Document_and_Entity_Informatio
Document and Entity Information | 9 Months Ended | |
Sep. 30, 2013 | Nov. 07, 2013 | |
Document Information [Line Items] | ' | ' |
Document Type | '10-Q | ' |
Amendment Flag | 'false | ' |
Document Period End Date | 30-Sep-13 | ' |
Document Fiscal Year Focus | '2013 | ' |
Document Fiscal Period Focus | 'Q3 | ' |
Trading Symbol | 'PBYI | ' |
Entity Registrant Name | 'PUMA BIOTECHNOLOGY, INC. | ' |
Entity Central Index Key | '0001401667 | ' |
Current Fiscal Year End Date | '--12-31 | ' |
Entity Filer Category | 'Accelerated Filer | ' |
Entity Common Stock, Shares Outstanding | ' | 28,689,304 |
Condensed_Consolidated_Balance
Condensed Consolidated Balance Sheets (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
In Thousands, unless otherwise specified | ||
Current assets: | ' | ' |
Cash and cash equivalents | $51,261 | $137,408 |
Marketable securities | 44,377 | ' |
Licensor receivable | 11,294 | 10,612 |
Prepaid expenses and other assets | 3,644 | 952 |
Total current assets | 110,576 | 148,972 |
Property and equipment, net | 1,619 | 1,479 |
Deposits | 1,701 | 36 |
Restricted cash | 1,213 | 1,212 |
Total assets | 115,109 | 151,699 |
Current liabilities: | ' | ' |
Accounts payable | 9,730 | 482 |
Accrued expenses | 9,496 | 21,219 |
Total current liabilities | 19,226 | 21,701 |
Deferred rent | 1,123 | 1,089 |
Total liabilities | 20,349 | 22,790 |
Stockholders' equity: | ' | ' |
Common stock - $.0001 par value; 100,000,000 shares authorized; 28,689,304 issued and outstanding at September 30, 2013 and 28,676,666 issued and outstanding at December 31, 2012 | 3 | 3 |
Additional paid-in capital | 218,070 | 213,498 |
Accumulated other comprehensive loss | -8 | ' |
Deficit accumulated during the development stage | -123,305 | -84,592 |
Total stockholders' equity | 94,760 | 128,909 |
Total liabilities and stockholders' equity | $115,109 | $151,699 |
Condensed_Consolidated_Balance1
Condensed Consolidated Balance Sheets (Parenthetical) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
Common stock, par value | $0.00 | $0.00 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares issued | 28,689,304 | 28,676,666 |
Common stock, shares outstanding | 28,689,304 | 28,676,666 |
Condensed_Consolidated_Stateme
Condensed Consolidated Statements of Operations (USD $) | 3 Months Ended | 9 Months Ended | 36 Months Ended | ||
In Thousands, except Share data, unless otherwise specified | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 |
Operating expenses: | ' | ' | ' | ' | ' |
General and administrative | $2,263 | $8,094 | $6,804 | $11,149 | $40,956 |
Research and development | 12,068 | 17,779 | 32,040 | 41,354 | 82,502 |
Totals | 14,331 | 25,873 | 38,844 | 52,503 | 123,458 |
Loss from operations | -14,331 | -25,873 | -38,844 | -52,503 | -123,458 |
Other income (expenses): | ' | ' | ' | ' | ' |
Interest income | 9 | 14 | 128 | 63 | 230 |
Other income (expense) | 39 | ' | 3 | ' | -77 |
Totals | 48 | 14 | 131 | 63 | 153 |
Net loss | -14,283 | -25,859 | -38,713 | -52,440 | -123,305 |
Net loss applicable to common stock | ($14,283) | ($25,859) | ($38,713) | ($52,440) | ($123,305) |
Net loss per common share-basic and diluted | ($0.50) | ($1.29) | ($1.35) | ($2.62) | ' |
Weighted-average common shares outstanding-basic and diluted | 28,682,055 | 20,040,000 | 28,678,439 | 20,040,000 | ' |
Condensed_Consolidated_Stateme1
Condensed Consolidated Statements of Comprehensive Loss (USD $) | 3 Months Ended | 9 Months Ended | 36 Months Ended | ||
In Thousands, unless otherwise specified | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 |
Net loss | ($14,283) | ($25,859) | ($38,713) | ($52,440) | ($123,305) |
Other comprehensive loss | ' | ' | ' | ' | ' |
Unrealized loss on available-for-sale securities | 66 | ' | -8 | ' | -8 |
Comprehensive loss | ($14,217) | ($25,859) | ($38,721) | ($52,440) | ($123,313) |
Condensed_Consolidated_Stateme2
Condensed Consolidated Statements of Stockholders' Equity (USD $) | Total | Private Placement | Public Offering | Common Stock | Common Stock | Common Stock | Common Stock | Additional Paid-in Capital | Additional Paid-in Capital | Additional Paid-in Capital | Accumulated Other Comprehensive Loss | Deficit Accumulated During the Development Stage |
In Thousands, except Share data | USD ($) | USD ($) | USD ($) | USD ($) | Cash | Private Placement | Public Offering | USD ($) | Private Placement | Public Offering | USD ($) | USD ($) |
USD ($) | USD ($) | USD ($) | USD ($) | |||||||||
Beginning Balance at Sep. 15, 2010 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Issuance of common stock (in shares) | ' | ' | ' | ' | 4,000,000 | ' | ' | ' | ' | ' | ' | ' |
Paid-in capital | $7 | ' | ' | ' | ' | ' | ' | $7 | ' | ' | ' | ' |
Net loss | -7 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | -7 |
Ending Balance at Dec. 31, 2010 | ' | ' | ' | ' | ' | ' | ' | 7 | ' | ' | ' | -7 |
Ending Balance (in shares) at Dec. 31, 2010 | ' | ' | ' | 4,000,000 | ' | ' | ' | ' | ' | ' | ' | ' |
Issuance of common stock (in shares) | ' | ' | ' | ' | ' | 16,000,000 | ' | ' | ' | ' | ' | ' |
Paid-in capital | 61 | ' | ' | ' | ' | ' | ' | 61 | ' | ' | ' | ' |
Issuance of common stock | ' | 56,741 | ' | ' | ' | 2 | ' | ' | 56,739 | ' | ' | ' |
Conversion of stockholder's note payable to equity (in shares) | ' | ' | ' | 40,000 | ' | ' | ' | ' | ' | ' | ' | ' |
Conversion of stockholder's note payable to equity | 150 | ' | ' | ' | ' | ' | ' | 150 | ' | ' | ' | ' |
Stock option compensation | 67 | ' | ' | ' | ' | ' | ' | 67 | ' | ' | ' | ' |
Anti-dilutive warrant | 7,586 | ' | ' | ' | ' | ' | ' | 7,586 | ' | ' | ' | ' |
Net loss | -10,233 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | -10,233 |
Ending Balance at Dec. 31, 2011 | 54,372 | ' | ' | 2 | ' | ' | ' | 64,610 | ' | ' | ' | -10,240 |
Ending Balance (in shares) at Dec. 31, 2011 | ' | ' | ' | 20,040,000 | ' | ' | ' | ' | ' | ' | ' | ' |
Issuance of common stock (in shares) | ' | ' | ' | ' | ' | ' | 8,625,000 | ' | ' | ' | ' | ' |
Issuance of common stock | ' | ' | 129,214 | ' | ' | ' | 1 | ' | ' | 129,213 | ' | ' |
Stock option compensation | 1,408 | ' | ' | ' | ' | ' | ' | 1,408 | ' | ' | ' | ' |
Anti-dilutive warrant | 18,222 | ' | ' | ' | ' | ' | ' | 18,222 | ' | ' | ' | ' |
Exercises of stock options (in shares) | ' | ' | ' | 11,666 | ' | ' | ' | ' | ' | ' | ' | ' |
Exercises of stock options | 45 | ' | ' | ' | ' | ' | ' | 45 | ' | ' | ' | ' |
Net loss | -74,352 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | -74,352 |
Ending Balance at Dec. 31, 2012 | 128,909 | ' | ' | 3 | ' | ' | ' | 213,498 | ' | ' | ' | -84,592 |
Ending Balance (in shares) at Dec. 31, 2012 | ' | ' | ' | 28,676,666 | ' | ' | ' | ' | ' | ' | ' | ' |
Unrealized loss on available for sale securities | -8 | ' | ' | ' | ' | ' | ' | ' | ' | ' | -8 | ' |
Stock option compensation | 4,426 | ' | ' | ' | ' | ' | ' | 4,426 | ' | ' | ' | ' |
Exercises of stock options (in shares) | ' | ' | ' | 12,638 | ' | ' | ' | ' | ' | ' | ' | ' |
Exercises of stock options | 146 | ' | ' | ' | ' | ' | ' | 146 | ' | ' | ' | ' |
Net loss | -38,713 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | -38,713 |
Ending Balance at Sep. 30, 2013 | $94,760 | ' | ' | $3 | ' | ' | ' | $218,070 | ' | ' | ($8) | ($123,305) |
Ending Balance (in shares) at Sep. 30, 2013 | ' | ' | ' | 28,689,304 | ' | ' | ' | ' | ' | ' | ' | ' |
Condensed_Consolidated_Stateme3
Condensed Consolidated Statements of Stockholders' Equity (Parenthetical) (USD $) | 3 Months Ended | 12 Months Ended | |
Dec. 31, 2010 | Dec. 31, 2012 | Dec. 31, 2011 | |
Issuance of common stock, per share | $0.00 | $16 | $3.75 |
Condensed_Consolidated_Stateme4
Condensed Consolidated Statements of Cash Flows (USD $) | 9 Months Ended | 36 Months Ended | |
In Thousands, unless otherwise specified | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 |
Operating activities: | ' | ' | ' |
Net loss | ($38,713) | ($52,440) | ($123,305) |
Adjustments to reconcile net loss to net cash used in operating activities: | ' | ' | ' |
Depreciation and amortization | 298 | 187 | 574 |
Build-out allowance received from landlord | ' | 237 | 903 |
Stock option expense | 4,426 | 820 | 5,901 |
Anti-dilutive warrant | ' | 6,250 | 25,808 |
Changes in operating assets and liabilities: | ' | ' | ' |
Licensor receivable | -682 | ' | -11,294 |
Prepaid expenses and other assets | -4,357 | -489 | -5,345 |
Accounts payable | 9,248 | 931 | 9,730 |
Accrued expenses | -11,723 | 25,142 | 9,496 |
Accrual of deferred rent | 34 | 159 | 220 |
Net cash used in operating activities | -41,469 | -19,203 | -87,312 |
Investing activities: | ' | ' | ' |
Purchase of property and equipment | -435 | -437 | -1,280 |
Expenditures for leasehold improvements | -3 | -236 | -913 |
Purchase of marketable securities | -44,385 | ' | -44,385 |
Restricted cash | -1 | -159 | -1,213 |
Net cash used in investing activities | -44,824 | -832 | -47,791 |
Financing activities: | ' | ' | ' |
Proceeds from issuance of stockholder's convertible note payable | ' | ' | 150 |
Net proceeds from issuance of common stock | ' | ' | 185,955 |
Net proceeds from exercise of stock options | 146 | ' | 191 |
Capital contributions by stockholder | ' | ' | 68 |
Net cash provided by financing activities | 146 | ' | 186,364 |
Net increase (decrease) in cash and cash equivalents | -86,147 | -20,035 | 51,261 |
Cash and cash equivalents, beginning of period | 137,408 | 53,382 | ' |
Cash and cash equivalents, end of period | 51,261 | 33,347 | 51,261 |
Supplemental disclosures of non-cash investing and financing activities: | ' | ' | ' |
Conversion of stockholder's note payable to common stock | ' | ' | $150 |
Business_and_Basis_of_Presenta
Business and Basis of Presentation | 9 Months Ended |
Sep. 30, 2013 | |
Business and Basis of Presentation | ' |
Note 1—Business and Basis of Presentation: | |
Business: | |
Puma Biotechnology, Inc., or Puma, is a development stage biopharmaceutical company based in Los Angeles, California that acquires and develops innovative products for the treatment of various forms of cancer. References in these Notes to Condensed Consolidated Financial Statements to the “Company” refer to Puma Biotechnology, Inc., a private Delaware company formed on September 15, 2010, for periods prior to the Merger (as defined below), which took place on October 4, 2011, and Puma Biotechnology, Inc., a Delaware company formed on April 27, 2007, and formerly known as Innovative Acquisitions Corp., for periods following the Merger. The Company focuses on in-licensing drug candidates that are undergoing or have already completed initial clinical testing for the treatment of cancer and then seeks to further develop those drug candidates for commercial use. | |
In November 2012, the Company established and incorporated Puma Biotechnology Ltd, a wholly owned subsidiary, for the sole purpose of serving as Puma’s legal representative in the United Kingdom and the European Union in connection with Puma’s clinical trial activity in those countries. | |
Basis of Presentation: | |
The Company is a development stage enterprise since it has not yet generated any revenue from the sale of products and, through September 30, 2013, its primary focus has been the transition of operational responsibility for its lead drug candidate, PB272 (neratinib (oral)), from Pfizer, Inc., or the Licensor, to the Company (see the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2012, for details of the license agreement) along with the initiation of a Phase III clinical trial in HER2-positive metastatic breast cancer, a Phase II clinical trial in non-small cell lung cancer and a Phase II clinical trial in HER2-mutation positive solid tumors. The accompanying unaudited condensed consolidated interim financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America, or GAAP, pursuant to the rules and regulations of the Securities and Exchange Commission, or the SEC, for interim financial information. Accordingly, the financial statements do not include all information and footnotes required by GAAP for complete annual financial statements. In the opinion of management, the accompanying unaudited condensed consolidated interim financial statements reflect all adjustments, consisting of normal recurring adjustments, considered necessary for a fair presentation. Interim operating results are not necessarily indicative of results that may be expected for the year ending December 31, 2013, or for any subsequent period. These unaudited condensed consolidated interim financial statements should be read in conjunction with the Company’s audited financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2012. The condensed consolidated balance sheet at December 31, 2012, has been derived from the audited financial statements included in the Annual Report on Form 10-K for the fiscal year ended December 31, 2012. | |
The Company has reported a net loss of approximately $14.3 million and $38.8 million and negative cash flows from operations of approximately $12.0 million and $41.5 million for the three and nine months ended September 30, 2013, respectively. The net loss from the date of inception, September 15, 2010, to September 30, 2013, amounted to approximately $123.3 million while the negative cash flows from operations from the date of inception amounted to approximately $87.3 million. Currently, the Company’s negative cash flows from operations are being adversely impacted by a timing difference related to the payment of “cap cost” expenses to vendors and receipt from the Licensor for said expenses (see Note 2—Significant Accounting Policies: Research and Development Reimbursement). Management believes that the Company will continue to incur net losses and negative net cash flows from operating activities through the drug development process. | |
The Company’s continued operations will depend on its ability to raise funds through various potential sources such as equity and debt financing. Through September 30, 2013, the Company’s financing was primarily through a public offering of Company common stock and private equity placements. Given the current and desired pace of clinical development of its three product candidates, management estimates that the Company has sufficient cash on hand to fund clinical development through 2014 and into 2015. The Company will need additional financing thereafter until it can achieve profitability, if ever. The Company may choose to raise additional capital before 2015 in order to fund its future development activities. There can be no assurance that such capital will be available on favorable terms, or at all, or that any additional capital that the Company is able to obtain will be sufficient to meet its needs. If it is unable to raise additional capital, the Company could likely be forced to curtail desired development activities, which will delay the development of its product candidates. | |
Merger with Public Company: | |
On September 29, 2011, the Company entered into an agreement and plan of merger, or the Merger Agreement, with Innovative Acquisitions Corp., or IAC, and IAC’s wholly-owned subsidiary, IAC Merger Corporation, or Merger Sub. On October 4, 2011, the Company completed a reverse merger in which Merger Sub merged with and into the Company and the Company became a wholly-owned subsidiary of IAC, or the Merger. At the effective time of the Merger, the Company’s then issued and outstanding 18,666,733 shares of common stock were exchanged for 18,666,733 shares of common stock of IAC and each share of the Company’s common stock that was outstanding immediately prior to the effective time was cancelled, with one share of the Company common stock issued to IAC. Concurrently, IAC redeemed all of its shares from its pre-Merger stockholders in exchange for aggregate consideration of $40,000 paid by the Company. The Company also paid $40,000 for IAC’s professional fees associated with the Merger directly to legal counsel for IAC’s former stockholders. Following the Merger and the redemption, the Company’s prior stockholders owned the same percentage of IAC’s common stock as they held of the Company’s common stock prior to the Merger. | |
Upon completion of the Merger, the Company merged with and into IAC, and IAC adopted the Company’s business plan and changed its name to “Puma Biotechnology, Inc.” Further, upon completion of the Merger, the existing officers and directors of IAC resigned and the existing officers and directors of the Company were appointed officers and directors of IAC. | |
The Merger was accounted for as a reverse acquisition, with the Company as the accounting acquirer and IAC as the accounting acquiree. The merger of a private operating company into a non-operating public shell corporation with nominal net assets is considered to be a capital transaction, in substance, rather than a business combination for accounting purposes. Accordingly, the Company treated this transaction as a capital transaction without recording goodwill or adjusting any of its other assets or liabilities. Consideration in the amount of $80,000 paid to the former stockholders of IAC and their attorney was recorded as an other expense item and included in the Company’s net loss for the year ended December 31, 2011. |
Significant_Accounting_Policie
Significant Accounting Policies | 9 Months Ended | ||||||||||||||||
Sep. 30, 2013 | |||||||||||||||||
Significant Accounting Policies | ' | ||||||||||||||||
Note 2—Significant Accounting Policies: | |||||||||||||||||
The significant accounting policies followed in the preparation of these condensed consolidated financial statements are as follows: | |||||||||||||||||
Use of Estimates: | |||||||||||||||||
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the balance sheet and reported amounts of expenses for the period presented. Accordingly, actual results could differ from those estimates. Significant estimates include the cost of services provided by consultants who manage clinical trials and conduct research and clinical trials on behalf of the Company that are billed on a delayed basis. As the actual costs become known, the Company adjusts its estimated cost in that period. The value of stock-based compensation includes estimates based on future events which are difficult to predict. It is at least reasonably possible that a change in the estimates will occur in the near term. | |||||||||||||||||
Principles of Consolidation: | |||||||||||||||||
The condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiary. All significant intercompany balances and transactions have been eliminated in consolidation. | |||||||||||||||||
Cash and Cash Equivalents: | |||||||||||||||||
The Company considers all highly liquid investments with original maturities of three months or less to be cash equivalents. Cash equivalents are carried at cost, which approximates fair value. | |||||||||||||||||
Licensor Receivable: | |||||||||||||||||
Licensor receivable represents external “out of pocket” clinical trial costs in excess of an agreed upon “cap” for clinical trials that were ongoing at the time the licensing agreement with the Licensor was reached. The licensing agreement allows the Company to bill the Licensor for all external “out of pocket” costs in excess of the cap cost on a quarterly basis. The Licensor, per the license agreement, has 60 days to review the invoice and supporting documentation. Licensor receivable includes both invoiced and non-invoiced costs in excess of the cap. The Company has not established a reserve against this receivable (approximately $11.3 million at September 30, 2013). | |||||||||||||||||
Marketable Securities: | |||||||||||||||||
The Company classifies all investment securities (short-term and long-term) as available-for-sale, as the sale of such securities may be required prior to maturity to implement management’s strategies. These securities are carried at fair value, with the unrealized gains and losses, if material, reported as a component of accumulated other comprehensive income (loss) in stockholders’ equity until realized. Realized gains and losses from the sale of available-for-sale securities, if any, are determined on a specific identification basis. A decline in the market value of any available-for-sale security below cost that is determined to be other than temporary results in a revaluation of its carrying amount to fair value. The impairment is charged to earnings and a new cost basis for the security is established. Premiums and discounts are amortized or accreted over the life of the related security as an adjustment to yield using the straight-line method. Interest income is recognized when earned. | |||||||||||||||||
Assets Measured at Fair Value on a Recurring Basis: | |||||||||||||||||
Accounting Standards Codification, or ASC 820, Fair Value Measurement, provides a single definition of fair value and a common framework for measuring fair value as well as new disclosure requirements for fair value measurements used in financial statements. Under ASC 820, fair value is determined based upon the exit price that would be received by a company to sell an asset or paid by a company to transfer a liability in an orderly transaction between market participants, exclusive of any transaction costs. Fair value measurements are determined by either the principal market or the most advantageous market. The principal market is the market with the greatest level of activity and volume for the asset or liability. Absent a principal market to measure fair value, the Company uses the most advantageous market, which is the market from which the Company would receive the highest selling price for the asset or pay the lowest price to settle the liability, after considering transaction costs. However, when using the most advantageous market, transaction costs are only considered to determine which market is the most advantageous and these costs are then excluded when applying a fair value measurement. ASC 820 creates a three-level hierarchy to prioritize the inputs used in the valuation techniques to derive fair values. The basis for fair value measurements for each level within the hierarchy is described below, with Level 1 having the highest priority and Level 3 having the lowest. | |||||||||||||||||
Level 1: | Quoted prices in active markets for identical assets or liabilities. | ||||||||||||||||
Level 2: | Quoted prices for similar assets or liabilities in active markets; quoted prices for identical or similar instruments in markets that are not active; and model-derived valuations in which all significant inputs are observable in active markets. | ||||||||||||||||
Level 3: | Valuations derived from valuation techniques in which one or more significant inputs are unobservable. | ||||||||||||||||
Following are the major categories of assets measured at fair value on a recurring basis as of September 30, 2013 and December 31, 2012, using quoted prices in active markets for identical assets (Level 1), significant other observable inputs (Level 2), and significant unobservable inputs (Level 3) (in thousands): | |||||||||||||||||
September 30, 2013 | Level 1 | Level 2 | Level 3 | Total | |||||||||||||
Cash equivalents | $ | 50,584 | $ | — | $ | — | $ | 50,584 | |||||||||
Corporate bonds | — | 44,377 | — | 44,377 | |||||||||||||
Total | $ | 50,584 | $ | 44,377 | $ | — | $ | 94,961 | |||||||||
December 31, 2012 | Level 1 | Level 2 | Level 3 | Total | |||||||||||||
Cash equivalents | $ | 134,867 | $ | — | $ | — | $ | 134,867 | |||||||||
Total | $ | 134,867 | $ | — | $ | — | $ | 134,867 | |||||||||
The Company’s investments in short-term investment securities are exposed to price fluctuations. The fair value measurements for short-term investment securities are based upon the quoted price in active markets multiplied by the number of securities owned, exclusive of any transaction costs and without any adjustments to reflect discounts that may be applied to selling a large block of securities at one time. | |||||||||||||||||
Concentration of Risk: | |||||||||||||||||
Financial instruments, which potentially subject the Company to concentrations of credit risk, principally consist of cash and cash equivalents. The Company’s cash and cash equivalents in excess of the Federal Deposit Insurance Corporation and the Securities Investor Protection Corporation insured limits at September 30, 2013, were approximately $52.6 million. The Company does not believe it is exposed to any significant credit risk. | |||||||||||||||||
Property and Equipment: | |||||||||||||||||
Property and equipment are recorded at cost and depreciated over estimated useful lives ranging from three to five years using the straight-line method. Leasehold improvements are recorded at cost and amortized over the shorter of their useful lives or the term of the lease by use of the straight-line method. Maintenance and repair costs are charged to operations as incurred. | |||||||||||||||||
The Company assesses the impairment of long-lived assets, primarily property and equipment, whenever events or changes in business circumstances indicate that carrying amounts of the assets may not be fully recoverable. When such events occur, management determines whether there has been impairment by comparing the asset’s carrying value with its fair value, as measured by the anticipated undiscounted net cash flows of the asset. Should impairment exist, the asset is written down to its estimated fair value. The Company has not recognized any impairment losses through September 30, 2013. | |||||||||||||||||
Research and Development Expenses: | |||||||||||||||||
Research and development expenses are charged to operations as incurred. The major components of research and development costs include clinical manufacturing costs, clinical trial expenses, consulting and other third-party costs, salaries and employee benefits, stock-based compensation expense, supplies and materials, and allocations of various overhead costs. Clinical trial expenses include, but are not limited to, investigator fees, site costs, comparator drug costs, and clinical research organization, or CRO, costs. In the normal course of business, the Company contracts with third parties to perform various clinical trial activities in the ongoing development of potential products. The financial terms of these agreements are subject to negotiation and variations from contract to contract and may result in uneven payment flows. Payments under the contracts depend on factors such as the achievement of certain events, the successful enrollment of patients and the completion of portions of the clinical trial or similar conditions. The Company’s cost accruals for clinical trials are based on estimates of the services received and efforts expended pursuant to contracts with numerous clinical trial sites, cooperative groups and CROs. The objective of the Company’s accrual policy is to match the recording of expenses in the condensed consolidated financial statements to the actual services received and efforts expended. As actual costs become known, the Company adjusts its accruals in that period. | |||||||||||||||||
In instances where the Company enters into agreements with third parties for clinical trials and other consulting activities, upfront amounts are recorded to prepaid expenses and deposits in the accompanying condensed consolidated balance sheets and expensed as services are performed or as the underlying goods are delivered. If the Company does not expect the services to be rendered or goods to be delivered, any remaining capitalized amounts for non-refundable upfront payments are charged to expense immediately. Amounts due under such arrangements may be either fixed fee or fee for service, and may include upfront payments, monthly payments and payments upon the completion of milestones or receipt of deliverables. | |||||||||||||||||
Costs related to the acquisition of technology rights and patents for which development work is still in process are charged to operations as incurred and considered a component of research and development costs. | |||||||||||||||||
Research and Development Reimbursement: | |||||||||||||||||
The licensing agreement set a “cap” on the amount of external expenses the Company would incur, beginning January 1, 2012, in completing the clinical trials transferred from the Licensor to the Company. The license agreement stipulates that the Licensor would be responsible for all external expenses associated with the transferred clinical trials and that the Company would invoice for such costs on a quarterly basis. The Licensor has 60 days to review the invoice and supporting documentation. All amounts reimbursed from the Licensor represent charges for services provided by third parties and not the Company. Accordingly, the Company has elected to treat the reimbursed costs as “pass-through” expenses billable to the Licensor and as an offset to research and development expenses. Research and development expenses are recorded net of any excess cap costs billed to the Licensor. The Company recognized approximately $3.4 million and $13.1 million of excess cap costs during the three months and nine months ended September 30, 2013, respectively. | |||||||||||||||||
Stock-Based Compensation: | |||||||||||||||||
Stock option awards: | |||||||||||||||||
ASC 718, Compensation-Stock Compensation, or ASC 718, requires the fair value of all share-based payments to employees, including grants of stock options, to be recognized in the statement of operations over the requisite service period. Under ASC 718, employee option grants are generally valued at the date of grant, or grant date, and those valuations do not change once they have been established. The fair value of each option award is estimated on the grant date using the Black-Scholes Option Pricing Method. As allowed by ASC 718 for companies with a short period of publicly traded stock history, the Company’s estimate of expected volatility is based on the average expected volatilities of a sampling of five companies with similar attributes to the Company, including industry, stage of life cycle, size and financial leverage. The risk-free rate for periods within the contractual life of the option is based on the U.S. Treasury yield curve in effect at the time of grant valuation. ASC 718 does not allow companies to account for option forfeitures as they occur; instead, estimated option forfeitures must be calculated when the option is granted to reduce the option expense to be recognized over the life of the award and updated upon receipt of further information as to the amount of options expected to be forfeited. Due to its limited history, the Company uses the simplified method to determine the expected life of the option grants. | |||||||||||||||||
Warrants: | |||||||||||||||||
Warrants granted to employees are normally valued at the fair value of the instrument on the grant date and are recognized in the statement of operations over the requisite service period. When the requisite service period precedes the grant date and a market condition exists in the warrant, the Company values the warrant using the Monte Carlo Simulation Method. When the terms of the warrant become fixed, the Company values the warrant using the Black-Scholes Option Pricing Method. As allowed by ASC 718 for companies with a short period of publicly traded stock history, the Company’s estimate of expected volatility is based on the average volatilities of a sampling of eight to nine companies with similar attributes to the Company, including industry, stage of life cycle, size and financial leverage. The risk-free rate for periods within the contractual life of the warrant is based on the U.S. Treasury yield curve in effect at the time of grant valuation. In determining the value of the warrant until the terms are fixed, the Company factors in the probability of the market condition occurring and several possible scenarios. When the requisite service period precedes the grant date and is deemed to be complete, the Company records the fair value of the warrant at the time of issuance as an equity stock-based compensation transaction. The warrant is revalued each reporting period up to the grant date when the final fair value of the warrant is established and recorded. The grant date is determined when all pertinent information, such as exercise price and quantity, is known. | |||||||||||||||||
Net Loss per Common Share: | |||||||||||||||||
Basic net loss per common share is computed by dividing net loss applicable to common stockholders by the weighted average number of common shares outstanding during the periods presented, as required by ASC 260, Earnings per Share. Diluted earnings per common share are the same as basic earnings per share because the assumed exercise of the Company’s outstanding options are anti-dilutive. For the three and nine months ended September 30, 2013, potentially dilutive securities excluded from the calculations were 2,373,309 shares issuable upon exercise of options and 2,116,250 shares issuable upon exercise of an outstanding warrant. For the three and nine months ended September 30, 2012, potentially dilutive securities excluded from the earnings per common share calculation were 1,422,500 shares issuable upon exercise of options. | |||||||||||||||||
Deferred Rent: | |||||||||||||||||
The Company has entered into operating lease agreements for its corporate offices in Los Angeles and South San Francisco that contain provisions for future rent increases, leasehold improvement allowances and rent abatements. The Company records monthly rent expense equal to the total of the payments due over the lease term, divided by the number of months of the lease term. The difference between the rent expense recorded and the amount paid is credited or charged to deferred rent, which is reflected as a separate line item in the accompanying condensed consolidated balance sheets. Additionally, the Company recorded as deferred rent the cost of the leasehold improvements paid by the landlord, which is amortized on a straight-line basis over the term of the lease. | |||||||||||||||||
Reclassifications: | |||||||||||||||||
Certain amounts for 2012 have been reclassified to conform to the current year’s presentation. |
Property_and_Equipment
Property and Equipment | 9 Months Ended | ||||||||
Sep. 30, 2013 | |||||||||
Property and Equipment | ' | ||||||||
Note 3—Property and Equipment: | |||||||||
Property and equipment consisted of the following (in thousands): | |||||||||
September 30, | December 31, | ||||||||
2013 | 2012 | ||||||||
Leasehold improvements | $ | 913 | $ | 910 | |||||
Computer equipment | 710 | 535 | |||||||
Telephone equipment | 57 | 34 | |||||||
Furniture and fixtures | 513 | 276 | |||||||
2,193 | 1,755 | ||||||||
Less: accumulated depreciation and amortization | (574 | ) | (276 | ) | |||||
Totals | $ | 1,619 | $ | 1,479 | |||||
Accrued_Expenses
Accrued Expenses | 9 Months Ended | ||||||||
Sep. 30, 2013 | |||||||||
Accrued Expenses | ' | ||||||||
Note 4—Accrued Expenses: | |||||||||
Accrued expenses consisted of the following (in thousands): | |||||||||
September 30, | December 31, | ||||||||
2013 | 2012 | ||||||||
Accrued CRO/licensor services | $ | 5,887 | $ | 19,846 | |||||
Accrued other clinical development | 1,371 | 389 | |||||||
Accrued legal fees | 294 | 121 | |||||||
Accrued compensation | 1,866 | 787 | |||||||
Other | 78 | 76 | |||||||
$ | 9,496 | $ | 21,219 | ||||||
Accrued CRO/licensor services represent the Company’s estimate of such costs as of September 30, 2013, and will be adjusted in the period the actual costs become known. Accrued compensation includes estimated bonus and earned but unused vacation for full-time employees. When actual performance bonuses are paid out to employees on the employee’s anniversary of hire, the bonus expense will be adjusted to reflect the actual expense for the year. Additionally, vacation is accrued at the rate the employee earns vacation and reduced as the vacation is used by the employee. |
Stockholders_Equity
Stockholders' Equity | 9 Months Ended | ||||||||||||||||
Sep. 30, 2013 | |||||||||||||||||
Stockholders' Equity | ' | ||||||||||||||||
Note 5—Stockholders’ Equity: | |||||||||||||||||
Warrants: | |||||||||||||||||
Following a private placement of the Company’s common stock in October 2011, Alan H. Auerbach, the Company’s founder, Chairman, Chief Executive Officer and President, held approximately 21% of the 18,666,733 outstanding shares of the Company’s common stock. Pursuant to the terms of the securities purchase agreement entered into in connection with this private placement, the Company issued an anti-dilutive warrant to Mr. Auerbach, as the Company’s founder. The warrant was issued to provide Mr. Auerbach with the right to maintain ownership of at least 20% of the Company’s common stock in the event that the Company raised capital through the sale of its securities in the future. | |||||||||||||||||
The warrant has a ten-year term and became exercisable upon the first subsequent financing, excluding certain types of financings set forth in the warrant, that resulted in gross cash proceeds to the Company of at least $15 million. The warrant’s exercise price equals the price per share in such financing and is exercisable for the number of shares of the Company’s common stock necessary for Mr. Auerbach to maintain ownership of at least 20% of the outstanding shares of Company common stock after such financing. The warrant may be exercised any time up to the ten-year expiration date of October 4, 2021. The Company determined that the warrant had an implied service requisite period in 2011 that was prior to its grant date. The Company also determined that a market condition subsequent to the implied service period exists as the exercise or partial exercise of the warrant could only occur if there is a subsequent financing. | |||||||||||||||||
In connection with the closing of a public offering of the Company’s common stock on October 24, 2012, the exercise price and number of shares underlying the warrant issued to Mr. Auerbach were established and, accordingly, the final value of the warrant became fixed. Pursuant to the terms of the warrant, Mr. Auerbach may exercise the warrant to acquire 2,116,250 shares of the Company’s common stock at $16.00 per share until October 4, 2021. | |||||||||||||||||
The warrant was valued at approximately $6.9 million at the time of issuance and $7.6 million at December 31, 2011, using the Monte Carlo Simulation Method, as both the exercise price per share and the number of shares were unknown at that time, and recorded to the consolidated statements of operations. The warrant was revalued at approximately $13.8 million on September 30, 2012, using the below Monte Carlo Simulation Method. The revaluation resulted in an adjustment to the fair value of approximately $6.5 million and $6.2 million, which was included in general and administrative expense in the accompanying condensed consolidated statement of operations for the three and nine months ended September 30, 2012, respectively. | |||||||||||||||||
The fair value of the warrant during the quarter ended September 30, 2012, was determined by the following assumptions using the Monte Carlo Simulation Method: | |||||||||||||||||
September 30, | |||||||||||||||||
2012 | |||||||||||||||||
Common stock price | $ | 15 | |||||||||||||||
Dividend yield | 0 | % | |||||||||||||||
Expected volatility | 75.7 | % | |||||||||||||||
Risk-free interest rate | 1.65 | % | |||||||||||||||
Warrant term in years | 10 | ||||||||||||||||
The fair value of the warrant at September 30, 2012, was estimated based on an assumption that the Company would complete an equity financing between $86 million and $100 million during October or November 2012. In conjunction with a public offering that closed in October 2012, the warrant was deemed to be granted as the quantity and exercise price of the warrant were determined to be 2,116,250 shares of the Company’s common stock at a price of $16.00 per share. | |||||||||||||||||
Once the terms of the warrant became fixed, the fair value of the warrant as of October 24, 2012, using the Black-Scholes Option Pricing Method, was approximately $25.8 million and resulted in an adjustment to the fair value of the warrant of $18.2 million for the year ended December 31, 2012. | |||||||||||||||||
Stock-Based Compensation: | |||||||||||||||||
The Company’s 2011 Incentive Award Plan, or the 2011 Plan, was adopted by the Board of Directors on September 15, 2011. Pursuant to the 2011 Plan, the Company may grant incentive stock options and nonqualified stock options, as well as other forms of equity-based compensation. Incentive stock options may be granted only to employees, while consultants, employees, officers and directors are eligible for the grant of nonqualified options under the 2011 Plan. The maximum term of stock options granted under the 2011 Plan is 10 years. The exercise price of incentive stock options granted under the 2011 Plan must be at least equal to the fair value of such shares on the date of grant. Through September 30, 2013, a total of 3,529,412 shares of the Company’s common stock have been reserved for issuance under the 2011 Plan. | |||||||||||||||||
The fair value of options granted to employees was estimated using the Black-Scholes Option Pricing Method (see Note 2—Significant Accounting Policies) with the following weighted-average assumptions used during the nine months ended September 30, 2013 and 2012: | |||||||||||||||||
Nine Months Ended | |||||||||||||||||
September 30, | |||||||||||||||||
2013 | 2012 | ||||||||||||||||
Dividend yield | 0 | % | 0 | % | |||||||||||||
Expected volatility | 85.4 | % | 85.4 | % | |||||||||||||
Risk-free interest rate | 1.3 | % | 1 | % | |||||||||||||
Expected life in years | 5.85 | 5.82 | |||||||||||||||
Employee stock-based compensation for the three and nine months ended September 30, 2013 and 2012, were as follows: | |||||||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||
2013 | 2012 | 2013 | 2012 | ||||||||||||||
(in thousands except per share data) | |||||||||||||||||
Stock-based compensation: | |||||||||||||||||
Options: | |||||||||||||||||
Research and development | $ | 1,333 | $ | 248 | $ | 3,072 | $ | 530 | |||||||||
General and administrative, or G&A | 473 | 101 | 1,354 | 290 | |||||||||||||
Warrants: G&A | — | (6,575 | ) | — | 6,250 | ||||||||||||
Total stock-based compensation expense | $ | 1,806 | $ | (6,226 | ) | $ | 4,426 | $ | 7,070 | ||||||||
Impact on basic and diluted net loss per share | $ | 0.06 | $ | (0.31 | ) | $ | 0.15 | $ | 0.35 | ||||||||
Weighted average shares (basic and diluted) | 28,682,055 | 20,040,000 | 28,678,439 | 20,040,000 | |||||||||||||
Activity with respect to options granted under the 2011 Plan is summarized as follows: | |||||||||||||||||
Shares | Weighted | Weighted Average | Aggregate | ||||||||||||||
Average | Remaining | Intrinsic Value | |||||||||||||||
Exercise | Contractual Term | (in thousands) | |||||||||||||||
Price | (years) | ||||||||||||||||
Outstanding at December 31, 2012 | 1,906,334 | $ | 8.93 | 9.4 | $ | 18,966 | |||||||||||
Granted during the nine months ended September 30, 2013 | 499,475 | 36.8 | — | — | |||||||||||||
Forfeited during the nine months ended September 30, 2013 | (19,862 | ) | 11.6 | — | — | ||||||||||||
Exercised during the nine months ended September 30, 2013 | (12,638 | ) | 11.6 | — | — | ||||||||||||
Outstanding at September 30, 2013 | 2,373,309 | 14.76 | 8.8 | $ | 90,329 | ||||||||||||
Nonvested at September 30, 2013 | 1,615,623 | $ | 19.42 | 9 | $ | 64,490 | |||||||||||
Exercisable at September 30, 2013 | 757,686 | $ | 4.82 | 8.4 | $ | 37,007 | |||||||||||
At September 30, 2013, total estimated unrecognized employee compensation cost related to non-vested stock options granted prior to that date was approximately $19.0 million, which is expected to be recognized over a weighted-average period of 2.4 years. The intrinsic value of stock options exercised during the nine months ended September 30, 2013 was approximately $486,000. The weighted-average grant date fair value of options granted during the nine months ended September 30, 2013 and 2012, was $25.95 per share and $4.63 per share, respectively. | |||||||||||||||||
Stock options | Shares | Weighted | |||||||||||||||
Average | |||||||||||||||||
Grant-Date | |||||||||||||||||
Fair Value | |||||||||||||||||
Nonvested shares at December 31, 2012 | 1,659,399 | $ | 7.03 | ||||||||||||||
Granted | 499,475 | 25.95 | |||||||||||||||
Vested/Issued | (523,389 | ) | 3.86 | ||||||||||||||
Forfeited | (19,862 | ) | 8.12 | ||||||||||||||
Nonvested shares at September 30, 2013 | 1,615,623 |
401k_Savings_Plan
401(k) Savings Plan | 9 Months Ended |
Sep. 30, 2013 | |
401(k) Savings Plan | ' |
Note 6—401(k) Savings Plan: | |
During 2012, the Company adopted a 401(k) savings plan for the benefit of its employees. The Company is required to make matching contributions to the 401(k) plan equal to 100% of the first 3% of wages deferred by each participating employee and 50% on the next 2% of wages deferred by each participating employee. The Company incurred expenses for employer matching contributions of approximately $97,000 and $200,600 for the three and nine months ended September 30, 2013, respectively. For the three and nine months ended September 30, 2012, the Company incurred expenses for employer matching contributions of approximately $40,800 and $97,400, respectively. |
Marketable_Securities
Marketable Securities | 9 Months Ended | ||||||||||||||||
Sep. 30, 2013 | |||||||||||||||||
Marketable Securities | ' | ||||||||||||||||
Note 7—Marketable Securities: | |||||||||||||||||
Marketable securities consist primarily of corporate bonds and are classified as “available for sale.” Available for sale securities are reported at fair value based on quoted market prices, with unrealized gains and losses reported in accumulated other comprehensive income (loss) within stockholders’ equity. The cost of a security sold or the amount reclassified out of accumulated other comprehensive income (loss) into earnings is determined using specific identification. The Company may pay a premium or receive a discount upon the purchase of marketable securities. Interest earned and gains/losses realized on marketable securities and amortization of discounts received and accretion of premiums paid on the purchase of marketable securities are included in investment income/expense. The weighted-average maturity of the Company’s current marketable securities as of September 30, 2013 was approximately four months. | |||||||||||||||||
Available-for-sale marketable securities consisted of the following (in thousands): | |||||||||||||||||
September 30, 2013 | |||||||||||||||||
Adjusted | Unrealized | Unrealized | Estimated | ||||||||||||||
Cost | Gains | Losses | Fair Value | ||||||||||||||
(In thousands) | |||||||||||||||||
Corporate bond investments—Current | $ | 44,385 | $ | 4 | $ | (12 | ) | $ | 44,377 |
Subsequent_Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2013 | |
Subsequent Events | ' |
Note 8 – Subsequent Events: | |
During October 2013, the Company entered into an agreement with a clinical research organization, or CRO. This CRO will provide services for initiating, managing and conducting a new Phase II clinical trial for patients with HER2-mutated solid tumors using PB272. The Company shall pay the CRO up to approximately $2.2 million over the life of the agreement (approximately 37 months). The Company may cancel the agreement at any time with a 30-day written notice. The Company would be obligated to pay for any services previously rendered, with any prepaid, unused funds returned to the Company. |
Significant_Accounting_Policie1
Significant Accounting Policies (Policies) | 9 Months Ended | ||||||||||||||||
Sep. 30, 2013 | |||||||||||||||||
Use of Estimates | ' | ||||||||||||||||
Use of Estimates: | |||||||||||||||||
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the balance sheet and reported amounts of expenses for the period presented. Accordingly, actual results could differ from those estimates. Significant estimates include the cost of services provided by consultants who manage clinical trials and conduct research and clinical trials on behalf of the Company that are billed on a delayed basis. As the actual costs become known, the Company adjusts its estimated cost in that period. The value of stock-based compensation includes estimates based on future events which are difficult to predict. It is at least reasonably possible that a change in the estimates will occur in the near term. | |||||||||||||||||
Principles of Consolidation | ' | ||||||||||||||||
Principles of Consolidation: | |||||||||||||||||
The condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiary. All significant intercompany balances and transactions have been eliminated in consolidation. | |||||||||||||||||
Cash and Cash Equivalents | ' | ||||||||||||||||
Cash and Cash Equivalents: | |||||||||||||||||
The Company considers all highly liquid investments with original maturities of three months or less to be cash equivalents. Cash equivalents are carried at cost, which approximates fair value. | |||||||||||||||||
Licensor Receivable | ' | ||||||||||||||||
Licensor Receivable: | |||||||||||||||||
Licensor receivable represents external “out of pocket” clinical trial costs in excess of an agreed upon “cap” for clinical trials that were ongoing at the time the licensing agreement with the Licensor was reached. The licensing agreement allows the Company to bill the Licensor for all external “out of pocket” costs in excess of the cap cost on a quarterly basis. The Licensor, per the license agreement, has 60 days to review the invoice and supporting documentation. Licensor receivable includes both invoiced and non-invoiced costs in excess of the cap. The Company has not established a reserve against this receivable (approximately $11.3 million at September 30, 2013). | |||||||||||||||||
Marketable Securities | ' | ||||||||||||||||
Marketable Securities: | |||||||||||||||||
The Company classifies all investment securities (short-term and long-term) as available-for-sale, as the sale of such securities may be required prior to maturity to implement management’s strategies. These securities are carried at fair value, with the unrealized gains and losses, if material, reported as a component of accumulated other comprehensive income (loss) in stockholders’ equity until realized. Realized gains and losses from the sale of available-for-sale securities, if any, are determined on a specific identification basis. A decline in the market value of any available-for-sale security below cost that is determined to be other than temporary results in a revaluation of its carrying amount to fair value. The impairment is charged to earnings and a new cost basis for the security is established. Premiums and discounts are amortized or accreted over the life of the related security as an adjustment to yield using the straight-line method. Interest income is recognized when earned. | |||||||||||||||||
Assets Measured at Fair Value on Recurring Basis | ' | ||||||||||||||||
Assets Measured at Fair Value on a Recurring Basis: | |||||||||||||||||
Accounting Standards Codification, or ASC 820, Fair Value Measurement, provides a single definition of fair value and a common framework for measuring fair value as well as new disclosure requirements for fair value measurements used in financial statements. Under ASC 820, fair value is determined based upon the exit price that would be received by a company to sell an asset or paid by a company to transfer a liability in an orderly transaction between market participants, exclusive of any transaction costs. Fair value measurements are determined by either the principal market or the most advantageous market. The principal market is the market with the greatest level of activity and volume for the asset or liability. Absent a principal market to measure fair value, the Company uses the most advantageous market, which is the market from which the Company would receive the highest selling price for the asset or pay the lowest price to settle the liability, after considering transaction costs. However, when using the most advantageous market, transaction costs are only considered to determine which market is the most advantageous and these costs are then excluded when applying a fair value measurement. ASC 820 creates a three-level hierarchy to prioritize the inputs used in the valuation techniques to derive fair values. The basis for fair value measurements for each level within the hierarchy is described below, with Level 1 having the highest priority and Level 3 having the lowest. | |||||||||||||||||
Level 1: | Quoted prices in active markets for identical assets or liabilities. | ||||||||||||||||
Level 2: | Quoted prices for similar assets or liabilities in active markets; quoted prices for identical or similar instruments in markets that are not active; and model-derived valuations in which all significant inputs are observable in active markets. | ||||||||||||||||
Level 3: | Valuations derived from valuation techniques in which one or more significant inputs are unobservable. | ||||||||||||||||
Following are the major categories of assets measured at fair value on a recurring basis as of September 30, 2013 and December 31, 2012, using quoted prices in active markets for identical assets (Level 1), significant other observable inputs (Level 2), and significant unobservable inputs (Level 3) (in thousands): | |||||||||||||||||
September 30, 2013 | Level 1 | Level 2 | Level 3 | Total | |||||||||||||
Cash equivalents | $ | 50,584 | $ | — | $ | — | $ | 50,584 | |||||||||
Corporate bonds | — | 44,377 | — | 44,377 | |||||||||||||
Total | $ | 50,584 | $ | 44,377 | $ | — | $ | 94,961 | |||||||||
December 31, 2012 | Level 1 | Level 2 | Level 3 | Total | |||||||||||||
Cash equivalents | $ | 134,867 | $ | — | $ | — | $ | 134,867 | |||||||||
Total | $ | 134,867 | $ | — | $ | — | $ | 134,867 | |||||||||
The Company’s investments in short-term investment securities are exposed to price fluctuations. The fair value measurements for short-term investment securities are based upon the quoted price in active markets multiplied by the number of securities owned, exclusive of any transaction costs and without any adjustments to reflect discounts that may be applied to selling a large block of securities at one time. | |||||||||||||||||
Concentration of Risk | ' | ||||||||||||||||
Concentration of Risk: | |||||||||||||||||
Financial instruments, which potentially subject the Company to concentrations of credit risk, principally consist of cash and cash equivalents. The Company’s cash and cash equivalents in excess of the Federal Deposit Insurance Corporation and the Securities Investor Protection Corporation insured limits at September 30, 2013, were approximately $52.6 million. The Company does not believe it is exposed to any significant credit risk. | |||||||||||||||||
Property and Equipment | ' | ||||||||||||||||
Property and Equipment: | |||||||||||||||||
Property and equipment are recorded at cost and depreciated over estimated useful lives ranging from three to five years using the straight-line method. Leasehold improvements are recorded at cost and amortized over the shorter of their useful lives or the term of the lease by use of the straight-line method. Maintenance and repair costs are charged to operations as incurred. | |||||||||||||||||
The Company assesses the impairment of long-lived assets, primarily property and equipment, whenever events or changes in business circumstances indicate that carrying amounts of the assets may not be fully recoverable. When such events occur, management determines whether there has been impairment by comparing the asset’s carrying value with its fair value, as measured by the anticipated undiscounted net cash flows of the asset. Should impairment exist, the asset is written down to its estimated fair value. The Company has not recognized any impairment losses through September 30, 2013. | |||||||||||||||||
Research and Development Expenses | ' | ||||||||||||||||
Research and Development Expenses: | |||||||||||||||||
Research and development expenses are charged to operations as incurred. The major components of research and development costs include clinical manufacturing costs, clinical trial expenses, consulting and other third-party costs, salaries and employee benefits, stock-based compensation expense, supplies and materials, and allocations of various overhead costs. Clinical trial expenses include, but are not limited to, investigator fees, site costs, comparator drug costs, and clinical research organization, or CRO, costs. In the normal course of business, the Company contracts with third parties to perform various clinical trial activities in the ongoing development of potential products. The financial terms of these agreements are subject to negotiation and variations from contract to contract and may result in uneven payment flows. Payments under the contracts depend on factors such as the achievement of certain events, the successful enrollment of patients and the completion of portions of the clinical trial or similar conditions. The Company’s cost accruals for clinical trials are based on estimates of the services received and efforts expended pursuant to contracts with numerous clinical trial sites, cooperative groups and CROs. The objective of the Company’s accrual policy is to match the recording of expenses in the condensed consolidated financial statements to the actual services received and efforts expended. As actual costs become known, the Company adjusts its accruals in that period. | |||||||||||||||||
In instances where the Company enters into agreements with third parties for clinical trials and other consulting activities, upfront amounts are recorded to prepaid expenses and deposits in the accompanying condensed consolidated balance sheets and expensed as services are performed or as the underlying goods are delivered. If the Company does not expect the services to be rendered or goods to be delivered, any remaining capitalized amounts for non-refundable upfront payments are charged to expense immediately. Amounts due under such arrangements may be either fixed fee or fee for service, and may include upfront payments, monthly payments and payments upon the completion of milestones or receipt of deliverables. | |||||||||||||||||
Costs related to the acquisition of technology rights and patents for which development work is still in process are charged to operations as incurred and considered a component of research and development costs. | |||||||||||||||||
Research and Development Reimbursement | ' | ||||||||||||||||
Research and Development Reimbursement: | |||||||||||||||||
The licensing agreement set a “cap” on the amount of external expenses the Company would incur, beginning January 1, 2012, in completing the clinical trials transferred from the Licensor to the Company. The license agreement stipulates that the Licensor would be responsible for all external expenses associated with the transferred clinical trials and that the Company would invoice for such costs on a quarterly basis. The Licensor has 60 days to review the invoice and supporting documentation. All amounts reimbursed from the Licensor represent charges for services provided by third parties and not the Company. Accordingly, the Company has elected to treat the reimbursed costs as “pass-through” expenses billable to the Licensor and as an offset to research and development expenses. Research and development expenses are recorded net of any excess cap costs billed to the Licensor. The Company recognized approximately $3.4 million and $13.1 million of excess cap costs during the three months and nine months ended September 30, 2013, respectively. | |||||||||||||||||
Stock-Based Compensation | ' | ||||||||||||||||
Stock-Based Compensation: | |||||||||||||||||
Stock option awards: | |||||||||||||||||
ASC 718, Compensation-Stock Compensation, or ASC 718, requires the fair value of all share-based payments to employees, including grants of stock options, to be recognized in the statement of operations over the requisite service period. Under ASC 718, employee option grants are generally valued at the date of grant, or grant date, and those valuations do not change once they have been established. The fair value of each option award is estimated on the grant date using the Black-Scholes Option Pricing Method. As allowed by ASC 718 for companies with a short period of publicly traded stock history, the Company’s estimate of expected volatility is based on the average expected volatilities of a sampling of five companies with similar attributes to the Company, including industry, stage of life cycle, size and financial leverage. The risk-free rate for periods within the contractual life of the option is based on the U.S. Treasury yield curve in effect at the time of grant valuation. ASC 718 does not allow companies to account for option forfeitures as they occur; instead, estimated option forfeitures must be calculated when the option is granted to reduce the option expense to be recognized over the life of the award and updated upon receipt of further information as to the amount of options expected to be forfeited. Due to its limited history, the Company uses the simplified method to determine the expected life of the option grants. | |||||||||||||||||
Warrants: | |||||||||||||||||
Warrants granted to employees are normally valued at the fair value of the instrument on the grant date and are recognized in the statement of operations over the requisite service period. When the requisite service period precedes the grant date and a market condition exists in the warrant, the Company values the warrant using the Monte Carlo Simulation Method. When the terms of the warrant become fixed, the Company values the warrant using the Black-Scholes Option Pricing Method. As allowed by ASC 718 for companies with a short period of publicly traded stock history, the Company’s estimate of expected volatility is based on the average volatilities of a sampling of eight to nine companies with similar attributes to the Company, including industry, stage of life cycle, size and financial leverage. The risk-free rate for periods within the contractual life of the warrant is based on the U.S. Treasury yield curve in effect at the time of grant valuation. In determining the value of the warrant until the terms are fixed, the Company factors in the probability of the market condition occurring and several possible scenarios. When the requisite service period precedes the grant date and is deemed to be complete, the Company records the fair value of the warrant at the time of issuance as an equity stock-based compensation transaction. The warrant is revalued each reporting period up to the grant date when the final fair value of the warrant is established and recorded. The grant date is determined when all pertinent information, such as exercise price and quantity, is known. | |||||||||||||||||
Net Loss per Common Share | ' | ||||||||||||||||
Net Loss per Common Share: | |||||||||||||||||
Basic net loss per common share is computed by dividing net loss applicable to common stockholders by the weighted average number of common shares outstanding during the periods presented, as required by ASC 260, Earnings per Share. Diluted earnings per common share are the same as basic earnings per share because the assumed exercise of the Company’s outstanding options are anti-dilutive. For the three and nine months ended September 30, 2013, potentially dilutive securities excluded from the calculations were 2,373,309 shares issuable upon exercise of options and 2,116,250 shares issuable upon exercise of an outstanding warrant. For the three and nine months ended September 30, 2012, potentially dilutive securities excluded from the earnings per common share calculation were 1,422,500 shares issuable upon exercise of options. | |||||||||||||||||
Deferred Rent | ' | ||||||||||||||||
Deferred Rent: | |||||||||||||||||
The Company has entered into operating lease agreements for its corporate offices in Los Angeles and South San Francisco that contain provisions for future rent increases, leasehold improvement allowances and rent abatements. The Company records monthly rent expense equal to the total of the payments due over the lease term, divided by the number of months of the lease term. The difference between the rent expense recorded and the amount paid is credited or charged to deferred rent, which is reflected as a separate line item in the accompanying condensed consolidated balance sheets. Additionally, the Company recorded as deferred rent the cost of the leasehold improvements paid by the landlord, which is amortized on a straight-line basis over the term of the lease. | |||||||||||||||||
Reclassifications | ' | ||||||||||||||||
Reclassifications: | |||||||||||||||||
Certain amounts for 2012 have been reclassified to conform to the current year’s presentation. |
Significant_Accounting_Policie2
Significant Accounting Policies (Tables) | 9 Months Ended | ||||||||||||||||
Sep. 30, 2013 | |||||||||||||||||
Assets Measured at Fair Value on Recurring Basis | ' | ||||||||||||||||
Following are the major categories of assets measured at fair value on a recurring basis as of September 30, 2013 and December 31, 2012, using quoted prices in active markets for identical assets (Level 1), significant other observable inputs (Level 2), and significant unobservable inputs (Level 3) (in thousands): | |||||||||||||||||
September 30, 2013 | Level 1 | Level 2 | Level 3 | Total | |||||||||||||
Cash equivalents | $ | 50,584 | $ | — | $ | — | $ | 50,584 | |||||||||
Corporate bonds | — | 44,377 | — | 44,377 | |||||||||||||
Total | $ | 50,584 | $ | 44,377 | $ | — | $ | 94,961 | |||||||||
December 31, 2012 | Level 1 | Level 2 | Level 3 | Total | |||||||||||||
Cash equivalents | $ | 134,867 | $ | — | $ | — | $ | 134,867 | |||||||||
Total | $ | 134,867 | $ | — | $ | — | $ | 134,867 | |||||||||
Property_and_Equipment_Tables
Property and Equipment (Tables) | 9 Months Ended | ||||||||
Sep. 30, 2013 | |||||||||
Property and Equipment | ' | ||||||||
Property and equipment consisted of the following (in thousands): | |||||||||
September 30, | December 31, | ||||||||
2013 | 2012 | ||||||||
Leasehold improvements | $ | 913 | $ | 910 | |||||
Computer equipment | 710 | 535 | |||||||
Telephone equipment | 57 | 34 | |||||||
Furniture and fixtures | 513 | 276 | |||||||
2,193 | 1,755 | ||||||||
Less: accumulated depreciation and amortization | (574 | ) | (276 | ) | |||||
Totals | $ | 1,619 | $ | 1,479 | |||||
Accrued_Expenses_Tables
Accrued Expenses (Tables) | 9 Months Ended | ||||||||
Sep. 30, 2013 | |||||||||
Accrued Expenses | ' | ||||||||
Accrued expenses consisted of the following (in thousands): | |||||||||
September 30, | December 31, | ||||||||
2013 | 2012 | ||||||||
Accrued CRO/licensor services | $ | 5,887 | $ | 19,846 | |||||
Accrued other clinical development | 1,371 | 389 | |||||||
Accrued legal fees | 294 | 121 | |||||||
Accrued compensation | 1,866 | 787 | |||||||
Other | 78 | 76 | |||||||
$ | 9,496 | $ | 21,219 | ||||||
Stockholders_Equity_Tables
Stockholders' Equity (Tables) | 9 Months Ended | ||||||||||||||||
Sep. 30, 2013 | |||||||||||||||||
Fair Value Options Weighted-Average Assumptions | ' | ||||||||||||||||
The fair value of options granted to employees was estimated using the Black-Scholes Option Pricing Method (see Note 2—Significant Accounting Policies) with the following weighted-average assumptions used during the nine months ended September 30, 2013 and 2012: | |||||||||||||||||
Nine Months Ended | |||||||||||||||||
September 30, | |||||||||||||||||
2013 | 2012 | ||||||||||||||||
Dividend yield | 0 | % | 0 | % | |||||||||||||
Expected volatility | 85.4 | % | 85.4 | % | |||||||||||||
Risk-free interest rate | 1.3 | % | 1 | % | |||||||||||||
Expected life in years | 5.85 | 5.82 | |||||||||||||||
Recognized Expense of Share Based Compensation | ' | ||||||||||||||||
Employee stock-based compensation for the three and nine months ended September 30, 2013 and 2012, were as follows: | |||||||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||
2013 | 2012 | 2013 | 2012 | ||||||||||||||
(in thousands except per share data) | |||||||||||||||||
Stock-based compensation: | |||||||||||||||||
Options: | |||||||||||||||||
Research and development | $ | 1,333 | $ | 248 | $ | 3,072 | $ | 530 | |||||||||
General and administrative, or G&A | 473 | 101 | 1,354 | 290 | |||||||||||||
Warrants: G&A | — | (6,575 | ) | — | 6,250 | ||||||||||||
Total stock-based compensation expense | $ | 1,806 | $ | (6,226 | ) | $ | 4,426 | $ | 7,070 | ||||||||
Impact on basic and diluted net loss per share | $ | 0.06 | $ | (0.31 | ) | $ | 0.15 | $ | 0.35 | ||||||||
Weighted average shares (basic and diluted) | 28,682,055 | 20,040,000 | 28,678,439 | 20,040,000 | |||||||||||||
Activity with Respect to Options Granted | ' | ||||||||||||||||
Activity with respect to options granted under the 2011 Plan is summarized as follows: | |||||||||||||||||
Shares | Weighted | Weighted Average | Aggregate | ||||||||||||||
Average | Remaining | Intrinsic Value | |||||||||||||||
Exercise | Contractual Term | (in thousands) | |||||||||||||||
Price | (years) | ||||||||||||||||
Outstanding at December 31, 2012 | 1,906,334 | $ | 8.93 | 9.4 | $ | 18,966 | |||||||||||
Granted during the nine months ended September 30, 2013 | 499,475 | 36.8 | — | — | |||||||||||||
Forfeited during the nine months ended September 30, 2013 | (19,862 | ) | 11.6 | — | — | ||||||||||||
Exercised during the nine months ended September 30, 2013 | (12,638 | ) | 11.6 | — | — | ||||||||||||
Outstanding at September 30, 2013 | 2,373,309 | 14.76 | 8.8 | $ | 90,329 | ||||||||||||
Nonvested at September 30, 2013 | 1,615,623 | $ | 19.42 | 9 | $ | 64,490 | |||||||||||
Exercisable at September 30, 2013 | 757,686 | $ | 4.82 | 8.4 | $ | 37,007 | |||||||||||
Stock Options | ' | ||||||||||||||||
Stock options | Shares | Weighted | |||||||||||||||
Average | |||||||||||||||||
Grant-Date | |||||||||||||||||
Fair Value | |||||||||||||||||
Nonvested shares at December 31, 2012 | 1,659,399 | $ | 7.03 | ||||||||||||||
Granted | 499,475 | 25.95 | |||||||||||||||
Vested/Issued | (523,389 | ) | 3.86 | ||||||||||||||
Forfeited | (19,862 | ) | 8.12 | ||||||||||||||
Nonvested shares at September 30, 2013 | 1,615,623 | ||||||||||||||||
Monte Carlo Simulation Valuation Model | ' | ||||||||||||||||
Warrant Fair Market Value Assumptions | ' | ||||||||||||||||
The fair value of the warrant during the quarter ended September 30, 2012, was determined by the following assumptions using the Monte Carlo Simulation Method: | |||||||||||||||||
September 30, | |||||||||||||||||
2012 | |||||||||||||||||
Common stock price | $ | 15 | |||||||||||||||
Dividend yield | 0 | % | |||||||||||||||
Expected volatility | 75.7 | % | |||||||||||||||
Risk-free interest rate | 1.65 | % | |||||||||||||||
Warrant term in years | 10 |
Marketable_Securities_Tables
Marketable Securities (Tables) | 9 Months Ended | ||||||||||||||||
Sep. 30, 2013 | |||||||||||||||||
Available-for-Sale Marketable Securities | ' | ||||||||||||||||
Available-for-sale marketable securities consisted of the following (in thousands): | |||||||||||||||||
September 30, 2013 | |||||||||||||||||
Adjusted | Unrealized | Unrealized | Estimated | ||||||||||||||
Cost | Gains | Losses | Fair Value | ||||||||||||||
(In thousands) | |||||||||||||||||
Corporate bond investments—Current | $ | 44,385 | $ | 4 | $ | (12 | ) | $ | 44,377 | ||||||||
Business_and_Basis_of_Presenta1
Business and Basis of Presentation - Additional Information (Detail) (USD $) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | 36 Months Ended | |||||
Sep. 30, 2011 | Sep. 30, 2013 | Sep. 30, 2012 | Dec. 31, 2010 | Sep. 30, 2013 | Sep. 30, 2012 | Dec. 31, 2012 | Dec. 31, 2011 | Sep. 30, 2013 | Sep. 29, 2011 | |
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Net loss | ' | ($14,283,000) | ($25,859,000) | ($7,000) | ($38,713,000) | ($52,440,000) | ($74,352,000) | ($10,233,000) | ($123,305,000) | ' |
Cash flows from operating activities | ' | -12,000,000 | ' | ' | -41,469,000 | -19,203,000 | ' | ' | -87,312,000 | ' |
Merger agreement, shares Issued | 18,666,733 | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Merger agreement, shares received in exchange | 18,666,733 | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Merger agreement, shares exchange ratio | ' | ' | ' | ' | ' | ' | ' | ' | ' | 1 |
Share redeemed, aggregate consideration | 40,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Merger related Professional fees paid | 40,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Consideration paid for former Stockholders of IAC and their attorney | ' | ' | ' | ' | ' | ' | ' | $80,000 | ' | ' |
Significant_Accounting_Policie3
Significant Accounting Policies - Additional Information (Detail) (USD $) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | Dec. 31, 2012 | |
Significant Accounting Policies [Line Items] | ' | ' | ' | ' | ' |
License Agreement, number of days to review the invoice and supporting documentation | ' | ' | '60 days | ' | ' |
Licensor receivable | $11,294,000 | ' | $11,294,000 | ' | $10,612,000 |
Cash and cash equivalents in excess of insured limits | 52,600,000 | ' | 52,600,000 | ' | ' |
Costs of excess cap billed to the licensor | $3,400,000 | ' | $13,100,000 | ' | ' |
Anti-dilutive securities excluded from the calculation of diluted earnings per share | ' | 1,422,500 | ' | 1,422,500 | ' |
Stock Options | ' | ' | ' | ' | ' |
Significant Accounting Policies [Line Items] | ' | ' | ' | ' | ' |
Anti-dilutive securities excluded from the calculation of diluted earnings per share | 2,373,309 | ' | 2,373,309 | ' | ' |
Warrants | ' | ' | ' | ' | ' |
Significant Accounting Policies [Line Items] | ' | ' | ' | ' | ' |
Anti-dilutive securities excluded from the calculation of diluted earnings per share | 2,116,250 | ' | 2,116,250 | ' | ' |
Maximum | ' | ' | ' | ' | ' |
Significant Accounting Policies [Line Items] | ' | ' | ' | ' | ' |
Cash equivalents, original maturity | ' | ' | '3 months | ' | ' |
Property and equipment, useful lives | ' | ' | '5 years | ' | ' |
Minimum | ' | ' | ' | ' | ' |
Significant Accounting Policies [Line Items] | ' | ' | ' | ' | ' |
Property and equipment, useful lives | ' | ' | '3 years | ' | ' |
Assets_Measured_at_Fair_Value_
Assets Measured at Fair Value on Recurring Basis (Detail) (Fair Value, Measurements, Recurring, USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
In Thousands, unless otherwise specified | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ' | ' |
Cash equivalents | $50,584 | $134,867 |
Total | 94,961 | 134,867 |
Corporate bonds | ' | ' |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ' | ' |
Corporate bonds | 44,377 | ' |
Level 1 | ' | ' |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ' | ' |
Cash equivalents | 50,584 | 134,867 |
Total | 50,584 | 134,867 |
Level 2 | ' | ' |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ' | ' |
Total | 44,377 | ' |
Level 2 | Corporate bonds | ' | ' |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ' | ' |
Corporate bonds | $44,377 | ' |
Property_and_Equipment_Detail
Property and Equipment (Detail) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
In Thousands, unless otherwise specified | ||
Property, Plant and Equipment [Line Items] | ' | ' |
Leasehold improvements | $913 | $910 |
Furniture and fixtures | 513 | 276 |
Property, Plant and Equipment, Gross | 2,193 | 1,755 |
Less: accumulated depreciation and amortization | -574 | -276 |
Totals | 1,619 | 1,479 |
Computer Equipment | ' | ' |
Property, Plant and Equipment [Line Items] | ' | ' |
Property and equipment other, gross | 710 | 535 |
Telephone Equipment | ' | ' |
Property, Plant and Equipment [Line Items] | ' | ' |
Property and equipment other, gross | $57 | $34 |
Accrued_Expenses_Detail
Accrued Expenses (Detail) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
In Thousands, unless otherwise specified | ||
Schedule of Accrued Liabilities [Line Items] | ' | ' |
Accrued CRO/licensor services | $5,887 | $19,846 |
Accrued other clinical development | 1,371 | 389 |
Accrued legal fees | 294 | 121 |
Accrued compensation | 1,866 | 787 |
Other | 78 | 76 |
Totals | $9,496 | $21,219 |
Stockholders_Equity_Additional
Stockholders Equity - Additional Information (Detail) (USD $) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 9 Months Ended | 12 Months Ended | 1 Months Ended | 1 Months Ended | ||||||||
Oct. 31, 2011 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | Dec. 31, 2012 | Dec. 31, 2011 | Sep. 30, 2013 | Sep. 30, 2013 | Dec. 31, 2012 | Sep. 30, 2012 | Oct. 31, 2011 | Sep. 30, 2012 | Sep. 30, 2013 | Oct. 31, 2011 | Oct. 31, 2011 | |
Stock Options | Equity Incentive Plan Twenty Eleven | Warrants | Minimum | Minimum | Maximum | Maximum | President | President | |||||||
Minimum gross proceed of first subsequent financing for warrants be exercisable | Equity Incentive Plan Twenty Eleven | Minimum | |||||||||||||
Stockholders Equity Note [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Percentage of shares held by related party | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 21.00% | ' |
Outstanding shares | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 18,666,733 | ' |
Minimum ownership percentage of outstanding shares of common stock the president need to maintain after issuance of warrants | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 20.00% |
Term of Warrant | '10 years | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Gross cash proceeds from minimum first subsequent financing of warrants exercisable | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | $15,000,000 | ' | ' | ' | ' |
Warrant expiration date | 4-Oct-21 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Shares of common stock that could be acquired by warrant | ' | ' | 2,116,250 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Common stock price | ' | ' | $16 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Value of warrants | 6,900,000 | 13,800,000 | ' | 13,800,000 | 25,800,000 | 7,600,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Adjustment to fair value of warrants | ' | 6,500,000 | ' | 6,200,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Fair value estimate assumption, projected equity raises | ' | ' | ' | ' | ' | ' | ' | ' | ' | 86,000,000 | ' | 100,000,000 | ' | ' | ' |
Adjustment to fair value of warrants | ' | ' | ' | ' | ' | ' | ' | ' | 18,200,000 | ' | ' | ' | ' | ' | ' |
Stock options granted, term | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | '10 years | ' | ' |
Common stock shares reserved for issuance | ' | ' | ' | ' | ' | ' | ' | 3,529,412 | ' | ' | ' | ' | ' | ' | ' |
Estimated unrecognized employee compensation cost related to non-vested stock options granted | ' | ' | 19,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Estimated unrecognized employee compensation cost related to non-vested stock options granted, Weighted-average period of recognition | ' | ' | '2 years 4 months 24 days | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Stock options exercised, intrinsic value | ' | ' | ' | ' | ' | ' | $486,000 | ' | ' | ' | ' | ' | ' | ' | ' |
Weighted-average grant date fair value of options granted | ' | ' | $25.95 | $4.63 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Fair_Value_of_Warrants_Determi
Fair Value of Warrants Determined Using Monte Carlo Simulation Method (Detail) (USD $) | Sep. 30, 2013 | Sep. 30, 2012 |
Monte Carlo Simulation Valuation Model | ||
Class of Warrant or Right [Line Items] | ' | ' |
Common stock price | $16 | $15 |
Dividend yield | ' | 0.00% |
Expected volatility | ' | 75.70% |
Risk-free interest rate | ' | 1.65% |
Warrant term in years | ' | '10 years |
Fair_Value_Options_WeightedAve
Fair Value Options Weighted-Average Assumptions (Detail) (Stock Options) | 9 Months Ended | |
Sep. 30, 2013 | Sep. 30, 2012 | |
Stock Options | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' |
Dividend yield | 0.00% | 0.00% |
Expected volatility | 85.40% | 85.40% |
Risk-free interest rate | 1.30% | 1.00% |
Expected life in years | '5 years 10 months 6 days | '5 years 9 months 26 days |
StockBased_Compensation_Expens
Stock-Based Compensation Expense (Detail) (USD $) | 3 Months Ended | 9 Months Ended | 36 Months Ended | ||
In Thousands, except Share data, unless otherwise specified | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 |
Share Based Compensation [Line Items] | ' | ' | ' | ' | ' |
Share-based compensation expense | ' | ' | $4,426 | $820 | $5,901 |
Total stock-based compensation expense | 1,806 | -6,226 | 4,426 | 7,070 | ' |
Impact on basic and diluted net loss per share | $0.06 | ($0.31) | $0.15 | $0.35 | ' |
Weighted average shares (basic and diluted) | 28,682,055 | 20,040,000 | 28,678,439 | 20,040,000 | ' |
Stock Options | Research and development | ' | ' | ' | ' | ' |
Share Based Compensation [Line Items] | ' | ' | ' | ' | ' |
Share-based compensation expense | 1,333 | 248 | 3,072 | 530 | ' |
Stock Options | General and administrative | ' | ' | ' | ' | ' |
Share Based Compensation [Line Items] | ' | ' | ' | ' | ' |
Share-based compensation expense | 473 | 101 | 1,354 | 290 | ' |
Warrants | ' | ' | ' | ' | ' |
Share Based Compensation [Line Items] | ' | ' | ' | ' | ' |
Share-based compensation expense | ' | ($6,575) | ' | $6,250 | ' |
Activity_with_Respect_to_Optio
Activity with Respect to Options Granted (Detail) (USD $) | 9 Months Ended |
In Thousands, except Share data, unless otherwise specified | Sep. 30, 2013 |
Shares | ' |
Beginning balance, shares | 1,906,334 |
Granted, shares | 499,475 |
Forfeited, shares | -19,862 |
Exercised, shares | -12,638 |
Ending balance, shares | 2,373,309 |
Unvested, shares | 1,615,623 |
Exercisable at June 30, 2013 | 757,686 |
Weighted Average Exercise Price | ' |
Beginning Balance, Weighted Average Exercise Price | $8.93 |
Granted, Weighted Average Exercise Price | $36.80 |
Forfeited, Weighted Average Exercise Price | $11.60 |
Exercised, Weighted Average Exercise Price | $11.60 |
Ending Balance, Weighted Average Exercise Price | $14.76 |
Unvested, Weighted Average Exercise Price | $19.42 |
Exercisable, Weighted Average Exercise Price | $4.82 |
Weighted Average Remaining Contractual Term (years) | ' |
Beginning balance, Weighted Average Remaining Contractual Term (years) | '9 years 4 months 24 days |
Ending balance, Weighted Average Remaining Contractual Term (years) | '8 years 9 months 18 days |
Unvested, Weighted Average Remaining Contractual Term (years) | '9 years |
Exercisable, Weighted Average Remaining Contractual Term (years) | '8 years 4 months 24 days |
Aggregate Intrinsic Value | ' |
Beginning balance, Aggregate Intrinsic Value | $18,966 |
Granted, Aggregate Intrinsic Value | ' |
Forfeited, Aggregate Intrinsic Value | ' |
Exercised, Aggregate Intrinsic Value | ' |
Ending balance, Aggregate Intrinsic Value | 90,329 |
Unvested, Aggregate Intrinsic Value | 64,490 |
Exercisable, Aggregate Intrinsic Value | $37,007 |
Stock_Options_Detail
Stock Options (Detail) (USD $) | 9 Months Ended | |
Sep. 30, 2013 | Sep. 30, 2012 | |
Shares | ' | ' |
Beginning balance, shares | 1,906,334 | ' |
Granted | 499,475 | ' |
Forfeited | -19,862 | ' |
Ending balance, shares | 2,373,309 | ' |
Weighted Average Grant-Date Fair Value | ' | ' |
Granted | $25.95 | $4.63 |
Non Vested Stock Options | ' | ' |
Shares | ' | ' |
Beginning balance, shares | 1,659,399 | ' |
Granted | 499,475 | ' |
Vested/Issued | -523,389 | ' |
Forfeited | -19,862 | ' |
Ending balance, shares | 1,615,623 | ' |
Weighted Average Grant-Date Fair Value | ' | ' |
Beginning balance, Weighted Average Grant-Date Fair Value | $7.03 | ' |
Granted | $25.95 | ' |
Vested/Issued | $3.86 | ' |
Forfeited | $8.12 | ' |
Savings_Plan_Additional_Inform
Savings Plan - Additional Information (Detail) (USD $) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | |
Savings Plan [Line Items] | ' | ' | ' | ' |
Employer matching contribution expenses | $97,000 | $40,800 | $200,600 | $97,400 |
First Three Percent of Each Participant's Contributions | ' | ' | ' | ' |
Savings Plan [Line Items] | ' | ' | ' | ' |
Company's matching contributions to the 401(k)plan | ' | ' | 100.00% | ' |
Second Two Percent Of Each Participant's Contributions | ' | ' | ' | ' |
Savings Plan [Line Items] | ' | ' | ' | ' |
Company's matching contributions to the 401(k)plan | ' | ' | 50.00% | ' |
Marketable_Securities_Addition
Marketable Securities - Additional Information (Detail) | 9 Months Ended |
Sep. 30, 2013 | |
Schedule Of Marketable Securities [Line Items] | ' |
Weighted-average maturity of marketable securities | '4 months |
AvailableforSale_Marketable_Se
Available-for-Sale Marketable Securities (Detail) (Corporate bonds, USD $) | Sep. 30, 2013 |
In Thousands, unless otherwise specified | |
Corporate bonds | ' |
Schedule of Available-for-sale Securities [Line Items] | ' |
Amortized Cost | $44,385 |
Unrealized Gains | 4 |
Unrealized Losses | -12 |
Fair Value | $44,377 |
Subsequent_Events_Additional_I
Subsequent Events - Additional Information (Detail) (Phase Two Clinical Trial, Subsequent Event, USD $) | 1 Months Ended |
In Millions, unless otherwise specified | Oct. 31, 2013 |
Phase Two Clinical Trial | Subsequent Event | ' |
Subsequent Event [Line Items] | ' |
Service agreement, maximum life time payment amount | $2.20 |
Life of the agreement | '37 months |
Written notice of termination, period | '30 days |