Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2015 | Aug. 05, 2015 | |
Document and Entity Information | ||
Entity Registrant Name | TREVENA INC | |
Entity Central Index Key | 1,429,560 | |
Document Type | 10-Q | |
Document Period End Date | Jun. 30, 2015 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Smaller Reporting Company | |
Entity Common Stock, Shares Outstanding | 43,062,179 | |
Document Fiscal Year Focus | 2,015 | |
Document Fiscal Period Focus | Q2 |
Balance Sheets
Balance Sheets - USD ($) | Jun. 30, 2015 | Dec. 31, 2014 |
Current assets: | ||
Cash and cash equivalents | $ 43,665,766 | $ 36,205,559 |
Marketable securities | 62,716,174 | 70,698,640 |
Prepaid expenses and other current assets | 883,165 | 669,155 |
Total current assets | 107,265,105 | 107,573,354 |
Property and equipment, net | 609,344 | 553,294 |
Restricted cash | 112,410 | 112,410 |
Total assets | 107,986,859 | 108,239,058 |
Current liabilities: | ||
Accounts payable | 4,061,369 | 4,342,480 |
Accrued expenses and other current liabilities | 1,569,315 | 2,578,269 |
Deferred revenue | 7,500,000 | |
Deferred rent | 42,074 | 38,359 |
Total current liabilities | 13,172,758 | 6,959,108 |
Loan payable, net | 1,748,667 | 1,692,884 |
Capital lease, net of current portion | 9,332 | 10,677 |
Deferred rent, net of current portion | 260,622 | 281,885 |
Warrant liability | 85,916 | 82,851 |
Other long term liabilities | 29,791 | 8,025 |
Total liabilities | $ 15,307,086 | $ 9,035,430 |
Commitments and contingencies (Note 6) | ||
Stockholders' equity: | ||
Common stock, $0.001 par value; 100,000,000 shares authorized, 42,060,179 and 39,241,173 shares issued and outstanding at June 30, 2015 and December 31, 2014, respectively | $ 42,060 | $ 39,241 |
Additional paid-in capital | 249,045,832 | 231,152,894 |
Accumulated deficit | (156,418,221) | (131,969,725) |
Accumulated other comprehensive income (loss) | 10,102 | (18,782) |
Total stockholders' equity | 92,679,773 | 99,203,628 |
Total liabilities and stockholders' equity | $ 107,986,859 | $ 108,239,058 |
Balance Sheets (Parenthetical)
Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2015 | Dec. 31, 2014 |
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 | 42,060,179 | 39,241,173 |
Common stock, shares outstanding | 42,060,179 | 39,241,173 |
Statements of Operations and Co
Statements of Operations and Comprehensive Loss - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | |
Revenue: | ||||
Collaboration revenue | $ 1,875,000 | $ 2,500,000 | ||
Total revenue | 1,875,000 | 2,500,000 | ||
Operating expenses: | ||||
General and administrative | 3,107,263 | $ 2,475,820 | 6,196,885 | $ 4,496,685 |
Research and development | 10,275,470 | 9,031,037 | 20,874,463 | 16,664,546 |
Total operating expenses | 13,382,733 | 11,506,857 | 27,071,348 | 21,161,231 |
Loss from operations | (11,507,733) | (11,506,857) | (24,571,348) | (21,161,231) |
Other income (expense): | ||||
Change in fair value of warrant liability | 5,348 | (581) | (3,065) | 98,341 |
Gain on asset disposal | 2,656 | 2,656 | ||
Miscellaneous income | 8,000 | 173,535 | 184,015 | |
Interest income | 53,219 | 3,757 | 92,688 | 9,780 |
Interest expense | (72,341) | (142,962) | ||
Total other income (expense) | (11,118) | 11,176 | 122,852 | 292,136 |
Net loss and comprehensive loss | (11,518,851) | (11,495,681) | (24,448,496) | (20,869,095) |
Accretion of redeemable convertible preferred stock | (28,521) | |||
Net loss attributable to common stockholders | $ (11,518,851) | $ (11,495,681) | $ (24,448,496) | $ (20,897,616) |
Per share information: | ||||
Net loss per share of common stock, basic and diluted (in dollars per share) | $ (0.28) | $ (0.44) | $ (0.61) | $ (0.98) |
Weighted average shares outstanding, basic and diluted (in shares) | 40,809,931 | 26,327,895 | 40,034,864 | 21,343,803 |
Statement of Stockholders' Equi
Statement of Stockholders' Equity - 6 months ended Jun. 30, 2015 - USD ($) | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Accumulated Other Comprehensive Income/(Loss) | Total |
Balance at Dec. 31, 2014 | $ 39,241 | $ 231,152,894 | $ (131,969,725) | $ (18,782) | $ 99,203,628 |
Balance (in shares) at Dec. 31, 2014 | 39,241,173 | 39,241,173 | |||
Increase (Decrease) in Stockholders' Equity | |||||
Stock-based compensation expense | 1,458,108 | $ 1,458,108 | |||
Exercise of stock options | $ 117 | 196,600 | 196,717 | ||
Exercise of stock options (in shares) | 116,609 | ||||
Net exercise of common stock warrant | $ 2 | (2) | |||
Net exercise of common stock warrant (in shares) | 2,397 | ||||
Issuance of common stock, net of issuance costs | $ 2,700 | 16,238,232 | 16,240,932 | ||
Issuance of common stock, net of issuance costs (in shares) | 2,700,000 | ||||
Unrealized gains on marketable securities | 28,884 | 28,884 | |||
Net loss | (24,448,496) | (24,448,496) | |||
Balance at Jun. 30, 2015 | $ 42,060 | $ 249,045,832 | $ (156,418,221) | $ 10,102 | $ 92,679,773 |
Balance (in shares) at Jun. 30, 2015 | 42,060,179 | 42,060,179 |
Statements of Cash Flows
Statements of Cash Flows - USD ($) | 6 Months Ended | |
Jun. 30, 2015 | Jun. 30, 2014 | |
Operating activities: | ||
Net loss | $ (24,448,496) | $ (20,869,095) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 104,499 | 142,118 |
Stock-based compensation | 1,458,107 | 1,195,566 |
Amortization of bond premium in marketable securities | 548,784 | |
Noncash interest expense on loans | 77,549 | |
Revaluation of warrant liability | 3,065 | (98,341) |
Changes in operating assets and liabilities: | ||
Prepaid expenses, offering costs and other assets | (214,010) | 1,407,495 |
Accounts payable and accrued expenses | (1,307,695) | 2,443,791 |
Deferred revenue | 7,500,000 | |
Net cash used in operating activities | (16,278,197) | (15,778,466) |
Investing activities: | ||
Purchase of property and equipment | (160,550) | (191,314) |
Maturities of marketable securities | 35,230,000 | |
Purchases of marketable securities | (27,767,435) | |
Net cash provided by (used in) investing activities | 7,302,015 | (191,314) |
Financing activities: | ||
Proceeds from exercise of common stock options | 196,717 | 88,782 |
Proceeds from issuance of common stock, net | 16,240,932 | 59,534,984 |
Capital lease payments | (1,260) | |
Net cash provided by financing activities | 16,436,389 | 59,623,766 |
Net increase in cash and cash equivalents | 7,460,207 | 43,653,986 |
Cash and cash equivalents-beginning of period | 36,205,559 | 37,965,198 |
Cash and cash equivalents-end of period | $ 43,665,766 | $ 81,619,184 |
Organization and Description of
Organization and Description of the Business | 6 Months Ended |
Jun. 30, 2015 | |
Organization and Description of the Business | |
Organization and Description of the Business | 1. Organization and Description of the Business Trevena, Inc. (the “Company”) is a Delaware corporation that commenced operations in December 2007. The Company is a clinical stage biopharmaceutical company that discovers, develops and intends to commercialize therapeutics that use a novel approach to target G protein coupled receptors. The Company operates in one segment and has its principal office in King of Prussia, Pennsylvania. Liquidity At June 30, 2015, the Company had an accumulated deficit of $156.4 million and its net loss was $24.4 million and $20.9 million for the six months ended June 30, 2015 and 2014, respectively. The Company expects its cash and cash equivalents of $43.7 million and marketable securities of $62.7 million as of June 30, 2015, together with interest thereon, to be sufficient to fund its operating expenses and capital expenditure requirements through the end of 2016. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2015 | |
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 of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative United States generally accepted accounting principles as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). The Company considers the U.S. dollar to be its functional currency. Unaudited Interim Financial Information The accompanying financial statements are unaudited. The interim unaudited financial statements have been prepared on the same basis as the annual audited financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair statement of the Company’s financial position as of June 30, 2015 and the results of its operations, its comprehensive loss and its cash flows for the three and six months ended June 30, 2015 and 2014. The financial data and other information disclosed in these notes related to the three and six months ended June 30, 2015 and 2014 are not necessarily indicative of the results to be expected for any future interim period or for the year ending December 31, 2015 or any future year. Significant Accounting Policies The Company’s significant accounting policies are described in Note 2 of the Notes to the Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2014. Since the date of those financial statements, there have been no changes to the Company’s significant accounting policies. Use of Estimates Management considers many factors in selecting appropriate financial accounting policies and controls, and in developing the estimates and assumptions that are used in the preparation of these financial statements. Management must apply significant judgment in this process. In addition, other factors may affect estimates, including expected business and operational changes, sensitivity and volatility associated with the assumptions used in developing estimates, and whether historical trends are expected to be representative of future trends. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes and management must select an amount that falls within that range of reasonable estimates. This process may result in actual results differing materially from those estimated amounts used in the preparation of the financial statements if these results differ from historical experience, or other assumptions do not turn out to be substantially accurate, even if such assumptions are reasonable when made. In preparing these financial statements, management used significant estimates in the following areas, among others: stock-based compensation expense, the determination of the fair value of stock-based awards, the fair value of liability-classified stock warrants, the accounting for research and development costs, accrued expenses and the recoverability of the Company’s net deferred tax assets and related valuation allowance. Recent Accounting Pronouncements On April 7, 2015, the FASB issued Accounting Standards Update 2015-03, Simplifying the Presentation of Debt Issuance Costs (“ASU 2015-03”). ASU 2015-03 requires debt issuance costs to be presented in the balance sheets as a direct deduction from the associated debt liability. Although the standard is retrospectively effective for annual reporting periods beginning after December 15, 2015, early adoption is permitted for any annual reporting period or interim period for which the entity’s financial statements have not yet been issued. The Company elected early adoption during the first quarter of 2015 which resulted in a balance sheet adjustment as of December 31, 2014 of $98,401 to other assets and loans payable, net. The Company’s adoption of this standard did not have a significant impact on its results of operations or cash flows. See Note 4. In May 2014, the FASB issued Accounting Standards Update 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. In July 2015, the FASB decided to defer the effective date of the standard from January 1, 2017, to January 1, 2018, with an option that permits companies to adopt the standard as early as the original effective date. Early application prior to the original effective date is not permitted. The standard permits the use of either the retrospective or cumulative effect transition method. The adoption of this standard is not expected to have a material impact on the Company’s financial statements. |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 6 Months Ended |
Jun. 30, 2015 | |
Fair Value of Financial Instruments | |
Fair Value of Financial Instruments | 3. Fair Value of Financial Instruments Cash, Cash Equivalents and Marketable Securities All highly liquid investments that have maturities of three months or less when acquired are considered by the Company to be cash equivalents and are valued at cost, which approximates their fair market value. The Company classifies its marketable securities as “available-for-sale”, carries them at fair market value and classifies them as current assets on its balance sheets. Unrealized gains and losses on marketable securities are recorded as a separate component of accumulated other comprehensive income/(loss) included in stockholders’ equity. There were no charges taken for other-than-temporary declines in fair value of investments during the three and six months ended June 30, 2015 and 2014. The following tables shows the Company’s cash and available-for-sales securities’ adjusted cost, gross unrealized gains, gross unrealized losses and fair value by significant investment category recorded as cash and cash equivalents or marketable securities as of June 30, 2015 and December 31, 2014: June 30, 2015 Adjusted Cost Unrealized Gains Unrealized Losses Fair Value Cash and Cash Equivalents Marketable Securities Cash $ $ — $ — $ $ $ — Level 1 (1) : Money market funds — — — U.S. Treasury securities ) — Subtotal ) Level 2 (2) : Repurchase agreements — — — U.S. agency securities ) — Subtotal ) Total $ $ $ ) $ $ $ December 31, 2014 Adjusted Cost Unrealized Gains Unrealized Losses Fair Value Cash and Cash Equivalents Marketable Securities Cash $ $ — $ — $ $ $ — Level 1 (1) : Money market funds — — — U.S. Treasury 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 on the assets or liabilities. As of June 30, 2015, the Company held $10.8 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. Warrant Liability At June 30, 2015, 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 $85,916 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, 2014 $ Changes in estimated fair value Balance as of June 30, 2015 $ 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 warrants, risk-free interest rates and dividend yields. Due to the nature of these inputs, the valuation of the warrants is considered a Level 3 measurement. The following assumptions were used at June 30, 2015 and December 31, 2014: June 30, 2015 December 31, 2014 Common stock warrant liability Common stock warrant liability Estimated remaining term 6.84 years 7.34 years Dividend yield % % Risk-free interest rate % % Fair value of underlying instrument $ $ Volatility % % 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 loss. |
Long Term Debt
Long Term Debt | 6 Months Ended |
Jun. 30, 2015 | |
Long Term Debt. | |
Long Term Debt | 4 . Long Term Debt On September 19, 2014, the Company entered into a loan and security agreement with Oxford Finance LLC, as collateral agent and lender, and Square 1 Bank, as lender, pursuant to which the lenders have agreed to lend the Company up to $35.0 million in a series of term loans. Upon entering into the agreement, the Company borrowed $2.0 million from the lenders (“Term Loan A”). On April 13, 2015, the Company and the lenders amended the agreement to change the draw period for Term Loan B. As amended, the Company may now, at its sole discretion, borrow from the lenders: · $16.5 million, at any time beginning on October 1, 2015 and ending on December 31, 2015 (“Term Loan B”) since the Company has satisfied specified conditions precedent related to the results of the Company’s ongoing Phase 2 studies of TRV130; and · an additional $16.5 million, at any time on or before March 31, 2016 (“Term Loan C” and together with Term Loan A and Term Loan B, the “Term Loans”), subject to the Company’s satisfaction of specified conditions precedent related to the results of the Company’s ongoing Phase 2 studies of TRV027. The proceeds from Term Loan A and future proceeds, if any, from Term Loan B and/or Term Loan C may be used to satisfy the Company’s future working capital needs, potentially including the development of its clinical and preclinical product candidates. 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 term loans accrue interest at a fixed rate of 6.50% per annum. The Company is required to make payments of interest only on Term Loan A on a monthly basis through and including April 1, 2016 after which consecutive equal monthly payments of principal, plus accrued interest, will be due until December 1, 2018. Both of these dates may be modified with respect to the term loans, as applicable, as follows: · If the Company meets the conditions to draw Term Loan C on or before March 31, 2016, then the date until which the Company is required to make payments of interest only will be extended from April 1, 2016 to October 1, 2016. · If the Company meets the condition to draw Term Loan C on or before March 31, 2016, and the Company has received net cash proceeds of at least $50.0 million from its existing strategic partnership and collaborative license option agreement with Allergan or another strategic partnership in form and substance satisfactory to the lenders, then the date until which consecutive equal monthly payments of principal, plus accrued interest, will be due will be extended from December 1, 2018 to September 1, 2019. The Company has paid the lenders a facility fee of $175,000 in connection with the execution of the loan and security agreement. Upon the last payment date of the amounts borrowed under the agreement, the Company will be required to pay the lenders a final payment fee equal to 6.1% of the term loans borrowed—increased from the initial 5.25% as the Company has satisfied specified conditions precedent related to the results of the Company’s completed Phase 2 bunionectomy study of TRV130—and subject to further adjustment as follows: · If the Company further meets the condition to draw Term Loan C on or before March 31, 2016, then the Company will be required to pay the lenders a final payment fee equal to 6.6% of the term loans borrowed; and · If the Company further meets the condition to draw Term Loan C on or before March 31, 2016, and the Company has received net cash proceeds of at least $50.0 million from its existing strategic partnership and collaborative license option agreement with Allergan or another strategic partnership in form and substance satisfactory to the lenders, then the Company will be required to pay the lenders a final payment fee equal to 7.0%. In addition, if the Company repays the term loans before the applicable maturity date, it will pay the lenders a prepayment fee of 3.00% of the total amount prepaid if the prepayment occurs prior to the first anniversary of the funding of the applicable term loan, 2.00% percent of the total amount prepaid if the prepayment occurs between the first and second anniversary of the funding of the applicable term loan, and 1.00% percent of the total amount prepaid if the prepayment occurs on or after the second anniversary of the funding of the applicable term loan. 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 Three Point $65,000 upon execution of the loan and security agreement and will be obligated to pay up to an additional $175,000 if the Company draws on Term Loan B and Term Loan C. In connection with entering into the loan and security agreement, the Company issued to each of Oxford, Square 1 and Three Point warrants to purchase an aggregate of 7,678 shares of the Company’s common stock. 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. The warrants are exercisable, in whole or in part, immediately, and have a per share exercise price of $5.8610, which is the average closing price of the Company’s common stock on the NASDAQ Global Market for the ten trading days prior to the effective date of the agreement. 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. If the Company borrows Term Loan B and/or Term Loan C, upon the funding of such Term Loan, the Company will issue additional warrants to purchase shares of the Company’s common stock, each with a per share exercise price of $5.8610 and on substantially the same terms as those contained in the warrants. The number of warrants issued or issuable by the Company is as follows: Entity Shares Underlying Warrants Issued on the Effective Date Maximum Number of Shares Underlying Warrants Issuable Assuming Full Draw of Term Loan B Maximum Number of Shares Underlying Warrants Issuable Assuming Full Draw of Term Loan C Oxford Square 1 Three Point As of June 30, 2015, only Term Loan A has been issued, all of which remains outstanding as of such date. Interest expense of $32,500 and $65,000 was recorded during the three and six months ended June 30, 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 lender costs are classified as a debt discount and the third party costs are classified as debt issuance costs. Per ASU 2015-03, 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 Term Loan A using the effective interest method. A total of $39,640 and $77,549 of debt discount and debt issuance costs was amortized to interest expense during the three and six months ended June 30, 2015, respectively. The following table summarizes how the issuance of Term Loan A is reflected on the balance sheet at June 30, 2015: June 30, 2015 Gross proceeds $ Debt discount ) Debt issuance costs ) Carrying value $ |
Stockholders' Equity
Stockholders' Equity | 6 Months Ended |
Jun. 30, 2015 | |
Stockholders' Equity | |
Stockholders' Equity | 5. Stockholders’ Equity Equity Offering On May 8, 2015, the Company issued and sold 2,700,000 shares of common stock through Cowen and Company, LLC, pursuant to an at-the-market sales facility dated April 3, 2015. The shares were sold at a weighted average price per share of $6.2503, for aggregate gross proceeds of $16.9 million. The net offering proceeds to the Company were approximately $16.2 million after deducting related expenses, including commissions of approximately $0.5 million. 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 up to 3,310,990 shares of common stock to eligible employees, directors and consultants to the Company, in the form of restricted stock and stock options. In 2013, the Company adopted the 2013 Equity Incentive Plan, as amended on May 14, 2014 and January 1, 2015 (collectively, the “2013 Plan”), that reserves for issuance under the plan up to 3,284,326 shares of common stock. The 2013 Plan contains an “evergreen” provision, pursuant to which the number of shares of common stock available for issuance under the plan will automatically increase on January 1 of each year beginning in 2015. The 2013 plan became effective upon the January 2014 IPO and, as of such date, the Company may not make further grants under the 2008 plan. The 2013 plan provides for the grant of incentive stock options, nonstatutory 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. Under both the 2008 and 2013 Plans, 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 share-based awards is amortized ratably over the awards’ service periods. Share-based compensation expense recognized was as follows: Three Months Ended June 30, Six Months Ended June 30, 2015 2014 2015 2014 Research and development $ $ $ $ General and administrative Total stock-based compensation $ $ $ $ A summary of stock option activity for the six months ended June 30, 2015 is as follows: Options Outstanding Number of Shares Weighted- Average Exercise Price Weighted Average Remaining Contractual Term (in years) Balance, December 31, 2014 $ Granted Exercised ) Forfeitures/Expirations ) Balance, June 30, 2015 $ Vested or expected to vest at June 30, 2015 $ Exercisable at June 30, 2015 $ The intrinsic value of the options exercisable as of June 30, 2015 was $7.0 million, based on the Company’s closing stock price of $6.26 per share and a weighted average exercise price of $2.76 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 stock. The per-share weighted-average grant date fair value of the options granted to employees and directors during the six months ended June 30, 2015 and 2014 was estimated at $4.26 and $4.62 per share, respectively, using the Black-Scholes option-pricing model with the following weighted-average assumptions: Six Months Ended June 30, 2015 2014 Risk-free interest rate % % Expected term of options (in years) 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 (SAB) 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 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 0.0%. · Estimated forfeiture rate: The Company’s estimated annual forfeiture rate for the six months ended June 30, 2015 and 2014 stock option grants was 9% and 7%, respectively, based on the historical forfeiture experience. The fair value of the Company’s common stock, prior to the Company’s IPO, was determined by its board of directors with assistance from its management. The board of directors and management considered numerous objective and subjective factors in the assessment of fair value, including the price for the Company’s preferred stock that was sold to investors and the rights, preferences and privileges of the preferred stock and common stock, the Company’s financial condition and results of operations during the relevant periods and the status of strategic initiatives. These estimates involved a significant level of judgment. As of June 30, 2015, there was $9.4 million of total unrecognized compensation expense related to unvested options that will be recognized over the weighted average remaining period of 3.01 years. Shares Available for Future Grant At June 30, 2015, the Company has the following shares available to be granted under the 2013 Plan: Available at December 31, 2014 Authorized Granted ) Forfeitures/Expirations Available at June 30, 2015 Shares Reserved for Future Issuance At June 30, 2015, the Company has reserved the following shares of common stock for issuance: Stock options outstanding Shares available for future grant under 2013 Plan Warrants outstanding |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2015 | |
Commitments and Contingencies. | |
Commitments and Contingencies | 6. Commitments and Contingencies Licenses On May 3, 2013, the Company entered into an option agreement and a license agreement with Allergan plc (formerly Actavis plc and Forest Laboratories Holdings Limited), under which the Company granted to Allergan an exclusive option to license its product candidate, TRV027. If Allergan exercises this option, the license agreement between the Company and Allergan will become effective and Allergan will have an exclusive worldwide license to develop and commercialize TRV027 and specified related compounds. At the Company’s request, Allergan will consider in good faith whether to grant the Company the right to co-promote the licensed products in the United States under terms to be agreed upon by the parties. Allergan will be responsible for subsequent development, regulatory approval and commercialization of TRV027 at Allergan’s sole cost and expense. Under the option agreement, the Company is conducting, at its expense, a Phase 2b trial of TRV027 in acute heart failure, or AHF. In March 2015, Allergan and the Company signed a letter agreement wherein Allergan agreed to pay the Company $10.0 million to fund the expansion of this ongoing Phase 2b trial of TRV027 from 500 patients to 620 patients. As part of this agreement, the Company and Allergan agreed to certain testing and analysis with respect to the study. The extended Phase 2b trial and related analysis are currently expected to be completed in the first half of 2016. Collaboration revenue will be recognized on a straight line basis over the study period. At the end of each reporting period, the Company will reassess the trial completion date and adjust the recognition period if applicable. The March 2015 letter agreement does not otherwise amend the terms of the May 2013 option agreement. Allergan may exercise its option during the pendency of the Phase 2b clinical trial or during a specified time period after the Company delivers the data from the Phase 2b clinical trial to Allergan. During the option period, the Company is not permitted to negotiate for or enter into any agreement with a third party for the development and commercialization of TRV027 and its related compounds. Under specified circumstances linked to adverse changes in the market or related to the results from the Phase 2b trial of TRV027, Allergan has the right to renegotiate the terms of the license agreement. If Allergan exercises such right, the Company will be obligated to negotiate in good faith with Allergan for a period of time the terms of any new arrangement. If the Company and Allergan are unable to agree on the terms of any new arrangement, then the option agreement will terminate and for a specified period of time thereafter the Company may not offer a license to any third party on terms better than those last proposed by either the Company or Allergan during the negotiations. If Allergan does not exercise its option during the specified period, the option will expire and the license agreement will not become effective. In that case, the Company would be free to enter into a collaboration arrangement with another party for the development and commercialization of TRV027 or to pursue development and commercialization on its own. The Company received no consideration upon the grant of the option to Allergan. If Allergan exercises the option, the Company would receive a $65.0 million option exercise fee and could potentially receive up to $365.0 million depending upon the achievement of future development and commercial milestones. The Company also could receive tiered royalties between 10% and 20% on net sales of licensed products worldwide, with the royalty rates on net sales of licensed products in the United States being somewhat higher than the royalty rates on net sales of licensed products outside the United States. The term of the royalty on sales of TRV027 for a given country would extend until the latest to occur of (i) 10 years from first commercial sale of TRV027 in that country, (ii) the expiration of the last to expire patent claiming TRV027 that is sufficient to block the entrance of a generic version of the product, or (iii) the expiration of any period of exclusivity granted by applicable law or any regulatory authority in such country that confers exclusive marketing rights on the product. If the license agreement becomes effective, Allergan has the right to grant sublicenses under the license agreement to affiliates and third parties. Any sublicensing does not act to relieve Allergan of any of its obligations under the license agreement, including Allergan’s obligation to make milestone payments to the Company with respect to TRV027 or pay royalties to the Company on sales of TRV027 by such sublicensee. Under the license, both Allergan and the Company have the right to terminate the agreement in the event of an uncured material breach or insolvency of the other party. In addition, Allergan is permitted to terminate the license agreement without cause at any time upon prior written notice or immediately for product safety reasons. Following a termination of the license agreement, all licenses granted to Allergan would terminate, and Allergan would grant the Company an exclusive royalty-bearing license under specified patents and know-how to develop and commercialize reverted licensed products. If not terminated, the license agreement would remain in effect until the expiration of the last royalty term for the last licensed product. 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 or cash flows. |
Revenue
Revenue | 6 Months Ended |
Jun. 30, 2015 | |
Revenue | |
Revenue | 7. Revenue For the three and six months ended June 30, 2015, the Company recognized collaboration revenue of $1.9 million and $2.5 million, respectively, related to its March 2015 letter agreement with Allergan. The terms of this agreement contain multiple deliverables which include (i) research and development activities and (ii) testing and analysis related to the ongoing Phase 2b trial of TRV027 in exchange for a nonrefundable upfront fee of $10.0 million. 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. For arrangements with multiple elements, the Company recognizes revenue in accordance with the FASB’s Accounting Standards Update No. 2009-13, Multiple-Deliverable Revenue Arrangements (“ASU 2009-13”), 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. |
Net Loss Per Common Share
Net Loss Per Common Share | 6 Months Ended |
Jun. 30, 2015 | |
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 June 30, Six Months Ended June 30, 2015 2014 2015 2014 Basic and diluted net loss per common share calculation: Net loss and comprehensive loss $ ) $ ) $ ) $ ) Accretion of redeemable convertible preferred stock — — — ) 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 June 30, 2015 and 2014 have been excluded from the computation of diluted weighted shares outstanding, as they would have been anti-dilutive: June 30, 2015 2014 Options outstanding Warrants Total |
Summary of Significant Accoun15
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2015 | |
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 of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative United States generally accepted accounting principles as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). The Company considers the U.S. dollar to be its functional currency. |
Unaudited Interim Financial Information | Unaudited Interim Financial Information The accompanying financial statements are unaudited. The interim unaudited financial statements have been prepared on the same basis as the annual audited financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair statement of the Company’s financial position as of June 30, 2015 and the results of its operations, its comprehensive loss and its cash flows for the three and six months ended June 30, 2015 and 2014. The financial data and other information disclosed in these notes related to the three and six months ended June 30, 2015 and 2014 are not necessarily indicative of the results to be expected for any future interim period or for the year ending December 31, 2015 or any future year. |
Use of Estimates | Use of Estimates Management considers many factors in selecting appropriate financial accounting policies and controls, and in developing the estimates and assumptions that are used in the preparation of these financial statements. Management must apply significant judgment in this process. In addition, other factors may affect estimates, including expected business and operational changes, sensitivity and volatility associated with the assumptions used in developing estimates, and whether historical trends are expected to be representative of future trends. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes and management must select an amount that falls within that range of reasonable estimates. This process may result in actual results differing materially from those estimated amounts used in the preparation of the financial statements if these results differ from historical experience, or other assumptions do not turn out to be substantially accurate, even if such assumptions are reasonable when made. In preparing these financial statements, management used significant estimates in the following areas, among others: stock-based compensation expense, the determination of the fair value of stock-based awards, the fair value of liability-classified stock warrants, the accounting for research and development costs, accrued expenses and the recoverability of the Company’s net deferred tax assets and related valuation allowance. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements On April 7, 2015, the FASB issued Accounting Standards Update 2015-03, Simplifying the Presentation of Debt Issuance Costs (“ASU 2015-03”). ASU 2015-03 requires debt issuance costs to be presented in the balance sheets as a direct deduction from the associated debt liability. Although the standard is retrospectively effective for annual reporting periods beginning after December 15, 2015, early adoption is permitted for any annual reporting period or interim period for which the entity’s financial statements have not yet been issued. The Company elected early adoption during the first quarter of 2015 which resulted in a balance sheet adjustment as of December 31, 2014 of $98,401 to other assets and loans payable, net. The Company’s adoption of this standard did not have a significant impact on its results of operations or cash flows. See Note 4. In May 2014, the FASB issued Accounting Standards Update 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. In July 2015, the FASB decided to defer the effective date of the standard from January 1, 2017, to January 1, 2018, with an option that permits companies to adopt the standard as early as the original effective date. Early application prior to the original effective date is not permitted. The standard permits the use of either the retrospective or cumulative effect transition method. The adoption of this standard is not expected to have a material impact on the Company’s financial statements. |
Fair Value of Financial Instr16
Fair Value of Financial Instruments (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
Summary of Significant Accounting Policies | |
Schedule of cash and available-for-sale securities' adjusted cost, gross unrealized gains, gross unrealized losses and fair values by significant investment category | June 30, 2015 Adjusted Cost Unrealized Gains Unrealized Losses Fair Value Cash and Cash Equivalents Marketable Securities Cash $ $ — $ — $ $ $ — Level 1 (1) : Money market funds — — — U.S. Treasury securities ) — Subtotal ) Level 2 (2) : Repurchase agreements — — — U.S. agency securities ) — Subtotal ) Total $ $ $ ) $ $ $ December 31, 2014 Adjusted Cost Unrealized Gains Unrealized Losses Fair Value Cash and Cash Equivalents Marketable Securities Cash $ $ — $ — $ $ $ — Level 1 (1) : Money market funds — — — U.S. Treasury 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 on 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, 2014 $ Changes in estimated fair value Balance as of June 30, 2015 $ |
Schedule of assumptions used for valuation of warrants | June 30, 2015 December 31, 2014 Common stock warrant liability Common stock warrant liability Estimated remaining term 6.84 years 7.34 years Dividend yield % % Risk-free interest rate % % Fair value of underlying instrument $ $ Volatility % % |
Long Term Debt (Tables)
Long Term Debt (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
Long Term Debt | |
Schedule of number of warrants issued or issuable by the Company | Entity Shares Underlying Warrants Issued on the Effective Date Maximum Number of Shares Underlying Warrants Issuable Assuming Full Draw of Term Loan B Maximum Number of Shares Underlying Warrants Issuable Assuming Full Draw of Term Loan C Oxford Square 1 Three Point |
Term Loan A | |
Long Term Debt | |
Schedule of loan reflected on Balance Sheet | June 30, 2015 Gross proceeds $ Debt discount ) Debt issuance costs ) Carrying value $ |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
Schedule of share-based compensation expense recognized | Three Months Ended June 30, Six Months Ended June 30, 2015 2014 2015 2014 Research and development $ $ $ $ General and administrative Total stock-based compensation $ $ $ $ |
Summary of stock option activity | Options Outstanding Number of Shares Weighted- Average Exercise Price Weighted Average Remaining Contractual Term (in years) Balance, December 31, 2014 $ Granted Exercised ) Forfeitures/Expirations ) Balance, June 30, 2015 $ Vested or expected to vest at June 30, 2015 $ Exercisable at June 30, 2015 $ |
Schedule of weighted-average assumptions: | Six Months Ended June 30, 2015 2014 Risk-free interest rate % % Expected term of options (in years) Expected volatility % % Dividend yield % % |
Schedule of shares of common stock reserved/available | At June 30, 2015, the Company has reserved the following shares of common stock for issuance: Stock options outstanding Shares available for future grant under 2013 Plan Warrants outstanding |
2013 plan | |
Schedule of shares of common stock reserved/available | Available at December 31, 2014 Authorized Granted ) Forfeitures/Expirations Available at June 30, 2015 |
Net Loss Per Common Share (Tabl
Net Loss Per Common Share (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
Net Loss Per Common Share | |
Schedule of computation of basic and diluted net loss per share | Three Months Ended June 30, Six Months Ended June 30, 2015 2014 2015 2014 Basic and diluted net loss per common share calculation: Net loss and comprehensive loss $ ) $ ) $ ) $ ) Accretion of redeemable convertible preferred stock — — — ) 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 | June 30, 2015 2014 Options outstanding Warrants Total |
Organization and Description 20
Organization and Description of the Business (Details) | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2015USD ($) | Jun. 30, 2014USD ($) | Jun. 30, 2015USD ($)item | Jun. 30, 2014USD ($) | Dec. 31, 2014USD ($) | Dec. 31, 2013USD ($) | |
Organization and Description of the Business | ||||||
Number of operating segments | item | 1 | |||||
Liquidity | ||||||
Accumulated deficit | $ 156,418,221 | $ 156,418,221 | $ 131,969,725 | |||
Net loss | (11,518,851) | $ (11,495,681) | (24,448,496) | $ (20,869,095) | ||
Cash and cash equivalents | 43,665,766 | $ 81,619,184 | 43,665,766 | $ 81,619,184 | 36,205,559 | $ 37,965,198 |
Marketable securities | $ 62,716,174 | $ 62,716,174 | $ 70,698,640 |
Summary of Significant Accoun21
Summary of Significant Accounting Policies (Details) - USD ($) | Jun. 30, 2015 | Dec. 31, 2014 |
Recent Accounting Pronouncements | ||
Loan payable, net | $ 1,748,667 | $ 1,692,884 |
Adjustments for New Accounting Principle, Early Adoption | ||
Recent Accounting Pronouncements | ||
Other assets | 98,401 | |
Loan payable, net | $ 98,401 |
Fair Value of Financial Instr22
Fair Value of Financial Instruments (Details) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | Dec. 31, 2014 | |
Fair value | |||||
Charges for other-than-temporary declines in fair value of investments | $ 0 | $ 0 | $ 0 | $ 0 | |
Available-for-sale investment securities with contractual maturity date of more than one but less than two years | 10,800,000 | 10,800,000 | |||
Cash | |||||
Fair value | |||||
Adjusted Cost | 16,544,547 | 16,544,547 | $ 7,141,548 | ||
Fair Value | 16,544,547 | 16,544,547 | 7,141,548 | ||
Cash and Cash Equivalents | Cash | |||||
Fair value | |||||
Fair Value | 16,544,547 | 16,544,547 | 7,141,548 | ||
Level 1 | |||||
Fair value | |||||
Adjusted Cost | 53,305,757 | 53,305,757 | 99,781,433 | ||
Unrealized Gains | 17,433 | 258 | |||
Unrealized Losses | (51) | (19,040) | |||
Fair Value | 53,323,139 | 53,323,139 | 99,762,651 | ||
Level 1 | Cash and Cash Equivalents | |||||
Fair value | |||||
Fair Value | 17,121,219 | 17,121,219 | 29,064,011 | ||
Level 1 | Marketable Securities. | |||||
Fair value | |||||
Fair Value | 36,201,920 | 36,201,920 | 70,698,640 | ||
Level 1 | Money market funds | |||||
Fair value | |||||
Adjusted Cost | 17,121,219 | 17,121,219 | 29,064,011 | ||
Fair Value | 17,121,219 | 17,121,219 | 29,064,011 | ||
Level 1 | Money market funds | Cash and Cash Equivalents | |||||
Fair value | |||||
Fair Value | 17,121,219 | 17,121,219 | 29,064,011 | ||
Level 1 | U.S. Treasury securities | |||||
Fair value | |||||
Adjusted Cost | 36,184,538 | 36,184,538 | 70,717,422 | ||
Unrealized Gains | 17,433 | 258 | |||
Unrealized Losses | (51) | (19,040) | |||
Fair Value | 36,201,920 | 36,201,920 | 70,698,640 | ||
Level 1 | U.S. Treasury securities | Marketable Securities. | |||||
Fair value | |||||
Fair Value | 36,201,920 | 36,201,920 | 70,698,640 | ||
Level 2 | |||||
Fair value | |||||
Adjusted Cost | 36,521,534 | 36,521,534 | |||
Unrealized Gains | 1,526 | ||||
Unrealized Losses | (8,806) | ||||
Fair Value | 36,514,254 | 36,514,254 | |||
Level 2 | Cash and Cash Equivalents | |||||
Fair value | |||||
Fair Value | 10,000,000 | 10,000,000 | |||
Level 2 | Marketable Securities. | |||||
Fair value | |||||
Fair Value | 26,514,254 | 26,514,254 | |||
Level 2 | Repurchase agreements | |||||
Fair value | |||||
Adjusted Cost | 10,000,000 | 10,000,000 | |||
Fair Value | 10,000,000 | 10,000,000 | |||
Level 2 | Repurchase agreements | Cash and Cash Equivalents | |||||
Fair value | |||||
Fair Value | 10,000,000 | 10,000,000 | |||
Level 2 | U.S. agency securities | |||||
Fair value | |||||
Adjusted Cost | 26,521,534 | 26,521,534 | |||
Unrealized Gains | 1,526 | ||||
Unrealized Losses | (8,806) | ||||
Fair Value | 26,514,254 | 26,514,254 | |||
Level 2 | U.S. agency securities | Marketable Securities. | |||||
Fair value | |||||
Fair Value | 26,514,254 | 26,514,254 | |||
Total | |||||
Fair value | |||||
Adjusted Cost | 106,371,838 | 106,371,838 | 106,922,981 | ||
Unrealized Gains | 18,959 | 258 | |||
Unrealized Losses | (8,857) | (19,040) | |||
Fair Value | 106,381,940 | 106,381,940 | 106,904,199 | ||
Total | Cash and Cash Equivalents | |||||
Fair value | |||||
Fair Value | 43,665,766 | 43,665,766 | 36,205,559 | ||
Total | Marketable Securities. | |||||
Fair value | |||||
Fair Value | $ 62,716,174 | $ 62,716,174 | $ 70,698,640 |
Fair Value of Financial Instr23
Fair Value of Financial Instruments (Details 2) - Jun. 30, 2015 - Warrants - USD ($) | Total |
Fair value, warrant liability | |
Fair value of the warrants outstanding | $ 85,916 |
Common Stock | Maximum | |
Fair value, warrant liability | |
Number of shares called upon exercise of warrants (in shares) | 20,161 |
Fair Value of Financial Instr24
Fair Value of Financial Instruments (Details 3) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | |
Warrant Liability | ||||
Changes in estimated fair value | $ (5,348) | $ 581 | $ 3,065 | $ (98,341) |
Warrants | ||||
Warrant Liability | ||||
Balance at the beginning of the period | 82,851 | |||
Changes in estimated fair value | 3,065 | |||
Balance at the end of the period | $ 85,916 | $ 85,916 |
Fair Value of Financial Instr25
Fair Value of Financial Instruments (Details 4) - Significant Unobservable Inputs (Level 3) - Warrants - Common Stock - $ / shares | 6 Months Ended | 12 Months Ended |
Jun. 30, 2015 | Dec. 31, 2014 | |
Fair value assumptions | ||
Estimated remaining term | 6 years 10 months 2 days | 7 years 4 months 2 days |
Dividend yield (as a percent) | 0.00% | 0.00% |
Risk-free interest rate (as a percent) | 2.03% | 1.99% |
Fair value of underlying instrument (in dollar per share) | $ 6.26 | $ 5.98 |
Volatility (as a percent) | 72.00% | 72.00% |
Long Term Debt (Detail)
Long Term Debt (Detail) - USD ($) | Sep. 19, 2014 | Sep. 09, 2014 | Jun. 30, 2015 | Jun. 30, 2015 | Apr. 13, 2015 |
Long Term Debt | |||||
Amortization of debt discount and issuance costs | $ 39,640 | $ 77,549 | |||
Interest expense | 72,341 | 142,962 | |||
Loan and security agreement | |||||
Long Term Debt | |||||
Face amount | $ 35,000,000 | ||||
Gross proceeds | 35,000,000 | ||||
Term Loan A | |||||
Long Term Debt | |||||
Face amount | $ 2,000,000 | 2,000,000 | 2,000,000 | ||
Interest rate (as a percent) | 6.50% | ||||
Debt issuance costs | $ 225,988 | ||||
Deferred financing fees | 106,545 | ||||
Gross proceeds | 2,000,000 | 2,000,000 | 2,000,000 | ||
Debt discount | (170,805) | (170,805) | |||
Debt issuance costs | (80,528) | (80,528) | |||
Carrying value | 1,748,667 | 1,748,667 | |||
Interest expense | $ 32,500 | 65,000 | |||
Term Loan B | |||||
Long Term Debt | |||||
Face amount | $ 16,500,000 | ||||
Gross proceeds | 16,500,000 | ||||
Term Loan C | |||||
Long Term Debt | |||||
Face amount | 16,500,000 | ||||
Gross proceeds | $ 16,500,000 | ||||
Minimum net cash proceeds from strategic partnerships as a condition to extend the date for payments | $ 50,000,000 | ||||
Lenders | Loan and security agreement | |||||
Fees | |||||
Facility fee | $ 175,000 | ||||
Final payment fee due upon that last payment date of the amounts borrowed under the agreement subject to adjustment (as a percent) | 6.10% | ||||
Final payment fee due upon that last payment date of the amounts borrowed under the agreement, scenario 1 (as a percent) | 6.60% | ||||
Final payment fee due upon that last payment date of the amounts borrowed under the agreement, scenario 2 (as a percent) | 5.25% | ||||
Final payment fee due upon that last payment date of the amounts borrowed under the agreement, scenario 3 (as a percent) | 7.00% | ||||
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 | ||||
Additional fee if draws are made on term loans | $ 175,000 | ||||
Warrants | |||||
Warrants | |||||
Exercise price (in dollars per share) | $ 5.8610 | ||||
Number of trading days prior to the effective date of the agreement that are used to determine the exercise price of warrants | 10 days | ||||
Warrants | Three Point | |||||
Warrants | |||||
Number of shares called upon exercise of warrants (in shares) | 853 | ||||
Maximum Number of Shares Underlying Warrants Issuable Assuming Full Draw of Term Loan B | 7,038 | ||||
Maximum Number of Shares Underlying Warrants Issuable Assuming Full Draw of Term Loan C | 7,038 | ||||
Warrants | Oxford | |||||
Warrants | |||||
Number of shares called upon exercise of warrants (in shares) | 4,875 | ||||
Maximum Number of Shares Underlying Warrants Issuable Assuming Full Draw of Term Loan B | 40,217 | ||||
Maximum Number of Shares Underlying Warrants Issuable Assuming Full Draw of Term Loan C | 40,217 | ||||
Warrants | Square I | |||||
Warrants | |||||
Number of shares called upon exercise of warrants (in shares) | 1,950 | ||||
Maximum Number of Shares Underlying Warrants Issuable Assuming Full Draw of Term Loan B | 16,087 | ||||
Maximum Number of Shares Underlying Warrants Issuable Assuming Full Draw of Term Loan C | 16,087 | ||||
Warrants | Common Stock | Maximum | |||||
Warrants | |||||
Number of shares called upon exercise of warrants (in shares) | 20,161 | 20,161 | |||
Warrants | Common Stock | Lenders and Placement Agent | |||||
Warrants | |||||
Number of shares called upon exercise of warrants (in shares) | 7,678 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - USD ($) | May. 08, 2015 | Jun. 30, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | Jan. 01, 2015 | Dec. 31, 2014 |
Equity Incentive Plans | |||||||
Number of shares may further be granted under the plan | 1,193,991 | 1,193,991 | |||||
Stock-based compensation | $ 844,220 | $ 668,264 | $ 1,458,107 | $ 1,195,566 | |||
Equity Offering | |||||||
Proceeds from issuance of common stock, net | 16,240,932 | 59,534,984 | |||||
Research and development | |||||||
Equity Incentive Plans | |||||||
Stock-based compensation | 350,022 | 291,996 | 577,823 | 616,184 | |||
General and administrative | |||||||
Equity Incentive Plans | |||||||
Stock-based compensation | $ 494,198 | $ 376,268 | $ 880,284 | $ 579,382 | |||
At-the-market sales facility | |||||||
Equity Offering | |||||||
Issuance of common stock (in shares) | 2,700,000 | ||||||
Aggregate gross proceeds from shares sold | $ 16,900,000 | ||||||
Payment of underwriting discounts and commissions | 500,000 | ||||||
Proceeds from issuance of common stock, net | $ 16,200,000 | ||||||
At-the-market sales facility | Weighted-average | |||||||
Equity Offering | |||||||
Offering price (in dollars per share) | $ 6.2503 | ||||||
2008 Plan | |||||||
Equity Incentive Plans | |||||||
Number of shares authorized to grant | 3,310,990 | 3,310,990 | |||||
2008 Plan | Stock options | Maximum | |||||||
Equity Incentive Plans | |||||||
Term of award | 10 years | ||||||
Vesting period | 4 years | ||||||
2013 plan | |||||||
Equity Incentive Plans | |||||||
Number of shares authorized to grant | 1,569,646 | 1,569,646 | 3,284,326 | ||||
Number of shares may further be granted under the plan | 1,193,991 | 1,193,991 | 829,364 | ||||
2013 plan | Stock options | Maximum | |||||||
Equity Incentive Plans | |||||||
Term of award | 10 years | ||||||
Vesting period | 4 years |
Stockholders' Equity (Details 2
Stockholders' Equity (Details 2) - $ / shares | 6 Months Ended | 12 Months Ended |
Jun. 30, 2015 | Dec. 31, 2014 | |
Number of Shares | ||
Balance at the end of the period (in shares) | 4,662,860 | |
Stock options | ||
Number of Shares | ||
Balance at the beginning of the period (in shares) | 3,574,450 | |
Granted (in shares) | 1,331,960 | |
Exercised (in shares) | (116,609) | |
Forfeitures (in shares) | (126,941) | |
Balance at the end of the period (in shares) | 4,662,860 | 3,574,450 |
Vested or expected to vest at the end of the period (in shares) | 4,506,251 | |
Exercisable at the end of the period (in shares) | 1,871,349 | |
Weighted-Average Exercise Price | ||
Balance at the beginning of the period (in dollars per share) | $ 3.75 | |
Balance at the end of the period (in dollars per share) | 4.60 | $ 3.75 |
Vested or expected to vest at the end of the period (in dollars per share) | 4.52 | |
Exercisable at the end of the period (in dollars per share) | $ 2.76 | |
Weighted Average Remaining Contractual Term | ||
Options Outstanding at the end of the period | 8 years 1 month 24 days | 8 years 22 days |
Stockholders' Equity (Details 3
Stockholders' Equity (Details 3) - USD ($) $ / shares in Units, $ in Millions | 6 Months Ended | ||||
Jun. 30, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | Jan. 01, 2015 | Dec. 31, 2014 | |
Weighted-average assumptions: | |||||
Estimated annual forfeiture rate (as a percent) | 9.00% | 7.00% | |||
Shares Available for Grant | |||||
Balance at the end of the period (in shares) | 1,193,991 | ||||
Shares of common stock reserved for issuance | |||||
Stock options outstanding (in shares) | 4,662,860 | ||||
Shares available for future grant under 2013 Plan (in shares) | 1,193,991 | 1,193,991 | |||
Warrants outstanding (in shares) | 27,839 | ||||
Total shares of common stock reserved for issuance | 5,884,690 | ||||
2013 plan | |||||
Shares Available for Grant | |||||
Balance at the beginning of the period (in shares) | 829,364 | ||||
Authorized (in shares) | 1,569,646 | 3,284,326 | |||
Granted (in shares) | (1,331,960) | ||||
Forfeitures/Expirations (in shares) | 126,941 | ||||
Balance at the end of the period (in shares) | 1,193,991 | ||||
Shares of common stock reserved for issuance | |||||
Shares available for future grant under 2013 Plan (in shares) | 829,364 | 1,193,991 | 829,364 | ||
Stock options | |||||
Equity Incentive Plans | |||||
Intrinsic value of options exercisable | $ 7 | ||||
Per share price of Company's closing stock price (in dollars per share) | $ 6.26 | ||||
Weighted average exercise price (in dollars per share) | $ 2.76 | ||||
Per-share weighted-average grant date fair value of options granted (in dollars per share) | $ 4.26 | $ 4.62 | |||
Weighted-average assumptions: | |||||
Unrecognized compensation expense | $ 9.4 | ||||
Weighted average remaining period for recognition of unrecognized compensation expense | 3 years 4 days | ||||
Shares of common stock reserved for issuance | |||||
Stock options outstanding (in shares) | 4,662,860 | 3,574,450 | |||
Stock options | Weighted-average | |||||
Weighted-average assumptions: | |||||
Risk-free interest rate (as a percent) | 1.68% | 1.85% | |||
Expected term of options (in years) | 6 years 2 months 12 days | 6 years | |||
Expected volatility (as a percent) | 68.90% | 75.70% | |||
Dividend yield (as a percent) | 0.00% | 0.00% |
Commitments and Contingencies (
Commitments and Contingencies (Details) $ in Millions | 1 Months Ended | 6 Months Ended |
Mar. 31, 2015USD ($)person | Jun. 30, 2015USD ($) | |
Allergan | ||
Collaboration Revenue. | ||
Payment received to fund expansion of clinical trial | $ 10 | $ 10 |
Number of patients before expansion of the trial | person | 500 | |
Number of patients after expansion of the trial | person | 620 | |
Option agreement and a license agreement | Minimum | ||
Collaboration Revenue. | ||
Tiered royalties that could be received, as a percentage of net sales of licensed products | 10.00% | |
Option agreement and a license agreement | Maximum | ||
Collaboration Revenue. | ||
Tiered royalties that could be received, as a percentage of net sales of licensed products | 20.00% | |
Option agreement and a license agreement | Allergan | ||
Collaboration Revenue. | ||
Consideration received upon the grant of the option | $ 0 | |
Option exercise fee | 65 | |
Aggregate potential consideration | $ 365 | |
Term of royalty on sales from the first commercial sale of product | 10 years |
Revenue (Details)
Revenue (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended |
Mar. 31, 2015 | Jun. 30, 2015 | Jun. 30, 2015 | |
Revenue. | |||
Collaboration revenue | $ 1,875,000 | $ 2,500,000 | |
Allergan | |||
Revenue. | |||
Collaboration revenue | $ 1,900,000 | 2,500,000 | |
Nonrefundable upfront fee | $ 10,000,000 | $ 10,000,000 |
Net Loss Per Common Share (Deta
Net Loss Per Common Share (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | |
Basic and diluted net loss per common share calculation: | ||||
Net loss and comprehensive loss | $ (11,518,851) | $ (11,495,681) | $ (24,448,496) | $ (20,869,095) |
Accretion of redeemable convertible preferred stock | (28,521) | |||
Net loss attributable to common stockholders | $ (11,518,851) | $ (11,495,681) | $ (24,448,496) | $ (20,897,616) |
Weighted average common shares outstanding | 40,809,931 | 26,327,895 | 40,034,864 | 21,343,803 |
Net loss per share of common stock-basic and diluted | $ (0.28) | $ (0.44) | $ (0.61) | $ (0.98) |
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) | 4,690,699 | 3,600,221 | ||
Stock options | ||||
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) | 4,662,860 | 3,577,641 | ||
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) | 27,839 | 22,580 |