Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2016 | Nov. 08, 2016 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2016 | |
Document Fiscal Year Focus | 2,016 | |
Document Fiscal Period Focus | Q3 | |
Trading Symbol | ARDM | |
Entity Registrant Name | ARADIGM CORP | |
Entity Central Index Key | 1,013,238 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Smaller Reporting Company | |
Entity Common Stock, Shares Outstanding | 14,951,089 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2016 | Dec. 31, 2015 |
Current assets: | ||
Cash and cash equivalents | $ 28,499 | $ 31,462 |
Restricted cash | 2,016 | |
Receivables | 40 | 150 |
Prepaid and other current assets | 1,438 | 3,634 |
Total current assets | 31,993 | 35,246 |
Property and equipment, net | 278 | 299 |
Other assets | 81 | |
Total assets | 32,271 | 35,626 |
Current liabilities: | ||
Accounts payable | 956 | 1,789 |
Accrued clinical and cost of other studies | 2,656 | 4,315 |
Accrued compensation | 1,343 | 1,159 |
Deferred rent | 37 | |
Facility lease exit obligation | 104 | |
Other accrued liabilities | 1,121 | 112 |
Total current liabilities | 6,076 | 7,516 |
Deferred revenue - related party, non-current | 5,000 | 5,000 |
Convertible debt, net of discount | 2,172 | |
Convertible debt - related party, net of discount | 10,634 | |
Total liabilities | 23,882 | 12,516 |
Commitments and contingencies | ||
Shareholders' equity: | ||
Preferred stock, 5,000,000 shares authorized, none outstanding | ||
Common stock, no par value; authorized shares: 35,045,765 at September 30, 2016 and 25,045,765 at December 31, 2015; issued and outstanding shares: 14,943,542 at September 30, 2016; 14,761,351 at December 31, 2015 | 438,871 | 428,591 |
Accumulated deficit | (430,482) | (405,481) |
Total shareholders' equity | 8,389 | 23,110 |
Total liabilities and shareholders' equity | $ 32,271 | $ 35,626 |
Condensed Consolidated Balance3
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2016 | Dec. 31, 2015 |
Statement of Financial Position [Abstract] | ||
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | ||
Common stock, shares authorized | 35,045,765 | 25,045,765 |
Common stock, shares issued | 14,943,542 | 14,761,351 |
Common stock, shares outstanding | 14,943,542 | 14,761,351 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Revenue: | ||||
Contract revenue - related party | $ 40 | $ 4,671 | $ 40 | $ 23,337 |
Grant revenue | 10 | 3 | 30 | 57 |
Total revenue | 50 | 4,674 | 70 | 23,394 |
Operating expenses: | ||||
Research and development | 5,836 | 8,880 | 18,522 | 26,995 |
General and administrative | 1,460 | 1,320 | 4,489 | 4,201 |
Restructuring and asset impairment | 2 | 2 | 9 | |
Total operating expenses | 7,296 | 10,202 | 23,013 | 31,205 |
Loss from operations | (7,246) | (5,528) | (22,943) | (7,811) |
Interest income | 34 | 7 | 70 | 22 |
Interest expense | (898) | (1,475) | ||
Other expense | (76) | (28) | (653) | (68) |
Net loss and comprehensive loss | $ (8,186) | $ (5,549) | $ (25,001) | $ (7,857) |
Basic and diluted net loss per common share | $ (0.55) | $ (0.38) | $ (1.69) | $ (0.53) |
Shares used in computing basic and diluted net loss per common share | 14,782 | 14,751 | 14,774 | 14,743 |
Condensed Consolidated Stateme5
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2016 | Sep. 30, 2015 | |
Cash flows from operating activities: | ||
Net loss | $ (25,001) | $ (7,857) |
Adjustments to reconcile net loss to cash used in operating activities | ||
Depreciation and amortization | 90 | 177 |
Stock-based compensation expense | 1,185 | 698 |
Amortization of convertible debt discount and deferred transaction costs | 643 | |
Financing costs, derivative liability and warrants | 997 | |
Change in value of derivative liability | (386) | |
Changes in operating assets and liabilities: | ||
Receivables | 110 | 865 |
Prepaid and other current assets | 2,196 | 44 |
Other assets | 81 | 30 |
Accounts payable | (1,011) | (765) |
Accrued compensation | 184 | 305 |
Current deferred revenue - related party | (790) | |
Accrued liabilities | (693) | 1,994 |
Deferred rent | (37) | (42) |
Accrued clinical and cost of other studies, non-current | 203 | |
Deferred revenue - related party | (2,845) | |
Facility lease exit obligation | (104) | (144) |
Net cash used in operating activities | (21,746) | (8,127) |
Cash flows from investing activities: | ||
Transfer to restricted cash | (2,016) | |
Capital expenditures | (69) | |
Net cash used in investing activities | (2,085) | |
Cash flows from financing activities: | ||
Proceeds from issuance of convertible debt | 3,050 | |
Proceeds from issuance of convertible debt - related party | 19,950 | |
Proceeds from issuance of common stock | 60 | 121 |
Payments for debt issuance costs | (2,192) | |
Net cash provided by financing activities | 20,868 | 121 |
Net decrease in cash and cash equivalents | (2,963) | (8,006) |
Cash and cash equivalents at beginning of period | 31,462 | 47,990 |
Cash and cash equivalents at end of period | 28,499 | $ 39,984 |
Non-cash disclosures of financing activities: | ||
Reclassification of derivative liability to equity | 8,362 | |
Reclassification of warrants to equity | 11 | |
Debt discount from warrants | 662 | |
Accrued financing costs | $ 221 |
Organization, Basis of Presenta
Organization, Basis of Presentation and Liquidity | 9 Months Ended |
Sep. 30, 2016 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization, Basis of Presentation and Liquidity | 1. Organization, Basis of Presentation and Liquidity Organization Aradigm Corporation (the “Company,” “we,” “our,” or “us”) is a California corporation, incorporated in 1991, focused on the development and commercialization of drugs delivered by inhalation for the treatment and prevention of severe respiratory diseases. The Company’s principal activities to date have included conducting research and development and developing collaborations. Management does not anticipate receiving revenues from the sale of any of its products during the 2016 fiscal year. The Company operates as a single operating segment. Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with United States generally accepted accounting principles (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Certain information and footnote disclosures normally included in financial statements prepared in accordance with United States GAAP have been condensed or omitted pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”). In the opinion of management, the financial statements reflect all adjustments, which are of a normal recurring nature, necessary for fair presentation. The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015, as filed with the SEC on March 30, 2016 (the “2015 Annual Report on Form 10-K”). The results of the Company’s consolidated operations for the interim periods presented are not necessarily indicative of operating results for the full fiscal year or any future interim period. The consolidated balance sheet at December 31, 2015 has been derived from the audited financial statements at that date, but does not include all of the information and footnotes required by GAAP for complete financial statements. For further information, please refer to the consolidated financial statements and notes thereto included in the 2015 Annual Report on Form 10-K. The accompanying unaudited condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All inter-company accounts and transactions have been eliminated in consolidation. Liquidity The Company has incurred significant operating losses and negative cash flows from operations. At September 30, 2016, the Company had an accumulated deficit of $430.5 million, working capital of $25.9 million and shareholders’ equity of $8.4 million. The Company had cash and cash equivalents of $28.5 million as of September 30, 2016. Management believes that this amount will be sufficient to meet its obligations through March 31, 2017. However, the Company’s business strategy will require it to raise additional capital through equity or debt financing(s), strategic transactions or otherwise, to develop and seek regulatory approval of the Company’s investigational product candidate. In addition, the Company may decide to raise capital opportunistically. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2016 | |
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 management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. These estimates include useful lives for property and equipment and related depreciation calculations, accruals for clinical trial expenses, assumptions for valuing options and warrants, and income taxes. Actual results could differ from these estimates. Cash and Cash Equivalents All highly liquid investments with maturities of three months or less at the time of purchase are classified as cash equivalents. Restricted Cash The Company classifies transfers to the restricted cash balance in the statement of cash flows based on the nature of the restriction. At September 30, 2016, the Company has $2.0 million in restricted cash held in an interest bearing escrow account for the purpose of making future interest payments on the Convertible Notes, as outlined in Note 6 below. The Company is required to maintain such deposits sufficient to pay all required payments of interest through May 1, 2017. Property and Equipment The Company records property and equipment at cost and calculates depreciation using the straight-line method over the estimated useful lives of the respective assets. Machinery and equipment includes external costs incurred for validation of the equipment. The Company does not capitalize internal validation expense. Computer equipment and software includes capitalized computer software. All of the Company’s capitalized software is purchased; the Company has no internally-developed computer software. Leasehold improvements are amortized over the shorter of the term of the lease or useful life of the improvement. Impairment of Long-Lived Assets The Company reviews for impairment whenever events or changes in circumstances indicate that the carrying amount of property and equipment may not be recoverable. Determination of recoverability is based on an estimate of undiscounted future cash flows resulting from the use of the asset and its eventual disposition. In the event that such cash flows are not expected to be sufficient to recover the carrying amount of the assets, the assets are written down to their estimated fair values and the loss is recognized in the consolidated statements of operations. Convertible Instruments The Company accounts for hybrid contracts that feature conversion options in accordance with generally accepted accounting principles in the United States. ASC 815, Derivatives and Hedging Activities The Company accounts for convertible instruments (when it has determined that the embedded conversion options should be bifurcated from their host instruments) in accordance with ASC 815. Under ASC 815, a portion of the proceeds received upon the issuance of the hybrid contract is allocated to the fair value of the derivative. The derivative is subsequently marked to market at each reporting date based on current fair value, with the changes in fair value reported in results of operations. Warrants Issued in Connection with Financings The Company generally accounts for warrants issued in connection with financings as a component of equity, unless there is a possibility that the Company may have to settle the warrants in cash. For warrants issued with the deemed possibility of a cash settlement, the Company records the fair value of the issued warrants as a liability at each reporting date and records changes in the estimated fair value as a non-cash gain or loss in the condensed consolidated statements of operations. The fair values of warrants have been determined using the Black Scholes Merton Option Pricing valuation model (the “Black-Scholes Model”). The Black-Scholes Model provides for assumptions regarding volatility, call and put features and risk-free interest rates within the total period to maturity. These values are subject to a significant degree of judgment on the part of the Company. Accounting for Costs Associated with Exit or Disposal Activities Costs to terminate an operating lease or other contracts are (a) costs to terminate the contract before the end of its term or (b) costs that will continue to be incurred under the contract for its remaining term without economic benefit to the entity. In periods subsequent to initial measurement, changes to the liability are measured using the credit-adjusted risk-free rate that was used to measure the liability initially. Revenue Recognition Contract revenues consist of revenues from grants, collaboration agreements and feasibility studies. License and collaboration revenue is primarily generated through agreements with strategic partners for the development and commercialization of our product candidates. The terms of the agreement typically include non-refundable upfront fees, funding of research and development activities, payments based upon achievement of milestones and royalties on net product sales. The Company recognizes revenue under the provisions of the Securities and Exchange Commission issued Staff Accounting Bulletin 104, Topic 13, Revenue Recognition Revised and Updated (“SAB Topic 13”) and ASC 605-25, Revenue Recognition-Multiple Elements. Revenue for arrangements not having multiple deliverables, as outlined in ASC 605-25, is recognized once costs are incurred and collectability is reasonably assured. Revenue is recognized when there is persuasive evidence that an arrangement exists, delivery has occurred, the price is fixed and determinable and collection is reasonably assured. Multiple-deliverable arrangements, such as license and development agreements, are analyzed to determine whether the deliverables can be separated or whether they must be accounted for as a single unit of accounting. When deliverables are separable, consideration received is allocated to the separate units of accounting based on the relative selling price method and the appropriate revenue recognition principles are applied to each unit. When the Company determines that an arrangement should be accounted for as a single unit of accounting, it must determine the period over which the performance obligations will be performed and revenue will be recognized. The Company estimates its performance period used for revenue recognition based on the specific terms of each agreement, and adjusts the performance periods, if appropriate, based on the applicable facts and circumstances. Significant management judgment may be required to determine the level of effort required under an arrangement and the period over which the Company is expected to complete its performance obligations under the arrangement. If the Company cannot reasonably estimate when its performance obligations either are completed or become inconsequential, then revenue recognition is deferred until the Company can reasonably make such estimates. Revenue is then recognized over the remaining estimated period of performance using the cumulative catch-up method. The Company adopted the provisions of Accounting Standards Update No. 2009-13, Revenue Recognition (Topic 605); Multiple-Deliverable Revenue Arrangements (“ASU 2009-13”) for new and materially modified arrangements originating on or after January 1, 2010. ASU 2009-13 provides updated guidance on how the deliverables in an arrangement should be separated, and how consideration should be allocated, and it changes the level of evidence of standalone selling price required to separate deliverables by allowing a vendor to make its best estimate of the standalone selling price of deliverables when vendor-specific objective evidence or third-party evidence of selling price is not available. The Company allocates non-contingent consideration to each stand-alone deliverable based upon the relative selling price of each element. When applying the relative selling price method, the Company determines the selling price for each deliverable using vendor-specific objective evidence, or VSOE, of selling price, if it exists, or third-party evidence, or TPE, of selling price, if it exists. If neither VSOE nor TPE of selling price exist for a deliverable, the Company uses best estimated selling price, or BESP, for that deliverable. Assuming the elements meet the revenue recognition guidelines, the revenue recognition methodology prescribed for each unit of accounting is summarized below: Upfront Fees Funded Research and Development and Grant Revenue Milestones Royalties Research and Development Research and development expenses consist of costs incurred for company-sponsored, collaborative and contracted research and development activities. These costs include direct and research-related overhead expenses. The Company expenses research and development costs as such costs are incurred. Stock-Based Compensation The Company accounts for share-based payment arrangements in accordance with ASC 718, Compensation-Stock Compensation Equity-Equity Based Payments to Non-Employees Income Taxes The Company makes certain estimates and judgments in determining income tax expense for financial statement purposes. These estimates and judgments occur in the calculation of certain tax assets and liabilities, which arise from differences in the timing of recognition of revenue and expense for tax and financial statement purposes. As part of the process of preparing the financial statements, the Company is required to estimate income taxes in each of the jurisdictions in which it operates. This process involves the Company estimating its current tax exposure under the most recent tax laws and assessing temporary differences resulting from differing treatment of items for tax and accounting purposes. These differences result in deferred tax assets and liabilities which are included in the Company’s consolidated balance sheets. The Company estimated its current tax exposure to be zero as it expects to be able to utilize its net operating loss carryovers (NOLs) to offset if any, the income recognized in the quarter and year to date. The Company has updated its Section 382 analysis through December 31, 2015 and noted no additional changes since the last change in 2010. The Company assesses the likelihood that it will be able to recover its deferred tax assets. The Company considers all available evidence, both positive and negative, including the historical levels of income and losses, expectations and risks associated with estimates of future taxable income and ongoing prudent and feasible tax planning strategies in assessing the need for a valuation allowance. If the Company does not consider it more likely than not that it will recover its deferred tax assets, the Company records a valuation allowance against the deferred tax assets that it estimates will not ultimately be recoverable. At September 30, 2016, and December 31, 2015 the Company believed that the amount of its deferred income taxes would not be ultimately recovered. Accordingly, the Company recorded a full valuation allowance for deferred tax assets. However, should there be a change in the Company’s ability to recover its deferred tax assets the Company would recognize a benefit to its tax provision in the period in which it determines that it is more likely than not that it will recover its deferred tax assets. Net Income/(Loss) Per Common Share Basic net income/(loss) per common share is computed using the weighted-average number of shares of common stock outstanding during the period less the weighted-average number of restricted shares of common stock subject to repurchase. Potentially dilutive securities were not included in the net loss per common share calculation for the three and nine months ended September 30, 2016, and 2015 because the inclusion of such shares would have had an anti-dilutive effect. Comprehensive Income (Loss) Comprehensive loss refers to revenues, expenses, gains and losses that under U.S. GAAP are included in comprehensive loss but are excluded from net loss as these amounts are recorded directly as an adjustment to shareholders’ equity. Comprehensive loss for the periods presented was comprised solely of the Company’s consolidated net loss. There were no changes in equity that were excluded from the Company’s consolidated net loss for all periods presented. Recently Issued Accounting Pronouncements There have been no recent accounting pronouncements or changes in accounting pronouncements during the nine months ended September 30, 2016, as compared to the recent accounting pronouncements described in the Company’s 2015 Annual Report on Form 10-K that are of significance or potential significance to the Company. |
Cash and Cash Equivalents
Cash and Cash Equivalents | 9 Months Ended |
Sep. 30, 2016 | |
Cash and Cash Equivalents [Abstract] | |
Cash and Cash Equivalents | 3. Cash and Cash Equivalents At September 30, 2016 and December 31, 2015, the amortized cost of the Company’s cash and cash equivalents approximated their fair values. The Company currently invests its cash and cash equivalents in money market funds. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2016 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 4. Fair Value Measurements The Company follows ASC 820, Fair Value Measurements The Company’s cash and cash equivalents at September 30, 2016 consist of cash and money market funds. Money market funds are valued using quoted market prices. |
Other Accrued Liabilities
Other Accrued Liabilities | 9 Months Ended |
Sep. 30, 2016 | |
Payables and Accruals [Abstract] | |
Other Accrued Liabilities | 5. Other Accrued Liabilities At September 30, 2016, other accrued liabilities consisted of accrued expenses for interest of $832,000, expenses for services of $212,000 and payroll withholding liabilities of $77,000. The liability for accrued interest of $832,000 is related to the Convertible Notes as outlined in Note 6 and represents the interest on the Convertible Notes that is accrued but unpaid as of September 30, 2016. At December 31, 2015, other accrued liabilities consisted of accrued expenses for services of $73,000 and payroll withholding liabilities of $39,000. |
Convertible Notes and Warrants
Convertible Notes and Warrants | 9 Months Ended |
Sep. 30, 2016 | |
Text Block [Abstract] | |
Convertible Notes and Warrants | 6. Convertible Notes and Warrants On April 21, 2016, the Company entered into a securities purchase agreement to conduct a private offering (the “Convertible Note Financing”) consisting of $23 million in aggregate principal amount of 9% senior convertible notes convertible into shares of common stock (the “Convertible Notes”) and 263,436 warrants to purchase shares of the Company’s common stock (the “Warrants”). The Convertible Notes bear interest at a rate of 9% per year, payable semiannually in arrears on November 1 and May 1 of each year commencing on November 1, 2016. The Convertible Notes mature on May 1, 2021, unless earlier redeemed or converted. The Convertible Notes are senior unsecured and unsubordinated obligations; rank equal in right of payment to the Company’s existing and future unsecured indebtedness that is not subordinated and are effectively subordinated in right of payment to the Company’s existing and future secured indebtedness. The Convertible Notes are initially convertible into the Company’s common stock at a conversion rate of 191.9386 shares of common stock per $1,000 principal amount of Convertible Notes, representing an initial effective conversion price of $5.21 per share of common stock. The conversion rate may be subject to adjustment upon the occurrence of certain specified events as provided in the indenture governing the Convertible Notes, dated April 25, 2016 between the Company and U.S. Bank National Association, as trustee (the “Indenture”), but will not be adjusted for accrued but unpaid interest. Upon conversion of a Convertible Note, the Company will settle the conversion obligation in common stock equal to the conversion rate, together with a cash payment, if applicable. The Convertible Notes are convertible at the option of the holders at any time prior to April 29, 2021. Holders of the Convertible Notes who convert their Convertible Notes in connection with a make-whole fundamental change, as defined in the Indenture, may be entitled to a make-whole premium in the form of an increase to the conversion rate during a specified period following the effective date of the make-whole fundamental change. In addition, upon the occurrence of a fundamental change prior to the maturity date of the Convertible Notes, as defined in the Indenture, holders of the Convertible Notes may require the Company to purchase all or a portion of their Convertible Notes for cash at a price equal to 100% of the principal amount of the Convertible Notes to be purchased plus any accrued but unpaid interest to, but excluding, the fundamental change purchase date. On or after December 1, 2017, the Company may redeem for cash all or a portion of the Convertible Notes if the last reported sale price of the Company’s common stock is at any time equal to or greater than 200% of the conversion price then in effect for at least twenty trading days immediately preceding the date on which the Company provides notice of redemption, at a redemption price equal to 100% of the principal amount of the Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date. The Indenture provides for customary events of default which may result in the acceleration of the maturity of the Notes, including, but not limited to, cross acceleration to certain other indebtedness of the Company and its subsidiaries. In the case of an event of default arising from specified events of bankruptcy or insolvency or reorganization all outstanding Convertible Notes will become due and payable immediately without further action or notice. If any other event of default under the Indenture occurs or is continuing, the trustee or holders of at least 25% in aggregate principal amount of the then outstanding Convertible Notes may declare all of the Convertible Notes to be due and payable immediately. The Warrants have a five-year term and are exercisable at $5.21 per share of common stock. The exercise price is subject to adjustment in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events or upon any distributions of assets, including cash, stock or other property to the Company’s shareholders. The Warrants are exercisable commencing on the later of October 25, 2016 and the date of the public release of top line data related to the conclusion of the ORBIT-3 and ORBIT-4 Phase 3 pivotal clinical trials for the Company’s investigational product Pulmaquin ® In accounting for the Convertible Notes and Warrants in the first closing, the Company bifurcated a derivative liability from the debt host and discounted the Convertible Notes for the estimated fair value of the conversion feature and the freestanding Warrants issued in connection with the Convertible Notes. The liability components were measured by estimating their fair value as of the commitment date. On June 9, 2016, the Company obtained Shareholder Approval for the Convertible Notes, the Warrants and the underlying shares, at which point the Conversion Share Cap on the Convertible Notes was lifted. As a result, the bifurcated derivative and warrant liability met the equity classification criteria under ASC 815-40-25 and the liabilities were remeasured at fair value on June 9, 2016 and reclassified to permanent equity. The equity component will not be remeasured in subsequent periods provided that the component continues to meet the conditions necessary for equity classification. The excess of the aggregate face value of the Convertible Notes over the estimated fair value of the liability components is recognized as a debt discount which will be amortized over the term of the Convertible Notes using the effective interest rate method. Amortization of the debt discount is recognized as non-cash interest expense. On April 25, 2016, the initial closing of the Convertible Notes took place under which the Company raised $20 million from a total of two investors and issued 4,319 Warrants to one investor. Of the $20 million, $19.9 million was financed by Grifols, a related party to the Company, as described in Note 7 below. There were 3,319,820 common shares underlying the conversion feature that was bifurcated as a derivative liability due to the Conversion Share Cap. The Company deposited $1.8 million of the net proceeds into an escrow account after the initial closing to fund, when due, the first two scheduled semi-annual interest payments on the notes. The effective interest rate of the liability component was equal to 22.9% for the three and nine months ended September 30, 2016. On July 14, 2016, the second and final closing of the Convertible Notes took place under which the Company raised $3 million from a total of two investors and issued 259,117 Warrants. The fair value of the warrants issued in the second closing was $662,000 and was recorded as a component of equity and discount to the debt host. The Company deposited $216,000 of the net proceeds into an escrow account after the second closing to fund, when due, the first two scheduled semi-annual interest payments on the Convertible Notes. The effective interest rate of the liability component was equal to 16.24% for the three and nine months ended September 30, 2016. The financing costs of $2.4 million incurred in connection with the issuance of the Convertible Notes were allocated to the derivative liability, warrants and Convertible Note components based on their relative fair values. Financing costs of $1.4 million allocated to the Convertible Note host are being amortized using the effective interest rate method and recognized as non-cash interest expense over the expected term of the Convertible Notes. For the three and nine months ended September 30, 2016, financing costs of $61,000 and $997,000, respectively, allocated to the derivative liability and Warrant components were expensed and are included in other expense in the Condensed Consolidated Statement of Operations and Comprehensive Loss. In connection with the first closing, the derivative and warrant liabilities were measured at fair value using certain estimated inputs, which are classified within Level 3 of the valuation hierarchy. The following assumptions were used in the Black-Scholes Model to measure the fair value of the derivative and warrant liability as of June 9, 2016 (the date of the shareholder vote) and April 21, 2016 (the date of the first closing): June 9, 2016 April 21, 2016 Fair value of underlying stock – per share $ 4.48 $ 4.55 Risk-free interest rate 1.20 % 1.35 % Expected life (years) 4.9 5 Expected volatility 73.16 % 73.95 % Dividend yield 0.0 % 0.0 % The following table summarizes the activity in the derivative liability and the warrant liability for the nine months ended September 30, 2016: Nine Months Ended September 30, 2016 (in thousands) Fair Value Fair Value of Change in Reclassifications to Equity Fair Value September 30, 2016 Derivative liability $ — $ 8,748 $ (386 ) $ (8,362 ) $ — Warrant liability — 11 — (11 ) — Total $ — $ 8,759 $ (386 ) $ (8,373 ) $ — For the nine months ended September 30, 2016, the Company recognized a gain of $386,000 and $500 on the derivative and warrant liabilities, respectively, related to the change in fair value from the date of commitment to the date the instruments met the equity classification criteria on June 9, 2016 at which point $8.4 million was reclassified from liabilities to equity. The gain has been recorded in other expense in the Condensed Consolidated Statement of Operations and Comprehensive Loss. There was no activity during the three months ended September 30, 2016 as the share cap provision had expired during the second quarter. In connection with the second closing, the Warrants issued as a component of equity were measured at fair value using certain estimated inputs, which are classified within Level 3 of the valuation hierarchy. The following assumptions were used in the Black-Scholes Model to measure the fair value of the Warrants as of July 14, 2016: July 14, 2016 Fair value of underlying stock – per share $ 4.58 Risk-free interest rate 1.07 % Expected life (years) 4.78 Expected volatility 72.87 % Dividend yield 0.0 % As of September 30, 2016, the Convertible Notes consisted of the following: September 30, 2016 (in thousands, except Principal value $ 23,000 Unamortized debt discount (8,859 ) Unamortized debt issuance costs (1,335 ) Carrying value of the convertible notes $ 12,806 Conversion rate (shares of common stock per $1,000 principal amount of notes) 191.9386 Conversion price (per share of common stock) $ 5.21 For the three and nine months ended September 30, 2016, the Company recognized interest expense associated with its Convertible Notes as follows: Three months ended Nine months ended (in thousands) (in thousands) Cash Interest Expense Coupon interest expense $ 507 $ 832 Noncash Interest Expense Amortization of debt discount $ 340 $ 562 Amortization of transaction costs $ 51 $ 81 $ 898 $ 1,475 As of September 30, 2016, the unamortized debt discount will be amortized over a remaining period of approximately 4.59 years. The if converted value as of September 30, 2016 exceeds the principal balance of the Convertible Notes by approximately $6.3 million. Accrued interest payable at September 30, 2016 is $832,000 and is included in other accrued liabilities. |
Collaboration Agreement
Collaboration Agreement | 9 Months Ended |
Sep. 30, 2016 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Collaboration Agreement | 7. Collaboration Agreement Grifols License and Collaboration Agreement See Note 6 to the audited consolidated financial statements included in Part II, Item 8 of the 2015 Annual Report on Form 10-K for information on the Grifols Collaboration Transaction. Grifols is a related party of the Company. Pursuant to the License Agreement, the Company recognized reimbursements for services performed and costs incurred related to the development of the Pulmaquin ® Reimbursable costs incurred under the Grifols License Agreement in the quarters ended September 30, 2016 and 2015 are zero and $4.7 million, respectively. Costs incurred under the Grifols License Agreement for the nine months ended September 30, 2016 and 2015 are zero and $23.3 million, respectively. Research and development expenses incurred under the Grifols License Agreement for the three and nine months ended September 30, 2015, were $4.7 million and $22.1 million, respectively. General and administrative expenses incurred under the Grifols License Agreement for the three and nine months ended September 30, 2015, were zero and $1.2 million, respectively. Development expenses are fully burdened and include direct costs reported as research and development expenses and collaboration-related general and administrative expenses. |
Stock-Based Compensation and St
Stock-Based Compensation and Stock Options and Awards | 9 Months Ended |
Sep. 30, 2016 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock-Based Compensation and Stock Options and Awards | 8. Stock-Based Compensation and Stock Options and Awards The following table shows the stock-based compensation expense included in the accompanying Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and nine months ended September 30, 2016 and 2015 (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2016 2015 2016 2015 Costs and expenses: Research and development $ 190 $ 150 $ 564 $ 367 General and administrative 196 106 621 331 Total stock-based compensation expense $ 386 $ 256 $ 1,185 $ 698 There was no capitalized stock-based employee compensation cost for the three and nine months ended September 30, 2016 and 2015. Since the Company did not record a tax provision during the quarters ended September 30, 2016 and 2015, there was no recognized tax benefit associated with stock-based compensation expense. Stock Option Plans: 2005 Equity Incentive Plan (the “2005 Plan”), and 2015 Equity Incentive Plan (the “2015” Plan) On March 13, 2015 the Board adopted and, on May 14, 2015 the Company’s shareholders approved, the 2015 Plan. The 2015 Plan replaces the Company’s 2005 Plan, which expired in March 2015. The 2015 Plan is intended to promote our long-term success and increase shareholder value by attracting, motivating, and retaining non-employee directors, officers, employees, advisors, consultants and independent contractors, and allows the flexibility to grant a variety of awards to eligible individuals, thereby strengthening their commitment to the Company’s success and aligning their interests with those of the Company’s shareholders. The Company did not request that shareholders authorize any new shares of Common Stock in connection with the approval of the 2015 Plan; rather, the shares authorized for issuance under the 2005 Plan were available for issuance under the 2015 Plan. In March 2016, the Company’s Board of Directors amended, and in June 2016 the Company’s shareholders approved, the amendment to the 2015 Plan increasing the shares of common stock authorized for issuance by 2,400,000 shares. Stock Option Activity The following is a summary of activity under the 2005 Plan and the 2015 Plan for the nine months ended September 30, 2016: Shares Available for Balance at January 1, 2016 252,725 Increase in authorized shares 2,400,000 Options granted (765,323 ) Options cancelled 26,697 Awards granted (166,000 ) Balance at September 30, 2016 1,748,099 Options Outstanding Number of Shares Weighted Average Exercise Price Weighted Aggregate Outstanding at January 1, 2016 947,142 $ 11.40 Options granted 765,323 $ 4.15 Options cancelled (26,697 ) $ 73.58 Outstanding at September 30, 2016 1,685,768 $ 7.12 8.33 $ 2,163,183 Exercisable at September 30, 2016 516,392 $ 10.29 7.00 $ 152,582 During the nine months ended September 30, 2016, zero stock options were exercised. Included in the $2.2 million of intrinsic value are performance options, which account for $1.7 million of the total. The vesting of these performance options is considered improbable at this time. The total amount of unrecognized compensation cost related to non-vested stock options and stock purchases, net of forfeitures, was $1.7 million as of September 30, 2016 and does not include performance options, the vesting of which is considered improbable at this time. This amount will be recognized over a weighted average period of 1.14 years. A summary of the Company’s unvested restricted stock award activities as of September 30, 2016 is presented below representing the maximum number of shares that could be earned or vested under the 2005 Plan and the 2015 Plan: Number of Shares Weighted Average Grant Date Fair Balance at December 31, 2015 300 $ 57.60 Restricted shares granted 166,000 $ 3.87 Restricted share awards vested (9,375 ) $ 4.04 Balance at September 30, 2016 156,925 $ 3.97 For restricted stock awards the Company recognizes compensation expense over the vesting period for the fair value of the stock award on the measurement date. The Company retained purchase rights with respect to 157,000 shares of unvested restricted stock awards issued pursuant to stock purchase agreements at no cost per share as of September 30, 2016. As of September 30, 2016, there was approximately $456,000 of total unrecognized compensation costs, net of forfeitures, related to non-vested stock award which are expected to be recognized over a weighted average period of 2.22 years. |
Net Loss and Comprehensive Loss
Net Loss and Comprehensive Loss Per Common Share | 9 Months Ended |
Sep. 30, 2016 | |
Earnings Per Share [Abstract] | |
Net Loss and Comprehensive Loss Per Common Share | 9. Net Loss and Comprehensive Loss Per Common Share The Company computes basic net loss per common share using the weighted-average number of shares of common stock outstanding during the period less the weighted-average number of shares of common stock subject to repurchase. The effects of including the incremental shares associated with options, warrants and unvested restrictive are anti-dilutive, and are not included in the diluted weighted average number of shares of common stock outstanding for the nine months ending September 30, 2016 and 2015. The Company excluded the following securities from the calculation of diluted net loss per common share for the nine months ended September 30, 2016 and 2015, as their effect would be anti-dilutive (in thousands): Nine months ended September 30, 2016 2015 Common shares underlying convertible notes 4,263 — Outstanding stock options 1,686 900 Common shares underlying warrants 334 — Unvested restricted stock 157 — Unvested restricted stock units 10 10 |
Summary of Significant Accoun15
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2016 | |
Accounting Policies [Abstract] | |
Use of Estimates | Use of Estimates The preparation of financial statements, in conformity with GAAP, requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. These estimates include useful lives for property and equipment and related depreciation calculations, accruals for clinical trial expenses, assumptions for valuing options and warrants, and income taxes. Actual results could differ from these estimates. |
Cash and Cash Equivalents | Cash and Cash Equivalents All highly liquid investments with maturities of three months or less at the time of purchase are classified as cash equivalents. |
Restricted Cash | Restricted Cash The Company classifies transfers to the restricted cash balance in the statement of cash flows based on the nature of the restriction. At September 30, 2016, the Company has $2.0 million in restricted cash held in an interest bearing escrow account for the purpose of making future interest payments on the Convertible Notes, as outlined in Note 6 below. The Company is required to maintain such deposits sufficient to pay all required payments of interest through May 1, 2017. |
Property and Equipment | Property and Equipment The Company records property and equipment at cost and calculates depreciation using the straight-line method over the estimated useful lives of the respective assets. Machinery and equipment includes external costs incurred for validation of the equipment. The Company does not capitalize internal validation expense. Computer equipment and software includes capitalized computer software. All of the Company’s capitalized software is purchased; the Company has no internally-developed computer software. Leasehold improvements are amortized over the shorter of the term of the lease or useful life of the improvement. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The Company reviews for impairment whenever events or changes in circumstances indicate that the carrying amount of property and equipment may not be recoverable. Determination of recoverability is based on an estimate of undiscounted future cash flows resulting from the use of the asset and its eventual disposition. In the event that such cash flows are not expected to be sufficient to recover the carrying amount of the assets, the assets are written down to their estimated fair values and the loss is recognized in the consolidated statements of operations. |
Convertible Instruments | Convertible Instruments The Company accounts for hybrid contracts that feature conversion options in accordance with generally accepted accounting principles in the United States. ASC 815, Derivatives and Hedging Activities The Company accounts for convertible instruments (when it has determined that the embedded conversion options should be bifurcated from their host instruments) in accordance with ASC 815. Under ASC 815, a portion of the proceeds received upon the issuance of the hybrid contract is allocated to the fair value of the derivative. The derivative is subsequently marked to market at each reporting date based on current fair value, with the changes in fair value reported in results of operations. |
Warrants Issued in Connection with Financings | Warrants Issued in Connection with Financings The Company generally accounts for warrants issued in connection with financings as a component of equity, unless there is a possibility that the Company may have to settle the warrants in cash. For warrants issued with the deemed possibility of a cash settlement, the Company records the fair value of the issued warrants as a liability at each reporting date and records changes in the estimated fair value as a non-cash gain or loss in the condensed consolidated statements of operations. The fair values of warrants have been determined using the Black Scholes Merton Option Pricing valuation model (the “Black-Scholes Model”). The Black-Scholes Model provides for assumptions regarding volatility, call and put features and risk-free interest rates within the total period to maturity. These values are subject to a significant degree of judgment on the part of the Company. |
Accounting for Costs Associated with Exit or Disposal Activities | Accounting for Costs Associated with Exit or Disposal Activities Costs to terminate an operating lease or other contracts are (a) costs to terminate the contract before the end of its term or (b) costs that will continue to be incurred under the contract for its remaining term without economic benefit to the entity. In periods subsequent to initial measurement, changes to the liability are measured using the credit-adjusted risk-free rate that was used to measure the liability initially. |
Revenue Recognition | Revenue Recognition Contract revenues consist of revenues from grants, collaboration agreements and feasibility studies. License and collaboration revenue is primarily generated through agreements with strategic partners for the development and commercialization of our product candidates. The terms of the agreement typically include non-refundable upfront fees, funding of research and development activities, payments based upon achievement of milestones and royalties on net product sales. The Company recognizes revenue under the provisions of the Securities and Exchange Commission issued Staff Accounting Bulletin 104, Topic 13, Revenue Recognition Revised and Updated (“SAB Topic 13”) and ASC 605-25, Revenue Recognition-Multiple Elements. Revenue for arrangements not having multiple deliverables, as outlined in ASC 605-25, is recognized once costs are incurred and collectability is reasonably assured. Revenue is recognized when there is persuasive evidence that an arrangement exists, delivery has occurred, the price is fixed and determinable and collection is reasonably assured. Multiple-deliverable arrangements, such as license and development agreements, are analyzed to determine whether the deliverables can be separated or whether they must be accounted for as a single unit of accounting. When deliverables are separable, consideration received is allocated to the separate units of accounting based on the relative selling price method and the appropriate revenue recognition principles are applied to each unit. When the Company determines that an arrangement should be accounted for as a single unit of accounting, it must determine the period over which the performance obligations will be performed and revenue will be recognized. The Company estimates its performance period used for revenue recognition based on the specific terms of each agreement, and adjusts the performance periods, if appropriate, based on the applicable facts and circumstances. Significant management judgment may be required to determine the level of effort required under an arrangement and the period over which the Company is expected to complete its performance obligations under the arrangement. If the Company cannot reasonably estimate when its performance obligations either are completed or become inconsequential, then revenue recognition is deferred until the Company can reasonably make such estimates. Revenue is then recognized over the remaining estimated period of performance using the cumulative catch-up method. The Company adopted the provisions of Accounting Standards Update No. 2009-13, Revenue Recognition (Topic 605); Multiple-Deliverable Revenue Arrangements (“ASU 2009-13”) for new and materially modified arrangements originating on or after January 1, 2010. ASU 2009-13 provides updated guidance on how the deliverables in an arrangement should be separated, and how consideration should be allocated, and it changes the level of evidence of standalone selling price required to separate deliverables by allowing a vendor to make its best estimate of the standalone selling price of deliverables when vendor-specific objective evidence or third-party evidence of selling price is not available. The Company allocates non-contingent consideration to each stand-alone deliverable based upon the relative selling price of each element. When applying the relative selling price method, the Company determines the selling price for each deliverable using vendor-specific objective evidence, or VSOE, of selling price, if it exists, or third-party evidence, or TPE, of selling price, if it exists. If neither VSOE nor TPE of selling price exist for a deliverable, the Company uses best estimated selling price, or BESP, for that deliverable. Assuming the elements meet the revenue recognition guidelines, the revenue recognition methodology prescribed for each unit of accounting is summarized below: Upfront Fees Funded Research and Development and Grant Revenue Milestones Royalties |
Research and Development | Research and Development Research and development expenses consist of costs incurred for company-sponsored, collaborative and contracted research and development activities. These costs include direct and research-related overhead expenses. The Company expenses research and development costs as such costs are incurred. |
Stock-Based Compensation | Stock-Based Compensation The Company accounts for share-based payment arrangements in accordance with ASC 718, Compensation-Stock Compensation Equity-Equity Based Payments to Non-Employees |
Income Taxes | Income Taxes The Company makes certain estimates and judgments in determining income tax expense for financial statement purposes. These estimates and judgments occur in the calculation of certain tax assets and liabilities, which arise from differences in the timing of recognition of revenue and expense for tax and financial statement purposes. As part of the process of preparing the financial statements, the Company is required to estimate income taxes in each of the jurisdictions in which it operates. This process involves the Company estimating its current tax exposure under the most recent tax laws and assessing temporary differences resulting from differing treatment of items for tax and accounting purposes. These differences result in deferred tax assets and liabilities which are included in the Company’s consolidated balance sheets. The Company estimated its current tax exposure to be zero as it expects to be able to utilize its net operating loss carryovers (NOLs) to offset if any, the income recognized in the quarter and year to date. The Company has updated its Section 382 analysis through December 31, 2015 and noted no additional changes since the last change in 2010. The Company assesses the likelihood that it will be able to recover its deferred tax assets. The Company considers all available evidence, both positive and negative, including the historical levels of income and losses, expectations and risks associated with estimates of future taxable income and ongoing prudent and feasible tax planning strategies in assessing the need for a valuation allowance. If the Company does not consider it more likely than not that it will recover its deferred tax assets, the Company records a valuation allowance against the deferred tax assets that it estimates will not ultimately be recoverable. At September 30, 2016, and December 31, 2015 the Company believed that the amount of its deferred income taxes would not be ultimately recovered. Accordingly, the Company recorded a full valuation allowance for deferred tax assets. However, should there be a change in the Company’s ability to recover its deferred tax assets the Company would recognize a benefit to its tax provision in the period in which it determines that it is more likely than not that it will recover its deferred tax assets. |
Net Income/(Loss) Per Common Share | Net Income/(Loss) Per Common Share Basic net income/(loss) per common share is computed using the weighted-average number of shares of common stock outstanding during the period less the weighted-average number of restricted shares of common stock subject to repurchase. Potentially dilutive securities were not included in the net loss per common share calculation for the three and nine months ended September 30, 2016, and 2015 because the inclusion of such shares would have had an anti-dilutive effect. |
Comprehensive Income (Loss) | Comprehensive Income (Loss) Comprehensive loss refers to revenues, expenses, gains and losses that under U.S. GAAP are included in comprehensive loss but are excluded from net loss as these amounts are recorded directly as an adjustment to shareholders’ equity. Comprehensive loss for the periods presented was comprised solely of the Company’s consolidated net loss. There were no changes in equity that were excluded from the Company’s consolidated net loss for all periods presented. |
Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements There have been no recent accounting pronouncements or changes in accounting pronouncements during the nine months ended September 30, 2016, as compared to the recent accounting pronouncements described in the Company’s 2015 Annual Report on Form 10-K that are of significance or potential significance to the Company. |
Convertible Notes and Warrants
Convertible Notes and Warrants (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Summary of activity in Derivative Liability and Warrant Liability | The following table summarizes the activity in the derivative liability and the warrant liability for the nine months ended September 30, 2016: Nine Months Ended September 30, 2016 (in thousands) Fair Value Fair Value of Change in Reclassifications to Equity Fair Value September 30, 2016 Derivative liability $ — $ 8,748 $ (386 ) $ (8,362 ) $ — Warrant liability — 11 — (11 ) — Total $ — $ 8,759 $ (386 ) $ (8,373 ) $ — |
Summary of Convertible Notes | As of September 30, 2016, the Convertible Notes consisted of the following: September 30, 2016 (in thousands, except Principal value $ 23,000 Unamortized debt discount (8,859 ) Unamortized debt issuance costs (1,335 ) Carrying value of the convertible notes $ 12,806 Conversion rate (shares of common stock per $1,000 principal amount of notes) 191.9386 Conversion price (per share of common stock) $ 5.21 |
Summary of Interest Expense Associated with Convertible Notes | For the three and nine months ended September 30, 2016, the Company recognized interest expense associated with its Convertible Notes as follows: Three months ended Nine months ended (in thousands) (in thousands) Cash Interest Expense Coupon interest expense $ 507 $ 832 Noncash Interest Expense Amortization of debt discount $ 340 $ 562 Amortization of transaction costs $ 51 $ 81 $ 898 $ 1,475 |
Initial Closing [Member] | |
Schedule of Fair Value Assumption Used to Measure Derivative and Warrant Liability | The following assumptions were used in the Black-Scholes Model to measure the fair value of the derivative and warrant liability as of June 9, 2016 (the date of the shareholder vote) and April 21, 2016 (the date of the first closing): June 9, 2016 April 21, 2016 Fair value of underlying stock – per share $ 4.48 $ 4.55 Risk-free interest rate 1.20 % 1.35 % Expected life (years) 4.9 5 Expected volatility 73.16 % 73.95 % Dividend yield 0.0 % 0.0 % |
Second and Final Closing [Member] | |
Schedule of Fair Value Assumption Used to Measure Derivative and Warrant Liability | The following assumptions were used in the Black-Scholes Model to measure the fair value of the Warrants as of July 14, 2016: July 14, 2016 Fair value of underlying stock – per share $ 4.58 Risk-free interest rate 1.07 % Expected life (years) 4.78 Expected volatility 72.87 % Dividend yield 0.0 % |
Stock-Based Compensation and 17
Stock-Based Compensation and Stock Options and Awards (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Schedule of Stock-Based Compensation Expense | The following table shows the stock-based compensation expense included in the accompanying Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and nine months ended September 30, 2016 and 2015 (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2016 2015 2016 2015 Costs and expenses: Research and development $ 190 $ 150 $ 564 $ 367 General and administrative 196 106 621 331 Total stock-based compensation expense $ 386 $ 256 $ 1,185 $ 698 |
Schedule of Activity Under Stock Option Plan | The following is a summary of activity under the 2005 Plan and the 2015 Plan for the nine months ended September 30, 2016: Shares Available for Balance at January 1, 2016 252,725 Increase in authorized shares 2,400,000 Options granted (765,323 ) Options cancelled 26,697 Awards granted (166,000 ) Balance at September 30, 2016 1,748,099 Options Outstanding Number of Shares Weighted Average Exercise Price Weighted Aggregate Outstanding at January 1, 2016 947,142 $ 11.40 Options granted 765,323 $ 4.15 Options cancelled (26,697 ) $ 73.58 Outstanding at September 30, 2016 1,685,768 $ 7.12 8.33 $ 2,163,183 Exercisable at September 30, 2016 516,392 $ 10.29 7.00 $ 152,582 |
Restricted Stock Award [Member] | |
Schedule of Unvested Restricted Stock Award Activities | A summary of the Company’s unvested restricted stock award activities as of September 30, 2016 is presented below representing the maximum number of shares that could be earned or vested under the 2005 Plan and the 2015 Plan: Number Shares Weighted Average Grant Date Fair Balance at December 31, 2015 300 $ 57.60 Restricted shares granted 166,000 $ 3.87 Restricted share awards vested (9,375 ) $ 4.04 Balance at September 30, 2016 156,925 $ 3.97 |
Net Loss and Comprehensive Lo18
Net Loss and Comprehensive Loss Per Common Share (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Earnings Per Share [Abstract] | |
Schedule of Securities Excluded from Calculation of Diluted Net Loss per Common Share | The Company excluded the following securities from the calculation of diluted net loss per common share for the nine months ended September 30, 2016 and 2015, as their effect would be anti-dilutive (in thousands): Nine months ended September 30, 2016 2015 Common shares underlying convertible notes 4,263 — Outstanding stock options 1,686 900 Common shares underlying warrants 334 — Unvested restricted stock 157 — Unvested restricted stock units 10 10 |
Organization, Basis of Presen19
Organization, Basis of Presentation and Liquidity - Additional Information (Detail) $ in Thousands | 9 Months Ended | |||
Sep. 30, 2016USD ($)Segment | Dec. 31, 2015USD ($) | Sep. 30, 2015USD ($) | Dec. 31, 2014USD ($) | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||||
Number of operating segment | Segment | 1 | |||
Accumulated deficit | $ (430,482) | $ (405,481) | ||
Working capital | 25,900 | |||
Shareholders' equity | 8,389 | 23,110 | ||
Cash and cash equivalents | $ 28,499 | $ 31,462 | $ 39,984 | $ 47,990 |
Summary of Significant Accoun20
Summary of Significant Accounting Policies - Additional Information (Detail) | 9 Months Ended |
Sep. 30, 2016USD ($) | |
Income Tax Disclosure [Abstract] | |
Restricted cash held in interest bearing escrow account | $ 2,000,000 |
Estimated current tax exposure | $ 0 |
Other Accrued Liabilities - Add
Other Accrued Liabilities - Additional Information (Detail) - USD ($) | Sep. 30, 2016 | Dec. 31, 2015 |
Other Accrued Liabilities [Line Items] | ||
Accrued expenses for interest | $ 832,000 | |
Accrued payroll withholding liabilities | 1,343,000 | $ 1,159,000 |
Other Accrued Liabilities [Member] | ||
Other Accrued Liabilities [Line Items] | ||
Accrued expenses for services | 212,000 | 73,000 |
Accrued payroll withholding liabilities | 77,000 | $ 39,000 |
Convertible Debt [Member] | Other Accrued Liabilities [Member] | ||
Other Accrued Liabilities [Line Items] | ||
Accrued expenses for interest | $ 832,000 |
Convertible Notes and Warrant22
Convertible Notes and Warrants - Additional Information (Detail) | Dec. 01, 2017$ / shares | Jul. 14, 2016USD ($)Investorshares | Jun. 09, 2016USD ($) | Apr. 25, 2016USD ($)Investorshares | Apr. 21, 2016USD ($)$ / sharesshares | Sep. 30, 2016USD ($)$ / shares | Sep. 30, 2016USD ($)$ / sharesshares |
Debt Instrument [Line Items] | |||||||
Aggregate principal amount | $ 23,000,000 | $ 23,000,000 | |||||
Debt conversion, initial conversion ratio, numerator | shares | 191.9386 | ||||||
Debt conversion, initial conversion ratio, denominator | $ 1,000 | ||||||
Debt conversion, initial conversion price per share | $ / shares | $ 5.21 | $ 5.21 | |||||
Purchasable portion of notes equal to percentage of principal amount of notes | 100.00% | ||||||
Proceeds from issuance of convertible debt | $ 3,050,000 | ||||||
Proceeds from related party convertible debt | 19,950,000 | ||||||
Fair value of the warrants issued | 662,000 | ||||||
Amortization of financing cost | $ 51,000 | 81,000 | |||||
Financing costs, derivative liability and warrant | 997,000 | ||||||
Gain recognized on derivative and warrant liabilities | 386,000 | ||||||
Reclassifications to equity | 8,373,000 | ||||||
Accrued interest payable | $ 832,000 | 832,000 | |||||
Debt instrument, If-converted value exceeds principal balance | $ 6,300,000 | ||||||
Second and Final Closing [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Escrow deposit | $ 216,000 | ||||||
Class of warrants or rights, issued | shares | 259,117 | ||||||
Effective interest rate on liability component | 16.24% | 16.24% | |||||
Fair value of the warrants issued | $ 662,000 | ||||||
Class of Warrant Issued April 22, 2016 [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Warrants exercisable, description | The Warrants are exercisable commencing on the later of October 25, 2016 and the date of the public release of top line data related to the conclusion of ORBIT-3 and ORBIT-4 Phase 3 pivotal clinical trials for the Company’s investigational product Pulmaquin® inhaled ciprofloxacin. If, at any time from and after October 25, 2016, the daily volume-weighted average price of the shares of the Company’s common stock for each of ten consecutive trading days exceeds 150% of the Exercise Price, the Company will have the right to call all or a portion of the Warrants for redemption upon twenty business days prior notice to the holders, at a redemption price of $0.01 per Warrant; provided that the holders of the Warrants may elect to exercise their Warrants upon receipt of any redemption notice from the Company. | ||||||
Class of Warrant Issued April 22, 2016 [Member] | Initial Closing [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Amount funded by number of investors | Investor | 2 | ||||||
Class of warrants or rights, issued | shares | 4,319 | ||||||
Class of Warrant Issued April 22, 2016 [Member] | Second and Final Closing [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Amount funded by number of investors | Investor | 2 | ||||||
Convertible Debt [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Financing cost | $ 2,400,000 | $ 2,400,000 | |||||
Amortization of financing cost | 1,400,000 | ||||||
Financing costs, derivative liability and warrant | $ 61,000 | $ 997,000 | |||||
Senior Convertible Notes Due 2021 [Member] | Convertible Debt [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Unamortized debt discount remaining amortization period | 4 years 7 months 2 days | ||||||
Senior Convertible Notes Due 2021 [Member] | Convertible Debt [Member] | Initial Closing [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Proceeds from issuance of convertible debt | $ 20,000,000 | ||||||
Escrow deposit | $ 1,800,000 | ||||||
Number of common shares convertible to derivative liability due to Conversion Share Cap | shares | 3,319,820 | ||||||
Effective interest rate on liability component | 22.90% | 22.90% | |||||
Senior Convertible Notes Due 2021 [Member] | Convertible Debt [Member] | Second and Final Closing [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Proceeds from issuance of convertible debt | $ 3,000,000 | ||||||
Senior Convertible Notes Due 2021 [Member] | Convertible Debt [Member] | Grifols [Member] | Initial Closing [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Proceeds from related party convertible debt | $ 19,900,000 | ||||||
Derivative Liability [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Gain recognized on derivative and warrant liabilities | $ 386,000 | ||||||
Reclassifications to equity | $ 8,400,000 | 8,362,000 | |||||
Derivative Liability [Member] | Fair Value, Inputs, Level 3 [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Gain recognized on derivative and warrant liabilities | 386,000 | ||||||
Warrants Liability [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Reclassifications to equity | 11,000 | ||||||
Warrants Liability [Member] | Fair Value, Inputs, Level 3 [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Gain recognized on derivative and warrant liabilities | $ 500 | ||||||
Private Placement [Member] | Class of Warrant Issued April 22, 2016 [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Number of shares into which the class of warrant may be converted | shares | 263,436 | ||||||
Private Placement [Member] | Senior Convertible Notes Due 2021 [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Debt conversion, initial conversion ratio, numerator | shares | 191.9386 | ||||||
Debt conversion, initial conversion ratio, denominator | $ 1,000 | ||||||
Debt conversion, initial conversion price per share | $ / shares | $ 5.21 | ||||||
Debt conversion, initial conversion ratio | 0.191939 | ||||||
Debt conversion, description | The Convertible Notes are initially convertible into the Company’s common stock at a conversion rate of 191.9386 shares of common stock per $1,000 principal amount of Convertible Notes, representing an initial effective conversion price of $5.21 per share of common stock. | ||||||
Private Placement [Member] | Senior Convertible Notes Due 2021 [Member] | Convertible Debt [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Aggregate principal amount | $ 23,000,000 | ||||||
Maturity date | May 1, 2021 | ||||||
Notes bear interest rate | 9.00% | ||||||
Frequency of periodic payment of interest | Payable semiannually in arrears on November 1 and May 1 of each year commencing on November 1, 2016. | ||||||
Scenario, Forecast [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Number of trading days for effectiveness preceding issuance of redemption notice | 20 days | ||||||
Redeemable portion of notes equal to percentage of principal amount of notes | 100.00% | ||||||
Scenario, Forecast [Member] | Minimum [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Redeemable portion of notes equal to or greater than percentage of sale price of common stock | 200.00% | ||||||
Scenario, Forecast [Member] | Class of Warrant Issued April 22, 2016 [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Warrants term | 5 years | ||||||
Warrants, exercise price | $ / shares | $ 5.21 | ||||||
Warrants, exercisable commencing date | Oct. 25, 2016 | ||||||
Warrants redemption Price | $ / shares | $ 0.01 | ||||||
Scenario, Forecast [Member] | Senior Convertible Notes Due 2021 [Member] | Convertible Debt [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Percentage of principal amount of outstanding debt held by trustee or holders, in which they may declare debt to be due and payable immediately in event of default | 25.00% |
Convertible Notes and Warrant23
Convertible Notes and Warrants - Schedule of Fair Value Assumption Used to Measure Derivative and Warrant Liability (Detail) - $ / shares | Jul. 14, 2016 | Jun. 09, 2016 | Apr. 21, 2016 |
Initial Closing [Member] | |||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | |||
Fair value of underlying stock - per share | $ 4.48 | $ 4.55 | |
Risk-free interest rate | 1.20% | 1.35% | |
Expected life (years) | 4 years 10 months 24 days | 5 years | |
Expected volatility | 73.16% | 73.95% | |
Dividend yield | 0.00% | 0.00% | |
Second and Final Closing [Member] | |||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | |||
Fair value of underlying stock - per share | $ 4.58 | ||
Risk-free interest rate | 1.07% | ||
Expected life (years) | 4 years 9 months 11 days | ||
Expected volatility | 72.87% | ||
Dividend yield | 0.00% |
Convertible Notes and Warrant24
Convertible Notes and Warrants - Summary of Activity in Derivative Liability and Warrant Liability (Detail) - USD ($) $ in Thousands | Jun. 09, 2016 | Sep. 30, 2016 |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Beginning balance | $ 0 | |
Fair Value of Instruments Issued | 8,759 | |
Change in Fair value | (386) | |
Reclassifications to Equity | (8,373) | |
Ending balance | 0 | |
Derivative Liability [Member] | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Beginning balance | 0 | |
Fair Value of Instruments Issued | 8,748 | |
Change in Fair value | (386) | |
Reclassifications to Equity | $ (8,400) | (8,362) |
Ending balance | 0 | |
Warrants Liability [Member] | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Beginning balance | 0 | |
Fair Value of Instruments Issued | 11 | |
Reclassifications to Equity | (11) | |
Ending balance | $ 0 |
Convertible Notes and Warrant25
Convertible Notes and Warrants - Summary of Convertible Notes (Detail) $ / shares in Units, $ in Thousands | 9 Months Ended |
Sep. 30, 2016USD ($)$ / sharesshares | |
Convertible Debt [Abstract] | |
Principal value | $ 23,000 |
Unamortized debt discount | (8,859) |
Unamortized debt issuance costs | (1,335) |
Carrying value of the convertible notes | $ 12,806 |
Conversion rate (shares of common stock per $1,000 principal amount of notes) | shares | 191.9386 |
Conversion price (per share of common stock) | $ / shares | $ 5.21 |
Convertible Notes and Warrant26
Convertible Notes and Warrants - Summary of Convertible Notes (Parenthetical) (Detail) | 9 Months Ended |
Sep. 30, 2016USD ($) | |
Convertible Debt [Abstract] | |
Debt conversion, initial conversion ratio, denominator | $ 1,000 |
Convertible Notes and Warrant27
Convertible Notes and Warrants - Summary of Interest Expense Associated with Convertible Notes (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended |
Sep. 30, 2016 | Sep. 30, 2016 | |
Noncash Interest Expense | ||
Amortization of debt discount | $ 340 | $ 562 |
Amortization of transaction costs | 51 | 81 |
Interest expense | 898 | 1,475 |
Coupon interest expense | $ 507 | $ 832 |
Collaboration Agreement - Grifo
Collaboration Agreement - Grifols License and Collaboration Agreement - Additional Information (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | Dec. 31, 2015 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Contract revenue-related party | $ 40,000 | $ 4,671,000 | $ 40,000 | $ 23,337,000 | |
Long-term deferred revenue-related party | 5,000,000 | 5,000,000 | $ 5,000,000 | ||
Long term deferred revenue-related party, milestone payment received | 5,000,000 | ||||
Research and development | 5,836,000 | 8,880,000 | 18,522,000 | 26,995,000 | |
General and administrative | 1,460,000 | 1,320,000 | 4,489,000 | 4,201,000 | |
Maximum [Member] | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Additional payments receivable upon the achievement of regulatory filing and approval milestones | 20,000,000 | 20,000,000 | |||
License Agreement with Grifols [Member] | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Fully utilized reimbursable research and development expenses | 65,000,000 | 65,000,000 | |||
Reimbursable costs incurred under the Grifols License Agreement | $ 0 | 4,700,000 | $ 0 | 23,300,000 | |
Research and development | 4,700,000 | 22,100,000 | |||
General and administrative | $ 0 | $ 1,200,000 |
Stock-Based Compensation and 29
Stock-Based Compensation and Stock Options and Awards - Schedule of Stock-Based Compensation Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Costs and expenses: | ||||
Total stock-based compensation expense | $ 386 | $ 256 | $ 1,185 | $ 698 |
Research and Development [Member] | ||||
Costs and expenses: | ||||
Total stock-based compensation expense | 190 | 150 | 564 | 367 |
General and Administrative [Member] | ||||
Costs and expenses: | ||||
Total stock-based compensation expense | $ 196 | $ 106 | $ 621 | $ 331 |
Stock-Based Compensation and 30
Stock-Based Compensation and Stock Options and Awards - Additional Information (Detail) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||
Jun. 30, 2016 | Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Capitalized stock-based employee compensation cost | $ 0 | $ 0 | $ 0 | $ 0 | |
Tax benefit associated with stock-based compensation expense | 0 | $ 0 | |||
Outstanding, aggregate intrinsic value | $ 2,200,000 | $ 2,200,000 | |||
Unvested Restricted Stock [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Weighted average period over which unrecognized compensation costs expected to be recognized | 2 years 2 months 19 days | ||||
Company retained purchase rights on unvested restricted stock awards, shares | 157,000 | 157,000 | |||
Unrecognized compensation expense | $ 456,000 | $ 456,000 | |||
Stock Options [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Increasing in shares of common stock authorized for issuance | 2,400,000 | ||||
Stock options exercised during the period | 0 | ||||
Outstanding, aggregate intrinsic value | 2,163,183 | $ 2,163,183 | |||
Unvested Stock Options and Stock Purchases [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Unrecognized compensation expense related to unvested stock options and stock purchases | 1,700,000 | $ 1,700,000 | |||
Weighted average period over which unrecognized compensation costs expected to be recognized | 1 year 1 month 21 days | ||||
Performance Options [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Outstanding, aggregate intrinsic value | $ 1,700,000 | $ 1,700,000 | |||
2005 [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Plan expiration date | 2015-03 | ||||
Increasing in shares of common stock authorized for issuance | 2,400,000 |
Stock-Based Compensation and 31
Stock-Based Compensation and Stock Options and Awards - Schedule of Activity Under Stock Option Plan - Shares Available for Future Grant (Detail) - Stock Options [Member] | 9 Months Ended |
Sep. 30, 2016shares | |
Shares Available for Future Grant | |
Balance at January 1, 2016 | 252,725 |
Increase in authorized shares | 2,400,000 |
Options granted | (765,323) |
Options cancelled | 26,697 |
Awards granted | (166,000) |
Balance at September 30, 2016 | 1,748,099 |
Stock-Based Compensation and 32
Stock-Based Compensation and Stock Options and Awards - Schedule of Activity Under Stock Option Plan - Options Outstanding (Detail) | 9 Months Ended |
Sep. 30, 2016USD ($)$ / sharesshares | |
Aggregate Intrinsic Value | |
Outstanding at September 30, 2016 | $ | $ 2,200,000 |
Stock Options [Member] | |
Number of Shares | |
Outstanding at January 1, 2016 | shares | 947,142 |
Options granted | shares | 765,323 |
Options cancelled | shares | (26,697) |
Outstanding at September 30, 2016 | shares | 1,685,768 |
Exercisable at September 30, 2016 | shares | 516,392 |
Weighted Average Exercise Price | |
Outstanding at January 1, 2016 | $ / shares | $ 11.40 |
Options granted | $ / shares | 4.15 |
Options cancelled | $ / shares | 73.58 |
Outstanding at September 30, 2016 | $ / shares | 7.12 |
Exercisable at September 30, 2016 | $ / shares | $ 10.29 |
Weighted Average Remaining Contractual Term | |
Outstanding at September 30, 2016 | 8 years 3 months 29 days |
Exercisable at September 30, 2016 | 7 years |
Aggregate Intrinsic Value | |
Outstanding at September 30, 2016 | $ | $ 2,163,183 |
Exercisable at September 30, 2016 | $ | $ 152,582 |
Stock-Based Compensation and 33
Stock-Based Compensation and Stock Options and Awards - Schedule of Unvested Restricted Stock Award Activities (Detail) - Restricted Stock Award [Member] | 9 Months Ended |
Sep. 30, 2016$ / sharesshares | |
Number of Shares | |
Balance at December 31, 2015 | shares | 300 |
Number of Shares, granted | shares | 166,000 |
Number of Shares, vested | shares | (9,375) |
Balance at September 30, 2016 | shares | 156,925 |
Weighted Average Grant Date Fair Value | |
Balance at December 31, 2015 | $ / shares | $ 57.60 |
Weighted Average Grant Date Fair Value, granted | $ / shares | 3.87 |
Weighted Average Grant Date Fair Value, vested | $ / shares | 4.04 |
Balance at September 30, 2016 | $ / shares | $ 3.97 |
Net Loss and Comprehensive Lo34
Net Loss and Comprehensive Loss Per Common Share - Schedule of Securities Excluded from Calculation of Diluted Net Loss per Common Share (Detail) - shares shares in Thousands | 9 Months Ended | |
Sep. 30, 2016 | Sep. 30, 2015 | |
Convertible Shares Underlying Convertible Notes [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Dilutive securities outstanding | 4,263 | |
Stock Options [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Dilutive securities outstanding | 1,686 | 900 |
Unvested Restricted Stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Dilutive securities outstanding | 157 | |
Unvested Restricted Stock Units [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Dilutive securities outstanding | 10 | 10 |
Common Shares Underlying Warrants [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Dilutive securities outstanding | 334 |