Document_and_Entity_Informatio
Document and Entity Information | 3 Months Ended | |
Mar. 31, 2014 | 27-May-14 | |
Document And Entity Information [Abstract] | ' | ' |
Document Type | '10-Q | ' |
Amendment Flag | 'false | ' |
Document Period End Date | 31-Mar-14 | ' |
Document Fiscal Year Focus | '2014 | ' |
Document Fiscal Period Focus | 'Q1 | ' |
Entity Registrant Name | 'VITAL THERAPIES INC | ' |
Entity Central Index Key | '0001280776 | ' |
Current Fiscal Year End Date | '--12-31 | ' |
Entity Filer Category | 'Non-accelerated Filer | ' |
Entity Common Stock, Shares Outstanding | ' | 21,790,745 |
Condensed_Consolidated_Balance
Condensed Consolidated Balance Sheets (USD $) | Mar. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Current assets: | ' | ' |
Cash and cash equivalents | $46,041 | $38,186 |
Restricted cash | 1,007 | 963 |
Deferred financing costs | 3,935 | 3,506 |
Other current assets and prepaid expenses | 1,281 | 1,200 |
Total current assets | 52,264 | 43,855 |
Property and equipment, net | 3,081 | 2,467 |
Other assets | 263 | 263 |
Total assets | 55,608 | 46,585 |
Current liabilities: | ' | ' |
Accounts payable | 1,325 | 1,224 |
Accrued expenses | 5,496 | 3,253 |
Other current liabilities | 340 | 369 |
Future purchase rights liabilities | 1,472 | 2,600 |
Total current liabilities | 8,633 | 7,446 |
Other long-term liabilities | 279 | 321 |
Commitments and contingencies | ' | ' |
Stockholders' (deficit) equity: | ' | ' |
Preferred stock, $0.0001 par value; 25,000,000 authorized (4,498,599 undesignated) at December 31, 2013 and March 31, 2014; no shares issued or outstanding at December 31, 2013 and March 31, 2014 | ' | ' |
Common stock, $0.0001 par value; 29,250,000 shares authorized at December 31, 2013 and March 31, 2014; 606,238 shares issued and outstanding at December 31, 2013 and March 31, 2014 | ' | ' |
Additional paid-in capital | 55,803 | 58,413 |
Accumulated other comprehensive income | 95 | 96 |
Deficit accumulated during development stage | -113,914 | -103,166 |
Total stockholders' (deficit) equity | -58,016 | -44,657 |
Total liabilities, redeemable convertible preferred stock, and stockholders' (deficit) equity | 55,608 | 46,585 |
Convertible Preferred Stock (Junior) [Member] | ' | ' |
Current liabilities: | ' | ' |
Convertible preferred stock | 1,363 | 1,359 |
Redeemable Convertible Preferred Stock (Senior) [Member] | ' | ' |
Current liabilities: | ' | ' |
Convertible preferred stock | $103,349 | $82,116 |
Condensed_Consolidated_Balance1
Condensed Consolidated Balance Sheets (Parenthetical) (USD $) | Mar. 31, 2014 | Dec. 31, 2013 |
In Thousands, except Share data, unless otherwise specified | ||
Preferred stock, par value | $0.00 | $0.00 |
Preferred stock, shares authorized | 25,000,000 | 25,000,000 |
Preferred stock, shares authorized undesignated | 4,498,599 | 4,498,599 |
Preferred stock, shares issued | ' | ' |
Preferred stock, shares outstanding | ' | ' |
Common stock, par value | $0.00 | $0.00 |
Common stock, shares authorized | 29,250,000 | 29,250,000 |
Common stock, shares issued | 606,238 | 606,238 |
Common stock, shares outstanding | 606,238 | 606,238 |
Convertible Preferred Stock (Junior) [Member] | ' | ' |
Convertible preferred stock, par value | $0.00 | $0.00 |
Convertible preferred stock, shares designated | 3,501,401 | 3,501,401 |
Convertible preferred stock, shares issued | 3,501,400 | 3,501,400 |
Convertible preferred stock, shares outstanding | 3,501,400 | 3,501,400 |
Convertible preferred stock, liquidation preference | $1,500 | ' |
Redeemable Convertible Preferred Stock (Senior) [Member] | ' | ' |
Convertible preferred stock, par value | $0.00 | $0.00 |
Convertible preferred stock, shares designated | 17,000,000 | 17,000,000 |
Convertible preferred stock, shares issued | 12,508,023 | 10,212,007 |
Convertible preferred stock, shares outstanding | 12,508,023 | 10,212,007 |
Convertible preferred stock, liquidation preference | $156,366 | ' |
Condensed_Consolidated_Stateme
Condensed Consolidated Statements of Operations (USD $) | 3 Months Ended | 130 Months Ended | |
In Thousands, except Share data, unless otherwise specified | Mar. 31, 2014 | Mar. 31, 2013 | Mar. 31, 2014 |
Income Statement [Abstract] | ' | ' | ' |
Revenues | ' | ' | $22 |
Cost of revenues | ' | ' | 13 |
Gross profit | ' | ' | 9 |
Operating expenses: | ' | ' | ' |
Research and development | 9,219 | 3,432 | 72,198 |
General and administrative | 2,657 | 1,494 | 43,972 |
Total operating expenses | 11,876 | 4,926 | 116,170 |
Loss from operations | -11,876 | -4,926 | -116,161 |
Other income (expense): | ' | ' | ' |
Interest income | 2 | 2 | 769 |
Interest expense | ' | ' | -14,298 |
Other income (expense), net | -2 | ' | 269 |
Revaluation of preferred stock warrant liabilities | ' | ' | 12,579 |
Revaluation of future purchase rights liabilities | 1,128 | -4,434 | 2,923 |
Total other income (expense) | 1,128 | -4,432 | 2,242 |
Net loss before cumulative effect of change in accounting principle | -10,748 | -9,358 | -113,919 |
Cumulative effect of change in accounting principle | ' | ' | 5 |
Net loss | -10,748 | -9,358 | -113,914 |
Amortization of deemed dividend | -22 | -3 | -86 |
Accretion to redemption value of redeemable convertible preferred stock | -3,048 | -970 | -11,738 |
Net loss attributable to common stockholders | ($13,818) | ($10,331) | ($125,738) |
Net loss per share attributable to common stockholders, basic and diluted | ($24.49) | ($22.11) | ' |
Weighted-average common shares outstanding, basic and diluted | 564,186 | 467,167 | ' |
Condensed_Consolidated_Stateme1
Condensed Consolidated Statements of Comprehensive Loss (USD $) | 3 Months Ended | 130 Months Ended | |
In Thousands, unless otherwise specified | Mar. 31, 2014 | Mar. 31, 2013 | Mar. 31, 2014 |
Statement Of Income And Comprehensive Income [Abstract] | ' | ' | ' |
Net loss | ($10,748) | ($9,358) | ($113,914) |
Other comprehensive income: | ' | ' | ' |
Foreign currency translation | -1 | 3 | 95 |
Total comprehensive loss | ($10,749) | ($9,355) | ($113,819) |
Condensed_Consolidated_Stateme2
Condensed Consolidated Statements of Cash Flows (USD $) | 3 Months Ended | 130 Months Ended | |
In Thousands, unless otherwise specified | Mar. 31, 2014 | Mar. 31, 2013 | Mar. 31, 2014 |
Cash flows from operating activities: | ' | ' | ' |
Net loss | ($10,748) | ($9,358) | ($113,914) |
Adjustments to reconcile net loss to net cash used in operating activities: | ' | ' | ' |
Depreciation and amortization | 297 | 163 | 6,283 |
Stock-based compensation | 435 | 105 | 1,762 |
Noncash interest expense | ' | ' | 13,517 |
Revaluation of preferred stock warrant liabilities | ' | ' | -12,584 |
Revaluation of future purchase rights liabilities | -1,128 | 4,434 | -2,923 |
Other | -45 | -13 | -18 |
Changes in operating assets and liabilities: | ' | ' | ' |
Other current assets and prepaid expenses | -81 | -216 | -1,295 |
Accounts payable | -58 | 83 | 502 |
Accrued expenses | 1,964 | 247 | 4,813 |
Net cash used in operating activities | -9,364 | -4,555 | -103,880 |
Cash flows from investing activities: | ' | ' | ' |
Purchases of short-term investments | ' | -1,000 | -16,991 |
Sales of short-term investments | ' | 4,999 | 17,000 |
Proceeds from sale of equipment | ' | ' | 140 |
Increase in restricted cash | -44 | 37 | -1,007 |
Purchases of property and equipment | -809 | -120 | -5,478 |
Net cash (used in) provided by investing activities | -853 | 3,916 | -6,336 |
Cash flows from financing activities: | ' | ' | ' |
Proceeds from debt, net of issuance costs | ' | ' | 30,277 |
Deferred financing costs | -94 | ' | -3,461 |
Principal payments on term loan | ' | ' | -2,154 |
Proceeds from issuance of common stock | ' | ' | 62 |
Proceeds from issuance of preferred stock, net of issuance costs | 18,167 | 2,311 | 130,884 |
Proceeds from exercise of stock options | ' | ' | 334 |
Proceeds from early exercise of stock options | ' | ' | 227 |
Net cash provided by financing activities | 18,073 | 2,311 | 156,169 |
Effect of exchange rate changes on cash and cash equivalents | -1 | 3 | 88 |
Net change in cash and cash equivalents | 7,855 | 1,675 | 46,041 |
Cash and cash equivalents, beginning of period | 38,186 | 4,477 | ' |
Cash and cash equivalents, end of period | 46,041 | 6,152 | 46,041 |
Supplemental cash flow information: | ' | ' | ' |
Cash paid for interest | ' | ' | 518 |
Supplemental disclosure of noncash investing and financing activities: | ' | ' | ' |
Deferred financing costs included in liabilities | 336 | ' | 730 |
Purchase of property and equipment through liabilities | 102 | 11 | 774 |
Release of repurchase liability | 26 | ' | 79 |
Leasehold improvements paid for by landlord | ' | ' | 478 |
Purchase of assets through debt | ' | ' | 2,807 |
Issuance of Series D warrant in connection with Series D redeemable convertible preferred stock | ' | ' | 3,265 |
Conversion of debt for redeemable convertible preferred stock | ' | ' | 33,996 |
Conversion of redeemable convertible preferred stock to common stock | ' | ' | 64,083 |
Valuation of future purchase rights upon issuance | ' | 672 | 4,395 |
Beneficial conversion underlying the senior preferred stock | ' | ' | 969 |
Accretion to redemption value of redeemable convertible preferred stock | $3,048 | $970 | $11,738 |
Description_of_Business_and_Ba
Description of Business and Basis of Financial Statements | 3 Months Ended |
Mar. 31, 2014 | |
Accounting Policies [Abstract] | ' |
Description of Business and Basis of Financial Statements | ' |
1. Description of Business and Basis of Financial Statements | |
Description of Business | |
We began operations as a California corporation on May 23, 2003 through the acquisition of the assets and business of VitaGen, Inc. and in June 2003 changed our name to Vital Therapies, Inc. In January 2004, we were re-incorporated in Delaware. We are a biotherapeutic company focused on developing a cell-based therapy targeting the treatment of all forms of acute liver failure. Our product candidate, currently in Phase 3 clinical trials, the ELAD® System, or ELAD, is an extracorporeal human cell-based bio-artificial liver therapy designed to allow the patient’s own liver to regenerate to a healthy state, or to stabilize the patient until transplant. Since inception, we have devoted essentially all of our efforts to product development, clinical testing and pilot manufacturing and have not realized revenues from our planned principal operations. Accordingly, we are considered to be a development stage enterprise. Our headquarters are located in San Diego, California. | |
Unaudited Interim Financial Information | |
The accompanying condensed consolidated balance sheet as of March 31, 2014, condensed consolidated statements of operations, comprehensive loss, and cash flows for the three months ended March 31, 2014 and 2013 are unaudited. The financial data and other information disclosed in these notes related to the three months ended March 31, 2014 and 2013 are unaudited. The results for the three months ended March 31, 2014 are not necessarily indicative of results to be expected for the year ending December 31, 2014, any other interim or any future year or period. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto for the year ended December 31, 2013, included in our final prospectus filed with the Securities and Exchange Commission on April 16, 2014 relating to our Registration Statement on Form S-1 (File No. 333-191711) for our initial public offering, or IPO. | |
Basis of Presentation and Consolidation | |
The accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (GAAP) and the rules and regulations of the Securities and Exchange Commission, or the SEC, related to a quarterly report on Form 10-Q. Certain information and note disclosures normally included in annual financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to those rules and regulations. The condensed consolidated balance sheet as of December 31, 2013 included in this report has been derived from the audited consolidated financial statements included in the Form S-1. The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the annual audited consolidated financial statements and, in the opinion of management, reflect all adjustments that are necessary for a fair statement of the financial position, results of operations and cash flows for the periods presented. All such adjustments are of a normal and recurring nature. Certain reclassifications have been made to the prior period amounts to conform to the current presentation. | |
The unaudited interim condensed consolidated financial statements include the accounts of Vital Therapies, Inc. and its wholly-owned subsidiaries located in the United Kingdom (currently inactive) and China. All intercompany accounts and transactions have been eliminated in consolidation. We manage our operations as a single segment for the purposes of assessing performance and making operating decisions. | |
Liquidity | |
We have incurred losses since inception and negative cash flows from operating activities for the three months ended March 31, 2014. As of March 31, 2014, we had working capital of $43.6 million and a deficit accumulated during the development stage of $113.9 million. In April 2014, we completed an IPO selling 4,500,000 shares of our common stock at $12.00 per share with the underwriters exercising their option to purchase an additional 675,000 shares for $12.00 per share in May 2014 for total estimated net proceeds of $52.4 million (see Note 9). We anticipate that we will continue to incur net losses into the foreseeable future as we work toward completing the ELAD System’s clinical development through the clinical trial process and expand our corporate and manufacturing infrastructure. | |
We plan to continue to fund our losses from operations and capital funding needs through future debt and equity financings. If we are not able to secure adequate additional capital funding, we may be forced to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible, or suspend or curtail planned programs. Any of these actions could materially harm our business, results of operations, and future prospects. |
Summary_of_Significant_Account
Summary of Significant Accounting Policies | 3 Months Ended | ||||||||
Mar. 31, 2014 | |||||||||
Accounting Policies [Abstract] | ' | ||||||||
Summary of Significant Accounting Policies | ' | ||||||||
2. Summary of Significant Accounting Policies | |||||||||
Use of Estimates | |||||||||
The preparation of financial statements in conformity with GAAP requires us to make certain estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Actual results could differ materially from those estimates and assumptions. | |||||||||
Cash and Cash Equivalents | |||||||||
Cash and cash equivalents consist of cash and highly-liquid investments with original maturities of three months or less when acquired and are stated at cost, which approximates market value. | |||||||||
Restricted Cash | |||||||||
Restricted cash relates to amounts reserved for various clinical trial obligations and lease arrangements at March 31, 2014 and December 31, 2013, as well as for certain provisions of the junior preferred stock agreement at December 31, 2013. | |||||||||
Fair Value of Financial Instruments | |||||||||
Fair value is defined as the price that would be received to sell an asset or be paid to transfer a liability in an orderly transaction between market participants on the measurement date. Accounting guidance establishes a fair value hierarchy that requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. The standard describes three levels of inputs that may be used to measure fair value: | |||||||||
Level 1—Quoted prices in active markets for identical assets or liabilities. Our Level 1 assets consisted of money market funds for the periods presented. We had no Level 1 liabilities for any period presented. | |||||||||
Level 2—Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities, quoted prices in markets with insufficient volume or infrequent transactions (less active markets), or model-derived valuations in which all significant inputs are observable or can be derived principally from or corroborated with observable market data for substantially the full term of the assets or liabilities. We had no Level 2 assets or liabilities for any period presented. | |||||||||
Level 3—Unobservable inputs to the valuation methodology that are significant to the measurement of the fair value of assets or liabilities. Our Level 3 liabilities consisted of future purchase rights liabilities during the periods presented. We had no Level 3 assets in any period presented. We estimated the fair value of the future purchase rights using a binomial lattice model depending on the underlying attributes of the future purchase rights, as applicable. See “Future Purchase Rights Liabilities” below. | |||||||||
The carrying value of cash and cash equivalents, restricted cash, other current assets and prepaid expenses, accounts payable, and accrued expenses approximate fair value due to the short period of time to maturity. | |||||||||
Deferred Financing Costs | |||||||||
Deferred financing costs represent direct costs associated with the future issuance of our corporate securities. Direct costs include, but are not limited to the legal, accounting and printing costs. Indirect costs, associated with the future issuance of corporate securities are expensed as incurred. The deferred financing costs will be offset against the proceeds from our IPO in April 2014 (see Note 9). | |||||||||
Property and Equipment, Depreciation and Amortization | |||||||||
Property and equipment are recorded at cost and depreciated using the straight-line method over the estimated useful lives of the assets (generally three to five years). Leasehold improvements are stated at cost and amortized on a straight-line basis over the lesser of the remaining term of the related lease or the estimated useful lives of the assets. Construction in progress is not depreciated until the underlying asset is available to be placed in service. Repairs and maintenance costs are charged to expense as incurred. | |||||||||
Impairment of Long-lived Assets | |||||||||
Long-lived assets consist primarily of property and equipment. An impairment loss is recorded if and when events and circumstances indicate that assets might be impaired and the undiscounted cash flows estimated to be generated by those assets are less than the carrying amount of those assets. While our current and historical operating losses and negative cash flows are indicators of impairment, we believe that our expected future cash flows to be received support the carrying value of our long-lived assets and, accordingly, have not recognized any impairment losses through March 31, 2014. | |||||||||
Redeemable Convertible Preferred Stock | |||||||||
Our junior convertible and senior redeemable convertible preferred stock are classified as mezzanine equity instead of a component of stockholders’ deficit in accordance with authoritative guidance for the classification and measurement of potentially redeemable securities, as the preferred stock is conditionally redeemable at the holder’s option or upon certain change in control events that are outside our control, including liquidation, sale, or transfer of control of the company. | |||||||||
Future Purchase Rights Liabilities | |||||||||
Our future purchase rights liabilities are recorded at their estimated fair value on the date of issuance as a discount on the underlying preferred stock and are remeasured to reflect changes in the estimated fair value at each reporting date, with any decrease or increase in the estimated fair value being recorded as other income or expense, respectively. The fair value of these liabilities is estimated using a binomial lattice model that is based on the characteristics of the common and preferred stock on the valuation date, probabilities related to our operations and clinical development, as well as assumptions for volatility, remaining expected life, risk-free interest rate and, in some cases, credit spread. Changes in the fair value of the future purchase rights fluctuate in conjunction with increases or decreases in the fair value of our common stock, and the number of preferred and common shares and future purchase rights outstanding relative to our enterprise value at each reporting date. | |||||||||
Revenues and Cost of Revenues | |||||||||
Revenues to date relate to compassionate use treatment for patients and are recognized when the product is shipped and the risks and rewards of ownership have transferred to the hospital administering the treatments. Shipping charges billed to hospitals are included in revenues and the related shipping costs are included in cost of revenues. Cost of revenues consists of direct materials costs incurred during the manufacturing of the ELAD cartridges. Revenues and cost of revenues have not been significant to date. | |||||||||
Research and Development | |||||||||
Research and development costs consist primarily of employee-related expenses, contractors, clinical trial sites and contract research organizations engaged in the development of the ELAD System, expenses associated with obtaining regulatory approvals, and the cost of acquiring and manufacturing clinical trial materials. All research and development costs are expensed as incurred. | |||||||||
Stock-based Compensation | |||||||||
We measure and recognize compensation expense for all stock-based payments made to employees and directors based on estimated fair value, net of an estimated forfeiture rate, and to consultants based on estimated fair value. Currently, our stock-based awards consist only of stock options; however, future grants under our equity compensation plans may consist of shares of restricted stock and restricted stock units. We estimate the fair value of stock options granted using the Black-Scholes-Merton, or BSM, option pricing model, which requires the use of estimates to value employee stock-based compensation at the date of grant. | |||||||||
We recognize stock-based compensation cost for employees and directors on a straight-line basis over the requisite service period of the award. Stock-based compensation expense is recognized only for those awards that are ultimately expected to vest. We estimate forfeitures based on an analysis of our historical employee turnover and will continue to evaluate the appropriateness of the forfeiture rate based on actual forfeiture experience, analysis of employee turnover and other factors. We will revise the forfeiture estimate, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Changes in forfeiture estimates, which have not been material to date, impact compensation cost in the period in which the change in estimate occurs. | |||||||||
The fair value of options granted to consultants is estimated using the BSM option pricing model and is remeasured at each reporting date with changes in fair value recognized as expense in the consolidated statements of operations. | |||||||||
The BSM option pricing model requires the input of highly subjective assumptions, including the risk-free interest rate, the expected dividend yield of our common stock, the expected volatility of the price of our common stock, and the expected term of the option. These estimates involve inherent uncertainties and the application of management’s judgment. If factors change and different assumptions are used, our stock-based compensation expense could be materially different in the future. These assumptions are estimated as follows: | |||||||||
Risk-free Interest Rate | |||||||||
We base the risk-free interest rate assumption on zero-coupon U.S. treasury instruments appropriate for the expected term of the stock option grants. | |||||||||
Expected Dividend Yield | |||||||||
We base the expected dividend yield assumption on the fact that we have never paid cash dividends and have no present intention to pay cash dividends. Consequently, we used an expected dividend yield of zero. | |||||||||
Expected Volatility | |||||||||
As we do not have a trading history for our common stock, the expected stock price volatility for our common stock is estimated based on volatilities of a peer group of similar companies by taking the average historic price volatility for these peers for a period equivalent to the expected term of the stock option grants. The peer group was developed based on companies in the biotechnology industry whose shares are publicly-traded. | |||||||||
Expected Term | |||||||||
The expected term represents the period of time that options are expected to be outstanding. As we do not have sufficient historical experience for determining the expected term of the stock option awards granted we determined the expected life assumption using either the simplified method, which is an average of the contractual term of the option and its ordinary vesting period, or the comparable average expected term utilizing those companies in the peer group noted above, as applicable. | |||||||||
Common Stock Valuation | |||||||||
Due to the absence of a public market trading our common stock prior to the completion of our IPO in April 2014, it was necessary to estimate the fair value of the common stock underlying our stock-based awards when performing fair value calculations using the BSM option pricing model. The fair value of the common stock underlying our stock-based awards was assessed by our board of directors. All options to purchase shares of our common stock have been granted with an exercise price per share no less than the fair value per share of our common stock underlying those options on the date of grant. | |||||||||
In the absence of a public trading market for our common stock, we determined the estimated fair value of our common stock using methodologies, approaches, and assumptions consistent with the American Institute of Certified Public Accountants, or AICPA, Audit and Accounting Practice Aid Series: Valuation of Privately Held Company Equity Securities Issued as Compensation, or the AICPA Practice Aid. | |||||||||
Leases | |||||||||
We lease all of our office space and enter into various other operating lease agreements in conducting our business. At the inception of each lease, we evaluate the lease agreement to determine whether the lease is an operating or capital lease. Some of our lease agreements may contain renewal options, tenant improvement allowances, rent holidays or rent escalation clauses. When such items are included in a lease agreement, we record a deferred rent asset or liability equal to the difference between the rent expense and future minimum lease payments due. The rent expense related to operating leases is recognized on a straight-line basis in the statements of operations over the terms of the leases. In cases where our lessor grants to us leasehold improvement allowances that reduce our rent expense, we capitalize the improvements as incurred and recognize deferred rent, which is amortized over the shorter of the lease term or the expected useful life of the improvements. | |||||||||
Comprehensive Loss | |||||||||
Comprehensive loss is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources and has been reflected as a separate component of stockholders’ (deficit) equity in the accompanying condensed consolidated balance sheets. | |||||||||
Foreign Currency Translation and Transactions | |||||||||
The functional currencies of each our subsidiaries in the United Kingdom (currently inactive) and China is the local currency. Assets and liabilities of the subsidiaries are translated at the rate of exchange at the balance sheet date. Expenses are translated at the average rate of exchange rates in effect during the reporting period. Gains and losses resulting from foreign currency translation are included in accumulated other comprehensive income in the accompanying condensed consolidated balance sheets. Gains and losses resulting from foreign currency transactions are included in the results of operations, which to date, have not been significant. | |||||||||
Income Taxes | |||||||||
We account for income taxes under the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the consolidated financial statements. Under this method, deferred tax assets and liabilities are determined on the basis of the differences between the financial statements and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. The effect of a change in tax rates on deferred tax assets and liabilities is recognized in income in the period that includes the enactment date. | |||||||||
We recognize net deferred tax assets to the extent we believe these assets are more likely than not to be realized. In making such a determination, management considers all available positive and negative evidence, including future reversals of existing taxable temporary differences, projected future taxable income, tax-planning strategies, and results of recent operations. If management determines that we would be able to realize our deferred tax assets in the future in excess of their net recorded amount, management would make an adjustment to the deferred tax asset valuation allowance, which would reduce the provision for income taxes. As of March 31, 2014 and December 31, 2013, we maintained a full valuation allowance against our entire balance of deferred tax assets. | |||||||||
We record uncertain tax positions in accordance with ASC 740 on the basis of a two-step process whereby (1) management determines whether it is more likely than not that the tax positions will be sustained on the basis of the technical merits of the position and (2) for those tax positions that meet the more-likely-than-not recognition threshold, management recognizes the largest amount of tax benefit that is more than 50 percent likely to be realized upon ultimate settlement with the related tax authority. We recognize interest and penalties related to unrecognized tax benefits, if any, within income tax expense and any accrued interest and penalties are included within the related tax liability line. | |||||||||
Net Loss Per Share | |||||||||
Basic net loss per share attributable to common stockholders is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding for the period, without consideration for common stock equivalents. Excluded from the weighted-average number of shares outstanding are shares that have been issued upon the early exercise of stock options and are subject to future vesting, which was a total of 39,979 shares as of March 31, 2014. Diluted net loss per share attributable to common stockholders is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common share equivalents outstanding for the period determined using the treasury-stock method. Common stock equivalents are comprised of redeemable convertible preferred stock, warrants for the purchase of common stock, and options outstanding under our stock option plan. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding due to our net loss position. | |||||||||
Potentially dilutive securities not included in the calculation of diluted net loss per share attributable to common stockholders because to do so would be anti-dilutive are as follows (in common stock equivalent shares): | |||||||||
As of March 31, | |||||||||
2014 | 2013 | ||||||||
Redeemable convertible preferred stock | 16,009,423 | 7,325,170 | |||||||
Options to purchase common stock | 3,143,565 | 2,422,000 | |||||||
Warrants to purchase common stock | 250,646 | 250,646 |
Other_Financial_Information
Other Financial Information | 3 Months Ended | ||||||||
Mar. 31, 2014 | |||||||||
Organization Consolidation And Presentation Of Financial Statements [Abstract] | ' | ||||||||
Other Financial Information | ' | ||||||||
3. Other Financial Information | |||||||||
Property and Equipment | |||||||||
Property and equipment, leasehold improvements, and related accumulated depreciation and amortization were as follows (in thousands): | |||||||||
March 31, | December 31, | ||||||||
2014 | 2013 | ||||||||
Manufacturing and laboratory equipment | $ | 3,230 | $ | 3,229 | |||||
Office furniture and equipment | 112 | 112 | |||||||
Clinical equipment | 1,727 | 1,606 | |||||||
Computer equipment and software | 132 | 122 | |||||||
Leasehold improvements | 3,207 | 2,830 | |||||||
Construction in progress | 725 | 323 | |||||||
9,133 | 8,222 | ||||||||
Less: accumulated depreciation and amortization | (6,052 | ) | (5,755 | ) | |||||
Total | $ | 3,081 | $ | 2,467 | |||||
Depreciation and amortization expense for the three months ended March 31, 2014 and 2013 was $297,000 and $163,000, respectively. | |||||||||
Accrued Expenses | |||||||||
Accrued expenses consist of (in thousands): | |||||||||
March 31, | December 31, | ||||||||
2014 | 2013 | ||||||||
Accrued clinical costs | $ | 3,785 | $ | 2,067 | |||||
Accrued financing costs | 672 | 496 | |||||||
Accrued compensation and related taxes | 915 | 512 | |||||||
Accrued other | 124 | 178 | |||||||
Total | $ | 5,496 | $ | 3,253 | |||||
Commitments_and_Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2014 | |
Commitments And Contingencies Disclosure [Abstract] | ' |
Commitments and Contingencies | ' |
4. Commitments and Contingencies | |
Operating Leases | |
We lease office, manufacturing and research and development facilities, and equipment under various non-cancellable operating lease agreements through 2017. Facility leases generally provide for periodic rent increases and many contain escalation clauses and renewal options. Certain leases require us to pay property taxes and routine maintenance. Total rent expense under our operating leases was $183,000 and $139,000 for the three months ended March 31, 2014 and 2013, respectively. | |
We recognize rent expense for our facility operating leases on a straight-line basis. We account for the difference between the minimum lease payments and the straight-line amount as deferred rent. Current and long-term deferred rent totaled $139,000 and $279,000 at March 31, 2014, and $142,000 and $321,000 at December 31, 2013, respectively. | |
Legal Proceedings | |
We are not currently a party to any litigation, nor are we aware of any pending or threatened litigation against us that we believe would materially affect our business, operating results, financial condition or cash flows. Our industry is characterized by frequent claims and litigation, including claims regarding patent and other intellectual property rights, as well as for product liability. As a result, in the future, we may be involved in various legal proceedings from time to time. |
Fair_Value
Fair Value | 3 Months Ended | ||||||||||||||||
Mar. 31, 2014 | |||||||||||||||||
Fair Value Disclosures [Abstract] | ' | ||||||||||||||||
Fair Value | ' | ||||||||||||||||
5. Fair Value | |||||||||||||||||
The following fair value hierarchy table presents information about each major category of our financial assets and liabilities measured at fair value on a recurring basis (in thousands): | |||||||||||||||||
Fair Value Measurement at March 31, 2014 | |||||||||||||||||
Fair Value | Level 1 | Level 2 | Level 3 | ||||||||||||||
Assets | |||||||||||||||||
Cash equivalents: | |||||||||||||||||
Money market funds | $ | 44,460 | $ | 44,460 | $ | — | $ | — | |||||||||
Liabilities | |||||||||||||||||
Future purchase rights | $ | 1,472 | $ | — | $ | — | $ | 1,472 | |||||||||
Fair Value Measurement at December 31, 2013 | |||||||||||||||||
Fair Value | Level 1 | Level 2 | Level 3 | ||||||||||||||
Assets | |||||||||||||||||
Cash equivalents: | |||||||||||||||||
Money market funds | $ | 37,158 | $ | 37,158 | $ | — | $ | — | |||||||||
Liabilities | |||||||||||||||||
Future purchase rights | $ | 2,600 | $ | — | $ | — | $ | 2,600 | |||||||||
We report the change in fair value during each period as a nonoperating gain or loss. There were no transfers between Level 1, Level 2 or Level 3 for our assets or liabilities during the three months ended March 31, 2014. | |||||||||||||||||
The following table summarizes the changes in Level 3 future purchase rights liabilities measured at fair value on a recurring basis for the three months ended March 31, 2014 (in thousands): | |||||||||||||||||
Fair Value of | |||||||||||||||||
Future Purchase | |||||||||||||||||
Rights Liabilities | |||||||||||||||||
Balance at January 1, 2014 | $ | 2,600 | |||||||||||||||
Revaluation of future purchase rights | (1,128 | ) | |||||||||||||||
Balance at March 31, 2014 | $ | 1,472 | |||||||||||||||
We valued the future purchase rights liabilities as of March 31, 2014 and December 31, 2013, using a binomial lattice option pricing model with the following assumptions: | |||||||||||||||||
March 31, | December 31, | ||||||||||||||||
2014 | 2013 | ||||||||||||||||
Common stock fair value | $ | 11.3 | $ | 5.93 | |||||||||||||
Preferred stock price | $ | 8 | $ | 8 | |||||||||||||
Volatility | 80 | % | 85 | % | |||||||||||||
Risk-free interest rate | 0.36 | % | 0.38 | % | |||||||||||||
Contractual life (years) | 1.84 | 2.08 | |||||||||||||||
Number of nodes | 22 | 25 | |||||||||||||||
Dividend yield | 0 | % | 0 | % |
Redeemable_Convertible_Preferr
Redeemable Convertible Preferred Stock | 3 Months Ended |
Mar. 31, 2014 | |
Equity [Abstract] | ' |
Redeemable Convertible Preferred Stock | ' |
6. Redeemable Convertible Preferred Stock | |
Junior Convertible Preferred Stock | |
In February 2012, we entered into a securities purchase agreement for the sale of junior convertible preferred stock. The junior preferred stock financing totaled $1.5 million of convertible, but not redeemable, preferred stock at approximately $0.43 a share, for an aggregate of 3,501,400 shares, receiving net proceeds of $1.3 million. | |
Senior Redeemable Convertible Preferred Stock | |
In September 2012, we entered into a senior preferred stock purchase agreement (as amended in December 2013, the Senior Preferred Purchase Agreement) that authorized the multi-stage issuance of shares of our senior redeemable convertible preferred stock for $8.00 per share. As of March 31, 2014, 12,508,023 shares have been issued under the Senior Preferred Purchase Agreement and additional shares were subject to future stock purchase rights, as described below. | |
Pursuant to the Senior Preferred Stock Purchase Agreement, we issued 555,000 shares of senior preferred stock for proceeds of $4.3 million, net of issuance costs of $135,000, in January 2014. | |
In January 2014, we also completed the sale of 1.5 million shares of our senior redeemable convertible preferred stock at a price of $8.00 per share in a private placement to new investors for proceeds of $12.0 million, net of issuance costs of $31,000. | |
In February 2014, we completed a pre-emptive rights offering, triggered by the private placement to new investors in January 2014, for 241,016 shares of our senior redeemable convertible preferred stock at a price of $8.00 per share for proceeds of $1.9 million, net of issuance costs of $35,000. | |
Future Purchase Rights | |
Pursuant to the Senior Preferred Purchase Agreement, we granted the investors in the senior preferred stock financing the right, subject to the satisfaction of certain conditions, to purchase additional shares of senior preferred stock for a purchase price of $8.00 per share at multiple subsequent closings in accordance with a schedule provided in the Senior Preferred Purchase Agreement. These future purchase rights terminate automatically upon certain events. | |
As the fair value received for certain shares of senior preferred stock sold during the year ended December 31, 2013 was less than the fair of our common stock on the date of issuance, we recorded beneficial conversion amounts associated with the rights of the holders of such preferred stock to convert their preferred stock to common stock. These beneficial conversion amounts were recorded as an offset to additional paid-in capital and are being amortized as a deemed dividend over the redemption period using an effective interest rate method. For the three months ended March 31, 2014, $22,000 was recognized as a deemed dividend. There were no deemed dividends in the three-month period ended March 31, 2013. | |
Subsequent to March 31, 2014, in April 2014, we completed our IPO (see Note 9). As a result of the IPO all outstanding junior and senior preferred stock was converted into common stock on a one-to-one basis and the remaining future purchase rights were terminated. | |
Warrants | |
Warrants outstanding and exercisable for 250,646 shares of common stock as of March 31, 2014 have a weighted-average exercise price of $95.21 and expire between February 2016 and September 2019. |
Common_Stock
Common Stock | 3 Months Ended | ||||
Mar. 31, 2014 | |||||
Equity [Abstract] | ' | ||||
Common Stock | ' | ||||
7. Common Stock | |||||
Stock Reserved for Future Issuance | |||||
Shares reserved for future issuance at March 31, 2014 are as follows: | |||||
Number of | |||||
Shares | |||||
Conversion of the Preferred Stock | 16,009,423 | ||||
Exercise of common stock warrants | 250,646 | ||||
Common stock options outstanding | 3,143,565 | ||||
Common stock options available for future grant | 84,500 | ||||
Total common shares reserved for future issuance | 19,488,134 | ||||
Stock_Compensation_Plans
Stock Compensation Plans | 3 Months Ended | ||||||||||||||||
Mar. 31, 2014 | |||||||||||||||||
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | ' | ||||||||||||||||
Stock Compensation Plans | ' | ||||||||||||||||
8. Stock Compensation Plans | |||||||||||||||||
Equity Incentive Plans | |||||||||||||||||
Our 2012 Stock Option Plan, or the 2012 Plan, as approved by our board of directors and stockholders, provides for the grant of stock options, restricted stock, restricted stock units, stock purchase rights, and performance awards to employees, directors, and consultants. Option grants under the 2012 Plan generally have a ten-year term and vest over four years. The 2012 Plan also provides that options granted under the 2012 Plan are exercisable immediately, subject to a repurchase right that lapses as the option vests. As of March 31, 2014, options for the purchase of 139,071 shares of our common stock had been exercised, of which 39,979 were unvested and subject to repurchase. As of March 31, 2014, we have not repurchased any shares related to these early exercises for which our repurchase liability was $201,000. As of March 31, 2014, the number of shares of common stock reserved for future issuance under the 2012 Plan was 84,500. | |||||||||||||||||
On February 3, 2014, options to purchase 257,987 shares of common stock originally granted in September 2013 were re-priced from an exercise price of $10.50 per share to an exercise price of $8.00 per share. The impact of the re-pricing was not material to the results of our operations for the three months ended March 31, 2014. | |||||||||||||||||
The following table summarizes stock option activity: | |||||||||||||||||
Options | Weighted- | Weighted- | Aggregate | ||||||||||||||
Average | Average | Intrinsic | |||||||||||||||
Exercise | Remaining | Value | |||||||||||||||
Price | Contractual | ||||||||||||||||
Term (Years) | |||||||||||||||||
Outstanding as of January 1, 2014 | 3,098,573 | $ | 6.71 | ||||||||||||||
Granted | 61,653 | $ | 8 | ||||||||||||||
Forfeited | (16,661 | ) | $ | 8.03 | |||||||||||||
Outstanding as of March 31, 2014 | 3,143,565 | $ | 6.52 | 8.57 | $ | 15,025,431 | |||||||||||
Options vested and expected to vest as of March 31, 2014 | 3,134,810 | $ | 6.52 | 8.57 | $ | 14,989,210 | |||||||||||
Options exercisable as of March 31, 2014 | 3,143,565 | $ | 6.52 | 8.57 | $ | 15,025,431 | |||||||||||
Stock-based Compensation Expense | |||||||||||||||||
The weighted-average grant date fair value of stock options granted during the three months ended March 31, 2014 and 2013 was $5.17, and $4.94, respectively. The following are the ranges of underlying assumptions used in the BSM option pricing model to determine the fair value of stock options granted to employees and nonemployees: | |||||||||||||||||
Three Months Ended March 31, | |||||||||||||||||
2014 | 2013 | ||||||||||||||||
Risk-free interest rate | 0.13% - 1.6 | % | 0.2% - 0.8 | % | |||||||||||||
Expected dividend yield | 0 | % | 0 | % | |||||||||||||
Expected volatility | 81 | % | 100 | % | |||||||||||||
Expected term of options (years) | 1.0 - 6.0 | 1.0 - 5.0 | |||||||||||||||
Fair value of common stock | $ | 7.55 - $11.30 | $6.85 | ||||||||||||||
Valuation Analyses | |||||||||||||||||
Due to our management’s and board of directors’ decision to pursue an IPO, coupled with our belief that we could reasonably estimate the form and timing of potential liquidity events, we utilized a Probability Weighted Expected Return Method, or PWERM, to determine the fair value of our common stock in 2014 and 2013. Under this method, the implied fair value of our common stock is estimated based upon an analysis of future values assuming various outcomes. The value is based on the probability-weighted present value of expected future investment returns considering each of the possible outcomes available to us as well as the rights of each share class. The possible outcomes considered are based upon an analysis of future scenarios as described below: | |||||||||||||||||
• | closing of an IPO; | ||||||||||||||||
• | sale to a strategic acquirer; | ||||||||||||||||
• | continuation as a private company with subsequent liquidation event; and | ||||||||||||||||
• | dissolution. | ||||||||||||||||
Critical assumptions required to perform the PWERM include the following: | |||||||||||||||||
• | Scenarios: Expected future events were identified. | ||||||||||||||||
• | Scenario probabilities: Estimates of the probability of occurrence of each event were identified. | ||||||||||||||||
• | Valuation: Expected future values under each scenario were estimated. | ||||||||||||||||
• | Timing: Expected timing to the event under each scenario were estimated. | ||||||||||||||||
• | Risk adjusted discount rates: Risk-adjusted discount rates were selected for each equity class based on the rights and preferences of each equity class and market data. | ||||||||||||||||
• | Discounts: Appropriate minority or marketability discounts, if any, required to estimate the per share value of the various equity classes were determined. | ||||||||||||||||
In determining the implied fair value of our common stock in the IPO scenario, we assumed that the redeemable convertible preferred stock then outstanding would be converted into common stock. In allocating value to our common stock in the merger or sale scenario, we first allocated to our outstanding shares of redeemable convertible preferred stock the greater of the liquidation preference of the redeemable convertible preferred stock and the amount that would have been payable had all such shares of redeemable convertible preferred stock been converted to common stock. | |||||||||||||||||
There is inherent uncertainty in these estimates and, if we had made different assumptions, the fair value of the underlying common stock and amount of our stock-based compensation expense, net loss and net loss per share amounts would have differed. | |||||||||||||||||
February 12, 2014 Valuation Analysis | |||||||||||||||||
Our analysis considered the following probability-weighted scenarios: | |||||||||||||||||
Scenario | Weight | ||||||||||||||||
IPO by May 15, 2014 | 25 | % | |||||||||||||||
Sale by September 30, 2015 | 10 | % | |||||||||||||||
Private company | 50 | % | |||||||||||||||
Dissolution | 15 | % | |||||||||||||||
A discount for lack of marketability was applied for common stockholders of 8%, 20% and 28% for the IPO, sale and private company scenarios, respectively, which resulted in an implied fair value of $7.55 per share. The increase in fair value of our common stock from December 31, 2013 was primarily related to the increase in likelihood of an IPO scenario based on progress toward a public offering, coupled with a slight decrease in discount for lack of marketability for the IPO and sale scenarios. These were partially offset by dilution from the issuance of additional shares of our senior redeemable convertible preferred stock in January 2014. | |||||||||||||||||
March 31, 2014 Valuation Analysis | |||||||||||||||||
Our analysis considered the following probability-weighted scenarios: | |||||||||||||||||
Scenario | Weight | ||||||||||||||||
IPO by April 15, 2014 | 65 | % | |||||||||||||||
Sale by September 30, 2015 | 10 | % | |||||||||||||||
Private company | 15 | % | |||||||||||||||
Dissolution | 10 | % | |||||||||||||||
A discount for lack of marketability was applied for common stockholders of 2%, 17% and 27% for the IPO, sale and private company scenarios, respectively, which resulted in an implied fair value of $11.30 per share. The increase in fair value of our common stock from December 31, 2013 and February 12, 2014, was related to the increase in likelihood of an IPO scenario as significant progress had been completed toward a public offering and the decrease in discount for lack of marketability for the IPO scenario that reflected the proximity to the projected time to liquidity. These were slightly offset by dilution from the issuance of additional shares of our senior redeemable convertible preferred stock in January and February 2014, as applicable. | |||||||||||||||||
Total stock-based compensation expense for all stock awards recognized in our condensed consolidated statements of operations is as follows (in thousands): | |||||||||||||||||
Three Months Ended | |||||||||||||||||
March 31, | |||||||||||||||||
2014 | 2013 | ||||||||||||||||
Research and development | $ | 234 | $ | 53 | |||||||||||||
General and administrative | 201 | 52 | |||||||||||||||
Total | $ | 435 | $ | 105 | |||||||||||||
As of March 31, 2014, there was $4.5 million of total compensation cost related to unvested stock option awards not yet recognized, which is expected to be recognized over a remaining weighted-average vesting period of 2.7 years. |
Subsequent_Events
Subsequent Events | 3 Months Ended | |||
Mar. 31, 2014 | ||||
Subsequent Events [Abstract] | ' | |||
Subsequent Events | ' | |||
9. Subsequent Events | ||||
In April 2014, we completed an IPO selling 4,500,000 shares of our common stock at $12.00 per share and received net proceeds of $50.2 million after underwriters’ discounts and commissions. In addition, we have incurred an estimated $5.4 million in offering expenses, resulting in total costs of $9.2 million and net estimated offering proceeds to us of $44.8 million. In connection with the closing our IPO, the following events occurred subsequent to March 31, 2014: | ||||
• | the 3,501,400 and 12,508,023 outstanding shares of junior convertible preferred stock and senior redeemable convertible preferred stock, respectively, were converted into an aggregate 16,009,423 shares of common stock immediately prior to the closing of our IPO; and | |||
• | we filed an amended and restated certificate of incorporation to authorize 150,000,000 shares of capital stock, consisting of 20,000,000 shares of preferred stock and 130,000,000 shares of common stock. | |||
In May 2014, the underwriters exercised their option to purchase an additional 675,000 shares of our common stock at $12.00 per share in full. As a result, we received an additional $7.5 million in net proceeds after underwriters’ discounts and commissions, for total net proceeds of $52.4 million, net of discounts, commissions and costs, from the offering. | ||||
Our 2014 Equity Incentive Plan, or the 2014 Plan, which was adopted by our board of directors and approved by the stockholders, became effective on the close of the IPO and replaces the 2012 Plan with respect to future awards. Shares available for grant under the 2014 Plan includes any shares remaining available or becoming available in the future under the 2012 Plan due to cancellation or forfeiture, or 85,455 shares at the closing of the IPO. In addition, the 2014 Plan provides for annual increases in the number of shares available for issuance thereunder beginning upon the effective date of our IPO, and on each annual anniversary of the effective date of the IPO, equal to the lower of: | ||||
• | 1,200,000 shares of our common stock; | |||
• | 3% of the outstanding shares of our common stock on the second-to-the-last day prior to each anniversary date of the effectiveness of our IPO; or | |||
• | an amount as our board of directors may determine. |
Description_of_Business_and_Ba1
Description of Business and Basis of Financial Statements (Policies) | 3 Months Ended | ||||||||
Mar. 31, 2014 | |||||||||
Accounting Policies [Abstract] | ' | ||||||||
Unaudited Interim Financial Information | ' | ||||||||
Unaudited Interim Financial Information | |||||||||
The accompanying condensed consolidated balance sheet as of March 31, 2014, condensed consolidated statements of operations, comprehensive loss, and cash flows for the three months ended March 31, 2014 and 2013 are unaudited. The financial data and other information disclosed in these notes related to the three months ended March 31, 2014 and 2013 are unaudited. The results for the three months ended March 31, 2014 are not necessarily indicative of results to be expected for the year ending December 31, 2014, any other interim or any future year or period. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto for the year ended December 31, 2013, included in our final prospectus filed with the Securities and Exchange Commission on April 16, 2014 relating to our Registration Statement on Form S-1 (File No. 333-191711) for our initial public offering, or IPO. | |||||||||
Basis of Presentation and Consolidation | ' | ||||||||
Basis of Presentation and Consolidation | |||||||||
The accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (GAAP) and the rules and regulations of the Securities and Exchange Commission, or the SEC, related to a quarterly report on Form 10-Q. Certain information and note disclosures normally included in annual financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to those rules and regulations. The condensed consolidated balance sheet as of December 31, 2013 included in this report has been derived from the audited consolidated financial statements included in the Form S-1. The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the annual audited consolidated financial statements and, in the opinion of management, reflect all adjustments that are necessary for a fair statement of the financial position, results of operations and cash flows for the periods presented. All such adjustments are of a normal and recurring nature. Certain reclassifications have been made to the prior period amounts to conform to the current presentation. | |||||||||
The unaudited interim condensed consolidated financial statements include the accounts of Vital Therapies, Inc. and its wholly-owned subsidiaries located in the United Kingdom (currently inactive) and China. All intercompany accounts and transactions have been eliminated in consolidation. We manage our operations as a single segment for the purposes of assessing performance and making operating decisions. | |||||||||
Liquidity | ' | ||||||||
Liquidity | |||||||||
We have incurred losses since inception and negative cash flows from operating activities for the three months ended March 31, 2014. As of March 31, 2014, we had working capital of $43.6 million and a deficit accumulated during the development stage of $113.9 million. In April 2014, we completed an IPO selling 4,500,000 shares of our common stock at $12.00 per share with the underwriters exercising their option to purchase an additional 675,000 shares for $12.00 per share in May 2014 for total estimated net proceeds of $52.4 million (see Note 9). We anticipate that we will continue to incur net losses into the foreseeable future as we work toward completing the ELAD System’s clinical development through the clinical trial process and expand our corporate and manufacturing infrastructure. | |||||||||
We plan to continue to fund our losses from operations and capital funding needs through future debt and equity financings. If we are not able to secure adequate additional capital funding, we may be forced to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible, or suspend or curtail planned programs. Any of these actions could materially harm our business, results of operations, and future prospects. | |||||||||
Use of Estimates | ' | ||||||||
Use of Estimates | |||||||||
The preparation of financial statements in conformity with GAAP requires us to make certain estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Actual results could differ materially from those estimates and assumptions. | |||||||||
Cash and Cash Equivalents | ' | ||||||||
Cash and Cash Equivalents | |||||||||
Cash and cash equivalents consist of cash and highly-liquid investments with original maturities of three months or less when acquired and are stated at cost, which approximates market value. | |||||||||
Restricted Cash | ' | ||||||||
Restricted Cash | |||||||||
Restricted cash relates to amounts reserved for various clinical trial obligations and lease arrangements at March 31, 2014 and December 31, 2013, as well as for certain provisions of the junior preferred stock agreement at December 31, 2013. | |||||||||
Fair Value of Financial Instruments | ' | ||||||||
Fair Value of Financial Instruments | |||||||||
Fair value is defined as the price that would be received to sell an asset or be paid to transfer a liability in an orderly transaction between market participants on the measurement date. Accounting guidance establishes a fair value hierarchy that requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. The standard describes three levels of inputs that may be used to measure fair value: | |||||||||
Level 1—Quoted prices in active markets for identical assets or liabilities. Our Level 1 assets consisted of money market funds for the periods presented. We had no Level 1 liabilities for any period presented. | |||||||||
Level 2—Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities, quoted prices in markets with insufficient volume or infrequent transactions (less active markets), or model-derived valuations in which all significant inputs are observable or can be derived principally from or corroborated with observable market data for substantially the full term of the assets or liabilities. We had no Level 2 assets or liabilities for any period presented. | |||||||||
Level 3—Unobservable inputs to the valuation methodology that are significant to the measurement of the fair value of assets or liabilities. Our Level 3 liabilities consisted of future purchase rights liabilities during the periods presented. We had no Level 3 assets in any period presented. We estimated the fair value of the future purchase rights using a binomial lattice model depending on the underlying attributes of the future purchase rights, as applicable. See “Future Purchase Rights Liabilities” below. | |||||||||
The carrying value of cash and cash equivalents, restricted cash, other current assets and prepaid expenses, accounts payable, and accrued expenses approximate fair value due to the short period of time to maturity. | |||||||||
Deferred Financing Costs | ' | ||||||||
Deferred Financing Costs | |||||||||
Deferred financing costs represent direct costs associated with the future issuance of our corporate securities. Direct costs include, but are not limited to the legal, accounting and printing costs. Indirect costs, associated with the future issuance of corporate securities are expensed as incurred. The deferred financing costs will be offset against the proceeds from our IPO in April 2014 (see Note 9). | |||||||||
Property and Equipment, Depreciation and Amortization | ' | ||||||||
Property and Equipment, Depreciation and Amortization | |||||||||
Property and equipment are recorded at cost and depreciated using the straight-line method over the estimated useful lives of the assets (generally three to five years). Leasehold improvements are stated at cost and amortized on a straight-line basis over the lesser of the remaining term of the related lease or the estimated useful lives of the assets. Construction in progress is not depreciated until the underlying asset is available to be placed in service. Repairs and maintenance costs are charged to expense as incurred. | |||||||||
Impairment of Long-lived Assets | ' | ||||||||
Impairment of Long-lived Assets | |||||||||
Long-lived assets consist primarily of property and equipment. An impairment loss is recorded if and when events and circumstances indicate that assets might be impaired and the undiscounted cash flows estimated to be generated by those assets are less than the carrying amount of those assets. While our current and historical operating losses and negative cash flows are indicators of impairment, we believe that our expected future cash flows to be received support the carrying value of our long-lived assets and, accordingly, have not recognized any impairment losses through March 31, 2014. | |||||||||
Redeemable Convertible Preferred Stock | ' | ||||||||
Redeemable Convertible Preferred Stock | |||||||||
Our junior convertible and senior redeemable convertible preferred stock are classified as mezzanine equity instead of a component of stockholders’ deficit in accordance with authoritative guidance for the classification and measurement of potentially redeemable securities, as the preferred stock is conditionally redeemable at the holder’s option or upon certain change in control events that are outside our control, including liquidation, sale, or transfer of control of the company. | |||||||||
Future Purchase Rights Liabilities | ' | ||||||||
Future Purchase Rights Liabilities | |||||||||
Our future purchase rights liabilities are recorded at their estimated fair value on the date of issuance as a discount on the underlying preferred stock and are remeasured to reflect changes in the estimated fair value at each reporting date, with any decrease or increase in the estimated fair value being recorded as other income or expense, respectively. The fair value of these liabilities is estimated using a binomial lattice model that is based on the characteristics of the common and preferred stock on the valuation date, probabilities related to our operations and clinical development, as well as assumptions for volatility, remaining expected life, risk-free interest rate and, in some cases, credit spread. Changes in the fair value of the future purchase rights fluctuate in conjunction with increases or decreases in the fair value of our common stock, and the number of preferred and common shares and future purchase rights outstanding relative to our enterprise value at each reporting date. | |||||||||
Revenues and Cost of Revenues | ' | ||||||||
Revenues and Cost of Revenues | |||||||||
Revenues to date relate to compassionate use treatment for patients and are recognized when the product is shipped and the risks and rewards of ownership have transferred to the hospital administering the treatments. Shipping charges billed to hospitals are included in revenues and the related shipping costs are included in cost of revenues. Cost of revenues consists of direct materials costs incurred during the manufacturing of the ELAD cartridges. Revenues and cost of revenues have not been significant to date. | |||||||||
Research and Development | ' | ||||||||
Research and Development | |||||||||
Research and development costs consist primarily of employee-related expenses, contractors, clinical trial sites and contract research organizations engaged in the development of the ELAD System, expenses associated with obtaining regulatory approvals, and the cost of acquiring and manufacturing clinical trial materials. All research and development costs are expensed as incurred. | |||||||||
Stock-based Compensation | ' | ||||||||
Stock-based Compensation | |||||||||
We measure and recognize compensation expense for all stock-based payments made to employees and directors based on estimated fair value, net of an estimated forfeiture rate, and to consultants based on estimated fair value. Currently, our stock-based awards consist only of stock options; however, future grants under our equity compensation plans may consist of shares of restricted stock and restricted stock units. We estimate the fair value of stock options granted using the Black-Scholes-Merton, or BSM, option pricing model, which requires the use of estimates to value employee stock-based compensation at the date of grant. | |||||||||
We recognize stock-based compensation cost for employees and directors on a straight-line basis over the requisite service period of the award. Stock-based compensation expense is recognized only for those awards that are ultimately expected to vest. We estimate forfeitures based on an analysis of our historical employee turnover and will continue to evaluate the appropriateness of the forfeiture rate based on actual forfeiture experience, analysis of employee turnover and other factors. We will revise the forfeiture estimate, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Changes in forfeiture estimates, which have not been material to date, impact compensation cost in the period in which the change in estimate occurs. | |||||||||
The fair value of options granted to consultants is estimated using the BSM option pricing model and is remeasured at each reporting date with changes in fair value recognized as expense in the consolidated statements of operations. | |||||||||
The BSM option pricing model requires the input of highly subjective assumptions, including the risk-free interest rate, the expected dividend yield of our common stock, the expected volatility of the price of our common stock, and the expected term of the option. These estimates involve inherent uncertainties and the application of management’s judgment. If factors change and different assumptions are used, our stock-based compensation expense could be materially different in the future. These assumptions are estimated as follows: | |||||||||
Risk-free Interest Rate | |||||||||
We base the risk-free interest rate assumption on zero-coupon U.S. treasury instruments appropriate for the expected term of the stock option grants. | |||||||||
Expected Dividend Yield | |||||||||
We base the expected dividend yield assumption on the fact that we have never paid cash dividends and have no present intention to pay cash dividends. Consequently, we used an expected dividend yield of zero. | |||||||||
Expected Volatility | |||||||||
As we do not have a trading history for our common stock, the expected stock price volatility for our common stock is estimated based on volatilities of a peer group of similar companies by taking the average historic price volatility for these peers for a period equivalent to the expected term of the stock option grants. The peer group was developed based on companies in the biotechnology industry whose shares are publicly-traded. | |||||||||
Expected Term | |||||||||
The expected term represents the period of time that options are expected to be outstanding. As we do not have sufficient historical experience for determining the expected term of the stock option awards granted we determined the expected life assumption using either the simplified method, which is an average of the contractual term of the option and its ordinary vesting period, or the comparable average expected term utilizing those companies in the peer group noted above, as applicable. | |||||||||
Common Stock Valuation | |||||||||
Due to the absence of a public market trading our common stock prior to the completion of our IPO in April 2014, it was necessary to estimate the fair value of the common stock underlying our stock-based awards when performing fair value calculations using the BSM option pricing model. The fair value of the common stock underlying our stock-based awards was assessed by our board of directors. All options to purchase shares of our common stock have been granted with an exercise price per share no less than the fair value per share of our common stock underlying those options on the date of grant. | |||||||||
In the absence of a public trading market for our common stock, we determined the estimated fair value of our common stock using methodologies, approaches, and assumptions consistent with the American Institute of Certified Public Accountants, or AICPA, Audit and Accounting Practice Aid Series: Valuation of Privately Held Company Equity Securities Issued as Compensation, or the AICPA Practice Aid. | |||||||||
Leases | ' | ||||||||
Leases | |||||||||
We lease all of our office space and enter into various other operating lease agreements in conducting our business. At the inception of each lease, we evaluate the lease agreement to determine whether the lease is an operating or capital lease. Some of our lease agreements may contain renewal options, tenant improvement allowances, rent holidays or rent escalation clauses. When such items are included in a lease agreement, we record a deferred rent asset or liability equal to the difference between the rent expense and future minimum lease payments due. The rent expense related to operating leases is recognized on a straight-line basis in the statements of operations over the terms of the leases. In cases where our lessor grants to us leasehold improvement allowances that reduce our rent expense, we capitalize the improvements as incurred and recognize deferred rent, which is amortized over the shorter of the lease term or the expected useful life of the improvements. | |||||||||
Comprehensive Loss | ' | ||||||||
Comprehensive Loss | |||||||||
Comprehensive loss is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources and has been reflected as a separate component of stockholders’ (deficit) equity in the accompanying condensed consolidated balance sheets. | |||||||||
Foreign Currency Translation and Transactions | ' | ||||||||
Foreign Currency Translation and Transactions | |||||||||
The functional currencies of each our subsidiaries in the United Kingdom (currently inactive) and China is the local currency. Assets and liabilities of the subsidiaries are translated at the rate of exchange at the balance sheet date. Expenses are translated at the average rate of exchange rates in effect during the reporting period. Gains and losses resulting from foreign currency translation are included in accumulated other comprehensive income in the accompanying condensed consolidated balance sheets. Gains and losses resulting from foreign currency transactions are included in the results of operations, which to date, have not been significant. | |||||||||
Income Taxes | ' | ||||||||
Income Taxes | |||||||||
We account for income taxes under the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the consolidated financial statements. Under this method, deferred tax assets and liabilities are determined on the basis of the differences between the financial statements and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. The effect of a change in tax rates on deferred tax assets and liabilities is recognized in income in the period that includes the enactment date. | |||||||||
We recognize net deferred tax assets to the extent we believe these assets are more likely than not to be realized. In making such a determination, management considers all available positive and negative evidence, including future reversals of existing taxable temporary differences, projected future taxable income, tax-planning strategies, and results of recent operations. If management determines that we would be able to realize our deferred tax assets in the future in excess of their net recorded amount, management would make an adjustment to the deferred tax asset valuation allowance, which would reduce the provision for income taxes. As of March 31, 2014 and December 31, 2013, we maintained a full valuation allowance against our entire balance of deferred tax assets. | |||||||||
We record uncertain tax positions in accordance with ASC 740 on the basis of a two-step process whereby (1) management determines whether it is more likely than not that the tax positions will be sustained on the basis of the technical merits of the position and (2) for those tax positions that meet the more-likely-than-not recognition threshold, management recognizes the largest amount of tax benefit that is more than 50 percent likely to be realized upon ultimate settlement with the related tax authority. We recognize interest and penalties related to unrecognized tax benefits, if any, within income tax expense and any accrued interest and penalties are included within the related tax liability line. | |||||||||
Net Loss Per Share | ' | ||||||||
Net Loss Per Share | |||||||||
Basic net loss per share attributable to common stockholders is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding for the period, without consideration for common stock equivalents. Excluded from the weighted-average number of shares outstanding are shares that have been issued upon the early exercise of stock options and are subject to future vesting, which was a total of 39,979 shares as of March 31, 2014. Diluted net loss per share attributable to common stockholders is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common share equivalents outstanding for the period determined using the treasury-stock method. Common stock equivalents are comprised of redeemable convertible preferred stock, warrants for the purchase of common stock, and options outstanding under our stock option plan. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding due to our net loss position. | |||||||||
Potentially dilutive securities not included in the calculation of diluted net loss per share attributable to common stockholders because to do so would be anti-dilutive are as follows (in common stock equivalent shares): | |||||||||
As of March 31, | |||||||||
2014 | 2013 | ||||||||
Redeemable convertible preferred stock | 16,009,423 | 7,325,170 | |||||||
Options to purchase common stock | 3,143,565 | 2,422,000 | |||||||
Warrants to purchase common stock | 250,646 | 250,646 |
Summary_of_Significant_Account1
Summary of Significant Accounting Policies (Tables) | 3 Months Ended | ||||||||
Mar. 31, 2014 | |||||||||
Accounting Policies [Abstract] | ' | ||||||||
Schedule of Potentially Dilutive Securities Not Included in Calculation of Diluted Net Loss per Share | ' | ||||||||
Potentially dilutive securities not included in the calculation of diluted net loss per share attributable to common stockholders because to do so would be anti-dilutive are as follows (in common stock equivalent shares): | |||||||||
As of March 31, | |||||||||
2014 | 2013 | ||||||||
Redeemable convertible preferred stock | 16,009,423 | 7,325,170 | |||||||
Options to purchase common stock | 3,143,565 | 2,422,000 | |||||||
Warrants to purchase common stock | 250,646 | 250,646 |
Other_Financial_Information_Ta
Other Financial Information (Tables) | 3 Months Ended | ||||||||
Mar. 31, 2014 | |||||||||
Organization Consolidation And Presentation Of Financial Statements [Abstract] | ' | ||||||||
Schedule of Property and Equipment, Leasehold Improvements, and Related Accumulated Depreciation and Amortization | ' | ||||||||
Property and equipment, leasehold improvements, and related accumulated depreciation and amortization were as follows (in thousands): | |||||||||
March 31, | December 31, | ||||||||
2014 | 2013 | ||||||||
Manufacturing and laboratory equipment | $ | 3,230 | $ | 3,229 | |||||
Office furniture and equipment | 112 | 112 | |||||||
Clinical equipment | 1,727 | 1,606 | |||||||
Computer equipment and software | 132 | 122 | |||||||
Leasehold improvements | 3,207 | 2,830 | |||||||
Construction in progress | 725 | 323 | |||||||
9,133 | 8,222 | ||||||||
Less: accumulated depreciation and amortization | (6,052 | ) | (5,755 | ) | |||||
Total | $ | 3,081 | $ | 2,467 | |||||
Schedule of Accrued Expenses | ' | ||||||||
Accrued expenses consist of (in thousands): | |||||||||
March 31, | December 31, | ||||||||
2014 | 2013 | ||||||||
Accrued clinical costs | $ | 3,785 | $ | 2,067 | |||||
Accrued financing costs | 672 | 496 | |||||||
Accrued compensation and related taxes | 915 | 512 | |||||||
Accrued other | 124 | 178 | |||||||
Total | $ | 5,496 | $ | 3,253 |
Fair_Value_Tables
Fair Value (Tables) | 3 Months Ended | ||||||||||||||||
Mar. 31, 2014 | |||||||||||||||||
Fair Value Disclosures [Abstract] | ' | ||||||||||||||||
Schedule of Financial Assets and Liabilities Measured at Fair Value on Recurring Basis | ' | ||||||||||||||||
The following fair value hierarchy table presents information about each major category of our financial assets and liabilities measured at fair value on a recurring basis (in thousands): | |||||||||||||||||
Fair Value Measurement at March 31, 2014 | |||||||||||||||||
Fair Value | Level 1 | Level 2 | Level 3 | ||||||||||||||
Assets | |||||||||||||||||
Cash equivalents: | |||||||||||||||||
Money market funds | $ | 44,460 | $ | 44,460 | $ | — | $ | — | |||||||||
Liabilities | |||||||||||||||||
Future purchase rights | $ | 1,472 | $ | — | $ | — | $ | 1,472 | |||||||||
Fair Value Measurement at December 31, 2013 | |||||||||||||||||
Fair Value | Level 1 | Level 2 | Level 3 | ||||||||||||||
Assets | |||||||||||||||||
Cash equivalents: | |||||||||||||||||
Money market funds | $ | 37,158 | $ | 37,158 | $ | — | $ | — | |||||||||
Liabilities | |||||||||||||||||
Future purchase rights | $ | 2,600 | $ | — | $ | — | $ | 2,600 | |||||||||
Schedule of Changes in Level 3 Future Purchase Rights Liabilities Measured at Fair Value on Recurring Basis | ' | ||||||||||||||||
The following table summarizes the changes in Level 3 future purchase rights liabilities measured at fair value on a recurring basis for the three months ended March 31, 2014 (in thousands): | |||||||||||||||||
Fair Value of | |||||||||||||||||
Future Purchase | |||||||||||||||||
Rights Liabilities | |||||||||||||||||
Balance at January 1, 2014 | $ | 2,600 | |||||||||||||||
Revaluation of future purchase rights | (1,128 | ) | |||||||||||||||
Balance at March 31, 2014 | $ | 1,472 | |||||||||||||||
Schedule of Future Purchase Rights Liabilities Using Binomial Lattice Option Pricing Model | ' | ||||||||||||||||
We valued the future purchase rights liabilities as of March 31, 2014 and December 31, 2013, using a binomial lattice option pricing model with the following assumptions: | |||||||||||||||||
March 31, | December 31, | ||||||||||||||||
2014 | 2013 | ||||||||||||||||
Common stock fair value | $ | 11.3 | $ | 5.93 | |||||||||||||
Preferred stock price | $ | 8 | $ | 8 | |||||||||||||
Volatility | 80 | % | 85 | % | |||||||||||||
Risk-free interest rate | 0.36 | % | 0.38 | % | |||||||||||||
Contractual life (years) | 1.84 | 2.08 | |||||||||||||||
Number of nodes | 22 | 25 | |||||||||||||||
Dividend yield | 0 | % | 0 | % |
Common_Stock_Tables
Common Stock (Tables) | 3 Months Ended | ||||
Mar. 31, 2014 | |||||
Equity [Abstract] | ' | ||||
Shares Reserved for Future Issuance | ' | ||||
Shares reserved for future issuance at March 31, 2014 are as follows: | |||||
Number of | |||||
Shares | |||||
Conversion of the Preferred Stock | 16,009,423 | ||||
Exercise of common stock warrants | 250,646 | ||||
Common stock options outstanding | 3,143,565 | ||||
Common stock options available for future grant | 84,500 | ||||
Total common shares reserved for future issuance | 19,488,134 | ||||
Stock_Compensation_Plans_Table
Stock Compensation Plans (Tables) | 3 Months Ended | ||||||||||||||||
Mar. 31, 2014 | |||||||||||||||||
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | ' | ||||||||||||||||
Summary of Stock Option Activity | ' | ||||||||||||||||
The following table summarizes stock option activity: | |||||||||||||||||
Options | Weighted- | Weighted- | Aggregate | ||||||||||||||
Average | Average | Intrinsic | |||||||||||||||
Exercise | Remaining | Value | |||||||||||||||
Price | Contractual | ||||||||||||||||
Term (Years) | |||||||||||||||||
Outstanding as of January 1, 2014 | 3,098,573 | $ | 6.71 | ||||||||||||||
Granted | 61,653 | $ | 8 | ||||||||||||||
Forfeited | (16,661 | ) | $ | 8.03 | |||||||||||||
Outstanding as of March 31, 2014 | 3,143,565 | $ | 6.52 | 8.57 | $ | 15,025,431 | |||||||||||
Options vested and expected to vest as of March 31, 2014 | 3,134,810 | $ | 6.52 | 8.57 | $ | 14,989,210 | |||||||||||
Options exercisable as of March 31, 2014 | 3,143,565 | $ | 6.52 | 8.57 | $ | 15,025,431 | |||||||||||
Ranges of Underlying Assumptions Used in BSM Option Pricing Model to Determine Fair Value of Stock Options Granted to Employees and Nonemployees | ' | ||||||||||||||||
The following are the ranges of underlying assumptions used in the BSM option pricing model to determine the fair value of stock options granted to employees and nonemployees: | |||||||||||||||||
Three Months Ended March 31, | |||||||||||||||||
2014 | 2013 | ||||||||||||||||
Risk-free interest rate | 0.13% - 1.6 | % | 0.2% - 0.8 | % | |||||||||||||
Expected dividend yield | 0 | % | 0 | % | |||||||||||||
Expected volatility | 81 | % | 100 | % | |||||||||||||
Expected term of options (years) | 1.0 - 6.0 | 1.0 - 5.0 | |||||||||||||||
Fair value of common stock | $ | 7.55 - $11.30 | $6.85 | ||||||||||||||
Schedule of Stock-based Compensation Expense Valuation Analysis Probability-Weighted Scenarios | ' | ||||||||||||||||
February 12, 2014 Valuation Analysis | |||||||||||||||||
Our analysis considered the following probability-weighted scenarios: | |||||||||||||||||
Scenario | Weight | ||||||||||||||||
IPO by May 15, 2014 | 25 | % | |||||||||||||||
Sale by September 30, 2015 | 10 | % | |||||||||||||||
Private company | 50 | % | |||||||||||||||
Dissolution | 15 | % | |||||||||||||||
March 31, 2014 Valuation Analysis | |||||||||||||||||
Our analysis considered the following probability-weighted scenarios: | |||||||||||||||||
Scenario | Weight | ||||||||||||||||
IPO by April 15, 2014 | 65 | % | |||||||||||||||
Sale by September 30, 2015 | 10 | % | |||||||||||||||
Private company | 15 | % | |||||||||||||||
Dissolution | 10 | % | |||||||||||||||
Schedule of Stock-based Compensation Expense for Stock Awards Recognized | ' | ||||||||||||||||
Total stock-based compensation expense for all stock awards recognized in our condensed consolidated statements of operations is as follows (in thousands): | |||||||||||||||||
Three Months Ended | |||||||||||||||||
March 31, | |||||||||||||||||
2014 | 2013 | ||||||||||||||||
Research and development | $ | 234 | $ | 53 | |||||||||||||
General and administrative | 201 | 52 | |||||||||||||||
Total | $ | 435 | $ | 105 | |||||||||||||
Description_of_Business_and_Ba2
Description of Business and Basis of Financial Statements - Additional Information (Detail) (USD $) | Mar. 31, 2014 | Dec. 31, 2013 | Apr. 30, 2014 | 9-May-14 |
Subsequent Event [Member] | Subsequent Event [Member] | |||
IPO [Member] | Underwriters [Member] | |||
Description Of Business And Basis Of Presentation [Line Items] | ' | ' | ' | ' |
Working capital during development stage | $43,600,000 | ' | ' | ' |
Deficit accumulated during development stage | -113,914,000 | -103,166,000 | ' | ' |
Common stock sold, shares | 606,238 | 606,238 | 4,500,000 | 675,000 |
Common stock sold, per share | ' | ' | $12 | $12 |
Net proceeds from IPO after underwriters' discounts, commissions and offering costs | ' | ' | ' | $52,400,000 |
Summary_of_Significant_Account2
Summary of Significant Accounting Policies - Additional Information (Detail) (USD $) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2014 | Dec. 31, 2013 | |
Summary Of Significant Accounting Policies [Line Items] | ' | ' |
Impairment losses | ' | ' |
Expected dividend yield | 0.00% | 0.00% |
Minimum [Member] | ' | ' |
Summary Of Significant Accounting Policies [Line Items] | ' | ' |
Property and equipment, estimated useful lives | '3 years | ' |
Maximum [Member] | ' | ' |
Summary Of Significant Accounting Policies [Line Items] | ' | ' |
Property and equipment, estimated useful lives | '5 years | ' |
Early Exercise of Stock Options [Member] | ' | ' |
Summary Of Significant Accounting Policies [Line Items] | ' | ' |
Shares issued upon early exercise of stock options and are subject to future vesting | 39,979 | ' |
Summary_of_Significant_Account3
Summary of Significant Accounting Policies - Schedule of Potentially Dilutive Securities Not Included in Calculation of Diluted Net Loss per Share (Detail) | 3 Months Ended | |
Mar. 31, 2014 | Mar. 31, 2013 | |
Redeemable Convertible Preferred Stock (Senior) [Member] | ' | ' |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ' | ' |
Potentially dilutive securities not included in the calculation of diluted net loss per share | 16,009,423 | 7,325,170 |
Options to Purchase Common Stock [Member] | ' | ' |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ' | ' |
Potentially dilutive securities not included in the calculation of diluted net loss per share | 3,143,565 | 2,422,000 |
Warrants to Purchase Common Stock [Member] | ' | ' |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ' | ' |
Potentially dilutive securities not included in the calculation of diluted net loss per share | 250,646 | 250,646 |
Other_Financial_Information_Sc
Other Financial Information - Schedule of Property and Equipment, Leasehold Improvements, and Related Accumulated Depreciation and Amortization (Detail) (USD $) | Mar. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Property, Plant and Equipment [Line Items] | ' | ' |
Property and equipment, gross | $9,133 | $8,222 |
Less: accumulated depreciation and amortization | -6,052 | -5,755 |
Property and equipment, net | 3,081 | 2,467 |
Manufacturing and Laboratory Equipment [Member] | ' | ' |
Property, Plant and Equipment [Line Items] | ' | ' |
Property and equipment, gross | 3,230 | 3,229 |
Office Furniture and Equipment [Member] | ' | ' |
Property, Plant and Equipment [Line Items] | ' | ' |
Property and equipment, gross | 112 | 112 |
Clinical Equipment [Member] | ' | ' |
Property, Plant and Equipment [Line Items] | ' | ' |
Property and equipment, gross | 1,727 | 1,606 |
Computer Equipment and Software [Member] | ' | ' |
Property, Plant and Equipment [Line Items] | ' | ' |
Property and equipment, gross | 132 | 122 |
Leasehold Improvements [Member] | ' | ' |
Property, Plant and Equipment [Line Items] | ' | ' |
Property and equipment, gross | 3,207 | 2,830 |
Construction in Progress [Member] | ' | ' |
Property, Plant and Equipment [Line Items] | ' | ' |
Property and equipment, gross | $725 | $323 |
Other_Financial_Information_Ad
Other Financial Information - Additional Information (Detail) (USD $) | 3 Months Ended | |
Mar. 31, 2014 | Mar. 31, 2013 | |
Property Plant And Equipment [Abstract] | ' | ' |
Depreciation and amortization expense | $297,000 | $163,000 |
Other_Financial_Information_Sc1
Other Financial Information - Schedule of Accrued Expenses (Detail) (USD $) | Mar. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Payables And Accruals [Abstract] | ' | ' |
Accrued clinical costs | $3,785 | $2,067 |
Accrued financing costs | 672 | 496 |
Accrued compensation and related taxes | 915 | 512 |
Accrued other | 124 | 178 |
Total | $5,496 | $3,253 |
Commitments_and_Contingencies_
Commitments and Contingencies - Additional Information (Detail) (USD $) | 3 Months Ended | ||
Mar. 31, 2014 | Mar. 31, 2013 | Dec. 31, 2013 | |
Commitments And Contingencies Disclosure [Abstract] | ' | ' | ' |
Non-cancellable operating lease agreements | '2017 | ' | ' |
Total rent expense under operating leases | $183,000 | $139,000 | ' |
Current deferred rent | 139,000 | ' | 142,000 |
Long-term deferred rent | $279,000 | ' | $321,000 |
Fair_Value_Schedule_of_Financi
Fair Value - Schedule of Financial Assets and Liabilities Measured at Fair Value on Recurring Basis (Detail) (Fair Value, Measurements, Recurring [Member], USD $) | Mar. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Level 1 [Member] | Future Purchase Rights [Member] | ' | ' |
Liabilities | ' | ' |
Liabilities | ' | ' |
Level 1 [Member] | Cash Equivalents [Member] | Money Market Funds [Member] | ' | ' |
Assets | ' | ' |
Assets | 44,460 | 37,158 |
Level 2 [Member] | Future Purchase Rights [Member] | ' | ' |
Liabilities | ' | ' |
Liabilities | ' | ' |
Level 2 [Member] | Cash Equivalents [Member] | Money Market Funds [Member] | ' | ' |
Assets | ' | ' |
Assets | ' | ' |
Level 3 [Member] | Future Purchase Rights [Member] | ' | ' |
Liabilities | ' | ' |
Liabilities | 1,472 | 2,600 |
Level 3 [Member] | Cash Equivalents [Member] | Money Market Funds [Member] | ' | ' |
Assets | ' | ' |
Assets | ' | ' |
Fair Value [Member] | Future Purchase Rights [Member] | ' | ' |
Liabilities | ' | ' |
Liabilities | 1,472 | 2,600 |
Fair Value [Member] | Cash Equivalents [Member] | Money Market Funds [Member] | ' | ' |
Assets | ' | ' |
Assets | $44,460 | $37,158 |
Fair_Value_Additional_Informat
Fair Value - Additional Information (Detail) (USD $) | 3 Months Ended |
Mar. 31, 2014 | |
Debt Instrument Fair Value Carrying Value [Abstract] | ' |
Fair value transfers of assets and liabilities between levels | ' |
Fair_Value_Schedule_of_Changes
Fair Value - Schedule of Changes in Level 3 Future Purchase Rights Liabilities Measured at Fair Value on Recurring Basis (Detail) (Fair Value Of Future Purchase Rights Liabilities [Member], Level 3 [Member], USD $) | 3 Months Ended |
In Thousands, unless otherwise specified | Mar. 31, 2014 |
Fair Value Of Future Purchase Rights Liabilities [Member] | Level 3 [Member] | ' |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ' |
Balance at January 1, 2014 | $2,600 |
Revaluation of future purchase rights | -1,128 |
Balance at March 31, 2014 | $1,472 |
Fair_Value_Schedule_of_Future_
Fair Value - Schedule of Future Purchase Rights Liabilities Using Binomial Lattice Option Pricing Model (Detail) (USD $) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2014 | Dec. 31, 2013 | |
Nodes | Nodes | |
Fair Value Disclosures [Abstract] | ' | ' |
Common stock fair value | $11.30 | $5.93 |
Preferred stock price | $8 | $8 |
Volatility | 80.00% | 85.00% |
Risk-free interest rate | 0.36% | 0.38% |
Contractual life (years) | '1 year 10 months 2 days | '2 years 29 days |
Number of nodes | 22 | 25 |
Dividend yield | 0.00% | 0.00% |
Redeemable_Convertible_Preferr1
Redeemable Convertible Preferred Stock - Additional Information (Detail) (USD $) | 3 Months Ended | 3 Months Ended | 1 Months Ended | 0 Months Ended | 1 Months Ended | 0 Months Ended | 3 Months Ended | 0 Months Ended | 3 Months Ended | |||
Mar. 31, 2014 | Mar. 31, 2013 | Mar. 31, 2014 | Mar. 31, 2014 | Apr. 30, 2014 | Feb. 29, 2012 | Feb. 29, 2012 | Feb. 28, 2014 | Jan. 31, 2014 | Mar. 31, 2014 | Jan. 31, 2014 | Mar. 31, 2014 | |
Minimum [Member] | Maximum [Member] | Subsequent Event [Member] | Nonredeemable Convertible Preferred Stock [Member] | Nonredeemable Convertible Preferred Stock [Member] | Redeemable Convertible Preferred Stock (Senior) [Member] | Redeemable Convertible Preferred Stock (Senior) [Member] | Redeemable Convertible Preferred Stock (Senior) [Member] | Redeemable Convertible Preferred Stock (Senior) [Member] | Redeemable Convertible Preferred Stock (Senior) [Member] | |||
Future Purchase Rights [Member] | Preferred Stock Purchase Agreement [Member] | Preferred Stock Purchase Agreement [Member] | ||||||||||
Class of Stock [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Net proceeds from issuance of preferred stock | ' | ' | ' | ' | ' | $1,500,000 | $1,300,000 | ' | ' | ' | ' | ' |
Convertible preferred stock, price per share | ' | ' | ' | ' | ' | $0.43 | ' | ' | ' | $8 | ' | $8 |
Convertible preferred stock, shares issued | ' | ' | ' | ' | ' | 3,501,400 | ' | 241,016 | 1,500,000 | ' | 555,000 | 12,508,023 |
Proceeds from issuance of preferred stock | ' | ' | ' | ' | ' | ' | ' | 1,900,000 | 12,000,000 | ' | 4,300,000 | ' |
Issuance costs | ' | ' | ' | ' | ' | ' | ' | 35,000 | 31,000 | ' | 135,000 | ' |
Deemed dividend | $22,000 | $0 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Preferred stock conversion basis | 'All outstanding junior and senior preferred stock was converted into common stock on a one to one basis | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Preferred stock, conversion ratio | ' | ' | ' | ' | 1 | ' | ' | ' | ' | ' | ' | ' |
Weighted-average exercise per share | 95.21 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Common stock warrants outstanding and exercisable | 250,646 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Common stock warrants expiration period | ' | ' | 29-Feb-16 | 30-Sep-19 | ' | ' | ' | ' | ' | ' | ' | ' |
Common_Stock_Shares_Reserved_f
Common Stock - Shares Reserved for Future Issuance (Detail) | Mar. 31, 2014 | Dec. 31, 2013 |
Equity [Abstract] | ' | ' |
Conversion of the Preferred Stock | 16,009,423 | ' |
Exercise of common stock warrants | 250,646 | ' |
Common stock options outstanding | 3,143,565 | 3,098,573 |
Common stock options available for future grant | 84,500 | ' |
Total common shares reserved for future issuance | 19,488,134 | ' |
Stock_Compensation_Plans_Addit
Stock Compensation Plans - Additional Information (Detail) (USD $) | 3 Months Ended | 0 Months Ended | 3 Months Ended | 0 Months Ended | 3 Months Ended | 0 Months Ended | 3 Months Ended | 0 Months Ended | 3 Months Ended | |||
Mar. 31, 2014 | Mar. 31, 2013 | Feb. 12, 2014 | Feb. 12, 2014 | Mar. 31, 2014 | Feb. 12, 2014 | Mar. 31, 2014 | Feb. 12, 2014 | Mar. 31, 2014 | Feb. 03, 2014 | Sep. 30, 2013 | Mar. 31, 2014 | |
IPO [Member] | IPO [Member] | Sale [Member] | Sale [Member] | Private Company [Member] | Private Company [Member] | Equity Incentive Plans [Member] | Equity Incentive Plans [Member] | Equity Incentive Plans [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Number of shares of common stock reserved for future issuance | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 84,500 |
Option grants under equity incentive plans, term | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | '10 years |
Option vesting under equity incentive plans, term | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | '4 years |
Common stock exercised | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 139,071 |
Common stock option subject to repurchase, unvested | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 39,979 |
Stock option repurchase liability | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | $201,000 |
Common stock option to purchase, granted | ' | ' | ' | ' | ' | ' | ' | ' | ' | 257,987 | ' | ' |
Options to purchase common stock exercise price | ' | ' | ' | ' | ' | ' | ' | ' | ' | $8 | $10.50 | ' |
Weighted-average grant date fair value of stock options granted | $5.17 | $4.94 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Discount for lack of marketability | ' | ' | ' | 8.00% | 2.00% | 20.00% | 17.00% | 28.00% | 27.00% | ' | ' | ' |
Fair value of per share | $11.30 | $6.85 | $7.55 | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Compensation cost related to unvested stock option awards | $4,500,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Remaining weighted-average vesting period | '2 years 8 months 12 days | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Stock_Compensation_Plans_Summa
Stock Compensation Plans - Summary of Stock Option Activity (Detail) (USD $) | 3 Months Ended |
Mar. 31, 2014 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | ' |
Options, Outstanding, Beginning balance | 3,098,573 |
Options, Granted | 61,653 |
Options, Forfeited | -16,661 |
Options, Outstanding, Ending balance | 3,143,565 |
Options vested and expected to vest, Ending balance | 3,134,810 |
Options exercisable, Ending balance | 3,143,565 |
Outstanding, Weighted Average Exercise Price, Beginning balance | $6.71 |
Granted, Weighted Average Exercise Price | $8 |
Forfeited, Weighted Average Exercise Price | $8.03 |
Outstanding, Weighted Average Exercise Price, Ending balance | $6.52 |
Options vested and expected to vest, Weighted Average Exercise Price, Ending balance | $6.52 |
Options exercisable, Weighted Average Exercise Price, Ending balance | $6.52 |
Outstanding, Weighted-Average Remaining Contractual Term (Years), Ending balance | '8 years 6 months 26 days |
Options vested and expected to vest , Weighted-Average Remaining Contractual Term (Years), Ending balance | '8 years 6 months 26 days |
Options exercisable, Weighted-Average Remaining Contractual Term (Years), Ending balance | '8 years 6 months 26 days |
Outstanding, Aggregate Intrinsic Value, Ending balance | $15,025,431 |
Options vested and expected to vest , Aggregate Intrinsic Value, Ending balance | 14,989,210 |
Options exercisable, Aggregate Intrinsic Value, Ending balance | $15,025,431 |
Stock_Compensation_Plans_Range
Stock Compensation Plans - Ranges of Underlying Assumptions Used in BSM Option Pricing Model to Determine Fair Value of Stock Options Granted to Employees and Nonemployees (Detail) (USD $) | 3 Months Ended | ||
Mar. 31, 2014 | Mar. 31, 2013 | Feb. 12, 2014 | |
Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Method Used [Line Items] | ' | ' | ' |
Risk-free interest rate, minimum | 0.13% | 0.20% | ' |
Risk-free interest rate, maximum | 1.60% | 0.80% | ' |
Expected dividend yield | 0.00% | 0.00% | ' |
Expected volatility | 81.00% | 100.00% | ' |
Fair value of common stock | $11.30 | $6.85 | $7.55 |
Minimum [Member] | ' | ' | ' |
Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Method Used [Line Items] | ' | ' | ' |
Expected term of options (years) | '1 year | '1 year | ' |
Fair value of common stock | $7.55 | ' | ' |
Maximum [Member] | ' | ' | ' |
Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Method Used [Line Items] | ' | ' | ' |
Expected term of options (years) | '6 years | '5 years | ' |
Fair value of common stock | $11.30 | ' | ' |
Stock_Compensation_Plans_Sched
Stock Compensation Plans - Schedule of Stock-based Compensation Expense Valuation Analysis Probability-Weighted Scenarios (Detail) | 0 Months Ended | 3 Months Ended |
Feb. 12, 2014 | Mar. 31, 2014 | |
IPO by May 15, 2014 [Member] | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' |
Probability-weighted scenarios, percentage | 25.00% | ' |
Sale by September 30, 2015 [Member] | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' |
Probability-weighted scenarios, percentage | 10.00% | 10.00% |
Private Company [Member] | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' |
Probability-weighted scenarios, percentage | 50.00% | 15.00% |
Dissolution [Member] | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' |
Probability-weighted scenarios, percentage | 15.00% | 10.00% |
IPO by April 15, 2014 [Member] | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' |
Probability-weighted scenarios, percentage | ' | 65.00% |
Stock_Compensation_Plans_Sched1
Stock Compensation Plans - Schedule of Stock-Based Compensation Expense for Stock Awards Recognized (Detail) (USD $) | 3 Months Ended | 130 Months Ended | |
In Thousands, unless otherwise specified | Mar. 31, 2014 | Mar. 31, 2013 | Mar. 31, 2014 |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ' | ' | ' |
Stock-based compensation expense | $435 | $105 | $1,762 |
Research and Development [Member] | ' | ' | ' |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ' | ' | ' |
Stock-based compensation expense | 234 | 53 | ' |
General and Administrative [Member] | ' | ' | ' |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ' | ' | ' |
Stock-based compensation expense | $201 | $52 | ' |
Subsequent_Events_Additional_I
Subsequent Events - Additional Information (Detail) (USD $) | Mar. 31, 2014 | Dec. 31, 2013 | Mar. 31, 2014 | Dec. 31, 2013 | Feb. 28, 2014 | Jan. 31, 2014 | Mar. 31, 2014 | Dec. 31, 2013 | Apr. 30, 2014 | Apr. 30, 2014 | Apr. 30, 2014 | Apr. 30, 2014 | Apr. 30, 2014 | 9-May-14 |
Convertible Preferred Stock (Junior) [Member] | Convertible Preferred Stock (Junior) [Member] | Redeemable Convertible Preferred Stock (Senior) [Member] | Redeemable Convertible Preferred Stock (Senior) [Member] | Redeemable Convertible Preferred Stock (Senior) [Member] | Redeemable Convertible Preferred Stock (Senior) [Member] | Subsequent Event [Member] | IPO [Member] | IPO [Member] | IPO [Member] | IPO [Member] | Underwriters [Member] | |||
2014 Equity Incentive Plan [Member] | Subsequent Event [Member] | Subsequent Event [Member] | Subsequent Event [Member] | Subsequent Event [Member] | Subsequent Event [Member] | |||||||||
Convertible Preferred Stock (Junior) [Member] | Redeemable Convertible Preferred Stock (Senior) [Member] | Capital Stock [Member] | ||||||||||||
Subsequent Event [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Common stock sold, shares | 606,238 | 606,238 | ' | ' | ' | ' | ' | ' | ' | 4,500,000 | ' | ' | ' | 675,000 |
Common stock sold, per share | ' | ' | ' | ' | ' | ' | ' | ' | ' | $12 | ' | ' | ' | $12 |
Net proceeds from IPO after underwriters' discounts and commissions | ' | ' | ' | ' | ' | ' | ' | ' | ' | $50,200,000 | ' | ' | ' | $7,500,000 |
Estimated offering expenses | ' | ' | ' | ' | ' | ' | ' | ' | ' | 5,400,000 | ' | ' | ' | ' |
Total costs | ' | ' | ' | ' | 35,000 | 31,000 | ' | ' | ' | 9,200,000 | ' | ' | ' | ' |
Net estimated offering proceeds | ' | ' | ' | ' | ' | ' | ' | ' | ' | 44,800,000 | ' | ' | ' | ' |
Shares converted | ' | ' | 3,501,400 | 3,501,400 | ' | ' | 12,508,023 | 10,212,007 | ' | ' | 3,501,400 | 12,508,023 | ' | ' |
Preferred stock converted into common stock | ' | ' | ' | ' | ' | ' | ' | ' | ' | 16,009,423 | ' | ' | ' | ' |
Authorized shares of capital stock | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 150,000,000 | ' |
Shares of preferred stock authorized | 25,000,000 | 25,000,000 | ' | ' | ' | ' | ' | ' | ' | 20,000,000 | ' | ' | ' | ' |
Shares of common stock authorized | 29,250,000 | 29,250,000 | ' | ' | ' | ' | ' | ' | ' | 130,000,000 | ' | ' | ' | ' |
Net proceeds from IPO after underwriters' discounts, commissions and offering costs | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | $52,400,000 |
Shares available for grant at the closing of IPO | 84,500 | ' | ' | ' | ' | ' | ' | ' | 85,455 | ' | ' | ' | ' | ' |
Shares of common stock for annual increase in shares available for issuance | ' | ' | ' | ' | ' | ' | ' | ' | 1,200,000 | ' | ' | ' | ' | ' |
Percentage of outstanding shares of common stock for annual increase in shares available for issuance | ' | ' | ' | ' | ' | ' | ' | ' | 3.00% | ' | ' | ' | ' | ' |