. The Company is required to make payments of interest only on borrowings under the loan agreement on a monthly basis through and including January 1, 2017, after which payments of principal in equal monthly installments and accrued interest will be due until the loan matures on March 1, 2020. If, based on the Company’s ongoing evaluation, it is eligible to draw on Term Loan C, monthly interest only payments will be extended to January 1, 2018 and the loan maturity date will be extended to December 1, 2020. The Company paid the lenders a facility fee of $175,000 in connection with the execution of the original agreement and an amendment fee of $20,000 in connection with the execution of the second amendment to the agreement. Upon the last payment date of the amounts borrowed under the agreement, the Company will be required to pay a final payment fee equal to 6.1% of the aggregate amounts borrowed. In addition, if the Company repays Term Loan A and Term Loan B prior to the applicable maturity date, it will pay the lenders a prepayment fee of 3.0% of the total amount prepaid if the prepayment occurs prior to December 23, 2016, 2.0% of the total amount prepaid if the prepayment occurs between December 23, 2016 and December 23, 2017, and 1.0% of the total amount prepaid if the prepayment occurs on or after December 24, 2017. The Company’s obligations under the loan and security agreement are secured by a first priority security interest in substantially all of the assets of the Company, other than intellectual property. The Company has agreed not to pledge or otherwise encumber its intellectual property, other than through grants of certain permitted non-exclusive or exclusive licenses or other conveyances of its intellectual property. The loan and security agreement includes affirmative and restrictive covenants, including: (a) financial reporting requirements; (b) limitations on the incurrence of indebtedness; (c) limitations on liens; (d) limitations on certain merger and acquisition transactions; (e) limitations on dispositions of certain assets; (f) limitations on fundamental corporate changes (including changes in control); (g) limitations on investments; (h) limitations on payments and distributions and (i) other covenants. The agreement also contains certain events of default, including for payment defaults, breaches of covenants, a material adverse change in the collateral, the Company’s business, operations or condition (financial or otherwise), certain levies, attachments and other restraints on the Company’s business, insolvency, defaults under other agreements and misrepresentations. Three Point Capital, LLC served as a placement agent in connection with the term loans. The Company paid the agent $65,000 upon execution of the agreement and $87,500 upon its draw of Term Loan B. In connection with entering into the original agreement, the Company issued to the lenders and the placement agent warrants to purchase an aggregate of 7,678 shares of the Company’s common stock; warrants to purchase an aggregate of 5,728 shares remain outstanding as of September 30, 2016. These detachable warrant instruments have qualified for equity classification and have been allocated upon the relative fair value of the base instrument and the warrants, according to the guidance of ASC 470-20-25-2. These warrants are exercisable immediately and have an exercise price of $5.8610 per share. The warrants may be exercised on a cashless basis and will terminate on the earlier of September 19, 2024 or the closing of a merger or consolidation transaction in which the Company is not the surviving entity. In connection with the draw of Term Loan B, the Company issued to the lenders and the placement agent additional warrants to purchase an aggregate of 34,961 shares of the Company’s common stock. These warrants have substantially the same terms as those described above, and have an exercise price of $10.6190 per share and an expiration date of December 23, 2025. As of September 30, 2016, borrowings of $18.5 million attributable to Term Loans A and B remain outstanding. Interest expense of $300,625 and $32,500 was recorded during the three months ended September 30, 2016 and 2015, respectively, and $901,875 and $97,500 was recorded during the nine months ended September 30, 2016 and 2015, respectively. The Company incurred lender and third party costs of $225,988 and $106,545, respectively, related to the issuance of Term Loan A. The Company incurred lender and third party costs of $44,058 and $87,500, respectively, related to the issuance of Term Loan B. The lender costs are classified as a debt discount and the third party costs are classified as debt issuance costs. Per ASU 2015-03, Interest-Imputation of Interest , debt discount and debt issuance costs are to be presented as a contra-liability to the debt on the balance sheet. These costs will be amortized to interest expense over the life of the loans using the effective interest method. A total of $30,022 and $39,639 of debt discount and debt issuance cost was amortized to interest expense during the three months ended September 30, 2016 and 2015 respectively, and $93,935 and $117,188 of debt discount and debt issuance costs was amortized to interest expense during the nine months ended September 30, 2016 and 2015, respectively. The following table summarizes how the issuance of Term Loans A and B are reflected on the balance sheet at September 30, 2016: September 30, 2016 Gross proceeds $ Debt discount Debt issuance costs Carrying value Current portion of loans payable, net Loans payable, net $ |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2016 | |
Stockholders' Equity | |
Stockholders' Equity | 5. Stockholders’ Equity Under its certificate of incorporation, the Company was authorized to issue up to 100,000,000 shares of common stock as of September 30, 2016. The Company also was authorized to issue up to 5,000,000 shares of preferred stock as of September 30, 2016. The Company is required, at all times, to reserve and keep available out of its authorized but unissued shares of common stock sufficient shares to effect the conversion of the shares of any outstanding preferred stock and all outstanding stock options and warrants. Equity Offerings In February 2016, the Company issued and sold 1,350,755 shares of common stock through Cowen and Company, LLC, pursuant to an at-the-market sales facility dated December 14, 2015. The shares were sold at a weighted average price per share of $9.00. The net offering proceeds to the Company were approximately $11.8 million after deducting related expenses, including commissions. Equity Incentive Plans In 2008, the Company adopted the 2008 Equity Incentive Plan, as amended on February 29, 2008, January 7, 2010, July 8, 2010, December 10, 2010, June 23, 2011 and June 17, 2013 (collectively, the “2008 Plan”) that authorized the Company to grant restricted stock and stock options to eligible employees, directors and consultants to the Company. As of January 2014, no further grants may be made under the 2008 Plan. In 2013, the Company adopted the 2013 Equity Incentive Plan, as amended on March 31, 2014 (collectively, the “2013 Plan”). The 2013 Plan became effective upon the Company’s entry into the underwriting agreement related to its initial public offering in January 2014. The 2013 Plan provides for the grant of incentive stock options, non-statutory stock options, stock appreciation rights, restricted stock awards, restricted stock unit awards, performance-based stock awards and other forms of equity compensation (collectively, stock awards), all of which may be granted to employees, including officers, non-employee directors and consultants of the Company. Additionally, the 2013 Plan provides for the grant of cash and stock based performance awards. The 2013 Plan contains an “evergreen” provision, pursuant to which the number of shares of common stock available for issuance under the plan automatically increases on January 1 of each year beginning in 2015. As of January 1, 2016, the number of shares of common stock that may be issued under the 2013 Plan was automatically increased by 2,032,104 shares, representing 4% of the total number of shares of common stock outstanding on December 31, 2015. Under both the 2008 Plan and the 2013 Plan, the amount, terms of grants and exercisability provisions are determined by the board of directors or its designee. The term of the options may be up to 10 years, and options are exercisable in cash or as otherwise determined by the board of directors. Vesting generally occurs over a period of not greater than four years. The estimated grant-date fair value of the Company’s stock-based awards is amortized ratably over the awards’ service periods. Stock-based compensation expense recognized was as follows: Three Months Ended September 30, Nine Months Ended September 30, 2016 2015 2016 2015 Research and development $ $ $ $ General and administrative Total stock-based compensation $ $ $ $ Options Outstanding Weighted Average Weighted Remaining Average Contractual Number of Exercise Term (in Shares Price years) Balance, December 31, 2015 $ Granted Exercised Forfeited/Cancelled Balance, September 30, 2016 $ Vested or expected to vest at September 30, 2016 $ Exercisable at September 30, 2016 $ The intrinsic value of the options exercisable as of September 30, 2016 was $8.0 million, based on the Company’s closing stock price of $6.75 per share and a weighted average exercise price of $4.02 per share. The Company uses the Black-Scholes option pricing model to estimate the fair value of stock options at the grant date. The Black-Scholes model requires the Company to make certain estimates and assumptions, including estimating the fair value of the Company’s common stock, assumptions related to the expected price volatility of the Company’s stock, the period during which the options will be outstanding, the rate of return on risk-free investments and the expected dividend yield for the Company’s common stock. The per-share weighted-average grant date fair value of the options granted to employees and directors during the nine months ended September 30, 2016 and 2015 was estimated at $5.29 and $4.37 per share, respectively, on the date of grant using the Black-Scholes option pricing model with the following weighted-average assumptions: Nine Months Ended September 30, 2016 2015 Expected term of options (in years) Risk-free interest rate % % Expected volatility % % Dividend yield % % The weighted-average valuation assumptions were determined as follows: · Risk-free interest rate: The Company based the risk-free interest rate on the interest rate payable on U.S. Treasury securities in effect at the time of grant for a period that is commensurate with the assumed expected option term. · Expected term of options: Due to its lack of sufficient historical data, the Company estimates the expected life of its employee stock options using the “simplified” method, as prescribed in Staff Accounting Bulletin No. 107, whereby the expected life equals the arithmetic average of the vesting term and the original contractual term of the option. · Expected stock price volatility: The Company estimated the expected volatility based on actual historical volatility of the stock price of similar companies with publicly-traded equity securities. The Company calculated the historical volatility of the selected companies by using daily closing prices over a period of the expected term of the associated award. The companies’ stock were selected based on their enterprise value, risk profiles, position within the industry and with historical share price information sufficient to meet the expected term of the associated award. A decrease in the selected volatility would have decreased the fair value of the underlying instrument. · Expected annual dividend yield: The Company estimated the expected dividend yield based on consideration of its historical dividend experience and future dividend expectations. The Company has not historically declared or paid dividends to stockholders. Moreover, it does not intend to pay dividends in the future, but instead expects to retain any earnings to invest in the continued growth of the business. Accordingly, the Company assumed an expected dividend yield of 0%. · Estimated forfeiture rate: The Company’s estimated annual forfeiture rate on stock option grants during 2016 and 2015 was 9%, based on the historical forfeiture experience. At September 30, 2016, there was $14.6 million of total unrecognized compensation expense related to unvested options that will be recognized over the weighted average remaining period of 2.85 years. Shares Available for Future Grant At September 30, 2016, the Company has the following shares available to be granted under the 2013 Plan: Available at December 31, 2015 Authorized Granted Forfeited/Cancelled Available at September 30, 2016 Shares Reserved for Future Issuance At September 30, 2016, the Company has reserved the following shares of common stock for issuance: Stock options outstanding Shares available for future grant under 2013 Plan Employee stock purchase plan Warrants outstanding Total shares of common stock reserved for future issuance |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2016 | |
Commitments and Contingencies. | |
Commitments and Contingencies | 6. Commitments and Contingencies Licenses On May 3, 2013, the Company entered into an agreement with Allergan plc (formerly Actavis plc and Forest Laboratories Holdings Limited) (“Allergan”), under which the Company granted to Allergan an exclusive option to license its product candidate, TRV027. Under the option agreement, the Company conducted, at its expense, a Phase 2b trial of TRV027 in acute heart failure. In March 2015, Allergan and the Company signed a letter agreement pursuant to which Allergan paid the Company $10.0 million to fund the expansion of the Phase 2b trial of TRV027 from 500 patients to 620 patients. Collaboration revenue has been recognized on a straight-line basis over the study period and has been fully recognized as of September 30, 2016. The March 2015 letter agreement does not otherwise amend the terms of the May 2013 option agreement. In August 2016, Allergan notified the Company of its decision to not exercise its option. As such, the Company has retained all rights to TRV027. Legal Proceedings The Company is not involved in any legal proceeding that it expects to have a material effect on its business, financial condition, results of operations and cash flows. |
Revenue
Revenue | 9 Months Ended |
Sep. 30, 2016 | |
Revenue | |
Revenue | 7. Revenue For arrangements with multiple elements, the Company recognizes revenue in accordance with the FASB’s ASU No. 2009-13, Multiple-Deliverable Revenue Arrangements , which provides guidance for separating and allocating consideration in a multiple element arrangement. Deliverables under the arrangement are separate units of accounting if the delivered item has value to the customer on a standalone basis and if the arrangement includes a general right of return relative to the delivery or performance of the undelivered item is considered probable and substantially within the Company’s control. The consideration that is fixed or determinable at the inception of the arrangement is allocated to the separate units of accounting based on their relative selling prices. Management exercises significant judgement in determining whether a deliverable is a separate unit of accounting. In determining the separate units of accounting, the Company evaluates whether the components have standalone value to the collaborator based on consideration of the relevant facts and circumstances for each arrangements. Whenever the Company determines that an element is delivered over a period of time, revenue is recognized using either a proportional performance model, if a pattern of performance can be determined or a straight-line model over the period of performance, which is typically the research and development term. The Company entered into a letter agreement with Allergan in March 2015 under which the Company received a nonrefundable upfront fee of $10.0 million. The terms of this agreement contain multiple deliverables which include (i) research and development activities and (ii) testing and analysis related to the Phase 2b trial of TRV027. Collaboration revenue is recognized only when the price is fixed or determinable, persuasive evidence of an arrangement exists, delivery has occurred or the services have been rendered and the Company has fulfilled its performance obligations under the contract. The collaboration revenue was recorded on a straight-line basis and was fully recognized as of June 30, 2016. For the three months ended September 30, 2015, the Company recognized collaboration revenue of $1.9 million. For the nine months ended September 30, 2016 and 2015, the Company recognized collaboration revenue of $3.8 million and $4.4 million, respectively. |
Net Loss Per Common Share
Net Loss Per Common Share | 9 Months Ended |
Sep. 30, 2016 | |
Net Loss Per Common Share | |
Net Loss Per Common Share | 8. Net Loss Per Common Share The following table sets forth the computation of basic and diluted net loss per share for the periods indicated: Three Months Ended September 30, Nine Months Ended September 30, 2016 2015 2016 2015 Basic and diluted net loss per common share calculation: Net loss $ $ $ $ Net loss attributable to common stockholders $ $ $ $ Weighted average common shares outstanding Net loss per share of common stock - basic and diluted $ $ $ $ The following outstanding securities at September 30, 2016 and 2015 have been excluded from the computation of diluted weighted shares outstanding, as they would have been anti-dilutive: September 30, 2016 2015 Options outstanding Warrants Total |
Other Comprehensive Income (Los
Other Comprehensive Income (Loss) | 9 Months Ended |
Sep. 30, 2016 | |
Other Comprehensive Income (Loss) | |
Comprehensive Income (Loss) | 9. Other Comprehensive Income (Loss) The following table presents changes in the components of accumulated other comprehensive income (loss), net of tax: Balance, December 31, 2015 $ Net unrealized gains on marketable securities Balance, September 30, 2016 $ There were no reclassifications out of accumulated other comprehensive income (loss) during the three or nine months ended September 30, 2016 and 2015. There was no tax effect during the three or nine months ended September 30, 2016 and 2015. |
Summary of Significant Accoun16
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2016 | |
Summary of Significant Accounting Policies | |
Basis of Presentation | Basis of Presentation The accompanying financial statements have been prepared in conformity with accounting principles generally accepted in the United States (“GAAP”) for interim financial information and are unaudited. The Company’s functional currency is the U.S. dollar. The financial statements include all normal and recurring adjustments that are considered necessary for the fair presentation of the Company’s balance sheet as of September 30, 2016, its results of operations and its comprehensive income (loss) for the three and nine months ended September 30, 2016 and 2015, its statement of stockholders’ equity for the period from January 1, 2016 to September 30, 2016 and its cash flows for the nine months ended September 30, 2016 and 2015. The information included in this Quarterly Report on Form 10-Q should be read in conjunction with the consolidated financial statements and accompanying notes included in the Company’s most recent Annual Report on Form 10-K for the year ended December 31, 2015. Since the date of those financial statements, there have been no changes to the Company’s significant accounting policies. The financial data and other information disclosed in these notes related to the three and nine months ended September 30, 2016 and 2015 are not necessarily indicative of the results to be expected for the year ending December 31, 2016, any other interim periods or any future year or period. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In August 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-15, Statement of Cash Flows (Topic 230) (“ASU 2016-15”). ASU 2016-15 was issued to clarify how certain cash receipts and payments should be presented in the statement of cash flows. The standard is effective for annual periods beginning after December 15, 2017 and interim periods within that reporting period. Early adoption is permitted. The Company is evaluating the effect this standard will have on its financial statements and related disclosures. In March 2016, the FASB issued ASU 2016-09, Compensation— Stock Compensation (“ASU 2016-09”). ASU 2016-09 was issued as part of the FASB Simplification Initiative. This update addresses the income tax effects of stock-based payments and eliminates the windfall pool concept, as all of the tax effects related to stock-based payments will now be recorded at settlement (or expiration) through the income statement. The new guidance also permits entities to make an accounting policy election for the impact of forfeitures on the recognition of expense for stock-based payment awards. Forfeitures can be estimated or recognized when they occur. The standard is effective for annual periods beginning after December 15, 2016 and interim periods within that reporting period. Early adoption is permitted in any interim or annual period, with any adjustment reflected as of the beginning of the fiscal year of adoption. The Company is evaluating the effect this standard will have on its financial statements and related disclosures. In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) (“ASU 2016-02”). ASU 2016-02 requires lessees to record most leases on their balance sheets and disclose key information about leasing arrangements in an effort to increase transparency and comparability among organizations. The standard is effective for annual periods beginning after December 15, 2018 and interim periods within that reporting period. Early adoption is permitted. The Company is evaluating the effect this standard will have on its financial statements and related disclosures. In August 2014, the FASB issued ASU 2014‑15, Presentation of Financial Statements‑Going Concern (Subtopic 205‑40): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern (“ASU 2014-15”), which defines management’s responsibility to assess an entity’s ability to continue as a going concern, and to provide related footnote disclosures if there is substantial doubt about its ability to continue as a going concern. The pronouncement is effective for annual reporting periods ending after December 15, 2016 with early adoption permitted. The Company is evaluating the effect this standard will have on its financial statements and related disclosures. In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers (“ASU 2014-09”). ASU 2014-09 is a comprehensive new revenue recognition model requiring a company to recognize revenue to depict the transfer of goods or services to a customer in an amount reflecting the consideration it expects to receive in exchange for those goods or services. Additionally, in March 2016, the FASB issued ASU 2016-08 Revenue from Contracts with Customers, Principal versus Agent Considerations (“ASU 2016-08”). ASU 2016-08 amends the principal versus agent guidance in ASU 2014-09 to clarify how an entity should identify the unit of accounting for the principal versus agent evaluation and how it should apply the control principal to certain types of arrangements. The effective date for both standards is January 1, 2018, with an option that permits companies to adopt the standard as early as January 1, 2017. Early application prior to January 1, 2017 is not permitted. The standards permit the use of either the retrospective or cumulative effect transition method. The Company is evaluating the transition method that it will elect. The adoption of these standards is not expected to have a material impact on the Company’s financial statements. |
Fair Value of Financial Instr17
Fair Value of Financial Instruments (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Fair Value of Financial Instruments | |
Schedule of cash and available-for-sale securities’ adjusted cost, gross unrealized gains, gross unrealized losses and fair values by significant investment category | September 30, 2016 Unrealized Unrealized Cash and Cash Marketable Adjusted Cost Gains Losses Fair Value Equivalents Securities Cash $ $ — $ — $ $ $ — Level 1 (1): Money market funds — — — Level 2 (2): Cash and cash equivalents — — U.S. government agency securities — Subtotal Total $ $ $ $ $ $ December 31, 2015 Unrealized Unrealized Cash and Cash Marketable Adjusted Cost Gains Losses Fair Value Equivalents Securities Cash $ $ — $ — $ $ $ — Level 1 (1): Money market funds — — — U.S. Treasury securities — Subtotal Level 2 (2): Repurchase agreements — — — U.S. government agency securities — Subtotal Total $ $ $ $ $ $ (1) The fair value of Level 1 securities is estimated based on quoted prices in active markets for identical assets or liabilities. (2) The fair value of Level 2 securities is estimated based on observable inputs other than quoted prices in active markets for identical assets and liabilities, quoted prices for identical or similar assets or liabilities in inactive markets, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. |
Schedule of changes in the fair value of the Company's warrant liability representing a recurring measurement classified within Level 3, wherein fair value is estimated using significant unobservable inputs | Warrant Liability Balance as of December 31, 2015 Amounts acquired or issued — Changes in estimated fair value Balance as of September 30, 2016 $ |
Schedule of assumptions used for valuation of warrants | September 30, 2016 December 31, 2015 Estimated remaining term years years Risk-free interest rate % % Volatility % % Dividend yield % % Fair value of underlying instrument* $ $ * |
Loans Payable (Tables)
Loans Payable (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Loans Payable. | |
Schedule of loans reflected on the balance sheet | September 30, 2016 Gross proceeds $ Debt discount Debt issuance costs Carrying value Current portion of loans payable, net Loans payable, net $ |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Schedule of share-based compensation expense recognized | Three Months Ended September 30, Nine Months Ended September 30, 2016 2015 2016 2015 Research and development $ $ $ $ General and administrative Total stock-based compensation $ $ $ $ |
Summary of stock option activity | Options Outstanding Weighted Average Weighted Remaining Average Contractual Number of Exercise Term (in Shares Price years) Balance, December 31, 2015 $ Granted Exercised Forfeited/Cancelled Balance, September 30, 2016 $ Vested or expected to vest at September 30, 2016 $ Exercisable at September 30, 2016 $ |
Schedule of weighted-average assumptions: | Nine Months Ended September 30, 2016 2015 Expected term of options (in years) Risk-free interest rate % % Expected volatility % % Dividend yield % % |
Schedule of shares of common stock reserved/available | Stock options outstanding Shares available for future grant under 2013 Plan Employee stock purchase plan Warrants outstanding Total shares of common stock reserved for future issuance |
2013 plan | |
Schedule of shares of common stock reserved/available | Available at December 31, 2015 Authorized Granted Forfeited/Cancelled Available at September 30, 2016 |
Net Loss Per Common Share (Tabl
Net Loss Per Common Share (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Net Loss Per Common Share | |
Schedule of computation of basic and diluted net loss per share | Three Months Ended September 30, Nine Months Ended September 30, 2016 2015 2016 2015 Basic and diluted net loss per common share calculation: Net loss $ $ $ $ Net loss attributable to common stockholders $ $ $ $ Weighted average common shares outstanding Net loss per share of common stock - basic and diluted $ $ $ $ |
Schedule of outstanding securities excluded from the computation of diluted weighted shares outstanding as they would have been anti-dilutive | September 30, 2016 2015 Options outstanding Warrants Total |
Other Comprehensive Income (L21
Other Comprehensive Income (Loss) (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Other Comprehensive Income (Loss) | |
Schedule of accumulated other comprehensive income (loss), net of tax | Balance, December 31, 2015 $ Net unrealized gains on marketable securities Balance, September 30, 2016 $ |
Organization and Description 22
Organization and Description of the Business (Details) | 3 Months Ended | 9 Months Ended | ||||
Sep. 30, 2016USD ($) | Sep. 30, 2015USD ($) | Sep. 30, 2016USD ($)item | Sep. 30, 2015USD ($) | Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($) | |
Organization and Description of the Business | ||||||
Number of operating segments | item | 1 | |||||
Liquidity | ||||||
Accumulated deficit | $ 249,391,918 | $ 249,391,918 | $ 182,497,965 | |||
Net loss | (29,898,656) | $ (10,615,483) | (66,893,953) | $ (35,063,979) | ||
Cash and cash equivalents | 25,228,034 | $ 39,034,709 | 25,228,034 | $ 39,034,709 | 46,773,566 | $ 36,205,559 |
Marketable securities | $ 94,386,006 | $ 94,386,006 | $ 125,864,447 |
Fair Value of Financial Instr23
Fair Value of Financial Instruments - Hierarchy Table (Details) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | Dec. 31, 2015 | |
Fair value | |||||
Available-for-sale investment securities with contractual maturity date of more than one but less than two years | $ 1,900,000 | $ 1,900,000 | |||
Unrealized gain (loss) on marketable securities | (19,200) | $ 32,298 | 261,773 | $ 61,182 | |
Transfers into Level 3 | 0 | $ 0 | |||
Transfers out of Level 3 | 0 | 0 | |||
Cash | |||||
Fair value | |||||
Adjusted Cost | 1,814,455 | 1,814,455 | 20,672,737 | ||
Fair Value | 1,814,455 | 1,814,455 | 20,672,737 | ||
Cash and Cash Equivalents | Cash | |||||
Fair value | |||||
Fair Value | 1,814,455 | 1,814,455 | 20,672,737 | ||
Total | |||||
Fair value | |||||
Adjusted Cost | 119,558,123 | 119,558,123 | |||
Unrealized Gains | 57,457 | ||||
Unrealized Losses | (1,540) | ||||
Fair Value | 119,614,040 | 119,614,040 | |||
Total | Cash and Cash Equivalents | |||||
Fair value | |||||
Fair Value | 25,228,034 | 25,228,034 | |||
Total | Marketable Securities. | |||||
Fair value | |||||
Fair Value | 94,386,006 | 94,386,006 | |||
Repurchase agreements | |||||
Fair value | |||||
Adjusted Cost | 22,000,000 | ||||
Fair Value | 22,000,000 | ||||
Repurchase agreements | Cash and Cash Equivalents | |||||
Fair value | |||||
Fair Value | 22,000,000 | ||||
U.S. government agency securities | |||||
Fair value | |||||
Adjusted Cost | 114,049,441 | ||||
Unrealized Gains | 269 | ||||
Unrealized Losses | (204,783) | ||||
Fair Value | 113,844,927 | ||||
U.S. government agency securities | Marketable Securities. | |||||
Fair value | |||||
Fair Value | 113,844,927 | ||||
Level 1 | |||||
Fair value | |||||
Adjusted Cost | 16,121,691 | ||||
Unrealized Gains | 92 | ||||
Unrealized Losses | (1,434) | ||||
Fair Value | 16,120,349 | ||||
Level 1 | Cash and Cash Equivalents | |||||
Fair value | |||||
Fair Value | 4,100,829 | ||||
Level 1 | Marketable Securities. | |||||
Fair value | |||||
Fair Value | 12,019,520 | ||||
Level 1 | Money market mutual funds | |||||
Fair value | |||||
Adjusted Cost | 19,296,757 | 19,296,757 | 4,100,829 | ||
Fair Value | 19,296,757 | 19,296,757 | 4,100,829 | ||
Level 1 | Money market mutual funds | Cash and Cash Equivalents | |||||
Fair value | |||||
Fair Value | 19,296,757 | 19,296,757 | |||
Level 1 | U.S. Treasury securities | |||||
Fair value | |||||
Adjusted Cost | 12,020,862 | ||||
Unrealized Gains | 92 | ||||
Unrealized Losses | (1,434) | ||||
Fair Value | 12,019,520 | ||||
Level 2 | |||||
Fair value | |||||
Adjusted Cost | 98,446,912 | 98,446,912 | 136,049,441 | ||
Unrealized Gains | 57,457 | 269 | |||
Unrealized Losses | (1,540) | (204,783) | |||
Fair Value | 98,502,829 | 98,502,829 | 135,844,927 | ||
Level 2 | Cash and Cash Equivalents | |||||
Fair value | |||||
Fair Value | 4,116,823 | 4,116,823 | 22,000,000 | ||
Level 2 | Marketable Securities. | |||||
Fair value | |||||
Fair Value | 94,386,006 | 94,386,006 | 113,844,927 | ||
Level 2 | Total | |||||
Fair value | |||||
Adjusted Cost | 172,843,869 | ||||
Unrealized Gains | 361 | ||||
Unrealized Losses | (206,217) | ||||
Fair Value | 172,638,013 | ||||
Level 2 | Total | Cash and Cash Equivalents | |||||
Fair value | |||||
Fair Value | 46,773,566 | ||||
Level 2 | Total | Marketable Securities. | |||||
Fair value | |||||
Fair Value | $ 125,864,447 | ||||
Level 2 | Parent Company [Member] | Cash and Cash Equivalents | |||||
Fair value | |||||
Adjusted Cost | 4,116,730 | 4,116,730 | |||
Unrealized Gains | 93 | ||||
Fair Value | 4,116,823 | 4,116,823 | |||
Level 2 | U.S. government agency securities | |||||
Fair value | |||||
Adjusted Cost | 94,330,182 | 94,330,182 | |||
Unrealized Gains | 57,364 | ||||
Unrealized Losses | (1,540) | ||||
Fair Value | 94,386,006 | 94,386,006 | |||
Level 2 | U.S. government agency securities | Marketable Securities. | |||||
Fair value | |||||
Fair Value | $ 94,386,006 | $ 94,386,006 |
Fair Value of Financial Instr24
Fair Value of Financial Instruments - Warrants (Details) - Warrants | Sep. 30, 2016USD ($)shares |
Warrants | |
Fair value of the warrant liability outstanding | $ | $ 90,561 |
Maximum | |
Warrants | |
Number of shares that can be purchased upon exercise of warrants (in shares) | shares | 20,161 |
Fair Value of Financial Instr25
Fair Value of Financial Instruments - Summary of Changes in Warrant Liability (Details) - Warrants - Warrant Liability | 9 Months Ended |
Sep. 30, 2016USD ($) | |
Warrant Liability | |
Balance at the beginning of the period | $ 153,238 |
Changes in estimated fair value | (62,677) |
Balance at the end of the period | $ 90,561 |
Fair Value of Financial Instr26
Fair Value of Financial Instruments - Warrant Liability Assumptions (Details) - $ / shares | 9 Months Ended | 12 Months Ended |
Sep. 30, 2016 | Dec. 31, 2015 | |
Warrants | Maximum | ||
Warrants | ||
Number of shares that can be purchased upon exercise of warrants (in shares) | 20,161 | |
Term Loans A and B | Warrants | ||
Warrants | ||
Number of shares that can be purchased upon exercise of warrants (in shares) | 40,689 | |
Level 3 | Warrants | ||
Fair value assumptions | ||
Estimated remaining term | 5 years 7 months 6 days | 6 years 3 months 18 days |
Risk-free interest rate (as a percent) | 1.20% | 2.00% |
Volatility (as a percent) | 77.10% | 67.40% |
Dividend yield (as a percent) | 0.00% | 0.00% |
Fair value of underlying instrument (in dollar per share) | $ 6.75 | $ 10.50 |
Loans Payable (Details)
Loans Payable (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | Dec. 31, 2015 | Sep. 30, 2014 | |
Long Term Debt | ||||||
Interest rate (as a percent) | 6.50% | 6.50% | ||||
Amortization of debt discount and issuance costs | $ 30,022 | $ 39,639 | $ 93,935 | $ 117,188 | ||
Carrying value | 13,644,787 | 13,644,787 | $ 18,185,898 | |||
Current portion of long term debt | 4,635,046 | 4,635,046 | ||||
Interest expense | 433,931 | 72,331 | $ 1,306,997 | 215,293 | ||
Fees | ||||||
Facility fee | $ 175,000 | |||||
Debt Instrument Amendment Fee | 20,000 | |||||
Final payment fee due upon that last payment date of the amounts borrowed under the agreement subject to adjustment (as a percent) | 6.10% | |||||
Loan and security agreement | ||||||
Long Term Debt | ||||||
Face amount | 35,000,000 | |||||
Term Loan A | ||||||
Long Term Debt | ||||||
Face amount | 2,000,000 | |||||
Deferred financing fees | 106,545 | |||||
Debt discount | (225,988) | |||||
Term Loan B | ||||||
Long Term Debt | ||||||
Face amount | 16,500,000 | |||||
Deferred financing fees | 87,500 | |||||
Debt discount | (44,058) | |||||
Term Loan C | ||||||
Long Term Debt | ||||||
Face amount | 16,500,000 | $ 16,500,000 | ||||
Term Loans A and B | ||||||
Long Term Debt | ||||||
Gross proceeds | 18,500,000 | 18,500,000 | ||||
Debt discount | (117,716) | (117,716) | ||||
Debt issuance costs | (102,451) | (102,451) | ||||
Carrying value | 18,279,833 | 18,279,833 | ||||
Current portion of long term debt | 4,635,046 | 4,635,046 | ||||
Loan payable, net | 13,644,787 | 13,644,787 | ||||
Interest expense | $ 300,625 | $ 32,500 | $ 901,875 | $ 97,500 | ||
Fees | ||||||
Prepayment fee as a percent of total amount prepaid if prepayment occurs prior to the first anniversary of the funding | 3.00% | |||||
Prepayment fee as a percent of total amount prepaid if prepayment occurs between the first and second anniversary of the funding | 2.00% | |||||
Prepayment fee as a percent of total amount prepaid if prepayment occurs on or after the second anniversary of the funding | 1.00% | |||||
Three Point | ||||||
Fees | ||||||
Facility fee | $ 65,000 | |||||
Three Point | Term Loan B | ||||||
Fees | ||||||
Facility fee | $ 87,500 | |||||
Warrants | ||||||
Warrants | ||||||
Exercise price (in dollars per share) | $ 10.6190 | $ 5.8610 | ||||
Warrants | Term Loans A and B | ||||||
Warrants | ||||||
Number of shares that can be purchased upon exercise of warrants (in shares) | 40,689 | 40,689 | ||||
Warrants | Common Stock | Term Loan A | ||||||
Warrants | ||||||
Number of shares that can be purchased upon exercise of warrants (in shares) | 5,728 | 5,728 | 7,678 | |||
Warrants | Common Stock | Term Loan B | ||||||
Warrants | ||||||
Number of shares that can be purchased upon exercise of warrants (in shares) | 34,961 |
Stockholders' Equity - Equity O
Stockholders' Equity - Equity Offerings (Details) - USD ($) | 1 Months Ended | 9 Months Ended | ||
Feb. 29, 2016 | Sep. 30, 2016 | Sep. 30, 2015 | Dec. 31, 2015 | |
Equity Offerings | ||||
Issuance of common stock, net of issuance costs | $ 11,792,398 | |||
Proceeds from issuance of common stock, net | $ 11,792,398 | $ 90,510,810 | ||
Common stock, shares authorized | 100,000,000 | 100,000,000 | ||
Preferred Stock, shares authorized | 5,000,000 | 5,000,000 | ||
At-the-market sales facility | ||||
Equity Offerings | ||||
Issuance of common stock, net of issuance costs (in shares) | 1,350,755 | |||
Proceeds from issuance of common stock, net | $ 11,800,000 | |||
At-the-market sales facility | Weighted-average | ||||
Equity Offerings | ||||
Offering price (in dollars per share) | $ 9 |
Stockholders' Equity - Equity I
Stockholders' Equity - Equity Incentive Plans (Details) - USD ($) | Jan. 01, 2016 | Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | Dec. 31, 2015 |
Equity Incentive Plans | ||||||
Stock-based compensation | $ 1,545,310 | $ 890,418 | $ 4,258,418 | $ 2,348,526 | ||
Research and development | ||||||
Equity Incentive Plans | ||||||
Stock-based compensation | 634,718 | 349,698 | 1,763,514 | 927,521 | ||
General and administrative | ||||||
Equity Incentive Plans | ||||||
Stock-based compensation | $ 910,592 | $ 540,720 | $ 2,494,904 | $ 1,421,005 | ||
2013 plan | ||||||
Equity Incentive Plans | ||||||
Increase in number of shares authorized for issuance | 2,032,104 | |||||
Newly authorized shares for issuance as a percentage of common stock outstanding | 4.00% | |||||
2008 Plan and 2013 Plan | Maximum | ||||||
Equity Incentive Plans | ||||||
Term of award | 10 years | |||||
Vesting period | 4 years |
Stockholder's Equity - Options
Stockholder's Equity - Options Outstanding (Details) - $ / shares | 9 Months Ended | 12 Months Ended |
Sep. 30, 2016 | Dec. 31, 2015 | |
Number of Shares | ||
Balance at the beginning of the period (in shares) | 4,630,073 | |
Granted (in shares) | 2,006,500 | |
Exercised (in shares) | (88,591) | |
Forfeitures (in shares) | (53,649) | |
Balance at the end of the period (in shares) | 6,494,333 | 4,630,073 |
Vested or expected to vest at the end of the period (in shares) | 6,250,402 | |
Exercisable at the end of the period (in shares) | 2,722,290 | |
Weighted-Average Exercise Price | ||
Balance at the beginning of the period (in dollars per share) | $ 4.98 | |
Granted (in dollars per share) | 8.52 | |
Exercised (in dollars per share) | 1.57 | |
Forfeitures/Expirations (in dollars per share) | 6.67 | |
Balance at the end of the period (in dollars per share) | 6.10 | $ 4.98 |
Vested or expected to vest at the end of the period (in dollars per share) | 6.03 | |
Exercisable at the end of the period (in dollars per share) | $ 4.02 | |
Weighted Average Remaining Contractual Term | ||
Options Outstanding at the end of the period | 7 years 9 months 29 days | 7 years 10 months 13 days |
Vested or expected to vest at the end of the period | 7 years 9 months 11 days | |
Exercisable at the end of the period | 6 years 5 months 16 days | |
Options outstanding | ||
Weighted-Average Exercise Price | ||
Exercisable at the end of the period (in dollars per share) | $ 4.02 |
Stockholder's Equity - Shares A
Stockholder's Equity - Shares Available for Future Issuance (Details) - USD ($) $ / shares in Units, $ in Millions | 9 Months Ended | 21 Months Ended | |||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2016 | Dec. 31, 2015 | |
Equity Incentive Plans | |||||
Weighted average exercise price (in dollars per share) | $ 4.02 | ||||
Weighted-average assumptions: | |||||
Estimated annual forfeiture rate (as a percent) | 9.00% | ||||
Shares Available for Future Grant | |||||
Balance at the end of the period (in shares) | 1,038,607 | 1,038,607 | |||
Shares Reserved for Future Issuance | |||||
Stock options outstanding (in shares) | 6,494,333 | 4,630,073 | |||
Shares available for future grant under 2013 Plan (in shares) | 1,038,607 | 1,038,607 | 1,038,607 | ||
Employee stock purchase plan | 225,806 | ||||
Warrants outstanding (in shares) | 60,850 | ||||
Total shares of common stock reserved for issuance | 7,819,596 | ||||
2013 plan | |||||
Shares Available for Future Grant | |||||
Balance at the beginning of the period (in shares) | 959,354 | ||||
Authorized (in shares) | 2,032,104 | ||||
Granted (in shares) | (2,006,500) | ||||
Forfeitures/Expirations (in shares) | 53,649 | ||||
Balance at the end of the period (in shares) | 1,038,607 | 1,038,607 | |||
Shares Reserved for Future Issuance | |||||
Shares available for future grant under 2013 Plan (in shares) | 959,354 | 1,038,607 | 1,038,607 | 959,354 | |
Options outstanding | |||||
Equity Incentive Plans | |||||
Intrinsic value of options exercisable | $ 8 | ||||
Per share price of Company's closing stock price (in dollars per share) | $ 6.75 | ||||
Weighted average exercise price (in dollars per share) | $ 4.02 | ||||
Per-share weighted-average grant date fair value of options granted (in dollars per share) | $ 5.29 | $ 4.37 | |||
Weighted-average assumptions: | |||||
Unrecognized compensation expense | $ 14.6 | ||||
Weighted average remaining period for recognition of unrecognized compensation expense | 2 years 10 months 6 days | ||||
Options outstanding | Weighted-average | |||||
Weighted-average assumptions: | |||||
Expected term of options (in years) | 6 years 2 months 12 days | 6 years 2 months 12 days | |||
Risk-free interest rate (as a percent) | 1.50% | 1.70% | |||
Expected volatility (as a percent) | 67.90% | 68.80% | |||
Dividend yield (as a percent) | 0.00% | 0.00% |
Commitments and Contingencies (
Commitments and Contingencies (Details) - Allergan $ in Millions | 1 Months Ended |
Mar. 31, 2015USD ($)person | |
Collaboration Revenue. | |
Payment received to fund expansion of clinical trial | $ | $ 10 |
Number of patients before expansion of the trial | 500 |
Number of patients after expansion of the trial | 620 |
Revenue (Details)
Revenue (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||
Mar. 31, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Revenue | |||||
Collaboration revenue | $ 1,875,000 | $ 3,750,000 | $ 4,375,000 | ||
Allergan | |||||
Revenue | |||||
Collaboration revenue | $ 1,900,000 | $ 1,900,000 | $ 3,800,000 | $ 4,400,000 | |
Nonrefundable upfront fee | $ 10,000,000 |
Net Loss Per Common Share (Deta
Net Loss Per Common Share (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Outstanding securities excluded from computation of diluted weighted shares outstanding as they would have been anti dilutive: | ||||
Outstanding securities excluded from computation of diluted weighted shares outstanding (in shares) | 6,555,183 | 4,685,788 | ||
Basic and diluted net loss per common share calculation: | ||||
Net loss | $ (29,898,656) | $ (10,615,483) | $ (66,893,953) | $ (35,063,979) |
Net loss attributable to common stockholders | $ (29,898,656) | $ (10,615,483) | $ (66,893,953) | $ (35,063,979) |
Weighted average common shares outstanding | 52,205,156 | 44,214,428 | 51,911,107 | 41,443,362 |
Net loss per share of common stock—basic and diluted | $ (0.57) | $ (0.24) | $ (1.29) | $ (0.85) |
Options outstanding | ||||
Outstanding securities excluded from computation of diluted weighted shares outstanding as they would have been anti dilutive: | ||||
Outstanding securities excluded from computation of diluted weighted shares outstanding (in shares) | 6,494,333 | 4,657,949 | ||
Warrants | ||||
Outstanding securities excluded from computation of diluted weighted shares outstanding as they would have been anti dilutive: | ||||
Outstanding securities excluded from computation of diluted weighted shares outstanding (in shares) | 60,850 | 27,839 |
Other Comprehensive Income (L35
Other Comprehensive Income (Loss) (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Accumulated Other Comprehensive Income (Loss), Net of Tax. | ||||
Balance | $ 143,131,465 | |||
Net unrealized gains on marketable securities | $ (19,200) | $ 32,298 | 261,773 | $ 61,182 |
Balance | 92,689,485 | 92,689,485 | ||
Accumulated Other Comprehensive Income (Loss) | ||||
Accumulated Other Comprehensive Income (Loss), Net of Tax. | ||||
Balance | (205,856) | |||
Net unrealized gains on marketable securities | 261,773 | |||
Balance | 55,917 | 55,917 | ||
Reclassifications out of accumulated other comprehensive income or loss, net of tax | 0 | 0 | 0 | 0 |
Tax effect | $ 0 | $ 0 | $ 0 | $ 0 |