Document And Entity Information
Document And Entity Information - shares | 6 Months Ended | |
Jun. 30, 2016 | Aug. 05, 2016 | |
Document Information [Line Items] | ||
Entity Registrant Name | WINDTREE THERAPEUTICS INC /DE/ | |
Entity Central Index Key | 946,486 | |
Trading Symbol | wint | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Smaller Reporting Company | |
Entity Current Reporting Status | Yes | |
Entity Voluntary Filers | No | |
Entity Well-known Seasoned Issuer | No | |
Entity Common Stock, Shares Outstanding (in shares) | 8,308,736 | |
Document Type | 10-Q | |
Document Period End Date | Jun. 30, 2016 | |
Document Fiscal Year Focus | 2,016 | |
Document Fiscal Period Focus | Q2 | |
Amendment Flag | false |
Consolidated Balance Sheets (Cu
Consolidated Balance Sheets (Current Period Unaudited) - USD ($) $ in Thousands | Jun. 30, 2016 | Dec. 31, 2015 |
Current assets: | ||
Cash and cash equivalents | $ 20,330 | $ 38,722 |
Prepaid interest, current portion | 1,164 | 1,710 |
Prepaid expenses and other current assets | 454 | 362 |
Total current assets | 21,948 | 40,794 |
Property and equipment, net | 1,048 | 1,039 |
Restricted cash | 225 | 225 |
Prepaid interest, non-current portion | 1,777 | 2,319 |
Total assets | 24,998 | 44,377 |
Current liabilities: | ||
Accounts payable | 7,713 | 3,263 |
Accrued expenses | 7,342 | 7,582 |
Common stock warrant liability | 223 | |
Total current liabilities | 15,055 | 11,068 |
Long-term debt | 25,000 | 25,000 |
Other liabilities | 162 | 43 |
Total liabilities | 40,217 | 36,111 |
Stockholders’ equity/(deficit): | ||
Preferred stock, $0.001 par value; 5,000,000 shares authorized; no shares issued or outstanding | ||
Common stock, $0.001 par value; 60,000,000 shares authorized; 8,292,312 and 8,196,011 shares issued at June 30, 2016 and December 31, 2015, respectively; 8,290,820 and 8,194,519 shares outstanding at June 30, 2016 and December 31, 2015, respectively | 8 | 8 |
Additional paid-in capital | 591,530 | 590,490 |
Accumulated deficit | (603,703) | (579,178) |
Treasury stock (at cost); 1,492 shares | (3,054) | (3,054) |
Total stockholders’ equity/(deficit) | (15,219) | 8,266 |
Total liabilities & stockholders’ equity | $ 24,998 | $ 44,377 |
Consolidated Balance Sheets (C3
Consolidated Balance Sheets (Current Period Unaudited) (Parentheticals) - $ / shares | Jun. 30, 2016 | Dec. 31, 2015 |
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 5,000,000 | 5,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 60,000,000 | 36,000,000 |
Common stock, shares issued (in shares) | 8,292,312 | 8,196,011 |
Common stock, shares outstanding (in shares) | 8,290,820 | 8,194,519 |
Treasury stock, shares (in shares) | 1,492 | 1,492 |
Consolidated Statements of Oper
Consolidated Statements of Operations (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Revenues: | ||||
Product sales | $ 7 | |||
Grant revenue | 106 | 75 | 181 | 259 |
Total revenues | 106 | 75 | 181 | 266 |
Expenses: | ||||
Cost of product sales | 929 | |||
Research and development | 8,316 | 7,129 | 18,676 | 14,211 |
Selling, general and administrative | 1,783 | 3,383 | 5,440 | 6,736 |
Total expenses | 10,099 | 10,512 | 24,116 | 21,876 |
Operating loss | (9,993) | (10,437) | (23,935) | (21,610) |
Change in fair value of common stock warrant liability | 469 | 223 | 438 | |
Other income / (expense): | ||||
Interest income | 5 | 1 | 12 | 2 |
Interest expense | (637) | (1,260) | (1,259) | (2,468) |
Other income / (expense) | 1 | (99) | 434 | 133 |
Other income / (expense), net | (631) | (1,358) | (813) | (2,333) |
Net loss | $ (10,624) | $ (11,326) | $ (24,525) | $ (23,505) |
Net loss per common share – Basic and diluted (in dollars per share) | $ (1.29) | $ (1.82) | $ (2.99) | $ (3.78) |
Weighted-average number of common shares outstanding – basic and diluted (in shares) | 8,238 | 6,125 | 8,215 | 6,119 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2016 | Jun. 30, 2015 | |
Cash flows from operating activities: | ||
Net loss | $ (24,525) | $ (23,505) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 140 | 561 |
Change in provision for excess inventory | (174) | |
Stock-based compensation and 401(k) plan employer match | 971 | 1,228 |
Fair value adjustment of common stock warrants | (223) | (438) |
Amortization of discount of long-term debt | 1,149 | |
Amortization of prepaid interest | 1,088 | |
Loss on sale of equipment | 84 | |
Changes in: | ||
Inventory | 201 | |
Prepaid expenses and other current assets | (92) | 250 |
Accounts payable | 4,450 | 1,964 |
Accrued expenses | (245) | 497 |
Deferred revenue | (43) | |
Other liabilities | 124 | (110) |
Net cash used in operating activities | (18,312) | (18,336) |
Cash flows from investing activities: | ||
Purchase of property and equipment | (149) | (503) |
Proceeds from sale of property and equipment | 260 | |
Net cash used in investing activities | (149) | (243) |
Cash flows from financing activities: | ||
Proceeds from issuance of securities, net of expenses | 69 | |
Repayment of equipment loans | (41) | |
Net cash provided by / (used in) financing activities | 69 | (41) |
Net decrease in cash and cash equivalents | (18,392) | (18,620) |
Cash and cash equivalents – beginning of period | 38,722 | 44,711 |
Cash and cash equivalents – end of period | 20,330 | 26,091 |
Supplementary disclosure of cash flows information: | ||
Interest paid | $ 61 | $ 1,303 |
Note 1 - The Company and Descri
Note 1 - The Company and Description of Business | 6 Months Ended |
Jun. 30, 2016 | |
Notes to Financial Statements | |
Organization, Consolidation and Presentation of Financial Statements Disclosure [Text Block] | Note 1 – The Company and Description of Business Windtree Therapeutics, Inc. (referred to as “we,” “us,” or the “Company”) is a biotechnology company focused on developing novel KL 4 surfactant therapies for respiratory diseases and other potential applications. Surfactants are produced naturally in the lung and are essential for normal respiratory function and survival. Our proprietary technology platform includes a synthetic, peptide-containing surfactant (KL 4 surfactant) that is structurally similar to endogenous pulmonary surfactant, and novel drug delivery technologies being developed to enable noninvasive administration of aerosolized KL 4 surfactant. We believe that our proprietary technology platform may make it possible to develop a pipeline of surfactant products to address a variety of respiratory diseases for which there are few or no approved therapies. Our lead development program is AEROSURF ® (lucinactant for inhalation), an investigational combination drug/device product that combines our proprietary synthetic KL 4 surfactant with our novel aerosol delivery system (ADS). We believe that AEROSURF has the potential to improve the management of respiratory distress syndrome (RDS) in premature infants. RDS, a serious respiratory condition caused by a deficiency of natural lung surfactant in lungs of premature infants, is the most prevalent respiratory disease in the neonatal intensive care unit (NICU) and can result in long-term respiratory problems, developmental delay and death. Surfactant therapy is a life-saving and the primary therapy to address RDS. In the U.S., surfactants are animal-derived and usually administered using invasive endotracheal intubation and mechanical ventilation, procedures that may result in serious respiratory conditions and other complications. To avoid the risks of these procedures, many premature infants are treated initially with noninvasive respiratory support such as nasal continuous positive airway pressure (nCPAP). Since nCPAP alone does not address surfactant deficiency, many premature infants on nCPAP respond poorly and may require intubation and delayed surfactant therapy (an outcome referred to as nCPAP failure). If surfactant therapy could be administered noninvasively, neonatologists would be able to provide surfactant therapy without exposing premature infants to the risks associated with intubation and mechanical ventilation. We are developing AEROSURF to enable administration of aerosolized KL 4 surfactant to premature infants receiving nCPAP without invasive intubation and mechanical ventilation. We believe that AEROSURF has the potential to transform the treatment of RDS and reduce the number of premature infants who are subjected to invasive administration procedures, whether within minutes of birth or following nCPAP failure. By enabling noninvasive delivery of aerosolized KL 4 surfactant, we believe that AEROSURF will address a serious unmet medical need and potentially provide transformative clinical and pharmacoeconomic benefits. |
Note 2 - Basis of Presentation
Note 2 - Basis of Presentation | 6 Months Ended |
Jun. 30, 2016 | |
Notes to Financial Statements | |
Basis of Accounting [Text Block] | Note 2 – Basis of Presentation The accompanying interim unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the U.S. for interim financial information in accordance with the instructions to Form 10-Q. Accordingly, they do not include all of the information and footnotes required by accounting principles generally accepted in the U.S. for complete consolidated financial statements. All share and per share information in this Quarterly Report related to our common stock has been retroactively restated to reflect the reverse stock split and reduction in authorized shares see Consolidated Financial Statements in our 2015 Form 10-K, as amended (2015 Form 10-K). Readers are encouraged to review those disclosures in conjunction with this Quarterly Report on Form 10-Q. |
Note 3 - Liquidity Risks and Ma
Note 3 - Liquidity Risks and Management's Plans | 6 Months Ended |
Jun. 30, 2016 | |
Notes to Financial Statements | |
Liquidity Disclosures [Text Block] | Note 3 – Liquidity Risks and Management’s Plans As of June 30, 2016, we had cash and cash equivalents of $20.3 million, current accounts payable and accrued expenses of $15.1 million, including $4.5 million (of which $0.2 million is interest accrued at a rate of 12% per annum) due to Battelle Memorial Institute (Battelle) under our collaboration agreement and $25 million of long-term debt under a secured loan (Deerfield Loan) with affiliates of Deerfield Management, L.P. (Deerfield). The principal portion of the Deerfield Loan is payable in two equal installments in February 2018 (subject to potential deferral if we achieve a specified market capitalization milestone) and February 2019. In addition, as of June 30, 2016, we had negative stockholders ’ equity of $15.2 million. We have incurred substantial losses since inception, due to investments in research and development, manufacturing, and our previous efforts to commercialize SURFAXIN ® , and we expect to continue to incur substantial losses over the next four to five years. The accompanying financial statements have been prepared assuming that we will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. As of June 30, 2016, the financial statements do not include any adjustments relating to recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should we be unable to continue as a going concern. See Before any additional financings or other transactions , we believe that we will have sufficient cash resources to support our development programs, business operations and debt service obligations through the planned completion of the AEROSURF phase 2b clinical trial and release of top line results, which currently is expected in the first quarter of 2017. million, our ability to use the 2014 Universal Shelf on Form S-3 is limited to no more than one third of our public float in a 12 month period, (ii) we have received a deficiency notice from The NASDAQ Stock Market (“Nasdaq”) that we are no longer in compliance with the minimum stockholders’ equity rule of the Nasdaq listing requirements (discussed below), (iii) our stockholders may not approve, as required under Nasdaq listing rules, a strategic transaction recommended by our Board that involves greater than 20% of our outstanding common stock, and (iv) our capital raising efforts may be affected by conditions in the broader financial and geopolitical markets. To secure the additional capital that we will require, we plan to pursue all or a combination of potential strategic alliances, collaboration agreements and other strategic transactions (including merger, acquisition or other corporate transaction). We also may seek additional capital through public or private equity offerings (including our ATM Program). In addition, we have from time to time collaborated with research organizations and universities to assess the potential utility of our KL 4 surfactant in studies funded in part through non-dilutive grants issued by U.S. Government-sponsored drug development programs, including grants in support of initiatives related to our AEROSURF clinical program. We also have received grants in support of medical and biodefense-related initiatives under programs that encourage private sector development of medical countermeasures against chemical, biological, radiological, and nuclear terrorism threat agents, and pandemic influenza, and provide a mechanism for federal acquisition of such countermeasures. Although there can be no assurance, we expect to pursue additional funding opportunities that may be announced and expect that we may qualify for similar programs in the future. Our ability to secure needed capital pursuant to our ATM Program or other public offerings pursuant to our 2014 Universal Shelf on Form S-3 is constrained under applicable rules of the Form S-3, which limits the size of primary securities offerings conducted by companies that have an aggregate market value of common stock held by nonaffiliated persons and entities (public float) of less than $75 million to no more than one-third of their public float in any 12-month period. With respect to our ATM Program, as of April 15, 2016, our public float was approximately $31.6 million. On May 24, 2016, we filed a Prospectus Supplement to our 2014 Universal Shelf with respect to approximately $10.5 million in securities. To raise additional capital, we may be required to seek other methods of completing primary offerings, including, for example, under a registration statement on Form S-1, the preparation and maintenance of which would be more time-consuming and costly, or private placements, potentially with registration rights or priced at a discount to the market value of our stock, or other transactions, any of which could result in substantial equity dilution of stockholders’ interests. T o be in a position to raise sufficient capital through strategic alliances or other strategic transactions involving the issuance of our capital stock, or through public or private equity offerings, we submitted to our stockholders for approval at the 2016 Annual Meeting of Stockholders held on June 21, 2016 a proposal to increase the number of shares of common stock authorized for issuance under our Amended and Restated Certificate of Incorporation from 36 million to 60 million shares. This proposal was approved by holders of a majority of the shares issued and outstanding on the record date for the meeting. In addition, if any offering were to involve the issuance of common stock in excess of 20% of our outstanding common stock, we may be required under Nasdaq listing rules to seek stockholder approval before we can proceed. There can be no assurance that we would be successful in obtaining such approvals. Failure to secure the additional capital that we will need, whether from non-dilutive sources or from equity offerings, would have a material adverse impact on our business and our ability to continue as a going concern. Even if we are able to secure additional capital, such transactions and financings may only be available on unattractive terms, or could result in significant dilution of stockholders ’ interests, and the issuance or even potential issuance of shares could have a negative effect on the market price of our common stock. If none of the foregoing alternatives is available, or if available, we are unable to raise sufficient capital through such transactions, we ultimately may be forced to limit or cease our development activities. Moreover, if we fail in the future to make any required payment under our Deerfield Loan or fail to comply with any commitments contained in the loan documents, Deerfield would be able to declare us in default regarding that indebtedness, which could result in the acceleration of the payment obligations under all or a portion of our indebtedness. Since we have pledged substantially all of our assets to secure our obligations under the Deerfield Loan, a debt default would enable the lenders to foreclose on our assets securing the debt and could significantly diminish the market value and marketability of our common stock. As of June 30, 2016, we had outstanding 2.9 million pre-funded warrants issued in a July 2015 public offering, of which the entire purchase price was pre-paid upon issuance. Upon exercise of the pre-funded warrants, we would issue the shares to the holders and receive no additional proceeds. In addition, as of June 30, 2016, there were 60 million shares of common stock and 5 million shares of preferred stock authorized under our Amended and Restated Certificate of Incorporation and approximately 41.0 million shares of common stock and 5 million shares of preferred stock were available for issuance and not otherwise reserved. Nasdaq Deficiency Notice On May 19, 2016, we received a notification letter from the Listing Qualifications Department (the “Staff”) of Nasdaq notifying us that we are no longer in compliance with the minimum stockholders ’ equity requirement for continued listing on the Nasdaq Capital Market. Nasdaq Listing Rule 5550(b)(1) requires listed companies to maintain stockholders’ equity of at least $2.5 million. In our Quarterly Report on Form 10-Q for the quarter ended March 31, 2016, we reported stockholders’ equity of (5.0 million). The Staff noted that, as of May 19, 2016, we also did not meet either of the alternative compliance standards under Nasdaq Listing Rule 5550(b) of (i) a market value of listed securities of at least $35 million, or (ii) net income of $500,000 from continuing operations. The deficiency notice has no immediate effect our listing status with the Nasdaq Capital Market. In accordance with the deficiency notice, on July 5, 2016, we submitted a plan outlining the steps we would take to regain compliance and requested additional time. On July 12, 2016, the Staff granted us an extension until November 15, 2016 (representing the maximum extension the Staff can grant under the applicable rule) to evidence our compliance with the minimum stockholders’ equity rule. Under the terms of the extension, we must regain compliance with the minimum stockholders’ equity rule no later than November 15, 2016, provide to the Staff a publicly available report that evidences such compliance and otherwise complies with conditions included in the extension notice. Under the plan as submitted, we are working diligently to achieve a combination of transactions that will allow us to regain compliance with the continued listing requirements of Nasdaq. These transactions include potential debt modifications, strategic alliances and collaboration agreements, and transactions to secure additional capital through public or private equity offerings (including our ATM Program). If after publicly reporting that we have regained compliance on or before November 15, 2016, we should fail to evidence compliance in the filing with the SEC of our periodic report on Form 10-K for the year ending December 31, 2016, we may be subject to delisting. If we fail to satisfy the terms of the extension, the Staff will provide a written delisting notification that our common stock will be delisted. At that time, we would be entitled to appeal the Staff’s determination to a Listing Qualifications Panel. There can be no assurance that we will be successful in implementing our plan to regain compliance with the minimum stockholders’ equity rule. As the rule is one of several alternatives, if during the extension period, we should succeed in regaining compliance with the alternative minimum value of listed securities rule under Nasdaq Listing Rule 5550(b), we would regain compliance with the Nasdaq Listing Rules in any event. There can be no assurance that we will be able to regain compliance with either the minimum stockholders’ equity rule or the minimum value of listed securities rule within the extension period, or at all. |
Note 4 - Stockholders' Equity
Note 4 - Stockholders' Equity | 6 Months Ended |
Jun. 30, 2016 | |
Notes to Financial Statements | |
Stockholders' Equity Note Disclosure [Text Block] | Note 4 – Stockholders’ Equity At-the-Market (ATM) Program We have an ATM Program with Stifel, Nicolaus & Company, Incorporated (Stifel), pursuant to which Stifel, as our exclusive agent, may sell through an “at-the-market” program (ATM Program), at such times that we may elect during a three-year term, up to a maximum of $25 million of shares of our common stock. In February 2016, we entered into an amendment to the Sales Agreement to extend the term three years to February 11, 2019. For a detailed description of our ATM Program, see see During the second quarter, we completed offerings under our ATM Program of 27,971 shares of our common stock for an aggregate purchase price of approximately $71,000, resulting in net proceeds to us of approximately $69,000, after deducting commissions due to Stifel. As of June 30, 2016, approximately $23.0 million remained available under the ATM Program. |
Note 5 - Summary of Significant
Note 5 - Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2016 | |
Notes to Financial Statements | |
Significant Accounting Policies [Text Block] | Note 5 – Summary of Significant Accounting Policies Use of Estimates The preparation of financial statements, in conformity with accounting principles generally accepted in the U.S., requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Severance Effective February 1, 2016, we terminated the Employment Agreement between ourselves and our then President and Chief Executive Officer ( Former CEO). During the first quarter of 2016, we incurred a severance charge of $1.2 million in selling, general and administrative expense under the terms of the Former CEO’s employment agreement, including $0.2 million related to stock option expense for those options that will continue to vest through August 1, 2017. Of the $1.0 million in severance not related to stock-based compensation, $0.1 million and $0.2 million was paid during the first and second quarters of 2016, respectively. The remaining $0.7 million will be paid through August 1, 2017. 2015 Restructuring Plan In April 2015, we implemented a restructuring plan to voluntarily cease commercial and manufacturing activities for SURFAXIN, close our manufacturing facility in Totowa, New Jersey, and focus our resources on the development of our aerosolized KL 4 surfactant pipeline for respiratory diseases, beginning with AEROSURF. The total severance cost for all impacted employees is $2.9 million, of which $1.0 million was accrued as of December 31, 2014 for Totowa employees. The remaining $1.9 million was charged to expense through the second quarter of 2015 ($1.0 million to research and development expenses and $0.9 million to selling, general and administrative expenses). We paid $2.6 million and $0.2 million of the severance and retention benefits during 2015 and the first half of 2016, respectively. The remaining $0.1 million was paid at the beginning of the third quarter of 2016. 2016 Restructuring Plan In May 2016, we implemented a restructuring plan to conserve our resources and focus on execution of the AEROSURF phase 2 clinical program in a timely manner. The total severance cost of $0.4 million for all impacted employees was charged to expense during the second quarter of 2016 . We paid $0.1 million of the severance during the second quarter of 2016. The remaining $0.3 million will be paid during the second half of 2016. Research and development expense We account for research and development expense by the following categories: (a) product development and manufacturing, (b) medical and regulatory operations, and (c) direct preclinical and clinical programs. Research and development expense includes personnel, facilities, manufacturing and quality operations, pharmaceutical and device development, research, clinical, regulatory, other preclinical and clinical activities and medical affairs. Research and development costs are charged to operations as incurred. Net loss per common share Basic net loss per share is computed by dividing net loss by the weighted average number of common shares outstanding for the period. Diluted net loss per common share is computed by giving effect to all potentially dilutive securities outstanding for the period. As of June 30, 2016 and 2015, the number of shares of common stock potentially issuable upon the exercise of stock options and warrants was 9.1 million and 1.5 million shares, respectively. For the three and six months ended June 30, 2016 and 2015, all potentially dilutive securities were anti-dilutive and therefore have been excluded from the computation of diluted net loss per share. In accordance with Accounting Standards Codification Topic 260 (ASC 260), Earnings per Share, We do not have any components of other comprehensive income (loss). Recent Accounting Pronouncements In August 2014, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2014-15, Presentation of Financial Statements – Going Concern See In February 2016, the FASB issued ASU No. 2016-02, amending the accounting for leases in Leases In March 2016, the FASB issued ASU 2016-09, Compensation- Stock Compensation In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses: Measurement of Credit Losses on Financial Instruments . |
Note 6 - Fair Value of Financia
Note 6 - Fair Value of Financial Instruments | 6 Months Ended |
Jun. 30, 2016 | |
Notes to Financial Statements | |
Fair Value Disclosures [Text Block] | Note 6 – Fair Value of Financial Instruments Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The fair value hierarchy is based on three levels of inputs, of which the first two are considered observable and the last unobservable, as follows: ● Level 1 – Quoted prices in active markets for identical assets and liabilities. ● Level 2 – Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. ● Level 3 – Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. Fair Value on a Recurring Basis The tables below categorize assets and liabilities measured at fair value on a recurring basis for the periods presented: Fair Value Fair value measurement using June 30, 2016 Level 1 Level 2 Level 3 Assets: Cash and cash equivalents $ 20,330 $ 20,330 $ – $ – Certificate of deposit 225 225 – – Total assets $ 20,555 $ 20,555 $ – $ – Fair Value Fair value measurement using December 31, 2015 Level 1 Level 2 Level 3 Assets: Cash and cash equivalents $ 38,722 $ 38,722 $ – $ – Certificate of deposit 225 225 – – Total assets $ 38,947 $ 38,947 $ – $ – Liabilities: Common stock warrant liability $ 223 $ – $ – $ 223 The tables below summarize the activity of Level 3 inputs measured on a recurring basis for the six months ended June 30, 2016 and 2015: (in thousands) Fair Value Measurements of Common Stock Warrants Using Significant Unobservable Inputs (Level 3) Balance at December 31, 2015 $ 223 Change in fair value of common stock warrant liability (223 ) Balance at June 30, 2016 $ – (in thousands) Fair Value Measurements of Common Stock Warrants Using Significant Unobservable Inputs (Level 3) Balance at December 31, 2014 $ 1,258 Change in fair value of common stock warrant liability (438 ) Balance at June 30, 2015 $ 820 The significant unobservable inputs for a trinomial model used in the fair value measurement of the common stock warrants measured on a recurring basis are the historical volatility of our common stock market price, expected term of the applicable warrants, and the risk-free interest rate based on the U.S. Treasury yield curve in effect at the measurement date. In addition to the significant unobservable inputs noted above, certain fair value measurements also take into account an assumption of the likelihood and timing of the occurrence of an event that would result in an adjustment to the exercise price in accordance with the anti-dilutive pricing provisions in certain of the warrants. Any significant increases or decreases in the unobservable inputs, with the exception of the risk-free interest rate, may result in significantly higher or lower fair value measurements. Significant Unobservable Input Assumptions of Level 3 Valuations June 30, 2016 June 30, 2015 Historical volatility – 82% Expected term (in years) – 0.6 Risk-free interest rate – 0.16% Fair Value of Long-Term Debt At June 30, 2016 and December 31, 2015, the estimated fair value of the Deerfield Loan ( see, |
Note 7 - Common Stock Warrant L
Note 7 - Common Stock Warrant Liability | 6 Months Ended |
Jun. 30, 2016 | |
Notes to Financial Statements | |
Derivative Instruments and Hedging Activities Disclosure [Text Block] | Note 7 – Common Stock Warrant Liability We account for common stock warrants in accordance with applicable accounting guidance provided in ASC Topic 815, Derivatives and Hedging – Contracts in Entity’s Own Equity On February 22, 2011, we issued registered warrants (2011 Warrants) that expired on February 22, 2016 and had a fair value at issuance of $8.0 million. These warrants contained anti-dilution provisions and were classified as derivative liabilities and reported, at each balance sheet date until their expiration, at estimated fair value determined using a trinomial pricing model. No warrants were exercised during the six months ended June 30, 2016 and 2015. Changes in the estimated fair value of warrants classified as derivative liabilities are reported in the accompanying Condensed Consolidated Statements of Operations as the “Change in fair value of common stock warrants.” The change for the six month ended June 30, 2016 represents the write-off of the derivative liability upon expiration of the underlying warrants in February 2016. |
Note 8 - Deerfield Loan
Note 8 - Deerfield Loan | 6 Months Ended |
Jun. 30, 2016 | |
Notes to Financial Statements | |
Long-term Debt [Text Block] | Note 8 – Deerfield Loan Long-term debt consists solely of amounts due under the Deerfield Loan for the periods presented: June 30, December 31, (in thousands) 2016 2015 Note payable $ 25,000 $ 25,000 The principal amount of the loan is payable in two equal annual installments of $12.5 million , payable in each of February 2018 and 2019. Under the Deerfield Loan agreement, the February 2018 installment is subject to a potential one-year deferral until February 2019 if we achieve the market capitalization milestone set forth in the Deerfield Loan agreement. See The following amounts comprise the Deerfield Loan interest expense for the periods presented: Three Months Ended Six Months Ended (in thousands) June 30, June 30, 2016 2015 2016 2015 Cash interest expense $ – $ 654 $ – $ 1,301 Amortization of prepaid interest expense 544 – 1,088 – Non-cash amortization of debt discount – 594 – 1,149 Amortization of debt costs – 5 – 10 Total interest expense $ 544 $ 1,253 $ 1,088 $ 2,460 For the three and six months ended June 30, 2016, amortization of prepaid interest expense represents non-cash amortization of $5 million of Series A and Series B units that Deerfield agreed to purchase in our July 2015 public offering and accept in satisfaction of $5 million of future interest payments due under the Deerfield Notes at an interest rate of 8.75%. For the three and six months ended June 30, 2015, non-cash amortization of debt discount represents the amortization of previously capitalized transaction fees and the amortization of the reduction of the carrying value of the debt due to the fair value of the Deerfield Warrants issued. |
Note 9 - Stock Options and Stoc
Note 9 - Stock Options and Stock-based Employee Compensation | 6 Months Ended |
Jun. 30, 2016 | |
Notes to Financial Statements | |
Disclosure of Compensation Related Costs, Share-based Payments [Text Block] | Note 9 – Stock Options and Stock-Based Employee Compensation We recognize in our condensed consolidated financial statements all stock-based awards to employees and non-employee directors based on their fair value on the date of grant, calculated using the Black-Scholes option-pricing model. Compensation expense related to stock-based awards is recognized ratably over the vesting period, which for employees is typically three years. A summary of activity under our long-term incentive plans is presented below : (in thousands, except for weighted-average data ) Share s Weighted-Average Exercise Pric e Weighted-Average Remaining Contractual Term (In Yrs ) Stock Option s Outstanding at December 31, 201 5 517 $ 51.35 Grante d 432 2.33 Forfeited or expire d (112 ) 77.84 Outstanding at June 30, 201 6 837 $ 22.46 7.6 Vested and exercisable at June 30, 201 6 315 $ 50.05 5.2 The fair value of each option award is estimated on the date of grant using the Black-Scholes option-pricing formula based on the following weighted average assumptions: Six Months Ended June 30, 2016 2015 Weighted average expected volatility 79% 83% Weighted average expected term (in years) 5.7 5.6 Weighted average risk-free interest rate 1.4% 1.5% Expected dividends – – The table below summarizes the total stock-based compensation expense included in the statements of operations for the periods presented: Three Months Ended Six Months Ended (in thousands) June 30, June 30, 2016 2015 2016 2015 Research and development $ 140 $ 146 $ 322 $ 359 Selling, general and administrative 110 189 531 575 Total $ 250 $ 335 $ 853 $ 934 |
Significant Accounting Policies
Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2016 | |
Accounting Policies [Abstract] | |
Use of Estimates, Policy [Policy Text Block] | Use of Estimates The preparation of financial statements, in conformity with accounting principles generally accepted in the U.S., requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. |
Severance Cost [Policy Text Block] | Severance Effective February 1, 2016, we terminated the Employment Agreement between ourselves and our then President and Chief Executive Officer ( Former CEO). During the first quarter of 2016, we incurred a severance charge of $1.2 million in selling, general and administrative expense under the terms of the Former CEO’s employment agreement, including $0.2 million related to stock option expense for those options that will continue to vest through August 1, 2017. Of the $1.0 million in severance not related to stock-based compensation, $0.1 million and $0.2 million was paid during the first and second quarters of 2016, respectively. The remaining $0.7 million will be paid through August 1, 2017. |
Restructuring Plan [Policy Text Block] | 2015 Restructuring Plan In April 2015, we implemented a restructuring plan to voluntarily cease commercial and manufacturing activities for SURFAXIN, close our manufacturing facility in Totowa, New Jersey, and focus our resources on the development of our aerosolized KL 4 surfactant pipeline for respiratory diseases, beginning with AEROSURF. The total severance cost for all impacted employees is $2.9 million, of which $1.0 million was accrued as of December 31, 2014 for Totowa employees. The remaining $1.9 million was charged to expense through the second quarter of 2015 ($1.0 million to research and development expenses and $0.9 million to selling, general and administrative expenses). We paid $2.6 million and $0.2 million of the severance and retention benefits during 2015 and the first half of 2016, respectively. The remaining $0.1 million was paid at the beginning of the third quarter of 2016. 2016 Restructuring Plan In May 2016, we implemented a restructuring plan to conserve our resources and focus on execution of the AEROSURF phase 2 clinical program in a timely manner. The total severance cost of $0.4 million for all impacted employees was charged to expense during the second quarter of 2016 . We paid $0.1 million of the severance during the second quarter of 2016. The remaining $0.3 million will be paid during the second half of 2016. |
Research and Development Expense, Policy [Policy Text Block] | Research and development expense We account for research and development expense by the following categories: (a) product development and manufacturing, (b) medical and regulatory operations, and (c) direct preclinical and clinical programs. Research and development expense includes personnel, facilities, manufacturing and quality operations, pharmaceutical and device development, research, clinical, regulatory, other preclinical and clinical activities and medical affairs. Research and development costs are charged to operations as incurred. |
Earnings Per Share, Policy [Policy Text Block] | Net loss per common share Basic net loss per share is computed by dividing net loss by the weighted average number of common shares outstanding for the period. Diluted net loss per common share is computed by giving effect to all potentially dilutive securities outstanding for the period. As of June 30, 2016 and 2015, the number of shares of common stock potentially issuable upon the exercise of stock options and warrants was 9.1 million and 1.5 million shares, respectively. For the three and six months ended June 30, 2016 and 2015, all potentially dilutive securities were anti-dilutive and therefore have been excluded from the computation of diluted net loss per share. In accordance with Accounting Standards Codification Topic 260 (ASC 260), Earnings per Share, We do not have any components of other comprehensive income (loss). |
New Accounting Pronouncements, Policy [Policy Text Block] | Recent Accounting Pronouncements In August 2014, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2014-15, Presentation of Financial Statements – Going Concern See In February 2016, the FASB issued ASU No. 2016-02, amending the accounting for leases in Leases In March 2016, the FASB issued ASU 2016-09, Compensation- Stock Compensation In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses: Measurement of Credit Losses on Financial Instruments . |
Note 6 - Fair Value of Financ16
Note 6 - Fair Value of Financial Instruments (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Notes Tables | |
Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis [Table Text Block] | Fair Value Fair value measurement using June 30, 2016 Level 1 Level 2 Level 3 Assets: Cash and cash equivalents $ 20,330 $ 20,330 $ – $ – Certificate of deposit 225 225 – – Total assets $ 20,555 $ 20,555 $ – $ – Fair Value Fair value measurement using December 31, 2015 Level 1 Level 2 Level 3 Assets: Cash and cash equivalents $ 38,722 $ 38,722 $ – $ – Certificate of deposit 225 225 – – Total assets $ 38,947 $ 38,947 $ – $ – Liabilities: Common stock warrant liability $ 223 $ – $ – $ 223 |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Table Text Block] | (in thousands) Fair Value Measurements of Common Stock Warrants Using Significant Unobservable Inputs (Level 3) Balance at December 31, 2015 $ 223 Change in fair value of common stock warrant liability (223 ) Balance at June 30, 2016 $ – (in thousands) Fair Value Measurements of Common Stock Warrants Using Significant Unobservable Inputs (Level 3) Balance at December 31, 2014 $ 1,258 Change in fair value of common stock warrant liability (438 ) Balance at June 30, 2015 $ 820 |
Significant Unobservable Input Assumption Used for Valuation [Table Text Block] | Significant Unobservable Input Assumptions of Level 3 Valuations June 30, 2016 June 30, 2015 Historical volatility – 82% Expected term (in years) – 0.6 Risk-free interest rate – 0.16% |
Note 8 - Deerfield Loan (Tables
Note 8 - Deerfield Loan (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Notes Tables | |
Schedule of Long-term Debt Instruments [Table Text Block] | June 30, December 31, (in thousands) 2016 2015 Note payable $ 25,000 $ 25,000 |
Schedule of Debt Instrument Interest Expense [Table Text Block] | Three Months Ended Six Months Ended (in thousands) June 30, June 30, 2016 2015 2016 2015 Cash interest expense $ – $ 654 $ – $ 1,301 Amortization of prepaid interest expense 544 – 1,088 – Non-cash amortization of debt discount – 594 – 1,149 Amortization of debt costs – 5 – 10 Total interest expense $ 544 $ 1,253 $ 1,088 $ 2,460 |
Note 9 - Stock Options and St18
Note 9 - Stock Options and Stock-based Employee Compensation (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Notes Tables | |
Disclosure of Share-based Compensation Arrangements by Share-based Payment Award [Table Text Block] | (in thousands, except for weighted-average data ) Share s Weighted-Average Exercise Pric e Weighted-Average Remaining Contractual Term (In Yrs ) Stock Option s Outstanding at December 31, 201 5 517 $ 51.35 Grante d 432 2.33 Forfeited or expire d (112 ) 77.84 Outstanding at June 30, 201 6 837 $ 22.46 7.6 Vested and exercisable at June 30, 201 6 315 $ 50.05 5.2 |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | Six Months Ended June 30, 2016 2015 Weighted average expected volatility 79% 83% Weighted average expected term (in years) 5.7 5.6 Weighted average risk-free interest rate 1.4% 1.5% Expected dividends – – |
Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Table Text Block] | Three Months Ended Six Months Ended (in thousands) June 30, June 30, 2016 2015 2016 2015 Research and development $ 140 $ 146 $ 322 $ 359 Selling, general and administrative 110 189 531 575 Total $ 250 $ 335 $ 853 $ 934 |
Note 3 - Liquidity Risks and 19
Note 3 - Liquidity Risks and Management's Plans (Details Textual) $ in Thousands | 1 Months Ended | 6 Months Ended | ||||||||
Jun. 30, 2016USD ($)shares | Jun. 30, 2016USD ($)shares | Jun. 21, 2016shares | Jun. 20, 2016shares | May 24, 2016USD ($) | Apr. 15, 2016USD ($) | Mar. 31, 2016USD ($) | Dec. 31, 2015USD ($)shares | Jun. 30, 2015USD ($) | Dec. 31, 2014USD ($) | |
Battelle 2014 Collaboration Agreement [Member] | ||||||||||
Accounts Payable and Accrued Liabilities, Current | $ 4,500 | $ 4,500 | ||||||||
Debt Instrument, Increase, Accrued Interest | $ 200 | |||||||||
Debt Instrument, Interest Rate, Stated Percentage | 12.00% | 12.00% | ||||||||
Deerfield Loan [Member] | ||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 8.75% | 8.75% | 8.75% | |||||||
Long-term Debt, Excluding Current Maturities | $ 25,000 | $ 25,000 | $ 25,000 | |||||||
Debt Instrument Repayment of Principal Portion Number of Installments | 2 | |||||||||
Maximum [Member] | ||||||||||
Entity Public Float | $ 75,000 | $ 75,000 | ||||||||
ATM Program [Member] | ||||||||||
Entity Public Float | $ 31,600 | |||||||||
July 2015 Public Offering [Member] | Prefunded Warrants [Member] | ||||||||||
Class of Warrant or Right, Outstanding | shares | 2,900,000 | 2,900,000 | ||||||||
Cash and Cash Equivalents, at Carrying Value | $ 20,330 | $ 20,330 | 38,722 | $ 26,091 | $ 44,711 | |||||
Accounts Payable and Accrued Liabilities, Current | 15,100 | 15,100 | ||||||||
Long-term Debt, Excluding Current Maturities | 25,000 | 25,000 | 25,000 | |||||||
Stockholders' Equity Attributable to Parent | $ (15,219) | $ (15,219) | $ (5,000) | $ 8,266 | ||||||
Prospectus Supplement to Universal Shelf, Equity Amount | $ 10,500 | |||||||||
Common Stock, Shares Authorized | shares | 60,000,000 | 60,000,000 | 60,000,000 | 36,000,000 | 36,000,000 | |||||
Excess Percentage of Common Stock Issued to Acquire Additional Capital | 20.00% | |||||||||
Preferred Stock, Shares Authorized | shares | 5,000,000 | 5,000,000 | 5,000,000 | |||||||
Common Stock Capital Shares Available for Issuance | shares | 41,000,000 | 41,000,000 | ||||||||
Preferred Stock Capital Shares Available for Issuance | shares | 5,000,000 | 5,000,000 |
Note 4 - Stockholders' Equity (
Note 4 - Stockholders' Equity (Details Textual) - Stifel ATM Program [Member] - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended |
Feb. 29, 2016 | Jun. 30, 2016 | Jun. 30, 2016 | |
Agency Agreement Period | 3 years | ||
Maximum Potential Common Stock Available for Issue, Value | $ 25,000,000 | $ 25,000,000 | |
Period of Agency Agreement, Extension | 3 years | ||
Stock Issued During Period, Shares, New Issues | 27,971 | ||
Stock Issued During Period, Value, New Issues | $ 71,000 | ||
Proceeds from Issuance of Common Stock | 69,000 | ||
Common Stock, Remaining Shares Available under Program, Value | $ 23,000,000 | $ 23,000,000 |
Note 5 - Summary of Significa21
Note 5 - Summary of Significant Accounting Policies (Details Textual) - USD ($) shares in Millions, $ in Millions | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | 13 Months Ended | |||||
Aug. 05, 2016 | Apr. 30, 2015 | Jun. 30, 2016 | Mar. 31, 2016 | Jun. 30, 2015 | Dec. 31, 2016 | Jun. 30, 2016 | Dec. 31, 2015 | Aug. 01, 2017 | Dec. 31, 2014 | |
Selling, General and Administrative Expenses [Member] | Former CEO's Employment Agreement [Member] | ||||||||||
Restructuring Charges | $ 1.2 | |||||||||
Selling, General and Administrative Expenses [Member] | Totowa Employees [Member] | ||||||||||
Severance Costs | $ 0.9 | |||||||||
Selling, General and Administrative Expenses [Member] | The 2016 Restructuring Plan [Member] | ||||||||||
Severance Costs | $ 0.1 | |||||||||
Research and Development Expense [Member] | Totowa Employees [Member] | ||||||||||
Severance Costs | 1 | |||||||||
Research and Development Expense [Member] | The 2016 Restructuring Plan [Member] | ||||||||||
Severance Costs | 0.3 | |||||||||
Former CEO's Employment Agreement [Member] | Stock Option Expense [Member] | ||||||||||
Restructuring Charges | 0.2 | |||||||||
Former CEO's Employment Agreement [Member] | Not Related to Stock-based Compensation [Member] | ||||||||||
Restructuring Charges | 1 | |||||||||
Former CEO's Employment Agreement [Member] | Scenario, Forecast [Member] | ||||||||||
Payments for Restructuring | $ 0.7 | |||||||||
Former CEO's Employment Agreement [Member] | ||||||||||
Payments for Restructuring | 0.2 | $ 0.1 | ||||||||
Scenario, Forecast [Member] | The 2016 Restructuring Plan [Member] | Employee Severance [Member] | ||||||||||
Payments for Restructuring | $ 0.3 | |||||||||
Totowa Employees [Member] | The 2015 Restructuring Plan [Member] | Subsequent Event [Member] | ||||||||||
Payments for Restructuring | $ 0.1 | |||||||||
Totowa Employees [Member] | The 2015 Restructuring Plan [Member] | ||||||||||
Payments for Restructuring | $ 0.2 | $ 2.6 | ||||||||
Totowa Employees [Member] | ||||||||||
Severance Costs | $ 2.9 | $ 1.9 | ||||||||
Restructuring Reserve | $ 1 | |||||||||
The 2016 Restructuring Plan [Member] | Employee Severance [Member] | ||||||||||
Payments for Restructuring | 0.1 | |||||||||
The 2016 Restructuring Plan [Member] | ||||||||||
Severance Costs | $ 0.4 | |||||||||
Number of Shares of Common Stock Potentially Issuable upon the Exercise of Stock Options and Warrants | 9.1 | 1.5 |
Note 6 - Fair Value of Financ22
Note 6 - Fair Value of Financial Instruments (Details Textual) - USD ($) $ in Millions | Jun. 30, 2016 | Dec. 31, 2015 |
Deerfield Loan [Member] | Estimate of Fair Value Measurement [Member] | ||
Long-term Debt, Fair Value | $ 25 | $ 25 |
Note 6 - Assets and Liabilities
Note 6 - Assets and Liabilities Measured at Fair Value (Details) - USD ($) $ in Thousands | Jun. 30, 2016 | Dec. 31, 2015 |
Fair Value, Measurements, Recurring [Member] | Fair Value, Inputs, Level 1 [Member] | Certificates of Deposit [Member] | ||
Assets: | ||
Certificate of deposit | $ 225 | $ 225 |
Fair Value, Measurements, Recurring [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Assets: | ||
Cash and cash equivalents | 20,330 | 38,722 |
Total assets | 20,555 | 38,947 |
Fair Value, Measurements, Recurring [Member] | Fair Value, Inputs, Level 3 [Member] | Certificates of Deposit [Member] | ||
Assets: | ||
Certificate of deposit | ||
Fair Value, Measurements, Recurring [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Assets: | ||
Cash and cash equivalents | ||
Total assets | ||
Liabilities: | ||
Derivative Liability, Current | 223 | |
Fair Value, Measurements, Recurring [Member] | Certificates of Deposit [Member] | ||
Assets: | ||
Certificate of deposit | 225 | 225 |
Fair Value, Measurements, Recurring [Member] | ||
Assets: | ||
Cash and cash equivalents | 20,330 | 38,722 |
Total assets | 20,555 | 38,947 |
Liabilities: | ||
Derivative Liability, Current | 223 | |
Derivative Liability, Current | $ 223 |
Note 6 - Fair Value of Financ24
Note 6 - Fair Value of Financial Instruments, Level 3 Rollforward (Details) - Fair Value, Inputs, Level 3 [Member] - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2016 | Jun. 30, 2015 | |
Beginning balance | $ 223 | $ 1,258 |
Change in fair value of common stock warrant liability | (223) | (438) |
Ending balance | $ 820 |
Note 6 - Fair Value of Financ25
Note 6 - Fair Value of Financial Instruments, Significant Unobservable Input Assumptions of Level 3 Valuations (Details) | 6 Months Ended | |
Jun. 30, 2016 | Jun. 30, 2015 | |
Historical volatility | 0.00% | 82.00% |
Expected term (in years) | 0 years | 219 days |
Risk-free interest rate | 0.00% | 0.16% |
Note 7 - Common Stock Warrant26
Note 7 - Common Stock Warrant Liability (Details Textual) - USD ($) $ in Thousands | 6 Months Ended | |||
Jun. 30, 2016 | Jun. 30, 2015 | Dec. 31, 2015 | Feb. 22, 2011 | |
The 2011 Warrants [Member] | ||||
Derivative Liability, Current | $ 8,000 | |||
Share-based Compensation Arrangement by Share-based Payment Award, Non-Option Equity Instruments, Exercised | 0 | 0 | ||
Derivative Liability, Current | $ 223 |
Note 8 - Deerfield Loan (Detail
Note 8 - Deerfield Loan (Details Textual) - Deerfield Loan [Member] $ in Millions | 3 Months Ended | 6 Months Ended | |
Jun. 30, 2016USD ($) | Jun. 30, 2015USD ($) | Jun. 30, 2016USD ($) | |
Debt Instrument Repayment of Principal Portion Number of Installments | 2 | ||
Long-term Debt, Maturities, Repayments of Principal in Year Two | $ 12.5 | $ 12.5 | |
Long-term Debt, Maturities, Repayments of Principal in Year Three | 12.5 | $ 12.5 | |
Deferred Period for Loan Payment | 1 year | ||
Debt Instrument, Periodic Payment, Principal | $ 5 | $ 5 | |
Debt Instrument, Periodic Payment, Interest | $ 5 | $ 5 | |
Debt Instrument, Interest Rate, Stated Percentage | 8.75% | 8.75% | 8.75% |
Note 8 - Long-term Debt (Detail
Note 8 - Long-term Debt (Details) - USD ($) $ in Thousands | Jun. 30, 2016 | Dec. 31, 2015 |
Deerfield Loan [Member] | ||
Long-term Debt, Excluding Current Maturities | $ 25,000 | $ 25,000 |
Long-term Debt, Excluding Current Maturities | $ 25,000 | $ 25,000 |
Note 8 - Long-term Debt Interes
Note 8 - Long-term Debt Interest Expense (Details) - Deerfield Loan [Member] - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Cash interest expense | $ 654 | $ 1,301 | ||
Amortization of prepaid interest expense | 544 | 1,088 | ||
Non-cash amortization of debt discount | 594 | 1,149 | ||
Amortization of debt costs | 5 | 10 | ||
Total interest expense | $ 544 | $ 1,253 | $ 1,088 | $ 2,460 |
Note 9 - Stock Options and St30
Note 9 - Stock Options and Stock-based Employee Compensation (Details Textual) | 6 Months Ended |
Jun. 30, 2016 | |
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 3 years |
Note 9 - Summary of Stock Optio
Note 9 - Summary of Stock Option Activity (Details) | 6 Months Ended |
Jun. 30, 2016$ / sharesshares | |
Shares Outstanding, Beginning Balance (in shares) | shares | 517 |
Weighted Average Exercise Price, Outstanding, at Beginning Period (in dollars per share) | $ / shares | $ 51.35 |
Shares Granted (in shares) | shares | 432 |
Weighted Average Exercise Price, Granted (in dollars per share) | $ / shares | $ 2.33 |
Shares Forfeited or Expired (in shares) | shares | (112) |
Weighted Average Exercise Price, Forfeited or Expired (in dollars per share) | $ / shares | $ 77.84 |
Shares Outstanding, Ending Balance (in shares) | shares | 837 |
Weighted Average Exercise Price, Outstanding, at Ending Period (in dollars per share) | $ / shares | $ 22.46 |
Weighted Average Remaining Contractual Life, Outstanding | 7 years 219 days |
Shares Vested and Exercisable (in shares) | shares | 315 |
Weighted Average Exercise Price, Vested and Exercisable (in dollars per share) | $ / shares | $ 50.05 |
Weighted Average Remaining Contractual Life, Vested and Exercisable | 5 years 73 days |
Note 9 - Stock Options Valuatio
Note 9 - Stock Options Valuation Assumptions (Details) | 6 Months Ended | |
Jun. 30, 2016 | Jun. 30, 2015 | |
Weighted average expected volatility | 79.00% | 83.00% |
Weighted average expected term (in years) | 5 years 255 days | 5 years 219 days |
Weighted average risk-free interest rate | 1.40% | 1.50% |
Expected dividends |
Note 9 - Stock-based Compensati
Note 9 - Stock-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Research and Development Expense [Member] | ||||
Research and development | $ 140 | $ 146 | $ 322 | $ 359 |
Selling, General and Administrative Expenses [Member] | ||||
Research and development | 110 | 189 | 531 | 575 |
Research and development | $ 250 | $ 335 | $ 853 | $ 934 |