Organization (Policies) | 12 Months Ended |
Dec. 31, 2016 |
Accounting Policies [Abstract] | |
Organization and Nature of Operations | Organization and Nature of Operations Ignyta, Inc. (“Ignyta” or the “Company”) is incorporated in the state of Delaware and was founded in 2011 (with the name “NexDx, Inc.”). The Company changed its name to “Ignyta, Inc.” on October 8, 2012. Ignyta is a biotechnology company focused on precision medicine in oncology. Its goal is not just to shrink tumors, but to eradicate residual disease – the source of cancer relapse and recurrence – in precisely defined patient populations. The Company is pursuing an integrated therapeutic (“Rx”) and companion diagnostic (“Dx”) strategy for treating patients with cancer. Its Rx efforts are focused on in-licensing On October 31, 2013, the Company merged with and into IGAS Acquisition Corp., a wholly owned subsidiary of Ignyta, Inc., a Nevada corporation previously named “Infinity Oil & Gas Company” (“Parent”), formerly a “shell company” under applicable rules of the Securities and Exchange Commission (the “SEC”). The Company changed its name to Ignyta Operating, Inc. in connection with this merger, and it survived the merger as a wholly owned subsidiary of Parent. In the merger, Parent acquired the business of the Company and continued the business operations of the Company. The merger was accounted for as a reverse merger and recapitalization, with the Company as the acquirer and Parent as the acquired company for financial reporting purposes. As a result, the assets and liabilities and the operations that are reflected in the historical financial statements prior to the merger are those of the Company and are recorded at the historical cost basis of the Company, and the financial statements after completion of the merger will include the assets and liabilities of Parent and the Company, the historical operations of the Company and the operations of the combined enterprise of Parent and the Company from and after the closing date of the merger. On June 12, 2014, Parent merged with and into the Company, with the Company surviving the merger and changing its name to “Ignyta, Inc.” (the “Reincorporation Merger”). This Reincorporation Merger had no material impact on the accounting of the Company. Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business as one operating segment. |
Liquidity | Liquidity The Company had negative cash flow from operations of approximately $90.1 million during 2016 and, as of December 31, 2016, had an accumulated deficit of approximately $251.7 million. The Company is focused primarily on its development programs, and management believes such activities will result in the continued incurrence of significant research and development and other expenses related to those programs. The Company expects that it will need additional capital to further fund development of, and seek regulatory approvals for, its product candidates, and begin to commercialize any approved products. If the clinical trials for any of the Company’s products fail or produce unsuccessful results and those product candidates do not gain regulatory approval, or if any of its product candidates, if approved, fails to achieve market acceptance, the Company may never become profitable. Even if the Company achieves profitability in the future, it may not be able to sustain profitability in subsequent periods. The Company intends to cover its future operating expenses through cash on hand and through additional financing from existing and prospective investors. The Company cannot be sure that additional financing will be available when needed or that, if available, financing will be obtained on terms favorable to the Company or to its stockholders. As of December 31, 2016, the Company had cash, cash equivalents and investment securities totaling $133.0 million. While the Company expects that its existing cash, cash equivalents and investment securities will enable it to fund its operations and capital expenditure requirements for at least the next twelve months, having insufficient funds may require the Company to delay, reduce, limit or terminate some or all of its development programs or future commercialization efforts or grant rights to develop and market product candidates that it would otherwise prefer to develop and market on its own. Failure to obtain adequate financing could eventually adversely affect the Company’s ability to operate as a going concern. If the Company raises additional funds from the issuance of equity securities, substantial dilution to its existing stockholders would likely result. If the Company raises additional funds by incurring debt financing, the terms of the debt may involve significant cash payment obligations as well as covenants and specific financial ratios that may restrict its ability to operate its business. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with United States generally accepted accounting principles (“GAAP”), requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities and expenses, and related disclosures. Significant estimates used in preparing the financial statements include those assumed in estimating expenses for the Company’s pre-clinical |
Reclassifications | Reclassifications Certain reclassifications have been made to prior year amounts to conform to the current year presentation. These changes had no impact on the Company’s total assets or reported net loss. |
Cash, Cash Equivalents and Investment Securities | Cash, Cash Equivalents and Investment Securities The Company considers all highly liquid investments with an original maturity of 90 days or less when purchased to be cash equivalents. Cash and cash equivalents represent bank demand deposits and amounts invested in money market funds. Investment securities are considered to be available-for-sale |
Fair Value of Financial Instruments | Fair Value of Financial Instruments Financial assets and liabilities are measured at fair value, which is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The valuation of assets and liabilities is subject to fair value measurements using a three tiered approach, and fair value measurement is classified and disclosed in one of the following categories: Level 1: Quoted prices in active markets for identical assets or liabilities; Level 2: Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities; or Level 3: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. Cash, cash equivalents, investment securities are carried at fair value (see Note 3). Other current assets, accounts payable and accrued expenses, and other liabilities are carried at costs which represents a reasonable estimate of fair value due to the short-term nature of these items. The carrying value of the term debt approximates its fair value as the interest rate and other terms are that which is currently available to the Company. Fair value estimates of these instruments at a specific point in time are made based on relevant market information. These estimates can be subjective, involve uncertainties and matters of judgment, and therefore cannot be determined with precision. |
Credit Risk | Credit Risk Financial instruments that may subject the Company to credit risk consist of cash, cash equivalents, investment securities and term loan obligations. The Company maintains demand deposits with financial institutions in amounts that typically exceed the amount of federal insurance provided on such deposits. Investment securities are invested in accordance with the Company’s investment policy which specifies the categories, allocations, and ratings of securities that may be considered for investment. Management does not believe that the Company’s cash equivalents and investment securities have a significant risk of default or illiquidity. The primary exposure to market risk with respect to investment securities and the Company’s term loans is the risk that prevailing interest rates change causing the value of the investment securities and the value of the obligation owed under term loans to fluctuate. |
Sources of supply | Sources of supply The Company relies on third-party manufacturers and single source third-party suppliers to manufacture its preclinical and clinical drug supplies for use in the conduct of preclinical studies and clinical trials. If the Company’s third-party manufacturers are unable to continue manufacturing our preclinical and clinical drug supplies, or if it lost the single source suppliers used in the manufacturing process, it may not be able to meet the demand to support ongoing clinical trials. The Company also does not currently have arrangements in place for the commercial supply of bulk drug substance or drug products. It may not be able to establish these or any other supply relationship when needed, on reasonable terms, or at all. Any failure to secure sufficient supply of its product candidates for preclinical or clinical testing or, in the future, for commercial purposes, would materially harm the Company’s operations and financial results. |
Property and Equipment | Property and Equipment Property and equipment are recorded at cost and depreciated using the straight-line method over the estimated useful lives of the related assets. Asset lives range from three to seven years, or, in the case of leasehold improvements, over the lesser of the useful life of the related asset or the lease term. Maintenance and repairs are expensed as incurred. The Company establishes assets and corresponding financing liabilities for the construction costs incurred under build-to-suit The Company reviews property and equipment for impairment whenever events or changes in circumstances indicate that the carrying value of an asset may not be recoverable. An impairment loss would be recognized when estimated future undiscounted cash flows relating to the asset are less than its carrying amount. An impairment loss is measured as the amount by which the carrying amount of an asset exceeds its fair value. To date, the Company has not experienced any significant impairment losses on its property and equipment. |
Research and Development | Research and Development Costs incurred in connection with research and development activities are expensed as incurred. Research and development expenses consist of (i) external research and development expenses incurred under arrangements with third parties, such as contract research organizations, investigational sites and consultants; (ii) employee-related expenses, including salaries, benefits, travel and stock compensation expense; (iii) the cost of acquiring, developing and manufacturing clinical study materials; (iv) facilities and other expenses, which include direct and allocated expenses for rent and maintenance of facilities and laboratory and other supplies, and (v) license fees and other expenses relating to the acquisition of rights to development programs. The Company enters into consulting, research and other agreements with commercial firms, researchers, universities and others for the provision of goods and services. Under such agreements, the Company may pay for services on a monthly, quarterly, project or other basis. Such arrangements are generally cancellable upon reasonable notice and payment of costs incurred. Costs are considered incurred based on an evaluation of the progress to completion of specific tasks under each contract using information and data provided to the Company by its clinical sites and vendors and other information. These costs consist of direct and indirect costs associated with specific projects, as well as fees paid to various entities that perform certain research on behalf of the Company. In certain circumstances, the Company is required to make advance payments to vendors for goods or services that will be received in the future for use in research and development activities. In such circumstances, the advance payments are deferred and are expensed when the activity has been performed or when the goods have been received. The Company expenses all costs as incurred in connection with patent applications (including direct application fees, and the legal and consulting expenses related to making such applications) and such costs are included in general and administrative expenses. |
Clinical Trial and Pre-Clinical Study Accruals | Clinical Trial and Pre-Clinical The Company makes estimates of accrued expenses as of each balance sheet date in its financial statements based on the facts and circumstances known to it at that time. Accrued expenses for pre-clinical |
Income Taxes | Income Taxes Deferred income taxes are recognized for the tax consequences in future years of differences between the tax basis of assets and liabilities and their financial reporting amounts at each year end based on enacted tax laws and statutory tax rates applicable to the periods in which the differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amount expected to be realized. Income tax expense is the combination of the tax payable for the year and the change during the year in deferred tax assets and liabilities. The Company follows the accounting guidance on accounting for uncertainty in income taxes. The guidance prescribes a recognition threshold and measurement attribute criteria for the financial statement recognition and measurement of tax positions taken or expected to be taken in a tax return. For those benefits to be recognized, a tax position must be more likely than not to be sustained upon examination by taxing authorities based on the technical merits of the position. |
Stock-Based Compensation | Stock-Based Compensation Stock-based compensation cost for equity awards to employees and directors is measured at the grant date based on the estimated fair value of the award using the Black-Scholes option-pricing model. The value of the award that is ultimately expected to vest is recognized as an expense under the straight-line method over the requisite service period (generally the vesting period of the equity grant). Any changes to the estimated forfeiture rates are accounted for prospectively. Stock options issued to non-employees non-employees re-measured |
Comprehensive Income (Loss) | Comprehensive Income (Loss) Comprehensive income or loss is defined as the change in equity during a period from transactions and other events and circumstances from non-owner available-for-sale |
Net Loss per Share | Net Loss per Share Basic and diluted net loss per share has been computed by dividing net loss by the weighted average number of common shares outstanding. The calculations of net loss per share exclude potentially dilutive securities (consisting of outstanding options, warrants and restricted stock units) of approximately 5.5 million and 5.4 million shares as of December 31, 2016 and 2015, respectively, as inclusion of these securities would be anti-dilutive for each of the years shown in the financial statements given the net loss position of the Company. |
Recently Adopted Accounting Standards / Recent Accounting Pronouncements | Recently Adopted Accounting Standards In April 2015, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU’) 2015-03 In August 2014, the FASB issued ASU 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern In November 2015, the FASB issued ASU No. 2015-17, Income Taxes (Topic 740) – Balance Sheet Classification of Deferred Taxes Recent Accounting Pronouncements On August 26, 2016, the FASB issued ASU 2016-15, Statement of Cash Flows In March 2016, the FASB issued ASU 2016-09, Compensation–Stock Compensation: Improvements to Employee Share-Based Payment Accounting In February 2016, the FASB issued ASU 2016-02, Leases In January 2016, the FASB issued ASU 2016-01, Financial Instruments: Recognition and Measurement of Financial Assets and Financial Liabilities |
Fair Value Measurements | Available-for-sale The fair value of cash, cash equivalents and available-for-sale in thousands As of December 31, 2016 As of December 31, 2015 Level 1 Level 2 Level 3 Total Level 1 Level 2 Level 3 Total Cash and cash equivalents $ 24,340 $ — $ — $ 24,340 $ 46,383 $ — $ — $ 46,383 Investment securities: Commercial paper — 8,996 — 8,996 — 7,992 — 7,992 Corporate debt securities — 49,125 — 49,125 — 94,782 — 94,782 U.S. government and government agency obligations 50,499 — — 50,499 22,992 — — 22,992 Total investment securities 50,499 58,121 — 108,620 22,992 102,774 — 125,766 Total assets measured at fair value $ 74,839 $ 58,121 $ — $ 132,960 $ 69,375 $ 102,774 $ — $ 172,149 The Company’s policy is to recognize transfers between levels of the fair value hierarchy on the date of the event or change in circumstances that caused the transfer. There were no transfers into or out of Level 1, 2, or 3 for the years ended December 31, 2016 and 2015. |