Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Feb. 29, 2016 | Jun. 30, 2015 | |
Document and Entity Information | |||
Entity Registrant Name | Trovagene, Inc. | ||
Entity Central Index Key | 1,213,037 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Filer Category | Accelerated Filer | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2015 | ||
Document Fiscal Year Focus | 2,015 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false | ||
Entity Common Stock, Shares Outstanding | 29,757,810 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | Yes | ||
Entity Current Reporting Status | Yes | ||
Entity Public Float | $ 195,681,564 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2015 | Dec. 31, 2014 |
Current assets: | ||
Cash and cash equivalents | $ 67,493,047 | $ 27,293,798 |
Accounts receivable | 98,736 | 56,694 |
Prepaid expenses and other assets | 789,285 | 369,259 |
Total current assets | 68,381,068 | 27,719,751 |
Property and equipment, net | 2,690,579 | 840,387 |
Other assets | 374,004 | 336,708 |
Total Assets | 71,445,651 | 28,896,846 |
Current liabilities: | ||
Accounts payable | 1,040,868 | 747,799 |
Accrued expenses | 1,934,411 | 1,841,808 |
Current portion of long-term debt | 5,225,818 | 1,898,548 |
Total current liabilities | 8,201,097 | 4,488,155 |
Long-term debt, less current portion | 11,246,188 | 13,053,117 |
Derivative financial instruments | 3,297,077 | 3,006,021 |
Total liabilities | $ 22,744,362 | $ 20,547,293 |
Commitments and contingencies | ||
Stockholders’ equity | ||
Preferred stock, $0.001 par value, 20,000,000 shares authorized, 60,600 shares outstanding at each of December 31, 2015 and 2014, designated as Series A Convertible Preferred Stock with liquidation preference of $606,000 at each of December 31, 2015 and 2014 | $ 60 | $ 60 |
Common stock, $0.0001 par value, 150,000,000 shares authorized at December 31, 2015 and 2014; 29,737,601 and 18,915,793 issued and outstanding at December 31, 2015 and 2014, respectively | 2,974 | 1,891 |
Additional paid-in capital | 157,585,498 | 89,739,511 |
Accumulated deficit | (108,887,243) | (81,391,909) |
Total stockholders’ equity | 48,701,289 | 8,349,553 |
Total Liabilities and Stockholders’ Equity | $ 71,445,651 | $ 28,896,846 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - USD ($) | Dec. 31, 2015 | Dec. 31, 2014 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 20,000,000 | 20,000,000 |
Preferred stock, shares outstanding | 60,600 | 60,600 |
Series A Convertible Preferred Stock, liquidation preference (in dollars) | $ 606,000 | $ 606,000 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 150,000,000 | 150,000,000 |
Common stock, shares issued | 29,737,601 | 18,915,793 |
Common stock, shares outstanding | 29,737,601 | 18,915,793 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Income Statement [Abstract] | |||
Royalty income | $ 274,648 | $ 270,178 | $ 259,246 |
License fees | 0 | 10,000 | 0 |
Diagnostic service revenue | 13,789 | 0 | 0 |
Other revenue | 24,375 | 0 | 0 |
Total revenues | 312,812 | 280,178 | 259,246 |
Costs and expenses: | |||
Cost of revenue | 629,191 | 15,441 | |
Research and development | 10,593,869 | 6,664,906 | 3,947,589 |
Selling and marketing | 6,443,578 | 2,734,903 | 1,530,160 |
General and administrative | 7,919,826 | 5,810,087 | 5,472,038 |
Total operating expenses | 25,586,464 | 15,225,337 | 10,949,787 |
Loss from operations | (25,273,652) | (14,945,159) | (10,690,541) |
Interest income | 57,261 | 12,239 | 3,663 |
Interest expense | (1,525,482) | (843,259) | (17,005) |
Other (income) expense, net | (2,800) | 24,845 | (22,941) |
Gain (loss) from change in fair value of derivative instruments—warrants | (726,421) | 1,425,850 | (1,084,114) |
Net loss and comprehensive loss | (27,471,094) | (14,325,484) | (11,810,938) |
Preferred stock dividend | (24,240) | (23,015) | (29,840) |
Net loss and comprehensive loss attributable to common stockholders | $ (27,495,334) | $ (14,348,499) | $ (11,840,778) |
Net loss per common share - basic (in dollars per share) | $ (1.05) | $ (0.76) | $ (0.70) |
Net loss per common share - diluted (in dollars per share) | $ (1.21) | $ (0.88) | $ (0.70) |
Weighted-average shares outstanding - basic (in shares) | 26,201,713 | 18,904,280 | 16,978,212 |
Weighted-average shares outstanding - diluted (in shares) | 26,452,165 | 19,071,112 | 16,978,212 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity (Deficit) - USD ($) | Total | Series A Convertible Preferred Stock | Preferred Stock | Preferred StockSeries A Convertible Preferred Stock | Common Stock | Common StockMultiGen Diagnostics, Inc | Common StockShareholder of the Company | Additional Paid-In Capital | Additional Paid-In CapitalMultiGen Diagnostics, Inc | Additional Paid-In CapitalShareholder of the Company | Deficit Accumulated | Public Offering And Private Placement | Public Offering And Private PlacementCommon Stock |
Balance (in shares) at Dec. 31, 2012 | 95,600 | 15,478,177 | |||||||||||
Balance at Dec. 31, 2012 | $ 2,169,028 | $ 96 | $ 1,547 | $ 57,370,017 | $ (55,202,632) | ||||||||
Increase (Decrease) in Stockholders' Equity | |||||||||||||
Sale of common stock, net of expenses (in shares) | 2,631,332 | ||||||||||||
Sale of common stock, net of expenses | 18,829,644 | 18,829,381 | $ 18,829,644 | $ 263 | |||||||||
Issuance of warrants in connection with services | 198,791 | 198,791 | |||||||||||
Stock-based compensation | 1,979,364 | 1,979,364 | |||||||||||
Derivative liability — Warrants reclassified to additional paid-in capital | 5,417,871 | 5,417,871 | |||||||||||
Conversion of Series A preferred stock and issuance of common stock (in shares) | (35,000) | (35,000) | |||||||||||
Conversion of preferred stock and issuance of common stock | $ 36 | ||||||||||||
Number of shares issued upon conversion of preferred stock into common stock | 36,458 | 36,458 | 36,458 | ||||||||||
Conversion of Series A preferred stock and issuance of common stock | $ 4 | $ 32 | |||||||||||
Issuance of common stock upon net exercise of warrant (in shares) | 7,284 | 7,284 | |||||||||||
Issuance of common stock upon net exercise of warrant | $ 1 | $ (1) | |||||||||||
Issuance of common stock upon exercise of warrant (in shares) | 715,743 | ||||||||||||
Issuance of common stock upon exercise of warrants | 3,599,831 | $ 72 | 3,599,759 | ||||||||||
Issuance of common stock upon net exercise of stock option (in shares) | 22,955 | ||||||||||||
Issuance of common stock upon net exercise of stock options | $ 2 | (2) | |||||||||||
Issuance of common stock upon exercise of stock options (in shares) | 10,833 | ||||||||||||
Issuance of common stock upon exercise of stock options | 38,249 | $ 1 | 38,248 | ||||||||||
Preferred stock dividend | (29,840) | (29,840) | |||||||||||
Net loss | (11,810,938) | (11,810,938) | |||||||||||
Balance (in shares) at Dec. 31, 2013 | 60,600 | 18,902,782 | |||||||||||
Balance at Dec. 31, 2013 | 20,392,000 | $ 60 | $ 1,890 | 87,433,460 | (67,043,410) | ||||||||
Increase (Decrease) in Stockholders' Equity | |||||||||||||
Issuance of warrant in connection with debt agreement | 235,857 | 235,857 | |||||||||||
Stock-based compensation | 2,070,195 | 2,070,195 | |||||||||||
Issuance of common stock upon net exercise of warrant (in shares) | 13,011 | ||||||||||||
Issuance of common stock upon net exercise of warrant | $ 1 | (1) | |||||||||||
Preferred stock dividend | (23,015) | (23,015) | |||||||||||
Net loss | (14,325,484) | (14,325,484) | |||||||||||
Balance (in shares) at Dec. 31, 2014 | 60,600 | 18,915,793 | |||||||||||
Balance at Dec. 31, 2014 | 8,349,553 | $ 60 | $ 1,891 | 89,739,511 | (81,391,909) | ||||||||
Increase (Decrease) in Stockholders' Equity | |||||||||||||
Sale of common stock, net of expenses (in shares) | 9,996,531 | ||||||||||||
Sale of common stock, net of expenses | 61,215,399 | $ 1,000 | 61,214,399 | ||||||||||
Stock-based compensation | 3,946,027 | 3,946,027 | |||||||||||
Derivative liability — Warrants reclassified to additional paid-in capital | 435,365 | 435,365 | |||||||||||
Issuance of common stock upon net exercise of warrant (in shares) | 277,136 | ||||||||||||
Issuance of common stock upon net exercise of warrant | $ 28 | (28) | |||||||||||
Issuance of common stock upon exercise of warrant (in shares) | 282,975 | ||||||||||||
Issuance of common stock upon exercise of warrants | 1,389,427 | $ 28 | 1,389,399 | ||||||||||
Issuance of common stock upon exercise of stock options (in shares) | 265,166 | ||||||||||||
Issuance of common stock upon exercise of stock options | 860,852 | $ 27 | 860,825 | ||||||||||
Preferred stock dividend | (24,240) | (24,240) | |||||||||||
Net loss | (27,471,094) | (27,471,094) | |||||||||||
Balance (in shares) at Dec. 31, 2015 | 60,600 | 29,737,601 | |||||||||||
Balance at Dec. 31, 2015 | $ 48,701,289 | $ 60 | $ 2,974 | $ 157,585,498 | $ (108,887,243) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Operating activities | |||
Net loss | $ (27,471,094) | $ (14,325,484) | $ (11,810,938) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Loss (gain) on disposal of fixed assets | 4,562 | (24,845) | 22,941 |
Depreciation and amortization | 378,711 | 234,813 | 130,520 |
Stock-based compensation expense | 3,946,027 | 2,070,194 | 1,979,364 |
Amortization of debt costs | 346,157 | 248,799 | |
Accretion of discount on debt | 88,123 | 57,117 | |
Change in fair value of financial instruments | 726,421 | (1,425,850) | 1,084,114 |
Stock and warrant issued in connection with consulting services | 0 | 0 | 198,791 |
Changes in operating assets and liabilities: | |||
Decrease (increase) in other assets | (37,296) | (258) | 25,631 |
Decrease (increase) in accounts receivable | (42,042) | 22,300 | 89,387 |
Increase in prepaid expenses | (420,026) | (216,470) | (92,748) |
Increase in accounts payable and accrued expenses | 361,432 | 632,299 | 1,055,690 |
Net cash used in operating activities | (22,119,025) | (12,727,385) | (7,317,248) |
Investing activities: | |||
Capital expenditures | (2,241,066) | (363,290) | (649,784) |
Proceeds from disposals of capital equipment | 7,600 | 63,500 | 500 |
Net cash used in investing activities | (2,233,466) | (299,790) | (649,284) |
Financing activities | |||
Proceeds from sale of common stock, net of expenses | 61,215,399 | 0 | 18,829,644 |
Proceeds from exercise of warrants | 1,389,427 | 0 | 3,599,831 |
Proceeds from exercise of options | 860,852 | 0 | 38,249 |
Borrowings under equipment line of credit | 1,086,062 | 0 | 515,964 |
Repayments under equipment line of credit | 0 | (515,964) | 0 |
Borrowings under debt agreement | 0 | 15,000,000 | 0 |
Net cash provided by financing activities | 64,551,740 | 14,484,036 | 22,983,688 |
Net change in cash and cash equivalents | 40,199,249 | 1,456,861 | 15,017,156 |
Cash and cash equivalents—Beginning of period | 27,293,798 | 25,836,937 | 10,819,781 |
Cash and cash equivalents—End of period | 67,493,047 | 27,293,798 | 25,836,937 |
Supplementary disclosure of cash flow activity: | |||
Cash paid for taxes | 16,934 | 2,400 | 7,650 |
Cash paid for interest | 1,061,993 | 425,256 | 9,459 |
Supplemental disclosure of non-cash investing and financing activities: | |||
Warrants issued in connection with Loan and Security Agreement | 0 | 235,857 | 0 |
Reclassification of derivative financial instruments to additional paid-in capital | 435,365 | 0 | (5,417,871) |
Preferred stock dividends accrued | $ 24,240 | $ 23,015 | $ 29,840 |
Business Overview and Liquidity
Business Overview and Liquidity | 12 Months Ended |
Dec. 31, 2015 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Business Overview and Liquidity | Business Overview and Liquidity Trovagene, Inc. (“Trovagene” or the “Company”) is a molecular diagnostic company that focuses on the development and commercialization of a proprietary urine-based cell-free molecular diagnostic technology for use in disease detection and monitoring across a variety of medical disciplines. Trovagene’s primary internal focus is to leverage its novel urine-based molecular diagnostic platform to facilitate improvements in the field of oncology, while the Company’s external focus includes entering into collaborations to develop the Company’s technology in areas such as infectious disease, transplant medicine and prenatal genetics. The Company’s goal is to improve treatment outcomes for cancer patients using its proprietary technology to detect and quantitatively monitor cell-free DNA in urine. To date, Trovagene’s efforts have been principally devoted to research and development, securing and protecting patents and raising capital. Through December 31, 2015 , the Company sustained cumulative net losses attributed to common stockholders of $108,887,243 . The Company’s losses have resulted primarily from expenditures incurred in connection with research and development activities, stock-based compensation expense, patent filing and maintenance expenses, outside accounting and legal services and regulatory, scientific and financial consulting fees, amortization and liquidated damages. To date, the Company has generated only limited revenue from operations and expects to incur additional losses to perform further research and development activities as well as expenses related to the commercialization of the diagnostic tests the Company had commercially available as of December 31, 2015 . Liquidity The Company will need to continue to raise funds until it is able to generate revenues from operations sufficient to fund its development and commercial operations. Cash used in operating activities was $22,119,025 , $12,727,385 , and $7,317,248 for the years ended December 31, 2015 , 2014 , and 2013 , respectively. During the years ended December 31, 2015 , 2014 , and 2013 , the Company incurred net loss and comprehensive loss attributable to common stockholders of $27,495,334 , $14,348,499 , and $11,840,778 , respectively. The Company believes that it currently has adequate capital to continue operations for the next twelve months. However, to carry the Company forward beyond the next twelve months, and until it can generate adequate cash flow from operations, additional cash resources will be necessary. To date, Trovagene’s sources of cash have been primarily limited to the sale of debt and equity securities and debt financing. Net cash provided by financing activities for the years ended December 31, 2015 , 2014 , and 2013 was $64,551,740 , $14,484,036 and $22,983,688 , respectively. The Company cannot be certain that additional funding will be available on acceptable terms, or at all. To the extent that the Company can raise additional funds by issuing equity securities, the Company’s stockholders may experience significant dilution. Any debt financing, if available, may involve restrictive covenants that impact the Company’s ability to conduct its business. If the Company is unable to raise additional capital when required or on acceptable terms, it may have to significantly delay, scale back or discontinue the development and/or commercialization of one or more of its product candidates. The Company may also be required to: • Seek collaborators for product candidates at an earlier stage than otherwise would be desirable and on terms that are less favorable than might otherwise be available; and • Relinquish licenses or otherwise dispose of rights to technologies, product candidates or products that the Company would otherwise seek to develop or commercialize itself. |
Basis of Presentation and Summa
Basis of Presentation and Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2015 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Summary of Significant Accounting Policies | Basis of Presentation and Summary of Significant Accounting Policies The accompanying consolidated financial statements of Trovagene, which include its wholly owned subsidiary Trovagene Srl, a subsidiary formed in Italy, have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”). All intercompany balances and transactions have been eliminated. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Cash and Cash Equivalents Cash and cash equivalents consist of operating and money market accounts as of December 31, 2015 and 2014 on deposit with U.S. commercial banks. Cash equivalents are considered by the Company to be highly liquid investments purchased with original maturities of three months or less from the date of purchase. Concentration of Credit Risk Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash and cash equivalents. The Company maintains deposit accounts that are not insured by the Federal Deposit Insurance Corporation in federally insured financial institutions. The Company has not experienced any losses in such accounts and believes it is not exposed to significant risk on its cash due to the financial position of the depository institution in which those deposits are held. Revenues Revenue is recognized when persuasive evidence that an arrangement exists, delivery has occurred, the price is fixed or determinable, and collection is reasonably assured. Milestone, Royalty and License Revenues The Company licenses and sublicenses its patent rights to healthcare companies, medical laboratories and biotechnology partners. These agreements may involve multiple elements such as license fees, royalties and milestone payments. Revenue is recognized when the criteria described above have been met as well as the following: • Up-front nonrefundable license fees pursuant to agreements under which the Company has no continuing performance obligations are recognized as revenues on the effective date of the agreement and when collection is reasonably assured. • Minimum royalties are recognized as earned, and royalties in excess of minimum amounts are recognized upon receipt of payment when collection is assured. • Milestone payments are recognized when both the milestone is achieved and the related payment is received. Diagnostic Service Revenues Revenue for clinical laboratory tests may come from several sources, including commercial third-party payors, such as insurance companies and health maintenance organizations, government payors, such as Medicare and Medicaid in the United States, patient self-pay and, in some cases, from hospitals or referring laboratories who, in turn, might bill third-party payors for testing. The Company is recognizing diagnostic service revenue on the cash collection basis until such time as it is able to properly estimate collections on third party reimbursements. Allowance for Doubtful Accounts The Company reviews the collectability of accounts receivable based on an assessment of historic experience, current economic conditions, and other collection indicators. At each of December 31, 2015 , 2014 and 2013 , the Company had not recorded an allowance for doubtful accounts. When accounts are determined to be uncollectible, they are written off against the reserve balance and the reserve is reassessed. When payments are received on reserved accounts, they are applied to the individual’s account and the reserve is reassessed. Derivative Financial Instruments—Warrants The Company has issued common stock warrants in connection with the execution of certain equity financings. Such warrants are classified as derivative liabilities under the provisions of Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 815, Derivatives and Hedging (“ASC 815”) and are recorded at their fair market value as of each reporting period. Such warrants do not meet the exemption that a contract should not be considered a derivative instrument if it is (1) indexed to its own stock and (2) classified in stockholders’ equity. Changes in fair value of derivative liabilities are recorded in the consolidated statement of operations under the caption “Change in fair value of derivative instruments.” The fair value of warrants is determined using the Black-Scholes option-pricing model using assumptions regarding the volatility of Trovagene’s common stock price, the remaining life of the warrant, and the risk-free interest rates at each period end. The Company thus uses model-derived valuations where inputs are observable in active markets to determine the fair value and accordingly classifies such warrants in Level 3 per FASB ASC Topic 820, Fair Value Measurements (“ASC 820”). At December 31, 2015 and 2014 , the fair value of these warrants was $3,297,077 and $3,006,021 , respectively, and was included in the derivative financial instruments liability on the balance sheet. Stock-Based Compensation FASB ASC Topic 718 “ Compensation—Stock Compensation ” (“ASC 718”) requires companies to measure the cost of employee services received in exchange for the award of equity instruments based on the estimated fair value of the award at the date of grant. The expense is recognized over the period during which an employee is required to provide services in exchange for the award. ASC 718 did not change the way Trovagene accounts for non-employee stock-based compensation. Trovagene continues to account for shares of common stock, stock options and warrants issued to non-employees based on the fair value of the stock, stock option or warrant, if that value is more reliably measurable than the fair value of the consideration or services received. The Company accounts for stock options issued and vesting to non-employees in accordance with FASB ASC Topic 505-50 “ Equity -Based Payment to Non-Employees ” , and, accordingly, the value of the stock compensation to non-employees is based upon the measurement date as determined at either (1) the date at which a performance commitment is reached, or (2) the date at which the necessary performance to earn the equity instruments is complete. Therefore, the fair value of these options is being “marked to market” quarterly until the measurement date is determined. Fair Value of Financial Instruments Financial instruments consist of cash and cash equivalents, accounts receivable, accounts payable, debt and derivative liabilities. The Company has adopted ASC 820 for financial assets and liabilities that are required to be measured at fair value and non-financial assets and liabilities that are not required to be measured at fair value on a recurring basis. These financial instruments are stated at their respective historical carrying amounts, which approximate fair value due to their short term nature as they reflect current market interest rates. Debt is stated at its respective historical carrying amounts, which approximate fair value as they reflect current market interest rates. In accordance with FASB ASC Subtopic 820-10, the Company measures certain assets and liabilities at fair value on a recurring basis using the three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value. The three tiers include: • Level 1 — Quoted prices for identical instruments in active markets. • Level 2 — Quoted prices for similar instruments in active markets; quoted prices for identical or similar instruments in markets that are not active; and model-derived valuations where inputs are observable or where significant value drivers are observable. • Level 3 — Instruments where significant value drivers are unobservable to third parties. Property, Equipment and Depreciation and Amortization Expenditures for additions, renewals and improvements are capitalized at cost. Depreciation and amortization is generally computed on a straight-line method based on the estimated useful lives of the related assets. Amortization of leasehold improvements is computed based on the shorter of the life of the asset or the term of the lease. The estimated useful lives of the major classes of depreciable assets are three to five years for laboratory equipment and furniture and fixtures. Expenditures for repairs and maintenance are charged to operations as incurred. Impairment of Indefinite and Long-Lived Assets The Company reviews its long-lived and indefinite assets to determine if any event has occurred that may indicate its intangible assets with indefinite lives and other long-lived assets are potentially impaired. If indicators of impairment exist, the Company performs an impairment test to assess the recoverability of the affected assets by determining whether the carrying amount of such assets exceeds the undiscounted expected future cash flows. If the affected assets are not recoverable, the Company estimates the fair value of the assets and records an impairment loss if the carrying value of the assets exceeds the fair value. Factors that would indicate potential impairment include a significant decline in the Company’s stock price and market capitalization compared to its net book value, significant changes in the ability of a particular asset to generate positive cash flows, and significant changes in the Company’s strategic business objectives and utilization of a particular asset. The Company noted no indications of impairment for the years ended December 31, 2015 , 2014 , and 2013 . Income Taxes Income taxes are determined using the asset and liability approach of accounting for income taxes. Under this approach, deferred taxes represent the future tax consequences expected to occur when the reported amounts of assets and liabilities are recovered or paid. Deferred taxes result from differences between the financial statement and tax bases of Trovagene’s assets and liabilities and are adjusted for changes in tax rates and tax laws when changes are enacted. Valuation allowances are recorded to reduce deferred tax assets when it is more likely than not that a tax benefit will not be realized. The assessment of whether or not a valuation allowance is required often requires significant judgment. Contingencies In the normal course of business, Trovagene is subject to loss contingencies, such as legal proceedings and claims arising out of its business, that cover a wide range of matters, including, among others, government investigations, stockholder lawsuits, product and environmental liability, and tax matters. In accordance with FASB ASC Topic 450, Accounting for Contingencies , Trovagene records such loss contingencies when it is probable that a liability has been incurred and the amount of loss can be reasonably estimated. Trovagene, in accordance with this guidance, does not recognize gain contingencies until realized. Cost of Revenue Cost of revenue represents the cost of materials, personnel costs, costs associated with processing specimens including pathological review, quality control analyses, and delivery charges necessary to render an individualized test result. Costs associated with performing tests are recorded as the tests are processed. Research and Development Research and development expenses, which include expenditures in connection with an in-house research and development laboratory, salaries and staff costs, purchased in-process research and development and regulatory and scientific consulting fees, as well as contract research and insurance, are accounted for in accordance with FASB ASC Topic 730-10-55-2, Research and Development. Also, as prescribed by this guidance, patent filing and maintenance expenses are considered legal in nature and therefore classified as general and administrative expense, if any. While certain of the Company’s research and development costs may have future benefits, the Company’s policy of expensing all research and development expenditures is predicated on the fact that Trovagene has no history of successful commercialization of molecular diagnostic products to base any estimate of the number of future periods that would be benefited. FASB ASC Topic 730, Research and Development requires that non-refundable advance payments for goods or services that will be used or rendered for future research and development activities be deferred and capitalized. As the related goods are delivered or the services are performed, or when the goods or services are no longer expected to be provided, the deferred amounts are recognized as an expense. There were no non-refundable advance payments as of December 31, 2015 , 2014 and 2013 . Net Loss Per Share Basic and diluted net loss per share is presented in conformity with FASB ASC Topic 260, Earnings per Share , for all periods presented. In accordance with this guidance, basic and diluted net loss per common share is determined by dividing net loss applicable to common stockholders by the weighted-average common shares outstanding during the period. Preferred dividends are included in income available to common stockholders in the computation of basic and diluted earnings per share. Shares used in calculating diluted net loss per common share exclude as anti-dilutive the following share equivalents: December 31, 2015 2014 2013 Options to purchase Common Stock 6,948,630 4,913,472 4,287,545 Warrants to purchase Common stock 4,565,947 5,251,660 6,233,483 Series A Convertible Preferred Stock 63,125 63,125 63,125 11,577,702 10,228,257 10,584,153 The following table summarizes the Company’s diluted net loss per share: December 31, 2015 2014 2013 Numerator: Net loss attributable to common stockholders $ (27,495,334 ) $ (14,348,499 ) $ (11,840,778 ) Adjustment for change in fair value of derivative instruments - warrants (4,396,061 ) (2,422,337 ) — Net loss used for diluted loss per share $ (31,891,395 ) $ (16,770,836 ) $ (11,840,778 ) Denominator: Weighted-average shares used to compute basic net loss per share 26,201,713 18,904,280 16,978,212 Adjustments to reflect assumed exercise of warrants 250,452 166,832 — Weighted-average shares used to compute diluted net loss per share 26,452,165 19,071,112 16,978,212 Net loss per share diluted $ (1.21 ) $ (0.88 ) $ (0.70 ) Recent Accounting Pronouncements In February 2016, the FASB issued Accounting Standards Update (“ASU”) 2016-02, Leases . The new standard establishes a right-of-use (“ROU”) model that requires a lessee to record a ROU asset and a lease liability on the balance sheet for all leases with terms longer than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern of expense recognition in the income statement. The new standard is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. A modified retrospective transition approach is required for capital and operating leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements, with certain practical expedients available. The Company is currently evaluating the impact the adoption of the new standard will have on its consolidated financial statements. In August 2014, the FASB issued ASU 2014-15, P resentation of Financial Statements — Going Concern , which impacts the accounting guidance related to the evaluation of an entity’s ability to continue as a going concern. The amendment establishes management’s responsibility to evaluate whether there is substantial doubt about an entity’s ability to continue as a going concern in connection with preparing financial statements for each annual and interim reporting period. The amendment also gives guidance to determine whether to disclose information about relevant conditions and events when there is substantial doubt about an entity’s ability to continue as a going concern. The amended guidance is effective prospectively for fiscal years beginning after December 15, 2016. The new guidance is not expected to have a material impact on the Company’s financial position, results of operations or cash flows. In May 2014, the FASB issued ASU 2014-9, Revenue from Contracts with Customers (“ASU 2014-9”). ASU 2014-9 provides companies with a single model for accounting for revenue arising from contracts with customers and supersedes current revenue recognition guidance, including industry-specific revenue guidance. The core principle of the model is to recognize revenue when control of the goods or services transfers to the customer, as opposed to recognizing revenue when the risks and rewards transfer to the customer under the existing revenue guidance. The guidance permits companies to either apply the requirements retrospectively to all prior periods presented, or apply the requirements in the year of adoption, through a cumulative adjustment. In August 2015, the FASB issued ASU 2015-14, Deferral of the Effective Date , which defers the required adoption date of ASU 2014-09 by one year. As a result of the deferred effective date, ASU 2014-09 will be effective for the Company in its first quarter of fiscal year 2018. Early adoption is permitted but not before the original effective date of the first quarter of fiscal year 2017. The Company is in the process of evaluating the transition method that will be elected and the impact of adoption of ASU 2014-09 on its consolidated financial statements. |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2015 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Property and Equipment Fixed assets consist of laboratory, testing and computer equipment and fixtures stated at cost. Depreciation and amortization expense for the years ended December 31, 2015 , 2014 , and 2013 was $378,711 , $234,813 , and $130,520 , respectively. Property and equipment consisted of the following: As of December 31, 2015 2014 Furniture and office equipment $ 1,483,227 $ 365,955 Leasehold Improvements 39,401 39,401 Laboratory equipment 2,022,733 968,901 3,545,361 1,374,257 Less—accumulated depreciation and amortization (854,782 ) (533,870 ) Property and equipment, net $ 2,690,579 $ 840,387 |
Stockholders' Equity (Deficit)
Stockholders' Equity (Deficit) | 12 Months Ended |
Dec. 31, 2015 | |
Stockholders' Equity Note [Abstract] | |
Stockholders' Equity (Deficit) | Stockholders’ Equity (Deficit) Common Stock On January 25, 2013, the Company filed a Registration Statement on Form S-3 (the “Registration Statement”) to offer and sell in one or more offerings, any combination of common stock, preferred stock, warrants, or units having an aggregate initial offering price of up to $150,000,000 . If issued, the preferred stock, warrants and units would be convertible, exercisable or exchangeable for common stock, preferred stock or other Trovagene securities. The Registration Statement was declared effective on February 4, 2013. In addition, in connection with the Registration Statement, the Company entered into an agreement with Cantor Fitzgerald & Co. (“Agent”) on January 25, 2013 to issue and sell up to $30,000,000 of shares of common stock. As payment for its services, the Agent is entitled to a 3% commission on gross proceeds on sales of the Company’s securities. The Company received gross proceeds of approximately $4.2 million from the sale of 488,476 shares of its common stock during the year ended December 31, 2013 under the agreement with the Agent. In addition, the Company received gross proceeds of approximately $15.0 million from the sale of 2,142,857 shares of its common stock through a registered direct offering that occurred in July 2013. During the year ended December 31, 2013, the Company issued a total of 3,424,605 shares of common stock. The Company sold 2,631,332 shares of common stock for net proceeds of $18,829,644 . In addition, 36,458 shares were issued upon conversion of Series A Preferred Stock, 715,743 shares were issued upon exercise of 715,743 warrants for a weighted-average price of $5.02 and 7,284 shares were issued upon net exercise of 12,745 warrants at an exercise price of $3.00 . The remaining 33,788 shares include 22,955 shares that were issued upon net exercise of an option to purchase 41,667 shares of common stock at an exercise price of $4.50 and the exercise of an option to purchase 10,833 shares of common stock at a weighted-average exercise price of $3.53 . During the year ended December 31, 2014, the Company issued a total of 13,011 shares of common stock upon the net exercise of warrants at a weighted-average exercise price of $3.00 . During the year ended December 31, 2015 , the Company issued a total of 10,821,808 shares of common stock. The Company received gross proceeds of approximately $63.2 million from the sale of 9,711,110 shares of its common stock through underwritten public offerings in February 2015 and July 2015. The Company also received gross proceeds of approximately $2.8 million from the sale of 285,421 shares of its common stock at a weighted-average price of $9.66 under the agreement with the Agent. In addition, 265,166 shares were issued upon exercise of options for a weighted-average price of $3.25 , 282,975 shares were issued upon exercise of warrants for a weighted-average price of $4.91 , and 277,136 shares were issued upon net exercise of 449,403 warrants at a weighted-average exercise price of $3.05 . Warrants A summary of warrant activity and changes in warrants outstanding, including both liability and equity classifications, is presented below: Number of Warrants Weighted-Average Exercise Price Per Share Weighted-Average Remaining Contractual Term Balance outstanding, December 31, 2012 6,985,070 $ 3.96 5.4 Granted 50,000 $ 8.00 Exercised (728,488 ) $ 4.99 Expired (73,099 ) $ 4.50 Balance outstanding, December 31, 2013 6,233,483 $ 3.87 4.5 Granted 85,470 $ 3.51 Exercised (36,666 ) $ 3.00 Expired (16,667 ) $ 10.80 Balance outstanding, December 31, 2014 6,265,620 $ 3.85 3.6 Exercised (732,378 ) $ 3.77 Balance outstanding, December 31, 2015 5,533,242 $ 3.86 2.5 The Company issued a warrant to purchase 50,000 shares of common stock at an exercise price of $8.00 per share during the year ended December 31, 2013. The warrant was issued in connection with an agreement to provide services related to investor and public relations materials and expires three years from date of grant. The estimated fair value of the warrant was determined on the date of grant using the Black-Scholes option valuation model using the following assumptions: a risk-free interest rate of 0.42% , dividend yield of 0% , expected volatility of 97% and expected term of three years. The resulting fair value of $198,791 was recorded as stock-based compensation expense. The Company issued warrants to purchase 85,470 shares of common stock at an exercise price of $3.51 per share during the year ended December 31, 2014. The warrants were issued in connection with a $15.0 million debt agreement. The estimated fair value of the warrants was determined on the date of grant using the Black-Scholes option valuation model using the following assumptions: a risk-free interest rate of 2.53% , dividend yield of 0% , expected volatility of 73.8% and expected term of ten years . The resulting fair value of $235,857 was recorded as a debt discount and was amortized to interest expense over the term of the loan using the effective interest method. Series A Convertible Preferred Stock The material terms of the Series A Convertible Preferred Stock consist of: 1) Dividends. Holders of the Company’s Series A Convertible Preferred Stock are entitled to receive cumulative dividends at the rate per share of 4% per annum, payable quarterly on March 31, June 30, September 30 and December 31, beginning with September 30, 2005. Dividends are payable, at the Company’s sole election, in cash or shares of common stock. As of December 31, 2015 , 2014 , and 2013 , the Company had $268,295 , $244,055 , and $221,040 , respectively in accrued cumulative unpaid preferred stock dividends, included in Accrued Expenses in the Company’s consolidated balance sheets, and $24,240 , $23,015 , and $29,840 of accrued dividends was recorded during the years ended December 31, 2015 , 2014 , and 2013 , respectively. 2) Voting Rights. Shares of the Series A Convertible Preferred Stock have no voting rights. However, so long as any shares of Series A Convertible Preferred Stock are outstanding, the Company may not, without the affirmative vote of the holders of the shares of Series A Convertible Preferred Stock then outstanding, (a) adversely change the powers, preferences or rights given to the Series A Convertible Preferred Stock, (b) authorize or create any class of stock senior or equal to the Series A Convertible Preferred Stock, (c) amend its certificate of incorporation or other charter documents, so as to affect adversely any rights of the holders of Series A Convertible Preferred Stock or (d) increase the authorized number of shares of Series A Convertible Preferred Stock. 3) Liquidation. Upon any liquidation, dissolution or winding-up of the Company, the holders of the Series A Convertible Preferred Stock are entitled to receive an amount equal to the Stated Value per share, which is currently $10 per share plus any accrued and unpaid dividends. 4) Conversion Rights. Each share of Series A Convertible Preferred Stock is convertible at the option of the holder into that number of shares of common stock determined by dividing the Stated Value, currently $10 per share, by the conversion price, originally $2.15 per share. 5) Subsequent Equity Sales. The conversion price is subject to adjustment for dilutive issuances for a period of 12 months beginning upon registration of the common stock underlying the Series A Convertible Preferred Stock. The relevant registration statement became effective on March 17, 2006 and during the following twelve month period the conversion price was adjusted to $9.60 per share. 6) Automatic Conversion. If the price of the Company’s common stock equals $25.80 per share for 20 consecutive trading days, and an average of 8,333 shares of common stock per day are traded during the 20 trading days, the Company will have the right to deliver a notice to the holders of the Series A Convertible Preferred Stock, requesting the holders to convert any portion of the shares of Series A Convertible Preferred Stock into shares of common stock at the applicable conversion price. As of the date of these financial statements, such conditions have not been met. During the year ended December 31, 2013, 35,000 shares of Series A Convertible Preferred Stock were converted into 36,458 shares of common stock, on a net converted basis. As of each of December 31, 2015 , 2014 , and 2013 , there were 60,600 shares of Series A Convertible Preferred Stock outstanding. |
Stock Option Plan
Stock Option Plan | 12 Months Ended |
Dec. 31, 2015 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock Option Plan | Stock Option Plan In June 2004, the Company adopted the Trovagene Stock Option Plan, as amended (the “2004 Plan”), under which up to 6,000,000 shares common stock were reserved for issuance to directors and eligible employees, including executive officers and consultants. Generally, vesting for options granted under the Plan was from three to four years , and options expired after a 10 -year period. Options were granted at an exercise price not less than the fair market value at the date of grant. As of December 31, 2014, the 2004 Plan was expired. As of December 31, 2013, there were 1,788,921 shares available for issuance under the 2004 Plan. During 2013, the Company issued 260,000 options over the authorized number of options in the 2004 Plan. As per FASB ASC Topic 815-40, the options were accounted for as liabilities and recorded at fair value with the changes in fair value being recorded in the Company’s statement of operations. Stockholder approval was obtained on July 18, 2013 to increase the number of authorized shares in the 2004 Plan from 3,666,667 to 6,000,000 . Accordingly, the options were remeasured as of the date of stockholder approval with the change recorded in stock based compensation expense and the $23,024 liability was reclassified to additional paid-in capital. In July 2013, an option to purchase 90,000 shares of common stock was granted to a member of the Board for services provided outside of routine Board activities. This option was vested in full upon grant. The fair value of this option was approximately $500,000 and is included in general and administrative expenses. The Trovagene, Inc. 2014 Equity Incentive Plan (the “2014 EIP’), authorizing up to 2,500,000 shares of common stock for issuance under the 2014 EIP, was approved by the Board in June 2014 and approved by the stockholders of the Company at the September 17, 2014 Annual Meeting of Stockholders. An additional 2,500,000 shares of common stock was authorized for issuance by the Board in March 2015 and was approved by the stockholders at the June 10, 2015 Annual Meeting of Stockholders. As of December 31, 2015 , there were 1,361,832 shares available for issuance under the 2014 EIP. Stock-based compensation has been recognized in operating results as follows: Years ended December 31, 2015 2014 2013 In cost of revenue $ 39,676 $ — $ — In research and development expenses 1,499,009 796,008 549,465 In selling and marketing expense 768,146 145,239 70,626 In general and administrative expenses 1,639,196 1,128,947 1,359,273 Total stock-based compensation $ 3,946,027 $ 2,070,194 $ 1,979,364 The estimated fair value of stock option awards was determined on the date of grant using the Black-Scholes option valuation model with the following assumptions during the years indicated below: Years ended December 31, 2015 2014 2013 Risk-free interest rate 1.35% - 2.15% 1.42% - 2.1% 0.74% - 1.5% Dividend yield 0% 0% 0% Expected volatility (range) 73% - 77% 81% - 86% 82% - 100% Expected volatility (weighted-average) 75% 85% 91% Expected term (in years) 6.0 years 5.8 years 5.0 years Risk-free interest rate — Based on the daily yield curve rates for U.S. Treasury obligations with maturities that correspond to the expected term of the Company’s stock options. Dividend yield — Trovagene has not paid any dividends on common stock since its inception and does not anticipate paying dividends on its common stock in the foreseeable future. Expected volatility — Based on the historical volatility of a group of peer companies with attributes similar to Trovagene. Expected term — The expected option term represents the period that stock-based awards are expected to be outstanding based on the simplified method provided in Staff Accounting Bulletin (“SAB”) No. 107, Share-Based Payment (“SAB No. 107”), which averages an award’s weighted-average vesting period and expected term for “plain vanilla” share options. Under SAB No. 107, options are considered to be “plain vanilla” if they have the following basic characteristics: (1) are granted “at-the-money”; (2) exercisability is conditioned upon service through the vesting date; (3) termination of service prior to vesting results in forfeiture; (4) limited exercise period following termination of service; and (5) are non-transferable and non-hedgeable. Forfeitures — FASB ASC Topic 718 (“ASC 718”) requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. The Company estimates forfeitures based on its historical experience. The weighted-average fair value per share of all options granted during the years ended December 31, 2015 , 2014 , and 2013 , estimated as of the grant date using the Black-Scholes option valuation model, was $4.60 , $3.16 and $4.54 per share, respectively. The unrecognized compensation cost related to non-vested stock options outstanding at December 31, 2015 and 2014 was $10,430,604 and $4,862,030 , respectively. The weighted-average remaining contractual term at December 31, 2015 and 2014 for options outstanding and vested options was 3.1 years and 3.0 years , respectively. The total intrinsic value of stock options exercised was $1,382,255 , $0 and $275,492 during the years ended December 31, 2015 , 2014 and 2013 , respectively. The total fair value of shares vested during the years ended December 31, 2015 , 2014 and 2013 was $2,634,688 , $1,960,256 and $1,633,071 , respectively. A summary of stock option activity and of changes in stock options outstanding is presented below: Number of Options Weighted-Average Exercise Price Per Share Intrinsic Value Weighted-Average Remaining Contractual Life Balance outstanding, December 31, 2012 3,711,303 $ 4.69 $ 8,301,484 6.3 years Granted 1,144,760 $ 6.33 Exercised (52,500 ) $ 4.30 Forfeited (516,018 ) $ 4.35 Balance outstanding, December 31, 2013 4,287,545 $ 5.18 $ 5,896,329 6.7 years Granted 1,410,038 $ 4.42 Forfeited (784,111 ) $ 7.08 Balance outstanding, December 31, 2014 4,913,472 $ 4.66 $ 2,808,083 7.6 years Granted 2,688,500 $ 7.02 Exercised (265,166 ) $ 3.25 Forfeited (388,176 ) $ 7.75 Balance outstanding, December 31, 2015 6,948,630 $ 5.45 $ 5,903,466 7.8 years Vested and exercisable, December 31, 2015 2,825,398 $ 4.38 $ 4,194,205 6.0 years ASC 718 requires that cash flows resulting from tax deductions in excess of the cumulative compensation cost recognized for options exercised (excess tax benefits) be classified as cash inflows from financing activities and cash outflows from operating activities. Due to Trovagene’s accumulated deficit position, no tax benefits have been recognized in the cash flow statement. |
Derivative Financial Instrument
Derivative Financial Instruments - Warrants | 12 Months Ended |
Dec. 31, 2015 | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | |
Derivative Financial Instruments - Warrants | Derivative Financial Instruments — Warrants Based upon the Company’s analysis of the criteria contained in ASC Topic 815-40, Contracts in Entity’s Own Equity (“ASC 815-40”), Trovagene has determined that certain warrants issued in connection with its private placements must be recorded as derivative liabilities with a charge to additional paid-in capital as they were issued with other equity instruments. In accordance with ASC 815-40, the warrants are also being re-measured at each balance sheet date based on estimated fair value, and any resultant change in fair value is being recorded in the Company’s statement of operations. The Company estimates the fair value of these warrants using the Black-Scholes option pricing model. The range of assumptions used to determine the fair value of the warrants valued using the Black-Scholes option pricing model during the periods indicated was: Year ended December 31 2015 2014 2013 Estimated fair value of Trovagene common stock $5.40 - $10.15 $3.00 - $6.74 $5.74 - $7.18 Expected warrant term 3.0-3.8 years 4.0 years 1 month to 5.8 years Risk-free interest rate 0.89%-1.31% 1.38% .03%-1.75% Expected volatility 73%-77% 86.4% 82%-100% Dividend yield —% —% —% Expected volatility is based on the volatility of a peer group of companies with attributes similar to Trovagene. The warrants have a transferability provision and based on guidance provided in SAB No. 107 for instruments issued with such a provision, Trovagene used the full contractual term as the expected term of the warrants. The risk-free interest rate is based on the U.S. Treasury security rates consistent with the expected remaining term of the warrants at each balance sheet date. The following table sets forth the components of changes in the Company’s derivative financial instruments liability balance, valued using the Black-Scholes option pricing method, for the periods indicated. Date Description Number of Warrants Derivative Instrument Liability December 31, 2013 Balance of derivative financial instruments liability 1,013,961 $ 4,431,871 Change in fair value of warrants during the year recognized as a gain in the statement of operations — (1,425,850 ) December 31, 2014 Balance of derivative financial instruments liability 1,013,961 3,006,021 Exercised warrants (46,666 ) (435,365 ) Change in fair value of warrants during the year recognized as a loss in the statement of operations — 726,421 December 31, 2015 Balance of derivative financial instruments liability 967,295 $ 3,297,077 The weighted-average remaining contractual term of all of the Company’s warrants outstanding at December 31, 2015 and 2014 was approximately 2.5 and 3.6 years, respectively. At December 31, 2015 and 2014 , the total fair value of the above warrants accounted for as derivative financial instruments, valued using the Black-Scholes option pricing model, was $3,297,077 and $3,006,021 , respectively, and is classified as derivative financial instruments liability on the balance sheet. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2015 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value Measurements The following table presents the Company’s assets and liabilities that are measured and recognized at fair value on a recurring basis classified under the appropriate level of the fair value hierarchy as of December 31, 2015 and 2014 : Fair Value Measurements at Quoted Prices in Active Markets for Identical Assets and Liabilities Significant Other Observable Inputs Significant Unobservable Inputs Total Assets: Money market fund (1) $ 65,016,222 $ — $ — $ 65,016,222 Total Assets $ 65,016,222 $ — $ — $ 65,016,222 Liabilities: Derivative liabilities related to warrants $ — $ — $ 3,297,077 $ 3,297,077 Total Liabilities $ — $ — $ 3,297,077 $ 3,297,077 Fair Value Measurements at Quoted Prices in Active Markets for Identical Assets and Liabilities Significant Other Observable Inputs Significant Unobservable Inputs Total Assets: Money market fund (1) $ 27,123,587 $ — $ — $ 27,123,587 Total Assets $ 27,123,587 $ — $ — $ 27,123,587 Liabilities: Derivative liabilities related to warrants $ — $ — $ 3,006,021 $ 3,006,021 Total Liabilities $ — $ — $ 3,006,021 $ 3,006,021 (1) Included as a component of cash and cash equivalents on the accompanying consolidated balance sheet. The following table sets forth a summary of changes in the fair value of the Company’s Level 3 liabilities for the years ended December 31, 2015 and 2014 : Description Balance at Fair Value of Warrants Reclassified to Additional Paid-in Capital Unrealized (gains) or losses Balance at Derivative liabilities related to Warrants $ 3,006,021 $ (435,365 ) $ 726,421 $ 3,297,077 Description Balance at Unrealized (gains) or losses Balance at Derivative liabilities related to Warrants $ 4,431,871 $ (1,425,850 ) $ 3,006,021 The unrealized gains or losses on the derivative liabilities are recorded as a change in fair value of derivative liabilities in the Company’s statement of operations. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. At each reporting period, the Company reviews the assets and liabilities that are subject to ASC Topic 815-40. At each reporting period, all assets and liabilities for which the fair value measurement is based on significant unobservable inputs or instruments that trade infrequently and therefore have little or no price transparency are classified as Level 3. |
Debt
Debt | 12 Months Ended |
Dec. 31, 2015 | |
Debt Disclosure [Abstract] | |
Debt | Debt Equipment Line of Credit In November 2015, the Company entered into a Loan and Security Agreement (“Equipment Line of Credit”) with Silicon Valley Bank that provided for cash borrowings for equipment (“Equipment Advances”) of up to $2.0 million , secured by the equipment financed. Under the terms of the agreement, interest is equal to 1.25% above the Prime Rate. Interest only payments are due on borrowings through November 30, 2016, with both interest and principal payments commencing in December 2016. Any equipment advances after November 30, 2016 are subject to principal and interest payments immediately over a 36 -month period following the advance. All unpaid principal and interest on each Equipment Advance will be due on November 1, 2019. The Company has an obligation to make a final payment equal to 7% of total amounts borrowed at the loan maturity date and the final payment is being accrued over the term of the loans using the effective-interest method. The Company is also subject to certain affirmative and negative covenants under the Equipment Line of Credit. As of December 31, 2015 , the Company was in compliance with all covenants. As of December 31, 2015 , $1,086,062 has been borrowed under the Equipment Line of Credit. As of December 31, 2015 , amounts due under the Equipment Line of Credit included $30,168 in current liabilities and $1,058,709 in long-term liabilities, which includes $2,815 of accrued financial payment. The Company recorded $5,702 in interest expense related to the Equipment Line of Credit during the year ended December 31, 2015 . Future maturities of long-term debt at December 31, 2015 are as follows: 2016 $ 30,168 2017 362,021 2018 362,021 2019 331,852 Total principal 1,086,062 Plus final fee premium accretion 2,815 Total long-term obligations $ 1,088,877 Loan and Security Agreement In June 2014, the Company entered into a $15,000,000 loan and security agreement (“Agreement”) with two banks pursuant to which the lenders provided the Company with a term loan, which was funded at closing. A portion of the proceeds were used to repay the existing outstanding amount under the Equipment Line of Credit entered into in June 2013. The repayment with the same lender was accounted for as a debt extinguishment under FASB ASC Topic 470-50, Debt . The interest rate on the new loan is 7.07% per annum. The Company made interest only payments on the outstanding amount of the loan on a monthly basis through July 2015, after which equal monthly payments of principal and interest were scheduled to become due until the loan maturity date of July 1, 2018. However, included in the Agreement is a provision to extend the interest only payments through January 1, 2016 upon the Company’s receipt of unrestricted net cash proceeds from the sale of equity securities of not less than $30 million by June 30, 2015. In June 2015, the Company entered into an amendment to the Agreement (“Amendment”), which reduced the amount of unrestricted net cash proceeds to not less than $21 million from the sale of equity securities to qualify for an interest-only extension. The Company met the conditions in the Amendment related to the interest-only extension and, as a result, the interest only payments that were to expire on August 1, 2015 were extended for six months to February 1, 2016, when both interest and principal payments will commence. The loan is secured by a security interest in all of the Company’s assets except intellectual property, which is subject to a negative pledge. In connection with the loan, each of the lenders received a warrant to purchase up to an aggregate of 85,470 shares of the Company’s common stock at an exercise price of $3.51 per share, which such warrants are exercisable for ten years from the date of issuance. The original value of the warrants, totaling $235,857 , was recorded as debt discount and additional paid-in capital as the warrants were equity classified. As of December 31, 2015 , a warrant to purchase 42,735 shares of common stock remains outstanding. At the Company’s option, it may prepay all of the outstanding principal balance, subject to certain pre-payment fees ranging from 1% to 3% of the prepayment amount. In the event of a final payment of the loans under the loan agreement, either in the event of repayment of the loan at maturity or upon any prepayment, the Company is obligated to pay the amortized portion of the final fee of $1,050,000 . The Company is also subject to certain affirmative and negative covenants under the Agreement, including limitations on its ability to: undergo certain change of control events; convey, sell, lease, license, transfer or otherwise dispose of any equipment financed by loans under the loan agreement; create, incur, assume, guarantee or be liable with respect to indebtedness, subject to certain exceptions; grant liens on any equipment financed under the loan agreement; make or permit any payment on specified subordinated debt; and pay dividends. In addition, under the Agreement, subject to certain exceptions, the Company is required to maintain with the lender its primary operating, other deposit and securities accounts. Furthermore, under the Amendment, the Company is required to be in compliance with healthcare laws and regulations and terms and conditions of healthcare permits. The Company was in compliance with all covenants under the Agreement, as amended, as of December 31, 2015 . As of December 31, 2015 , amounts due under the Agreement include $5,195,650 in current liabilities and $10,187,479 in long-term liabilities, which include $535,024 of accrued financial payment. The Company recorded $1,590,750 in interest expense related to the Agreement during the year ended December 31, 2015 . Closing costs are being accreted over the life of the loan to interest expense. Future maturities of long-term debt at December 31, 2015 are as follows: 2016 $ 5,195,650 2017 6,064,315 2018 3,740,035 Total principal 15,000,000 Less discount (151,895 ) Plus final fee premium accretion 535,024 Total long-term obligations $ 15,383,129 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2015 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes At December 31, 2015 , Trovagene had federal net operating loss carryforwards (NOLs) of approximately $72.6 million , which, if not used, expire beginning in 2020. Trovagene also has California NOLs of approximately $52.6 million that will begin to expire in 2021 and New Jersey NOLs of approximately $6.9 million that begin to expire on January 31, 2016. Trovagene also has research and development tax credits available for federal and California purposes of approximately $1.2 million and $0.5 million , respectively. The federal research and development tax credits will begin to expire on January 31, 2025. The California research and development tax credits are not set to expire. The utilization of these NOLs and research and development tax credits is subject to limitations based on past and future changes in ownership of Trovagene pursuant to Section 382 (“Section 382”) of the Internal Revenue Code of 1986, as amended (the “Code”). The Company has determined that ownership changes have occurred for purposes of Section 382 and, therefore, the ability of the Company to utilize its NOLs is limited. The provision for income taxes based on losses from continuing operations consists of the following at December 31 (in thousands): Years ended December 31, 2015 2014 2013 Deferred benefit Federal $ (9,602 ) $ (5,651 ) $ (3,806 ) State (1,742 ) (449 ) (593 ) Total deferred benefit (11,344 ) (6,100 ) (4,399 ) Valuation allowance 11,344 6,100 4,399 Total income tax provision $ — $ — $ — Significant components of the Company’s taxes and the rates as of December 31 are shown below (in thousands, except percentages): Years ended December 31, 2015 2014 Tax computed at the federal statutory rate $ (9,340 ) 34 % $ (4,871 ) 35 % State tax, net of federal tax benefit (1,559 ) 6 % (891 ) 6 % Permanent Items 258 (1 )% (320 ) 2 % Tax credits (997 ) 3 % — — % Valuation allowance increase 11,638 (42 )% 6,081 (43 )% Other — — % 1 — % Provision for income taxes $ — — % $ — — % Significant components of the Company’s deferred tax assets and liabilities from federal and state income taxes as of December 31 are shown below: Years ended December 31, 2015 2014 Deferred tax assets Tax loss carryforwards $ 27,962,000 $ 19,010,900 Research and development credits and other tax credits 1,698,300 698,000 Stock-based compensation 3,225,200 2,193,900 Other 782,000 420,800 Total deferred tax assets 33,667,500 22,323,600 Valuation allowance (33,667,500 ) (22,323,600 ) Net deferred tax asset $ — $ — Trovagene records a valuation allowance against deferred tax assets to the extent that it is more likely than not that some portion, or all of, the deferred tax assets will not be realized. Due to the substantial doubt related to Trovagene’s ability to utilize its deferred tax assets, the Company recorded a valuation allowance against the deferred tax. FASB ASC Topic 740-10-30-7, Accounting for Income Taxes had no effect on Trovagene’s financial position, cash flows or results of operations upon adoption, as Trovagene does not have any unrecognized tax benefits. Trovagene’s practice is to recognize interest and/or penalties related to income tax matters in income tax expense, and none have been incurred to date. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2015 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Research and Development and License Agreements The Company has entered into a variety of collaboration and specimen transfer agreements relating to its development efforts. Included in research and development expense, the Company has incurred and recorded approximately $1,362,000 , $712,000 , and $217,000 as of December 31, 2015 , 2014 and 2013 , respectively, relating to services provided by the collaborators in connection with these agreements. The Company is a party to various agreements under which it licenses technology on an exclusive basis in the field of human diagnostics. License fees are generally calculated as a percentage of product revenues, with rates that vary by agreement. To date, payments have not been material. Litigation Trovagene does not believe that the Company has legal liabilities that are probable or reasonably possible that require either accrual or disclosure. From time to time, the Company may become involved in various lawsuits and legal proceedings that arise in the ordinary course of business. However, litigation is subject to inherent uncertainties, and an adverse result in these or other matters may arise from time to time that may harm the Company’s business. The Company is not currently a party to any material legal proceedings. Employment and Consulting Agreements The Company has longer-term contractual commitments with various consultants and employees, including the Company’s CEO and CFO. The executive agreements with the CEO, CFO and CCO provide for severance payments. The executive agreement with the CEO also provides for a bonus payment in cash or stock upon the earlier of meeting certain trading volumes and market price of Trovagene’s common stock for a minimum period of ninety days or in the event of a change in control where the Company’s per share enterprise value equal or exceeds $7.50 . If the market price and volume target is realized, the bonus is approximately $3.5 million . If a change of control occurs at the targeted enterprise values, the bonus is equal to 4% of the enterprise value. The executive agreements with the CEO and CFO were replaced by the employment agreements that became effective in January 2016. See Note 14. Subsequent Events. Lease Agreements The Company leases laboratory and office spaces under various non-cancelable lease agreements. The Company is headquartered in San Diego, California and leases facilities in San Diego and Italy. The Company currently leases its facilities in San Diego under an operating lease that expires in 2017. On June 11, 2015, the Company entered into an amendment to the lease agreement which expands the square footage leased by the Company to approximately 22,600 square feet at a monthly rental rate of approximately $60,000 . The amended lease expires on December 31, 2021. The amended monthly rental rate will be effective when the Company commences business operations in the expanded premises, expected to occur in the second quarter of 2016. In November 2015, the Company entered into a lease agreement, under the terms of which the Company will lease certain office building in Torino, Italy, consisting of approximately 2,300 square feet at a monthly rental rate of approximately $3,100 . The lease is for a period of three years with an effective date of January 1, 2016. Rent expense for the years ended December 31, 2015 , 2014 , and 2013 was approximately $471,000 , $315,000 and $294,000 , respectively. The Company is also a party to various operating lease agreements for office equipment. Total annual commitments under non-cancelable lease agreements for each of the years ended December 31 are as follows: 2016 $ 683,871 2017 792,221 2018 811,797 2019 796,716 2020 817,989 Thereafter 842,529 Total $ 4,745,123 |
Employee Benefit Plan
Employee Benefit Plan | 12 Months Ended |
Dec. 31, 2015 | |
Compensation and Retirement Disclosure [Abstract] | |
Employee Benefit Plan | Employee Benefit Plan The Company has a retirement savings plan under Section 401(k) of the Code covering its employees. The plan allows employees to defer, up to the maximum allowed, a percentage of their income on a pre-tax basis through contributions to the plans, plus any employee age 50 and over can participate in the caught-up dollars as allowed by Internal Revenue Service codes. The Company also has a Roth investment plan that is taken after taxes. The Company does not currently make matching contributions. |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2015 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Related Party Transactions In January 2015, the Company entered into a one year consulting agreement with Thomas H. Adams, Ph.D., the Chairman of the Board, pursuant to which Dr. Adams provides consulting services to the Company in connection with applying the Company’s technology in the field of infectious disease with the first application to be detection of John Cunningham virus mutants in the presence of wild type in human urine as a prognostic indicator of the development of progressive multifocal leukoencephalopathy disease. Under the agreement, the Company committed to pay $9,500 per month for the services performed by Dr. Adams. During the year ended December 31, 2015 , the Company incurred and recorded $114,000 of consulting fees related to the agreement. In September 2015, the Company entered into a research agreement with the University of Torino (“University”) to collaborate on a program of research to develop, optimize and test molecular profiling tools for plasma and urine ctDNA in cancer. Dr. Alberto Bardelli, the Principal Investigator of the University who oversees this research program, is also a member of the Scientific Advisory Board of the Company. Under the agreement, the Company committed to pay up to $529,000 for the services performed by the University. In addition, the Company may pay royalties to the University on revenue generated by the Company from the commercialization of any tools developed during the collaboration. During the year ended December 31, 2015 , the Company incurred and recorded approximately $188,000 of research and development expenses related to the agreement. No royalty expense has been incurred as of December 31, 2015 . |
Selected Quarterly Financial Da
Selected Quarterly Financial Data (Unaudited) | 12 Months Ended |
Dec. 31, 2015 | |
Quarterly Financial Data [Abstract] | |
Selected Quarterly Financial Data (Unaudited) | Selected Quarterly Financial Data (Unaudited) The following is a summary of the quarterly results of operations of the Company for years ended December 31, 2015 and 2014 : Quarter Ended(1) March 31 June 30 September 30 December 31 (dollars in thousands, except per share data) 2015 Revenues $ 127 $ 49 $ 58 $ 79 Operating expenses $ 4,975 $ 6,682 $ 6,467 $ 7,463 Net loss and comprehensive loss attributable to common stockholders $ (7,180 ) $ (10,186 ) $ (2,742 ) $ (7,387 ) Net loss per common share - basic $ (0.33 ) $ (0.41 ) $ (0.10 ) $ (0.25 ) Net loss per common share - diluted $ (0.33 ) $ (0.41 ) $ (0.23 ) $ (0.26 ) Shares used in the calculation of net loss attributable to common stockholders - basic 21,817,710 24,592,883 28,560,211 29,723,254 Shares used in the calculation of net loss attributable to common stockholders - diluted 21,817,710 24,592,883 29,128,235 30,157,038 2014 Revenues $ 111 $ 56 $ 57 $ 56 Operating expenses $ 3,371 $ 3,297 $ 3,997 $ 4,560 Net loss and comprehensive loss attributable to common stockholders $ (3,198 ) $ (1,079 ) $ (5,382 ) $ (4,689 ) Net loss per common share - basic $ (0.17 ) $ (0.06 ) $ (0.28 ) $ (0.25 ) Net loss per common share - diluted $ (0.17 ) $ (0.17 ) $ (0.28 ) $ (0.25 ) Shares used in the calculation of net loss attributable to common stockholders - basic 18,902,783 18,902,783 18,902,783 18,904,280 Shares used in the calculation of net loss attributable to common stockholders - diluted 18,902,783 19,232,760 18,902,783 19,071,112 (1) Basic and diluted net loss per common share are computed independently for each of the periods presented. Accordingly, the sum of the quarterly net loss per common share amount may not agree to the total for the year. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2015 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent Events Employment Agreements In January 2016, the Company entered into an employment agreement with Antonius Schuh, Ph.D. in which he agreed to serve as our Chief Executive Officer. The term of the agreement is effective as of January 1, 2016 and continues until January 1, 2020 and is automatically renewed for successive one year periods at the end of each term. Dr. Schuh’s base compensation is $488,800 per year. Dr. Schuh is eligible to receive an annual bonus of up to 50% of his base compensation based on meeting certain performance objectives and bonus criteria. Upon entering the agreement, Dr. Schuh was granted 450,000 non-qualified stock options which have an exercise price of $5.18 per share and vest monthly in equal amounts over a period of four years. Dr. Schuh was also granted 350,000 non-qualified stock options which have an exercise price of $5.18 per share and vested immediately upon grant. If the employment agreement is terminated by the Company without cause, Dr. Schuh is entitled to receive a severance payment equal to base compensation for twenty-four months and the potential bonus and any benefits Dr. Schuh would be eligible during such twenty-four month period. If the employment agreement is terminated as a result of a change of control, in addition to the severance payment described above, all unvested equity awards would immediately vest and become fully exercisable for a period of six months following the date of termination. In January 2016, the Company entered into an employment agreement with Stephen Zaniboni in which he agreed to serve as our Chief Financial Officer. The term of the agreement is effective as of January 1, 2016 and continues until January 1, 2020 and is automatically renewed for successive one year periods at the end to each term. Mr. Zaniboni’s base compensation is $357,500 per year. Mr. Zaniboni is eligible to receive an annual bonus of up to 50% of his base compensation based on meeting certain performance objectives and bonus criteria. Upon entering the agreement, Mr. Zaniboni was granted 150,000 non-qualified stock options which have an exercise price of $5.18 per share and vest monthly in equal amounts over a period of four years. If the employment agreement is terminated by the Company without cause, Mr. Zaniboni is entitled to receive a severance payment equal to base compensation for twelve months and the potential bonus and any benefits Mr. Zaniboni would be eligible during such twelve month period. If the employment agreement is terminated as a result of a change of control, in addition to the severance payment, all unvested equity awards would immediately vest and become fully exercisable for a period of six months following the date of termination. Debt Agreement In February 2016, the Company signed a term sheet to refinance its existing term loan entered into on June 2014. Under the term sheet, interest would be equal to 3.75% plus the Wall Street Journal Prime Rate, subject to a floor of 7.25% . Interest only payments would be for 12 months, followed by equal monthly payments of principal and interest over the following 30 months. The Company would also have an obligation to make a final payment equal to 7.50% of total funded amounts at the loan maturity date. In addition, the lenders would receive a warrant to purchase such number of shares of the Company’s common stock as is equal to 1% of the funded amount divided by an average closing price of the Company’s common stock. Registration Statement Effective February 4, 2016, the Registration Statement expired and the Company therefore will no longer be able to issue securities pursuant to the Registration Statement, including pursuant to its agreement with the Agent. |
Basis of Presentation and Sum21
Basis of Presentation and Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2015 | |
Accounting Policies [Abstract] | |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. |
Cash and Cash Equivalents | Cash and Cash Equivalents Cash and cash equivalents consist of operating and money market accounts as of December 31, 2015 and 2014 on deposit with U.S. commercial banks. Cash equivalents are considered by the Company to be highly liquid investments purchased with original maturities of three months or less from the date of purchase. |
Concentration of credit risk | Concentration of Credit Risk Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash and cash equivalents. The Company maintains deposit accounts that are not insured by the Federal Deposit Insurance Corporation in federally insured financial institutions. The Company has not experienced any losses in such accounts and believes it is not exposed to significant risk on its cash due to the financial position of the depository institution in which those deposits are held. |
Revenues | Revenues Revenue is recognized when persuasive evidence that an arrangement exists, delivery has occurred, the price is fixed or determinable, and collection is reasonably assured. Milestone, Royalty and License Revenues The Company licenses and sublicenses its patent rights to healthcare companies, medical laboratories and biotechnology partners. These agreements may involve multiple elements such as license fees, royalties and milestone payments. Revenue is recognized when the criteria described above have been met as well as the following: • Up-front nonrefundable license fees pursuant to agreements under which the Company has no continuing performance obligations are recognized as revenues on the effective date of the agreement and when collection is reasonably assured. • Minimum royalties are recognized as earned, and royalties in excess of minimum amounts are recognized upon receipt of payment when collection is assured. • Milestone payments are recognized when both the milestone is achieved and the related payment is received. Diagnostic Service Revenues Revenue for clinical laboratory tests may come from several sources, including commercial third-party payors, such as insurance companies and health maintenance organizations, government payors, such as Medicare and Medicaid in the United States, patient self-pay and, in some cases, from hospitals or referring laboratories who, in turn, might bill third-party payors for testing. The Company is recognizing diagnostic service revenue on the cash collection basis until such time as it is able to properly estimate collections on third party reimbursements. |
Allowance for Doubtful Accounts | Allowance for Doubtful Accounts The Company reviews the collectability of accounts receivable based on an assessment of historic experience, current economic conditions, and other collection indicators. At each of December 31, 2015 , 2014 and 2013 , the Company had not recorded an allowance for doubtful accounts. When accounts are determined to be uncollectible, they are written off against the reserve balance and the reserve is reassessed. When payments are received on reserved accounts, they are applied to the individual’s account and the reserve is reassessed. |
Derivative Financial Instruments-Warrants | Derivative Financial Instruments—Warrants The Company has issued common stock warrants in connection with the execution of certain equity financings. Such warrants are classified as derivative liabilities under the provisions of Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 815, Derivatives and Hedging (“ASC 815”) and are recorded at their fair market value as of each reporting period. Such warrants do not meet the exemption that a contract should not be considered a derivative instrument if it is (1) indexed to its own stock and (2) classified in stockholders’ equity. Changes in fair value of derivative liabilities are recorded in the consolidated statement of operations under the caption “Change in fair value of derivative instruments.” The fair value of warrants is determined using the Black-Scholes option-pricing model using assumptions regarding the volatility of Trovagene’s common stock price, the remaining life of the warrant, and the risk-free interest rates at each period end. The Company thus uses model-derived valuations where inputs are observable in active markets to determine the fair value and accordingly classifies such warrants in Level 3 per FASB ASC Topic 820, Fair Value Measurements (“ASC 820”). |
Stock-Based Compensation | Stock-Based Compensation FASB ASC Topic 718 “ Compensation—Stock Compensation ” (“ASC 718”) requires companies to measure the cost of employee services received in exchange for the award of equity instruments based on the estimated fair value of the award at the date of grant. The expense is recognized over the period during which an employee is required to provide services in exchange for the award. ASC 718 did not change the way Trovagene accounts for non-employee stock-based compensation. Trovagene continues to account for shares of common stock, stock options and warrants issued to non-employees based on the fair value of the stock, stock option or warrant, if that value is more reliably measurable than the fair value of the consideration or services received. The Company accounts for stock options issued and vesting to non-employees in accordance with FASB ASC Topic 505-50 “ Equity -Based Payment to Non-Employees ” , and, accordingly, the value of the stock compensation to non-employees is based upon the measurement date as determined at either (1) the date at which a performance commitment is reached, or (2) the date at which the necessary performance to earn the equity instruments is complete. Therefore, the fair value of these options is being “marked to market” quarterly until the measurement date is determined. |
Fair value of financial instruments | Fair Value of Financial Instruments Financial instruments consist of cash and cash equivalents, accounts receivable, accounts payable, debt and derivative liabilities. The Company has adopted ASC 820 for financial assets and liabilities that are required to be measured at fair value and non-financial assets and liabilities that are not required to be measured at fair value on a recurring basis. These financial instruments are stated at their respective historical carrying amounts, which approximate fair value due to their short term nature as they reflect current market interest rates. Debt is stated at its respective historical carrying amounts, which approximate fair value as they reflect current market interest rates. In accordance with FASB ASC Subtopic 820-10, the Company measures certain assets and liabilities at fair value on a recurring basis using the three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value. The three tiers include: • Level 1 — Quoted prices for identical instruments in active markets. • Level 2 — Quoted prices for similar instruments in active markets; quoted prices for identical or similar instruments in markets that are not active; and model-derived valuations where inputs are observable or where significant value drivers are observable. • Level 3 — Instruments where significant value drivers are unobservable to third parties. |
Property, equipment and depreciation and amortization | Property, Equipment and Depreciation and Amortization Expenditures for additions, renewals and improvements are capitalized at cost. Depreciation and amortization is generally computed on a straight-line method based on the estimated useful lives of the related assets. Amortization of leasehold improvements is computed based on the shorter of the life of the asset or the term of the lease. The estimated useful lives of the major classes of depreciable assets are three to five years for laboratory equipment and furniture and fixtures. Expenditures for repairs and maintenance are charged to operations as incurred. |
Impairment of Indefinite and Long-Lived Assets | Impairment of Indefinite and Long-Lived Assets The Company reviews its long-lived and indefinite assets to determine if any event has occurred that may indicate its intangible assets with indefinite lives and other long-lived assets are potentially impaired. If indicators of impairment exist, the Company performs an impairment test to assess the recoverability of the affected assets by determining whether the carrying amount of such assets exceeds the undiscounted expected future cash flows. If the affected assets are not recoverable, the Company estimates the fair value of the assets and records an impairment loss if the carrying value of the assets exceeds the fair value. Factors that would indicate potential impairment include a significant decline in the Company’s stock price and market capitalization compared to its net book value, significant changes in the ability of a particular asset to generate positive cash flows, and significant changes in the Company’s strategic business objectives and utilization of a particular asset. |
Income Taxes | Income Taxes Income taxes are determined using the asset and liability approach of accounting for income taxes. Under this approach, deferred taxes represent the future tax consequences expected to occur when the reported amounts of assets and liabilities are recovered or paid. Deferred taxes result from differences between the financial statement and tax bases of Trovagene’s assets and liabilities and are adjusted for changes in tax rates and tax laws when changes are enacted. Valuation allowances are recorded to reduce deferred tax assets when it is more likely than not that a tax benefit will not be realized. The assessment of whether or not a valuation allowance is required often requires significant judgment. |
Contingencies | Contingencies In the normal course of business, Trovagene is subject to loss contingencies, such as legal proceedings and claims arising out of its business, that cover a wide range of matters, including, among others, government investigations, stockholder lawsuits, product and environmental liability, and tax matters. In accordance with FASB ASC Topic 450, Accounting for Contingencies , Trovagene records such loss contingencies when it is probable that a liability has been incurred and the amount of loss can be reasonably estimated. Trovagene, in accordance with this guidance, does not recognize gain contingencies until realized. |
Cost of Revenue | Cost of Revenue Cost of revenue represents the cost of materials, personnel costs, costs associated with processing specimens including pathological review, quality control analyses, and delivery charges necessary to render an individualized test result. Costs associated with performing tests are recorded as the tests are processed. |
Research and Development | Research and Development Research and development expenses, which include expenditures in connection with an in-house research and development laboratory, salaries and staff costs, purchased in-process research and development and regulatory and scientific consulting fees, as well as contract research and insurance, are accounted for in accordance with FASB ASC Topic 730-10-55-2, Research and Development. Also, as prescribed by this guidance, patent filing and maintenance expenses are considered legal in nature and therefore classified as general and administrative expense, if any. While certain of the Company’s research and development costs may have future benefits, the Company’s policy of expensing all research and development expenditures is predicated on the fact that Trovagene has no history of successful commercialization of molecular diagnostic products to base any estimate of the number of future periods that would be benefited. FASB ASC Topic 730, Research and Development requires that non-refundable advance payments for goods or services that will be used or rendered for future research and development activities be deferred and capitalized. As the related goods are delivered or the services are performed, or when the goods or services are no longer expected to be provided, the deferred amounts are recognized as an expense. |
Net Loss Per Share | Net Loss Per Share Basic and diluted net loss per share is presented in conformity with FASB ASC Topic 260, Earnings per Share , for all periods presented. In accordance with this guidance, basic and diluted net loss per common share is determined by dividing net loss applicable to common stockholders by the weighted-average common shares outstanding during the period. Preferred dividends are included in income available to common stockholders in the computation of basic and diluted earnings per share. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In February 2016, the FASB issued Accounting Standards Update (“ASU”) 2016-02, Leases . The new standard establishes a right-of-use (“ROU”) model that requires a lessee to record a ROU asset and a lease liability on the balance sheet for all leases with terms longer than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern of expense recognition in the income statement. The new standard is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. A modified retrospective transition approach is required for capital and operating leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements, with certain practical expedients available. The Company is currently evaluating the impact the adoption of the new standard will have on its consolidated financial statements. In August 2014, the FASB issued ASU 2014-15, P resentation of Financial Statements — Going Concern , which impacts the accounting guidance related to the evaluation of an entity’s ability to continue as a going concern. The amendment establishes management’s responsibility to evaluate whether there is substantial doubt about an entity’s ability to continue as a going concern in connection with preparing financial statements for each annual and interim reporting period. The amendment also gives guidance to determine whether to disclose information about relevant conditions and events when there is substantial doubt about an entity’s ability to continue as a going concern. The amended guidance is effective prospectively for fiscal years beginning after December 15, 2016. The new guidance is not expected to have a material impact on the Company’s financial position, results of operations or cash flows. In May 2014, the FASB issued ASU 2014-9, Revenue from Contracts with Customers (“ASU 2014-9”). ASU 2014-9 provides companies with a single model for accounting for revenue arising from contracts with customers and supersedes current revenue recognition guidance, including industry-specific revenue guidance. The core principle of the model is to recognize revenue when control of the goods or services transfers to the customer, as opposed to recognizing revenue when the risks and rewards transfer to the customer under the existing revenue guidance. The guidance permits companies to either apply the requirements retrospectively to all prior periods presented, or apply the requirements in the year of adoption, through a cumulative adjustment. In August 2015, the FASB issued ASU 2015-14, Deferral of the Effective Date , which defers the required adoption date of ASU 2014-09 by one year. As a result of the deferred effective date, ASU 2014-09 will be effective for the Company in its first quarter of fiscal year 2018. Early adoption is permitted but not before the original effective date of the first quarter of fiscal year 2017. The Company is in the process of evaluating the transition method that will be elected and the impact of adoption of ASU 2014-09 on its consolidated financial statements. |
Basis of Presentation and Sum22
Basis of Presentation and Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Accounting Policies [Abstract] | |
Schedule of Antidilutive Securities Excluded from the Calculation of Basic and Diluted Loss Per Share | Shares used in calculating diluted net loss per common share exclude as anti-dilutive the following share equivalents: December 31, 2015 2014 2013 Options to purchase Common Stock 6,948,630 4,913,472 4,287,545 Warrants to purchase Common stock 4,565,947 5,251,660 6,233,483 Series A Convertible Preferred Stock 63,125 63,125 63,125 11,577,702 10,228,257 10,584,153 |
Summary of the Company’s Diluted Net Loss Per Share | The following table summarizes the Company’s diluted net loss per share: December 31, 2015 2014 2013 Numerator: Net loss attributable to common stockholders $ (27,495,334 ) $ (14,348,499 ) $ (11,840,778 ) Adjustment for change in fair value of derivative instruments - warrants (4,396,061 ) (2,422,337 ) — Net loss used for diluted loss per share $ (31,891,395 ) $ (16,770,836 ) $ (11,840,778 ) Denominator: Weighted-average shares used to compute basic net loss per share 26,201,713 18,904,280 16,978,212 Adjustments to reflect assumed exercise of warrants 250,452 166,832 — Weighted-average shares used to compute diluted net loss per share 26,452,165 19,071,112 16,978,212 Net loss per share diluted $ (1.21 ) $ (0.88 ) $ (0.70 ) |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Components of Property and Equipment | Property and equipment consisted of the following: As of December 31, 2015 2014 Furniture and office equipment $ 1,483,227 $ 365,955 Leasehold Improvements 39,401 39,401 Laboratory equipment 2,022,733 968,901 3,545,361 1,374,257 Less—accumulated depreciation and amortization (854,782 ) (533,870 ) Property and equipment, net $ 2,690,579 $ 840,387 |
Stockholders' Equity (Deficit)
Stockholders' Equity (Deficit) (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Stockholders' Equity Note [Abstract] | |
Summary of Warrant Activity and Changes in Warrants Outstanding | A summary of warrant activity and changes in warrants outstanding, including both liability and equity classifications, is presented below: Number of Warrants Weighted-Average Exercise Price Per Share Weighted-Average Remaining Contractual Term Balance outstanding, December 31, 2012 6,985,070 $ 3.96 5.4 Granted 50,000 $ 8.00 Exercised (728,488 ) $ 4.99 Expired (73,099 ) $ 4.50 Balance outstanding, December 31, 2013 6,233,483 $ 3.87 4.5 Granted 85,470 $ 3.51 Exercised (36,666 ) $ 3.00 Expired (16,667 ) $ 10.80 Balance outstanding, December 31, 2014 6,265,620 $ 3.85 3.6 Exercised (732,378 ) $ 3.77 Balance outstanding, December 31, 2015 5,533,242 $ 3.86 2.5 |
Stock Option Plan (Tables)
Stock Option Plan (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Schedule of Stock-Based Compensation Expense | Stock-based compensation has been recognized in operating results as follows: Years ended December 31, 2015 2014 2013 In cost of revenue $ 39,676 $ — $ — In research and development expenses 1,499,009 796,008 549,465 In selling and marketing expense 768,146 145,239 70,626 In general and administrative expenses 1,639,196 1,128,947 1,359,273 Total stock-based compensation $ 3,946,027 $ 2,070,194 $ 1,979,364 |
Schedule of Assumptions to Estimate Fair Value of Stock Option Awards | The estimated fair value of stock option awards was determined on the date of grant using the Black-Scholes option valuation model with the following assumptions during the years indicated below: Years ended December 31, 2015 2014 2013 Risk-free interest rate 1.35% - 2.15% 1.42% - 2.1% 0.74% - 1.5% Dividend yield 0% 0% 0% Expected volatility (range) 73% - 77% 81% - 86% 82% - 100% Expected volatility (weighted-average) 75% 85% 91% Expected term (in years) 6.0 years 5.8 years 5.0 years |
Summary of Stock Option Activity of Changes in Stock Options Outstanding | A summary of stock option activity and of changes in stock options outstanding is presented below: Number of Options Weighted-Average Exercise Price Per Share Intrinsic Value Weighted-Average Remaining Contractual Life Balance outstanding, December 31, 2012 3,711,303 $ 4.69 $ 8,301,484 6.3 years Granted 1,144,760 $ 6.33 Exercised (52,500 ) $ 4.30 Forfeited (516,018 ) $ 4.35 Balance outstanding, December 31, 2013 4,287,545 $ 5.18 $ 5,896,329 6.7 years Granted 1,410,038 $ 4.42 Forfeited (784,111 ) $ 7.08 Balance outstanding, December 31, 2014 4,913,472 $ 4.66 $ 2,808,083 7.6 years Granted 2,688,500 $ 7.02 Exercised (265,166 ) $ 3.25 Forfeited (388,176 ) $ 7.75 Balance outstanding, December 31, 2015 6,948,630 $ 5.45 $ 5,903,466 7.8 years Vested and exercisable, December 31, 2015 2,825,398 $ 4.38 $ 4,194,205 6.0 years |
Derivative Financial Instrume26
Derivative Financial Instruments - Warrants (Tables) - Black Scholes Option Pricing Method | 12 Months Ended |
Dec. 31, 2015 | |
Derivative financial instruments | |
Schedule of Assumptions Used to Determine the Fair Value of Warrants | The range of assumptions used to determine the fair value of the warrants valued using the Black-Scholes option pricing model during the periods indicated was: Year ended December 31 2015 2014 2013 Estimated fair value of Trovagene common stock $5.40 - $10.15 $3.00 - $6.74 $5.74 - $7.18 Expected warrant term 3.0-3.8 years 4.0 years 1 month to 5.8 years Risk-free interest rate 0.89%-1.31% 1.38% .03%-1.75% Expected volatility 73%-77% 86.4% 82%-100% Dividend yield —% —% —% |
Schedule of Components of Changes in the Company’s Derivative Financial Instruments Liability Balance | The following table sets forth the components of changes in the Company’s derivative financial instruments liability balance, valued using the Black-Scholes option pricing method, for the periods indicated. Date Description Number of Warrants Derivative Instrument Liability December 31, 2013 Balance of derivative financial instruments liability 1,013,961 $ 4,431,871 Change in fair value of warrants during the year recognized as a gain in the statement of operations — (1,425,850 ) December 31, 2014 Balance of derivative financial instruments liability 1,013,961 3,006,021 Exercised warrants (46,666 ) (435,365 ) Change in fair value of warrants during the year recognized as a loss in the statement of operations — 726,421 December 31, 2015 Balance of derivative financial instruments liability 967,295 $ 3,297,077 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Fair Value Disclosures [Abstract] | |
Schedule of Company’s Assets and Liabilities that are Measured and Recognized at Fair Value on a Recurring Basis Classified Under the Appropriate Level of the Fair Value Hierarchy | The following table presents the Company’s assets and liabilities that are measured and recognized at fair value on a recurring basis classified under the appropriate level of the fair value hierarchy as of December 31, 2015 and 2014 : Fair Value Measurements at Quoted Prices in Active Markets for Identical Assets and Liabilities Significant Other Observable Inputs Significant Unobservable Inputs Total Assets: Money market fund (1) $ 65,016,222 $ — $ — $ 65,016,222 Total Assets $ 65,016,222 $ — $ — $ 65,016,222 Liabilities: Derivative liabilities related to warrants $ — $ — $ 3,297,077 $ 3,297,077 Total Liabilities $ — $ — $ 3,297,077 $ 3,297,077 Fair Value Measurements at Quoted Prices in Active Markets for Identical Assets and Liabilities Significant Other Observable Inputs Significant Unobservable Inputs Total Assets: Money market fund (1) $ 27,123,587 $ — $ — $ 27,123,587 Total Assets $ 27,123,587 $ — $ — $ 27,123,587 Liabilities: Derivative liabilities related to warrants $ — $ — $ 3,006,021 $ 3,006,021 Total Liabilities $ — $ — $ 3,006,021 $ 3,006,021 (1) Included as a component of cash and cash equivalents on the accompanying consolidated balance sheet. |
Schedule of Changes in the Fair Value of the Company’s Level 3 Liabilities | The following table sets forth a summary of changes in the fair value of the Company’s Level 3 liabilities for the years ended December 31, 2015 and 2014 : Description Balance at Fair Value of Warrants Reclassified to Additional Paid-in Capital Unrealized (gains) or losses Balance at Derivative liabilities related to Warrants $ 3,006,021 $ (435,365 ) $ 726,421 $ 3,297,077 Description Balance at Unrealized (gains) or losses Balance at Derivative liabilities related to Warrants $ 4,431,871 $ (1,425,850 ) $ 3,006,021 |
Debt (Tables)
Debt (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Debt Disclosure [Abstract] | |
Schedule of Future Maturities of Long-Term Debt | Future maturities of long-term debt at December 31, 2015 are as follows: 2016 $ 30,168 2017 362,021 2018 362,021 2019 331,852 Total principal 1,086,062 Plus final fee premium accretion 2,815 Total long-term obligations $ 1,088,877 Future maturities of long-term debt at December 31, 2015 are as follows: 2016 $ 5,195,650 2017 6,064,315 2018 3,740,035 Total principal 15,000,000 Less discount (151,895 ) Plus final fee premium accretion 535,024 Total long-term obligations $ 15,383,129 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Income Tax Disclosure [Abstract] | |
Provision for Income Taxes Based on Losses from Continuing Operations | The provision for income taxes based on losses from continuing operations consists of the following at December 31 (in thousands): Years ended December 31, 2015 2014 2013 Deferred benefit Federal $ (9,602 ) $ (5,651 ) $ (3,806 ) State (1,742 ) (449 ) (593 ) Total deferred benefit (11,344 ) (6,100 ) (4,399 ) Valuation allowance 11,344 6,100 4,399 Total income tax provision $ — $ — $ — |
Schedule of Significant Components of the Company’s Taxes and the Rates | Significant components of the Company’s taxes and the rates as of December 31 are shown below (in thousands, except percentages): Years ended December 31, 2015 2014 Tax computed at the federal statutory rate $ (9,340 ) 34 % $ (4,871 ) 35 % State tax, net of federal tax benefit (1,559 ) 6 % (891 ) 6 % Permanent Items 258 (1 )% (320 ) 2 % Tax credits (997 ) 3 % — — % Valuation allowance increase 11,638 (42 )% 6,081 (43 )% Other — — % 1 — % Provision for income taxes $ — — % $ — — % |
Schedule of Significant Components of the Company’s Deferred Tax Assets | Significant components of the Company’s deferred tax assets and liabilities from federal and state income taxes as of December 31 are shown below: Years ended December 31, 2015 2014 Deferred tax assets Tax loss carryforwards $ 27,962,000 $ 19,010,900 Research and development credits and other tax credits 1,698,300 698,000 Stock-based compensation 3,225,200 2,193,900 Other 782,000 420,800 Total deferred tax assets 33,667,500 22,323,600 Valuation allowance (33,667,500 ) (22,323,600 ) Net deferred tax asset $ — $ — |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Annual Commitments Under Current Lease Agreements | Total annual commitments under non-cancelable lease agreements for each of the years ended December 31 are as follows: 2016 $ 683,871 2017 792,221 2018 811,797 2019 796,716 2020 817,989 Thereafter 842,529 Total $ 4,745,123 |
Selected Quarterly Financial 31
Selected Quarterly Financial Data (Unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Quarterly Financial Data [Abstract] | |
Summary of the Quarterly Results of Operations | The following is a summary of the quarterly results of operations of the Company for years ended December 31, 2015 and 2014 : Quarter Ended(1) March 31 June 30 September 30 December 31 (dollars in thousands, except per share data) 2015 Revenues $ 127 $ 49 $ 58 $ 79 Operating expenses $ 4,975 $ 6,682 $ 6,467 $ 7,463 Net loss and comprehensive loss attributable to common stockholders $ (7,180 ) $ (10,186 ) $ (2,742 ) $ (7,387 ) Net loss per common share - basic $ (0.33 ) $ (0.41 ) $ (0.10 ) $ (0.25 ) Net loss per common share - diluted $ (0.33 ) $ (0.41 ) $ (0.23 ) $ (0.26 ) Shares used in the calculation of net loss attributable to common stockholders - basic 21,817,710 24,592,883 28,560,211 29,723,254 Shares used in the calculation of net loss attributable to common stockholders - diluted 21,817,710 24,592,883 29,128,235 30,157,038 2014 Revenues $ 111 $ 56 $ 57 $ 56 Operating expenses $ 3,371 $ 3,297 $ 3,997 $ 4,560 Net loss and comprehensive loss attributable to common stockholders $ (3,198 ) $ (1,079 ) $ (5,382 ) $ (4,689 ) Net loss per common share - basic $ (0.17 ) $ (0.06 ) $ (0.28 ) $ (0.25 ) Net loss per common share - diluted $ (0.17 ) $ (0.17 ) $ (0.28 ) $ (0.25 ) Shares used in the calculation of net loss attributable to common stockholders - basic 18,902,783 18,902,783 18,902,783 18,904,280 Shares used in the calculation of net loss attributable to common stockholders - diluted 18,902,783 19,232,760 18,902,783 19,071,112 (1) Basic and diluted net loss per common share are computed independently for each of the periods presented. Accordingly, the sum of the quarterly net loss per common share amount may not agree to the total for the year. |
Business Overview and Liquidi32
Business Overview and Liquidity (Details) - USD ($) | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Cumulative net losses attributed to common stockholders | $ (108,887,243) | $ (81,391,909) | $ (108,887,243) | $ (81,391,909) | |||||||
Net cash used in operating activities | 22,119,025 | 12,727,385 | $ 7,317,248 | ||||||||
Net loss and comprehensive loss attributable to common stockholders | $ 7,387,000 | $ 2,742,000 | $ 10,186,000 | $ 7,180,000 | $ 4,689,000 | $ 5,382,000 | $ 1,079,000 | $ 3,198,000 | 27,495,334 | 14,348,499 | 11,840,778 |
Net cash provided by financing activities | $ 64,551,740 | $ 14,484,036 | $ 22,983,688 |
Basis of Presentation and Sum33
Basis of Presentation and Summary of Significant Accounting Policies (Details) - USD ($) | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 |
Derivative financial instruments | |||
Derivative liabilities related to warrants | $ 3,297,077 | $ 3,006,021 | |
Warrants | Black Scholes Option Pricing Method | |||
Derivative financial instruments | |||
Derivative liabilities related to warrants | $ 3,297,077 | $ 3,006,021 | $ 4,431,871 |
Basis of Presentation and Sum34
Basis of Presentation and Summary of Significant Accounting Policies (Details 2) | 12 Months Ended |
Dec. 31, 2015 | |
Laboratory equipment | Minimum | |
Property, equipment and depreciation and amortization | |
Estimated useful lives | 3 years |
Laboratory equipment | Maximum | |
Property, equipment and depreciation and amortization | |
Estimated useful lives | 5 years |
Furniture and fixtures | Minimum | |
Property, equipment and depreciation and amortization | |
Estimated useful lives | 3 years |
Furniture and fixtures | Maximum | |
Property, equipment and depreciation and amortization | |
Estimated useful lives | 5 years |
Basis of Presentation and Sum35
Basis of Presentation and Summary of Significant Accounting Policies (Details 3) - shares | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Net Loss Per Share | |||
Antidilutive securities excluded from computation of earnings per share (in shares) | 11,577,702 | 10,228,257 | 10,584,153 |
Stock options | |||
Net Loss Per Share | |||
Antidilutive securities excluded from computation of earnings per share (in shares) | 6,948,630 | 4,913,472 | 4,287,545 |
Warrants | |||
Net Loss Per Share | |||
Antidilutive securities excluded from computation of earnings per share (in shares) | 4,565,947 | 5,251,660 | 6,233,483 |
Series A Convertible Preferred Stock | |||
Net Loss Per Share | |||
Antidilutive securities excluded from computation of earnings per share (in shares) | 63,125 | 63,125 | 63,125 |
Basis of Presentation and Sum36
Basis of Presentation and Summary of Significant Accounting Policies (Details 4) - USD ($) | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Numerator: | |||||||||||
Net loss attributable to common stockholders | $ (7,387,000) | $ (2,742,000) | $ (10,186,000) | $ (7,180,000) | $ (4,689,000) | $ (5,382,000) | $ (1,079,000) | $ (3,198,000) | $ (27,495,334) | $ (14,348,499) | $ (11,840,778) |
Adjustment for change in fair value of derivative instruments - warrants | (4,396,061) | (2,422,337) | 0 | ||||||||
Net loss used for diluted loss per share | $ (31,891,395) | $ (16,770,836) | $ (11,840,778) | ||||||||
Denominator: | |||||||||||
Weighted-average shares outstanding - basic (in shares) | 29,723,254 | 28,560,211 | 24,592,883 | 21,817,710 | 18,904,280 | 18,902,783 | 18,902,783 | 18,902,783 | 26,201,713 | 18,904,280 | 16,978,212 |
Adjustments to reflect assumed exercise of warrants (in shares) | 250,452 | 166,832 | 0 | ||||||||
Weighted-average shares used to compute diluted net loss (in shares) | 30,157,038 | 29,128,235 | 24,592,883 | 21,817,710 | 19,071,112 | 18,902,783 | 19,232,760 | 18,902,783 | 26,452,165 | 19,071,112 | 16,978,212 |
Net loss per share diluted (in dollars per share) | $ (0.26) | $ (0.23) | $ (0.41) | $ (0.33) | $ (0.25) | $ (0.28) | $ (0.17) | $ (0.17) | $ (1.21) | $ (0.88) | $ (0.70) |
Property and Equipment (Details
Property and Equipment (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Property, equipment and depreciation and amortization | |||
Depreciation and amortization | $ 378,711 | $ 234,813 | $ 130,520 |
Property and equipment, gross | 3,545,361 | 1,374,257 | |
Less—accumulated depreciation and amortization | (854,782) | (533,870) | |
Property and equipment, net | 2,690,579 | 840,387 | |
Furniture and office equipment | |||
Property, equipment and depreciation and amortization | |||
Property and equipment, gross | 1,483,227 | 365,955 | |
Leasehold Improvements | |||
Property, equipment and depreciation and amortization | |||
Property and equipment, gross | 39,401 | 39,401 | |
Laboratory equipment | |||
Property, equipment and depreciation and amortization | |||
Property and equipment, gross | $ 2,022,733 | $ 968,901 |
Stockholders' Equity (Deficit38
Stockholders' Equity (Deficit) (Common Stock Narrative) (Details) - USD ($) | Jan. 25, 2013 | Jul. 31, 2013 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | Jun. 30, 2015 |
Class of Stock [Line Items] | ||||||
Common stock, shares issued | 29,737,601 | 18,915,793 | ||||
Proceeds from the sale of common stock | $ 61,215,399 | $ 0 | $ 18,829,644 | |||
Net proceeds from the sale of common stock | $ 61,215,399 | $ 18,829,644 | ||||
Shares issued upon exercise of warrants | 732,378 | 36,666 | 728,488 | |||
Warrant exercise price of $3.00 | ||||||
Class of Stock [Line Items] | ||||||
Exercise price of warrants (in dollars per share) | $ 3 | |||||
Number of warrants exercised (in shares) | 12,745 | |||||
Shares issued upon exercise of warrants | 449,403 | |||||
Common Stock | ||||||
Class of Stock [Line Items] | ||||||
Aggregate stock issued during period (in shares) | 3,424,605 | |||||
Shares of common stock issued | 9,996,531 | 2,631,332 | ||||
Net proceeds from the sale of common stock | $ 1,000 | |||||
Number of shares issued upon conversion of preferred stock into common stock | 36,458 | |||||
Issuance of common stock upon exercise of warrant (in shares) | 282,975 | 715,743 | ||||
Exercise price of warrants (in dollars per share) | $ 3 | |||||
Stock issued during period including share-based compensation | 10,821,808 | |||||
Issuance of common stock upon net exercise of warrant (in shares) | 277,136 | 13,011 | 7,284 | |||
Number of stock issued from stock option exercise | 33,788 | |||||
Issuance of common stock upon net exercise of stock option (in shares) | 22,955 | |||||
Issuance of common stock upon exercise of stock options (in shares) | 265,166 | 10,833 | ||||
Common Stock | Option exercise price of $4.50 | ||||||
Class of Stock [Line Items] | ||||||
Issuance of common stock upon exercise of stock options (in shares) | 265,166 | 41,667 | ||||
Weighted average price of shares (in dollars per share) | $ 3.25 | $ 4.50 | ||||
Common Stock | Option exercise price, weighted average of $3.53 | ||||||
Class of Stock [Line Items] | ||||||
Issuance of common stock upon exercise of stock options (in shares) | 10,833 | |||||
Weighted average price of shares (in dollars per share) | $ 3.53 | |||||
Common Stock | Warrant exercise price, weighted average of $5.02 | ||||||
Class of Stock [Line Items] | ||||||
Exercise price of warrants (in dollars per share) | $ 4.91 | $ 5.02 | ||||
Shares issued upon exercise of warrants | 282,975 | |||||
Common Stock | Warrant exercise price of $3.00 | ||||||
Class of Stock [Line Items] | ||||||
Exercise price of warrants (in dollars per share) | $ 3.05 | |||||
Issuance of common stock upon net exercise of warrant (in shares) | 277,136 | |||||
Public Offering and Controlled Equity Offering | ||||||
Class of Stock [Line Items] | ||||||
Proceeds from the sale of common stock | $ 15,000,000 | |||||
Common stock, shares issued | 2,142,857 | |||||
Agent | Public Offering and Controlled Equity Offering | ||||||
Class of Stock [Line Items] | ||||||
Commission as percentage of gross proceeds | 3.00% | |||||
Proceeds from the sale of common stock | $ 4,200,000 | |||||
Common stock, shares issued | 488,476 | |||||
Secured Debt | Loan and Security Agreement | ||||||
Class of Stock [Line Items] | ||||||
Exercise price of warrants (in dollars per share) | $ 3.51 | |||||
Maximum | Public Offering and Controlled Equity Offering | ||||||
Class of Stock [Line Items] | ||||||
Aggregate initial offering price | $ 150,000,000 | |||||
Maximum | Agent | Public Offering and Controlled Equity Offering | ||||||
Class of Stock [Line Items] | ||||||
Aggregate initial offering price | $ 30,000,000 | |||||
Underwritten Public Offering 2015 | Public Offering and Controlled Equity Offering | Common Stock | ||||||
Class of Stock [Line Items] | ||||||
Shares of common stock issued | 9,711,110 | |||||
Proceeds from the sale of common stock | $ 63,200,000 | |||||
Price per share (in dollars per share) | $ 9.66 | |||||
Underwritten Public Offering 2015 | Agent | Public Offering and Controlled Equity Offering | Common Stock | ||||||
Class of Stock [Line Items] | ||||||
Shares of common stock issued | 285,421 | |||||
Proceeds from the sale of common stock | $ 2,800,000 |
Stockholders' Equity (Deficit39
Stockholders' Equity (Deficit) (Schedule of Warrants) (Details 2) - $ / shares | 12 Months Ended | |||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Number of Warrants | ||||
Balance of warrants outstanding at the beginning of the period (in shares) | 6,265,620 | 6,233,483 | 6,985,070 | |
Granted (in shares) | 85,470 | 50,000 | ||
Exercised (in shares) | (732,378) | (36,666) | (728,488) | |
Expired (in shares) | (16,667) | (73,099) | ||
Balance of warrants outstanding at the end of the period (in shares) | 5,533,242 | 6,265,620 | 6,233,483 | 6,985,070 |
Weighted-Average Exercise Price Per Share | ||||
Weighted average exercise price of warrants at the beginning of the period (in dollars per share) | $ 3.85 | $ 3.87 | $ 3.96 | |
Granted (in dollars per share) | 3.51 | 8 | ||
Exercised (in dollars per share) | 3.77 | 3 | 4.99 | |
Expired (in dollars per share) | 10.80 | 4.50 | ||
Weighted average exercise price of warrants at the end of the period (in dollars per share) | $ 3.86 | $ 3.85 | $ 3.87 | $ 3.96 |
Weighted-Average Remaining Contractual Term | ||||
Weighted-Average Remaining Contractual Term | 2 years 6 months 11 days | 3 years 6 months 26 days | 4 years 5 months 23 days | 5 years 4 months 28 days |
Stockholders' Equity (Deficit40
Stockholders' Equity (Deficit) (Warrants Narrative) (Details 3) - USD ($) | 1 Months Ended | 12 Months Ended | ||||
Jun. 30, 2014 | Jul. 31, 2013 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2015 | Jun. 30, 2015 | |
Class of Stock [Line Items] | ||||||
Dividend yield related to stock-based compensation (as a percent) | 0.00% | |||||
Fair value of warrants issued for services (in dollars) | $ 198,791 | |||||
Warrants granted (in shares) | 85,470 | 50,000 | ||||
Warrants granted (in dollars per share) | $ 3.51 | $ 8 | ||||
Value of warrants recorded as debt discount and additional paid in capital | $ 235,857 | $ 0 | $ 0 | |||
Service Agreement [Member] | ||||||
Class of Stock [Line Items] | ||||||
Number of shares that can be purchased from exercise of warrants | 50,000 | |||||
Exercise price of warrants (in dollars per share) | $ 8 | |||||
Term of warrants | 3 years | |||||
Risk-free interest rate related to stock-based compensation (as a percent) | 0.42% | |||||
Expected volatility related to stock-based compensation (as a percent) | 97.00% | |||||
Expected term related to stock-based compensation | 3 years | |||||
Fair value of warrants issued for services (in dollars) | $ 198,791 | |||||
Public Offering and Controlled Equity Offering | ||||||
Class of Stock [Line Items] | ||||||
Proceeds from the sale of common stock | $ 15,000,000 | |||||
Secured Debt | ||||||
Class of Stock [Line Items] | ||||||
Number of shares that can be purchased from exercise of warrants | 42,735 | |||||
Line of Credit | Secured Debt | ||||||
Class of Stock [Line Items] | ||||||
Number of shares that can be purchased from exercise of warrants | 85,470 | |||||
Exercise price of warrants (in dollars per share) | $ 3.51 | |||||
Value of warrants recorded as debt discount and additional paid in capital | $ 235,857 | |||||
Line of Credit | Secured Debt | Black Scholes Option Pricing Method | ||||||
Class of Stock [Line Items] | ||||||
Risk-free interest rate (as a percent) | 2.53% | |||||
Dividend yield (as a percent) | 0.00% | |||||
Expected volatility (as a percent) | 73.80% | |||||
Expected warrant term | 10 years |
Stockholders' Equity (Deficit41
Stockholders' Equity (Deficit) (Preferred Stock) (Details 4) - USD ($) | Mar. 17, 2007 | Jul. 13, 2006 | Mar. 17, 2006 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 |
Accrued dividend during the period | $ 24,240 | $ 23,015 | $ 29,840 | |||
Stated value per share (in dollars per share) | $ 0.001 | $ 0.001 | ||||
Number of shares outstanding | 60,600 | 60,600 | ||||
Deficit Accumulated | ||||||
Accrued dividend during the period | $ 24,240 | $ 23,015 | 29,840 | |||
Series A Convertible Preferred Stock | ||||||
Cumulative dividend rate (as a percent) | 4.00% | |||||
Accrued cumulative unpaid preferred stock dividends | $ 268,295 | $ 244,055 | $ 221,040 | |||
Stated value per share (in dollars per share) | $ 10 | |||||
Conversion price per share (in dollars per share) | $ 9.60 | $ 2.15 | ||||
Period during which the conversion price is subject to adjustment for dilutive issuances | 12 months | |||||
Share price for 20 consecutive trading days for automatic conversion | $ 25.80 | |||||
Number of consecutive trading days in which the closing price of the entity's common stock must equal or exceed a specified price in order for the preferred stock to be automatically converted | 20 days | |||||
Number of common stock shares traded per day during the 20 trading days for the preferred stock to be automatically converted | 8,333 | |||||
Number of trading days in which the specified volume of common stock must be traded for the preferred stock to be automatically converted | 20 days | |||||
Number of shares converted | 35,000 | |||||
Number of shares issued upon conversion of preferred stock into common stock | 36,458 | |||||
Number of shares outstanding | 60,600 | 60,600 | 60,600 |
Stock Option Plan (Details)
Stock Option Plan (Details) - USD ($) | Jun. 10, 2015 | Jul. 31, 2013 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | Sep. 17, 2014 | Jul. 18, 2013 | Jul. 17, 2013 |
Stock Options | ||||||||
Intrinsic value of options exercised | $ 1,382,255 | $ 0 | $ 275,492 | |||||
Fair value of shares vested | $ 2,634,688 | $ 1,960,256 | $ 1,633,071 | |||||
2014 EIP | ||||||||
Stock Options | ||||||||
Number of authorized shares under the plan | 2,500,000 | |||||||
Number of remaining shares available for issuance | 1,361,832 | |||||||
Equity Incentive Plan 2014 | ||||||||
Stock Options | ||||||||
Number of additional shares authorized (in shares) | 2,500,000 | |||||||
Stock options | ||||||||
Stock Options | ||||||||
Number of shares of common stock granted | 2,688,500 | 1,410,038 | 1,144,760 | |||||
Stock options | 2004 Plan | ||||||||
Stock Options | ||||||||
Number of authorized shares under the plan | 6,000,000 | 3,666,667 | ||||||
Expiration term of options | 10 years | |||||||
Number of remaining shares available for issuance | 1,788,921 | |||||||
Number of options issued over the authorized number of options in the Plan (in shares) | 260,000 | |||||||
Option overage liability | $ 23,024 | |||||||
Stock options | Minimum | 2004 Plan | ||||||||
Stock Options | ||||||||
Vesting period of options | 3 years | |||||||
Stock options | Maximum | 2004 Plan | ||||||||
Stock Options | ||||||||
Vesting period of options | 4 years | |||||||
Board of Directors | Stock options | 2004 Plan | ||||||||
Stock Options | ||||||||
Number of shares of common stock granted | 90,000 | |||||||
Fair value of option granted | $ 500,000 |
Stock Option Plan (Details 2)
Stock Option Plan (Details 2) - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Stock-based compensation expense | |||
Total stock based compensation expense | $ 3,946,027 | $ 2,070,194 | $ 1,979,364 |
Cost of Sales [Member] | |||
Stock-based compensation expense | |||
Total stock based compensation expense | 39,676 | 0 | 0 |
Research and Development Expense [Member] | |||
Stock-based compensation expense | |||
Total stock based compensation expense | 1,499,009 | 796,008 | 549,465 |
Selling and Marketing Expense [Member] | |||
Stock-based compensation expense | |||
Total stock based compensation expense | 768,146 | 145,239 | 70,626 |
General and Administrative Expense [Member] | |||
Stock-based compensation expense | |||
Total stock based compensation expense | $ 1,639,196 | $ 1,128,947 | $ 1,359,273 |
Stock Option Plan (Details 3)
Stock Option Plan (Details 3) - USD ($) | 12 Months Ended | |||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Intrinsic Value | ||||
Intrinsic value of options exercised | $ 1,382,255 | $ 0 | $ 275,492 | |
Tax benefits recognized | $ 0 | |||
Stock options | ||||
Stock Options | ||||
Weighted average grant date fair value (in dollars per share) | $ 4.60 | $ 3.16 | $ 4.54 | |
Unrecognized compensation cost | ||||
Unrecognized compensation cost | $ 10,430,604 | $ 4,862,030 | ||
Weighted-average remaining vesting period for recognition | 3 years 1 month 6 days | 3 years | ||
Weighted-average assumptions | ||||
Dividend yield | 0.00% | 0.00% | 0.00% | |
Expected volatility (weighted-average) | 75.00% | 85.00% | 91.00% | |
Expected term (in years) | 6 years 16 days | 5 years 9 months 18 days | 5 years | |
Number of Options | ||||
Balance outstanding | 4,913,472 | 4,287,545 | 3,711,303 | |
Granted (in shares) | 2,688,500 | 1,410,038 | 1,144,760 | |
Exercised (in shares) | (265,166) | (52,500) | ||
Forfeited (in shares) | (388,176) | (784,111) | (516,018) | |
Balance outstanding | 6,948,630 | 4,913,472 | 4,287,545 | 3,711,303 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Number | 2,825,398 | |||
Weighted-Average Exercise Price Per Share | ||||
Balance outstanding at the beginning of the period (in dollars per share) | $ 4.66 | $ 5.18 | $ 4.69 | |
Granted (in dollars per share) | 7.02 | 4.42 | 6.33 | |
Exercised (in dollars per share) | 3.25 | 4.30 | ||
Forfeited (in dollars per share) | 7.75 | 7.08 | 4.35 | |
Balance outstanding at the end of the period (in dollars per share) | 5.45 | $ 4.66 | $ 5.18 | $ 4.69 |
Vested and exercisable at the end of the period (in dollars per share) | $ 4.38 | |||
Intrinsic Value | ||||
Intrinsic value of options outstanding | $ 5,903,466 | $ 2,808,083 | $ 5,896,329 | $ 8,301,484 |
Vested and Exercisable at the end of the period, Intrinsic Value | $ 4,194,205 | |||
Weighted Average Remaining Contractual Life | 7 years 9 months 11 days | 7 years 7 months 6 days | 6 years 8 months 12 days | 6 years 3 months 18 days |
Weighted average life vested and exercisable | 6 years 17 days | |||
Stock options | Minimum | ||||
Weighted-average assumptions | ||||
Risk-free interest rate | 1.35% | 1.42% | 0.74% | |
Expected volatility (range) | 73.00% | 81.00% | 82.00% | |
Stock options | Maximum | ||||
Weighted-average assumptions | ||||
Risk-free interest rate | 2.15% | 2.10% | 1.50% | |
Expected volatility (range) | 77.00% | 86.00% | 100.00% |
Derivative Financial Instrume45
Derivative Financial Instruments - Warrants (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Changes in the Company's derivative financial instruments liability balance | |||
Balance of warrants outstanding at the beginning of the period (in shares) | 6,265,620 | 6,233,483 | 6,985,070 |
Exercised (in shares) | (732,378) | (36,666) | (728,488) |
Balance of warrants outstanding at the end of the period (in shares) | 5,533,242 | 6,265,620 | 6,233,483 |
Balance of derivative financial instruments liability at the beginning of the period | $ 3,006,021 | ||
Change in fair value of warrants during the period recognized as a gain in the condensed consolidated statement of operations | 726,421 | $ (1,425,850) | $ 1,084,114 |
Decrease in derivative liability due to exercise of warrants | (435,365) | ||
Balance of derivative financial instruments liability at the end of the period | $ 3,297,077 | $ 3,006,021 | |
Warrants | |||
Changes in the Company's derivative financial instruments liability balance | |||
Weighted average remaining contractual life | 2 years 6 months 11 days | 3 years 7 months 6 days | |
Warrants | Black Scholes Option Pricing Method | |||
Range of assumptions used to determine the fair value of warrants | |||
Dividend yield (as a percent) | 0.00% | 0.00% | 0.00% |
Changes in the Company's derivative financial instruments liability balance | |||
Balance of warrants outstanding at the beginning of the period (in shares) | 1,013,961 | 1,013,961 | |
Exercised (in shares) | (46,666) | ||
Balance of warrants outstanding at the end of the period (in shares) | 967,295 | 1,013,961 | 1,013,961 |
Balance of derivative financial instruments liability at the beginning of the period | $ 3,006,021 | $ 4,431,871 | |
Change in fair value of warrants during the period recognized as a gain in the condensed consolidated statement of operations | 726,421 | (1,425,850) | |
Balance of derivative financial instruments liability at the end of the period | $ 3,297,077 | $ 3,006,021 | $ 4,431,871 |
Warrants | Black Scholes Option Pricing Method | Minimum | |||
Range of assumptions used to determine the fair value of warrants | |||
Estimated fair value of Trovagene common stock (in dollars per share) | $ 5.40 | $ 3 | $ 5.74 |
Expected warrant term | 3 years | 4 years | 1 month 6 days |
Risk-free interest rate (as a percent) | 0.89% | 1.38% | 0.03% |
Expected volatility (as a percent) | 73.00% | 86.40% | 82.00% |
Warrants | Black Scholes Option Pricing Method | Maximum | |||
Range of assumptions used to determine the fair value of warrants | |||
Estimated fair value of Trovagene common stock (in dollars per share) | $ 10.15 | $ 6.74 | $ 7.18 |
Expected warrant term | 3 years 9 months | 4 years | 5 years 9 months 18 days |
Risk-free interest rate (as a percent) | 1.31% | 1.38% | 1.75% |
Expected volatility (as a percent) | 77.00% | 86.40% | 100.00% |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) | Dec. 31, 2015 | Dec. 31, 2014 |
Liabilities: | ||
Derivative liabilities related to warrants | $ 3,297,077 | $ 3,006,021 |
Recurring basis | Estimate of Fair Value Measurement | ||
Assets: | ||
Money market fund | 65,016,222 | 27,123,587 |
Total Assets | 65,016,222 | 27,123,587 |
Liabilities: | ||
Derivative liabilities related to warrants | 3,297,077 | 3,006,021 |
Total Liabilities | 3,297,077 | 3,006,021 |
Recurring basis | Quoted Prices in Active Markets for Identical Assets and Liabilities (Level 1) | ||
Assets: | ||
Money market fund | 65,016,222 | 27,123,587 |
Total Assets | 65,016,222 | 27,123,587 |
Recurring basis | Significant Unobservable Inputs (Level 3) | ||
Liabilities: | ||
Derivative liabilities related to warrants | 3,297,077 | 3,006,021 |
Total Liabilities | $ 3,297,077 | $ 3,006,021 |
Fair Value Measurements (Deta47
Fair Value Measurements (Details 2) - Warrants - USD ($) | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Reconciliation of the beginning and ending balances | ||
Balance at the beginning of the period | $ 3,006,021 | $ 4,431,871 |
Fair Value of Warrants Reclassified to Additional Paid-in Capital | (435,365) | |
Unrealized (gains) or losses | 726,421 | (1,425,850) |
Balance at the end of the period | $ 3,297,077 | $ 3,006,021 |
Debt - Equipment Line of Credit
Debt - Equipment Line of Credit (Details) - USD ($) | 1 Months Ended | 12 Months Ended |
Nov. 30, 2015 | Dec. 31, 2015 | |
Line of Credit Facility [Line Items] | ||
Long-term line of credit | $ 1,086,062 | |
Amounts due under current line of credit | 30,168 | |
Long-term liabilities | 1,058,709 | |
Line of Credit | ||
Line of Credit Facility [Line Items] | ||
Maximum borrowing capacity for line of credit | $ 2,000,000 | |
Line of credit facility period for principal and interest payments after date of advance | 36 months | |
Repayment of total amounts borrowed as a percent | 7.00% | |
Accrued interest | 2,815 | |
Interest expenses recorded | 5,702 | |
Long-term Debt, Fiscal Year Maturity [Abstract] | ||
2,016 | 30,168 | |
2,017 | 362,021 | |
2,018 | 362,021 | |
2,019 | 331,852 | |
Total principal | 1,086,062 | |
Plus final fee premium accretion | 2,815 | |
Total long-term obligations | $ 1,088,877 | |
Prime Rate | Line of Credit | ||
Line of Credit Facility [Line Items] | ||
Interest rate above reference rate | 1.25% |
Debt - Loan and Security Agreem
Debt - Loan and Security Agreement (Details 2) | 1 Months Ended | 12 Months Ended | |||
Jun. 30, 2015USD ($)intangible_asset$ / sharesshares | Jun. 30, 2014USD ($) | Dec. 31, 2015USD ($)shares | Dec. 31, 2014USD ($) | Dec. 31, 2013USD ($) | |
Debt | |||||
Threshold of unrestricted net cash proceeds required to extend interest only payment date | $ 30,000,000 | ||||
Threshold level of unrestricted net cash proceeds required to extend interest only payment date after amendment | $ 21,000,000 | ||||
Term of extension for interest only payment | 6 months | ||||
Value of warrants recorded as debt discount and additional paid in capital | $ 0 | $ 235,857 | $ 0 | ||
Current portion of long-term debt | 5,225,818 | 1,898,548 | |||
Amount borrow, long-term liabilities | $ 11,246,188 | $ 13,053,117 | |||
Secured Debt | |||||
Debt | |||||
Number of common shares that can be purchased upon exercise of warrant | shares | 42,735 | ||||
Loan and Security Agreement | |||||
Debt | |||||
Accrued interest | $ 2,815 | ||||
Future maturities of long-term debt | |||||
2,016 | 30,168 | ||||
2,017 | 362,021 | ||||
2,018 | 362,021 | ||||
Total principal | 1,086,062 | ||||
Plus final fee premium accretion | 2,815 | ||||
Total long-term obligations | 1,088,877 | ||||
Interest expenses recorded | 5,702 | ||||
Loan and Security Agreement | Secured Debt | |||||
Debt | |||||
Face value of term loan | $ 15,000,000 | ||||
Number of banks with which agreement is entered | intangible_asset | 2 | ||||
Interest rate (as a percent) | 7.07% | ||||
Number of common shares that can be purchased upon exercise of warrant | shares | 85,470 | ||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 3.51 | ||||
Exercisable term | 10 years | ||||
Value of warrants recorded as debt discount and additional paid in capital | $ 235,857 | ||||
Amortized portion of final fee upon repayment | 1,050,000 | ||||
Current portion of long-term debt | 5,195,650 | ||||
Amount borrow, long-term liabilities | 10,187,479 | ||||
Accrued interest | 535,024 | ||||
Future maturities of long-term debt | |||||
2,016 | 5,195,650 | ||||
2,017 | 6,064,315 | ||||
2,018 | 3,740,035 | ||||
Total principal | 15,000,000 | ||||
Less discount | (151,895) | ||||
Plus final fee premium accretion | 535,024 | ||||
Total long-term obligations | 15,383,129 | ||||
Interest expenses recorded | $ 1,590,750 | ||||
Loan and Security Agreement | Secured Debt | Minimum | |||||
Debt | |||||
Pre-payment fees (as a percent) | 1.00% | ||||
Loan and Security Agreement | Secured Debt | Maximum | |||||
Debt | |||||
Pre-payment fees (as a percent) | 3.00% |
Income Taxes (Details)
Income Taxes (Details) | 12 Months Ended |
Dec. 31, 2015USD ($) | |
Operating loss carryforwards (NOLs) | |
Interest and/or penalties incurred | $ 0 |
Federal | |
Operating loss carryforwards (NOLs) | |
NOLs | 72,600,000 |
California | |
Operating loss carryforwards (NOLs) | |
NOLs | 52,600,000 |
New Jersey | |
Operating loss carryforwards (NOLs) | |
NOLs | 6,900,000 |
R&D credits | Federal | |
Operating loss carryforwards (NOLs) | |
Tax credits | 1,200,000 |
R&D credits | California Franchise Tax Board [Member] | |
Operating loss carryforwards (NOLs) | |
Tax credits | $ 500,000 |
Income Taxes (Details 1)
Income Taxes (Details 1) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Deferred benefit | |||
Federal | $ (9,602) | $ (5,651) | $ (3,806) |
State | (1,742) | (449) | (593) |
Total deferred benefit | (11,344) | (6,100) | (4,399) |
Valuation allowance | 11,344 | 6,100 | 4,399 |
Total income tax provision | $ 0 | $ 0 | $ 0 |
Income Taxes (Details 2)
Income Taxes (Details 2) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Effective Income Tax Rate Reconciliation, Amount [Abstract] | |||
Tax computed at the federal statutory rate | $ (9,340) | $ (4,871) | |
State tax, net of federal tax benefit | (1,559) | (891) | |
Permanent Items | 258 | (320) | |
Tax credits | (997) | 0 | |
Valuation allowance increase | 11,638 | 6,081 | |
Other | 0 | 1 | |
Provision for income taxes | $ 0 | $ 0 | $ 0 |
Effective Income Tax Rate Reconciliation, Percent [Abstract] | |||
Tax computed at the federal statutory rate (as a percent) | 34.00% | 35.00% | |
State tax, net of federal tax benefit (as a percent) | 6.00% | 6.00% | |
Permanent Items (as a percent) | (1.00%) | 2.00% | |
Tax credits (as a percent) | 3.00% | (0.00%) | |
Valuation allowance increase (decrease) (as a percent) | (42.00%) | (43.00%) | |
Other (as a percent) | 0.00% | 0.00% | |
Provision for income taxes (as a percent) | 0.00% | 0.00% |
Income Taxes (Details 3)
Income Taxes (Details 3) - USD ($) | Dec. 31, 2015 | Dec. 31, 2014 |
Deferred tax assets | ||
Tax loss carryforwards | $ 27,962,000 | $ 19,010,900 |
Research and development credits and other tax credits | 1,698,300 | 698,000 |
Stock-based compensation | 3,225,200 | 2,193,900 |
Other | 782,000 | 420,800 |
Total deferred tax assets | 33,667,500 | 22,323,600 |
Valuation allowance | (33,667,500) | (22,323,600) |
Net deferred tax asset | $ 0 | $ 0 |
Commitments and Contingencies54
Commitments and Contingencies (Details) | Jun. 11, 2015USD ($)ft² | Nov. 30, 2015USD ($)ft² | Dec. 31, 2015USD ($)$ / shares | Dec. 31, 2014USD ($) | Dec. 31, 2013USD ($) |
Other Commitments [Line Items] | |||||
Square footage of leased space | ft² | 22,600 | 2,300 | |||
Monthly lease rent | $ 60,000 | $ 3,100 | |||
Rent expense | $ 471,000 | $ 315,000 | $ 294,000 | ||
Lease period | 3 years | ||||
Research and Development Expense [Member] | |||||
Other Commitments [Line Items] | |||||
Expense related to services provided by collaborators | $ 1,362,000 | $ 712,000 | $ 217,000 | ||
Deferred Bonus | Management [Member] | |||||
Other Commitments [Line Items] | |||||
Minimum measurement period of stock price | 90 months | ||||
Minimum share price for bonus (in dollars per share) | $ / shares | $ 7.50 | ||||
Contingent bonus awarded | $ 3,500,000 | ||||
Bonus amount as a percentage of enterprise value | 4.00% |
Commitments and Contingencies55
Commitments and Contingencies (Details 2) | Dec. 31, 2015USD ($) |
Total annual commitments under current lease agreements | |
2,016 | $ 683,871 |
2,017 | 792,221 |
2,018 | 811,797 |
2,019 | 796,716 |
2,020 | 817,989 |
Thereafter | 842,529 |
Total | $ 4,745,123 |
Employee Benefit Plan (Details)
Employee Benefit Plan (Details) | 12 Months Ended |
Dec. 31, 2015 | |
Defined Contribution Plan | |
Threshold age to be eligible to make catch-up contributions to the plan per IRS code | 50 years |
Related Party Transactions (Det
Related Party Transactions (Details) | 12 Months Ended |
Dec. 31, 2015USD ($) | |
Board of Directors Chairman [Member] | |
Related Party Transaction [Line Items] | |
Length of contract | 1 year |
Per month commitment amount | $ 9,500 |
Scientific Advisory Board Member [Member] | |
Related Party Transaction [Line Items] | |
Research and development expense | 188,000 |
Maximum commitment for related party services | 529,000 |
Royalty expense | 0 |
541690 Other Scientific and Technical Consulting Services [Member] | Board of Directors Chairman [Member] | |
Related Party Transaction [Line Items] | |
Research and development expense | $ 114,000 |
Selected Quarterly Financial 58
Selected Quarterly Financial Data (Unaudited) (Details) - USD ($) | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Quarterly Financial Data [Abstract] | |||||||||||
Revenues | $ 79,000 | $ 58,000 | $ 49,000 | $ 127,000 | $ 56,000 | $ 57,000 | $ 56,000 | $ 111,000 | $ 312,812 | $ 280,178 | $ 259,246 |
Operating expenses | 7,463,000 | 6,467,000 | 6,682,000 | 4,975,000 | 4,560,000 | 3,997,000 | 3,297,000 | 3,371,000 | 25,586,464 | 15,225,337 | 10,949,787 |
Net loss and comprehensive loss attributable to common stockholders | $ (7,387,000) | $ (2,742,000) | $ (10,186,000) | $ (7,180,000) | $ (4,689,000) | $ (5,382,000) | $ (1,079,000) | $ (3,198,000) | $ (27,495,334) | $ (14,348,499) | $ (11,840,778) |
Net loss per common share - basic (in dollars per share) | $ (0.25) | $ (0.10) | $ (0.41) | $ (0.33) | $ (0.25) | $ (0.28) | $ (0.06) | $ (0.17) | $ (1.05) | $ (0.76) | $ (0.70) |
Net loss per common share - diluted (in dollars per share) | $ (0.26) | $ (0.23) | $ (0.41) | $ (0.33) | $ (0.25) | $ (0.28) | $ (0.17) | $ (0.17) | $ (1.21) | $ (0.88) | $ (0.70) |
Shares used in the calculation of net loss attributable to common stockholders - basic | 29,723,254 | 28,560,211 | 24,592,883 | 21,817,710 | 18,904,280 | 18,902,783 | 18,902,783 | 18,902,783 | 26,201,713 | 18,904,280 | 16,978,212 |
Shares used in the calculation of net loss attributable to common stockholders - diluted | 30,157,038 | 29,128,235 | 24,592,883 | 21,817,710 | 19,071,112 | 18,902,783 | 19,232,760 | 18,902,783 | 26,452,165 | 19,071,112 | 16,978,212 |
Subsequent Events (Details)
Subsequent Events (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |||||
Feb. 29, 2016 | Jan. 31, 2016 | Nov. 30, 2015 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | Jun. 30, 2015 | |
Stock options | |||||||
Subsequent Event [Line Items] | |||||||
Number of options granted (in shares) | 2,688,500 | 1,410,038 | 1,144,760 | ||||
Chief Executive Officer | Subsequent Event | |||||||
Subsequent Event [Line Items] | |||||||
Base compensation | $ 488,800 | ||||||
Percentage of base compensation | 50.00% | ||||||
Severance payment period | 24 months | ||||||
Period following termination that options become vested and exercisable | 6 months | ||||||
Chief Executive Officer | Stock options | Subsequent Event | |||||||
Subsequent Event [Line Items] | |||||||
Vesting period of options | 4 years | ||||||
Chief Financial Officer | Subsequent Event | |||||||
Subsequent Event [Line Items] | |||||||
Base compensation | $ 357,500 | ||||||
Percentage of base compensation | 50.00% | ||||||
Number of options granted (in shares) | 150,000 | ||||||
Exercise price (in dollars per share) | $ 5.18 | ||||||
Severance payment period | 12 months | ||||||
Period following termination that options become vested and exercisable | 6 months | ||||||
Term of agreement | 1 year | ||||||
Chief Financial Officer | Stock options | Subsequent Event | |||||||
Subsequent Event [Line Items] | |||||||
Vesting period of options | 4 years | ||||||
Line of Credit | Secured Debt | |||||||
Subsequent Event [Line Items] | |||||||
Interest rate floor (as a percent) | 7.07% | ||||||
Line of Credit | Secured Debt | Subsequent Event | |||||||
Subsequent Event [Line Items] | |||||||
Final payment as a percentage of amount borrowed | 7.50% | ||||||
Interest only payment period | 12 months | ||||||
Interest and principal payment period | 30 months | ||||||
Percentage of funded amount divided by average closing price from warrant to purchase common stock | 1.00% | ||||||
Minimum | Line of Credit | Secured Debt | Subsequent Event | |||||||
Subsequent Event [Line Items] | |||||||
Interest rate floor (as a percent) | 7.25% | ||||||
Prime Rate | Line of Credit | |||||||
Subsequent Event [Line Items] | |||||||
Interest rate above reference rate | 1.25% | ||||||
Prime Rate | Line of Credit | Secured Debt | Subsequent Event | |||||||
Subsequent Event [Line Items] | |||||||
Interest rate above reference rate | 3.75% | ||||||
Vesting Over Four Years | Chief Executive Officer | Subsequent Event | |||||||
Subsequent Event [Line Items] | |||||||
Number of options granted (in shares) | 450,000 | ||||||
Exercise price (in dollars per share) | $ 5.18 | ||||||
Vest Upon Grant | Chief Executive Officer | Subsequent Event | |||||||
Subsequent Event [Line Items] | |||||||
Number of options granted (in shares) | 350,000 | ||||||
Exercise price (in dollars per share) | $ 5.18 |