Document And Entity Information
Document And Entity Information - shares | 3 Months Ended | |
Mar. 31, 2017 | May 11, 2017 | |
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) | 10,301,287 | |
Document Type | 10-Q | |
Document Period End Date | Mar. 31, 2017 | |
Document Fiscal Year Focus | 2,017 | |
Document Fiscal Period Focus | Q1 | |
Amendment Flag | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Current Period Unaudited) - USD ($) $ in Thousands | Mar. 31, 2017 | Dec. 31, 2016 |
Current Assets: | ||
Cash and cash equivalents | $ 8,022 | $ 5,588 |
Prepaid interest, current portion | 1,094 | 1,094 |
Prepaid expenses and other current assets | 392 | 512 |
Total current assets | 9,508 | 7,194 |
Property and equipment, net | 1,018 | 1,054 |
Restricted cash | 225 | 225 |
Prepaid interest, non-current portion | 956 | 1,226 |
Total assets | 11,707 | 9,699 |
Current Liabilities: | ||
Accounts payable | 2,312 | 1,813 |
Collaboration payable | 4,098 | 3,967 |
Accrued expenses | 5,926 | 7,611 |
Long-term debt, current portion | 12,500 | |
Total current liabilities | 24,836 | 13,391 |
Long-term debt, non-current portion | 12,500 | 25,000 |
Other liabilities | 131 | 138 |
Total liabilities | 37,467 | 38,529 |
Stockholders' Equity: | ||
Preferred stock, $0.001 par value; 5,000,000 shares authorized; 7,049 and 0 shares issued and outstanding at March 31, 2017 and December 31, 2016, respectively | ||
Common stock, $0.001 par value; 60,000,000 authorized; 9,592,048 and 8,725,069 shares issued at March 31, 2017 and December 31, 2016, respectively; 9,590,556 and 8,723,577 shares outstanding at March 31, 2017 and December 31, 2016, respectively | 10 | 9 |
Additional paid-in capital | 604,676 | 592,883 |
Accumulated deficit | (627,392) | (618,668) |
Treasury stock (at cost); 1,492 shares | (3,054) | (3,054) |
Total stockholders' equity | (25,760) | (28,830) |
Total liabilities & stockholders' equity | $ 11,707 | $ 9,699 |
Condensed Consolidated Balance3
Condensed Consolidated Balance Sheets (Current Period Unaudited) (Parentheticals) - $ / shares | Mar. 31, 2017 | Dec. 31, 2016 |
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) | 7,049 | 0 |
Preferred stock, shares outstanding (in shares) | 7,049 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 60,000,000 | 60,000,000 |
Common stock, shares issued (in shares) | 9,592,048 | 8,725,069 |
Common stock, shares outstanding (in shares) | 9,590,556 | 8,723,577 |
Treasury stock, shares (in shares) | 1,492 | 1,492 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2017 | Mar. 31, 2016 | |
Revenues: | ||
Grant revenue | $ 219 | $ 75 |
Expenses: | ||
Research and development | 6,413 | 10,360 |
General and administrative | 1,922 | 3,657 |
Total operating expenses | 8,335 | 14,017 |
Operating loss | (8,116) | (13,942) |
Change in fair value of common stock warrant liability | 223 | |
Other income / (expense): | ||
Interest income | 3 | 7 |
Interest expense | (611) | (622) |
Other income | 433 | |
Other income / (expense), net | (608) | (182) |
Net loss | (8,724) | (13,901) |
Deemed dividend on preferred stock | (3,604) | |
Net loss attributable to common shareholders | $ (12,328) | $ (13,901) |
Net loss per common share | ||
Basic and diluted (in dollars per share) | $ (1.37) | $ (1.70) |
Weighted average number of common shares outstanding | ||
Basic and diluted (in shares) | 8,998 | 8,191 |
Condensed Consolidated Stateme5
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2017 | Mar. 31, 2016 | |
Cash flows from operating activities: | ||
Net loss | $ (8,724) | $ (13,901) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 56 | 76 |
Stock-based compensation and 401(k) plan employer match | 370 | 658 |
Fair value adjustment of common stock warrants | (223) | |
Amortization of prepaid interest | 270 | 544 |
Changes in: | ||
Prepaid expenses and other current assets | 120 | (138) |
Accounts payable | 1,697 | 2,149 |
Collaboration payable | 131 | 815 |
Accrued expenses | (1,252) | 835 |
Net cash used in operating activities | (7,332) | (9,185) |
Cash flows from investing activities: | ||
Purchase of property and equipment | (20) | (137) |
Net cash used in investing activities | (20) | (137) |
Cash flows from financing activities: | ||
Proceeds from private placement issuance of securities, net of expenses | 8,796 | |
Proceeds from ATM Program, net of expenses | 990 | |
Net cash provided by financing activities | 9,786 | |
Net increase/(decrease) in cash and cash equivalents | 2,434 | (9,322) |
Cash, cash equivalents and restricted cash - beginning of year | 5,813 | 38,947 |
Cash, cash equivalents and restricted cash - end of year | 8,247 | 29,625 |
Supplementary disclosure of cash flows information: | ||
Interest paid | $ 259 | $ 22 |
Note 1 - The Company and Descri
Note 1 - The Company and Description of Business | 3 Months Ended |
Mar. 31, 2017 | |
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 Our lead development program is AEROSURF ® (lucinactant for inhalation), an investigational combination drug/device product that combines our KL 4 surfactant with our novel aerosol delivery system (ADS). We are developing AEROSURF to improve the management of respiratory distress syndrome (RDS) in premature infants. RDS is a serious respiratory condition caused by a deficiency of natural lung surfactant in lungs of premature infants, and the most prevalent respiratory disease in the neonatal intensive care unit (NICU). By enabling administration of aerosolized KL 4 surfactant, AEROSURF may 4 surfactant therapy for infants receiving nCPAP alone, reducing the number of premature infants who are subjected to invasive surfactant administration, and potentially providing transformative clinical and pharmacoeconomic benefits. We are conducting an AEROSURF phase 2b 4 surfactant administered to premature infants 28 32 two (25 50 two 50 July 2017. |
Note 2 - Liquidity Risks and Ma
Note 2 - Liquidity Risks and Management's Plans | 3 Months Ended |
Mar. 31, 2017 | |
Notes to Financial Statements | |
Liquidity Disclosures [Text Block] | Note 2 – Liquidity Risks and Management ’s Plans As of March 31, 2017, $8.0 24.8 $12.5 $12.5 In February 2017, $10.5 $1.6 In addition, from January 1, 2017 March 31, 2017, $1.0 ® phase 2b July 2017. We expect to continue to incur significant losses and require significant additional capital to further advance our AEROSURF clinical development program, if warranted by the results of our phase 2b 2017, one se financial statements are issued. To potentially alleviate the conditions that raise substantial doubt about our ability to continue as a going concern, management plans to seek additional capital through the following: (i) all or a combination of strategic transactions, including potential alliances and collaborations focused on markets outside the U.S., as well as potential combinations (including by merger or acquisition) or other corporate transactions; and (ii) through public or private equity offerings. However, there can be no assurance that these alternatives will be available, or if available, that we will be able to raise sufficient capital through such transactions. If we are unable to raise the required capital, we will not have sufficient cash resources and liquidity to fund our business operations for at least the next year following the date that the financial statements are issued. Accordingly, management has concluded that substantial doubt exists with respect to our ability to continue as a going concern through one The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business, and 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. Our ability to secure the needed capital through equity financings and other similar transactions is subject to regulatory and other restrictions (discussed below) and we cannot be certain that we will be able to raise a sufficient amount when needed, if at all, on favorable terms or otherwise. In the event that we cannot raise sufficient capital, we may transactions on less-than-favorable terms, or limit or cease our development activities, or consider other means of creating value for our stockholders. If we are unable to raise the required capital, we may may may We believe that our ability to fund our activities in the near term will be highly dependent upon whether our AEROSURF phase 2b 2b may Moreover, our ability to secure additional capital at a time when we would like or require may following the suspension of our common stock from The Nasdaq Capital Market ® (Nasdaq) effective May 5, 2017, ® Market (“OTCQB”), which is operated by OTC Market Groups Inc., under the symbol “WINT;” (ii) our 2014 3 June 12, 2017 $75 3 may 12 one third 60 may 2017 60 120 may $25 may 3, one third 1, 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 development program. In August 2016, $2.6 2b 28 32 March 31, 2017, $1.0 June 2016, 4 surfactant could potentially be an effective medical countermeasure to mitigate acute and chronic/late-phase radiation-induced lung injury (pneumonopathy) due to exposure from a nuclear accident or act of terrorism. In addition, in February 2017 4 surfactant could be a potential medical intervention to reduce morbidity and mortality associated with both seasonal and pandemic influenza pneumonia. Although there can be no assurance, we expect to pursue potential additional funding opportunities as they arise and expect that we may If we fail in the future to make any required payment under a secured loan (Deerfield Loan) with affiliates of Deerfield Management, L.P. (Deerfield) or if we fail to comply with any commitments contained in the loan documents, Deerfield would be able to declare a default under the loan agreement, 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 March 31, 2017, 2.9 July 2015 7,049 February 2017 1,000 March 31, 2017, 60 5 25.7 5 There can be no assurance that our phase 2b may Nasdaq Suspension of Listing On May 3 , 2017, and that trading in our common stock would be suspended on The Nasdaq Capital Market effective at the open of business on Friday, May 5, 2017. 5550(b)(1). May 5, 2017. The transition to the OTCQB does not have an immediate effect on our business operations, including our plans to complete and release top-line results from the AEROSURF phase 2b 2017. may may . If our common stock falls within the definition of a “penny stock,” brokers trading in our common stock will be required to adhere to more stringent market rules, which could result in reduced trading activity in our common stock, which could result in reduced trading levels and limited or no analyst coverage. Moreover, reduced trading activity in our common stock could adversely affect liquidity and make it more difficult for stockholders to sell their common stock. |
Note 3 - Basis of Presentation
Note 3 - Basis of Presentation | 3 Months Ended |
Mar. 31, 2017 | |
Notes to Financial Statements | |
Basis of Accounting [Text Block] | Note 3 – 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 three March 31, 2017 may December 31, 2017. December 31, 2016. see 4 2016 10 10 |
Note 4 - Stockholders' Equity
Note 4 - Stockholders' Equity | 3 Months Ended |
Mar. 31, 2017 | |
Notes to Financial Statements | |
Stockholders' Equity Note Disclosure [Text Block] | Note 4 – Stockholders ’ Equity February 2017 On February 15, 2017, 7,049 at a price per Unit of $1,495, $10.5 $1.6 December 31, 2016 first second 2017. one $0.001 1,000 1 one $1.37 may 1,000 $1.37 may six seventh may 9.99% until February 13, 2018, may At-the-Market (ATM) Program During the three March 31, 2017, 805,916 $1,034,000 ($990,000 March 31, 2017, $21.3 three March 31, 2016, Effective on May 5, 2017, see 2 |
Note 5 - Summary of Significant
Note 5 - Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2017 | |
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, first 2016, $1.2 ’s employment agreement, including $0.2 August 1, 2017. $1.0 $0.8 March 31, 2017. $0.2 third 2017. 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 March 31, 2017 2016, 24.3 9.2 three March 31, 2017 2016, In accordance with Accounting Standards Codification Topic 260, Earnings per Share, three March 31, 2017 2016, We do not have any components of other comprehensive income (loss). Beneficial Conversion Feature The issuance of our Series A Convertible Preferred Stock ( see 4 $3.6 one Recently Adopted Accounting Standards In August 2014, 2014 15, Presentation of Financial Statements Going Concern (Subtopic 205 40): Disclosure of Uncertainties about an Entity's Ability to Continue as a Going Concern one 2014 15 December 15, 2016, 2014 15 December 31, 2016. one See 2 In March 2016, 2016 09, Compensation - Stock Compensation (Topic 718): 2016 09 three March 31, 2017 2017 In November 2016, 2016 18, Statement of Cash Flows (Topic 230): 2016 18 March 31, 2017 $0.2 three March 31, 2017 2016. Recent Accounting Pronouncements In May 2017, 2017 09, Compensation Stock Compensation (Topic 718): December 31, 2018 2017 09 may |
Note 6 - Fair Value of Financia
Note 6 - Fair Value of Financial Measurements | 3 Months Ended |
Mar. 31, 2017 | |
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 first two ● Level 1 – Quoted prices in active markets for identical assets and liabilities. ● Level 2 – Inputs other than Level 1 ● 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 March 31, (in thousands) 2017 Level 1 Level 2 Level 3 Assets: Cash and cash equivalents $ 8,022 $ 8,022 $ - $ - Certificate of deposit 225 225 - - Total Assets $ 8,247 $ 8,247 $ - $ - Fair Value Fair value measurement using December 31, (in thousands) 2016 Level 1 Level 2 Level 3 Assets: Cash and cash equivalents $ 5,588 $ 5,588 $ - $ - Certificate of deposit 225 225 - - Total Assets $ 5,813 $ 5,813 $ - $ - The following table summarizes changes in the fair value of common stock warrant liability measured on a recurring basis using Level 3 three March 31, 2016 February 2016. (in thousands) Balance at January 1, 2016 $ 223 Change in fair value of common stock warrant liability (223 ) Balance at March 31, 2016 $ - Fair Value of Long-Term Debt At March 31, 2017, see, 7 $21.4 $25.0 3 |
Note 7 - Long-term Debt
Note 7 - Long-term Debt | 3 Months Ended |
Mar. 31, 2017 | |
Notes to Financial Statements | |
Long-term Debt [Text Block] | Note 7 – Long-term Debt Long-term debt consists solely of amounts due under the Deerfield Loan for the periods presented: March 31, December 31, (in thousands) 2017 2016 Current portion $ 12,500 $ - Non-current portion 12,500 25,000 Total Deerfield Loan $ 25,000 $ 25,000 The principal amount of the loan is payable in two $12.5 February 2018 2019. February 2018 one February 2019 $250 See 9 2016 10 The following amounts comprise the Deerfield Loan interest expense for the periods presented: Three Months Ended March 31, (in thousands) 2017 2016 Amortization of prepaid interest expense $ 270 $ 544 Cash interest expense 254 - Total interest expense $ 524 $ 544 Amortization of prepaid interest expense represents non-cash amortization of $5 purchased by Deerfield in our July 2015 $5 8.75% 8.25% 2017, |
Note 8 - Stock Options and Stoc
Note 8 - Stock Options and Stock-based Employee Compensation | 3 Months Ended |
Mar. 31, 2017 | |
Notes to Financial Statements | |
Disclosure of Compensation Related Costs, Share-based Payments [Text Block] | Note 8 – 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 A summary of activity under our long-term incentive plans is presented below: (in thousands, except for weighted-average data) Stock Options Shares Weighted- Average Exercise Price Weighted- Average Remaining Contractual Term (In Yrs) Outstanding at January 1, 2017 1,142 $ 14.66 Granted 822 1.23 Forfeited or expired (1 ) 112.42 Outstanding at March 31, 2017 1,963 $ 8.96 8.7 Vested and exercisable at March 31, 2017 486 $ 29.89 6.2 Vested and expected to vest at March 31, 2017 1,798 $ 9.07 8.6 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: Three Months Ended March 31, 2017 2016 Weighted average expected volatility 79% 79% Weighted average expected term (in years) 6.6 5.7 Weighted average risk-free interest rate 2.22% 1.40% 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 March 31, (in thousands) 2017 2016 Research and development $ 159 $ 182 Selling, general and administrative 141 421 Total $ 300 $ 603 |
Significant Accounting Policies
Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2017 | |
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, first 2016, $1.2 ’s employment agreement, including $0.2 August 1, 2017. $1.0 $0.8 March 31, 2017. $0.2 third 2017. |
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 March 31, 2017 2016, 24.3 9.2 three March 31, 2017 2016, In accordance with Accounting Standards Codification Topic 260, Earnings per Share, three March 31, 2017 2016, We do not have any components of other comprehensive income (loss). |
Stockholders' Equity Note, Convertible Preferred Stock, Beneficial Conversion Feature, Policy [Policy Text Block] | Beneficial Conversion Feature The issuance of our Series A Convertible Preferred Stock ( see 4 $3.6 one |
New Accounting Pronouncements, Policy [Policy Text Block] | Recently Adopted Accounting Standards In August 2014, 2014 15, Presentation of Financial Statements Going Concern (Subtopic 205 40): Disclosure of Uncertainties about an Entity's Ability to Continue as a Going Concern one 2014 15 December 15, 2016, 2014 15 December 31, 2016. one See 2 In March 2016, 2016 09, Compensation - Stock Compensation (Topic 718): 2016 09 three March 31, 2017 2017 In November 2016, 2016 18, Statement of Cash Flows (Topic 230): 2016 18 March 31, 2017 $0.2 three March 31, 2017 2016. Recent Accounting Pronouncements In May 2017, 2017 09, Compensation Stock Compensation (Topic 718): December 31, 2018 2017 09 may |
Note 6 - Fair Value of Financ15
Note 6 - Fair Value of Financial Measurements (Tables) | 3 Months Ended |
Mar. 31, 2017 | |
Notes Tables | |
Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis [Table Text Block] | Fair Value Fair value measurement using March 31, (in thousands) 2017 Level 1 Level 2 Level 3 Assets: Cash and cash equivalents $ 8,022 $ 8,022 $ - $ - Certificate of deposit 225 225 - - Total Assets $ 8,247 $ 8,247 $ - $ - Fair Value Fair value measurement using December 31, (in thousands) 2016 Level 1 Level 2 Level 3 Assets: Cash and cash equivalents $ 5,588 $ 5,588 $ - $ - Certificate of deposit 225 225 - - Total Assets $ 5,813 $ 5,813 $ - $ - |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Table Text Block] | (in thousands) Balance at January 1, 2016 $ 223 Change in fair value of common stock warrant liability (223 ) Balance at March 31, 2016 $ - |
Note 7 - Long-term Debt (Tables
Note 7 - Long-term Debt (Tables) | 3 Months Ended |
Mar. 31, 2017 | |
Notes Tables | |
Schedule of Long-term Debt Instruments [Table Text Block] | March 31, December 31, (in thousands) 2017 2016 Current portion $ 12,500 $ - Non-current portion 12,500 25,000 Total Deerfield Loan $ 25,000 $ 25,000 |
Schedule of Debt Instrument Interest Expense [Table Text Block] | Three Months Ended March 31, (in thousands) 2017 2016 Amortization of prepaid interest expense $ 270 $ 544 Cash interest expense 254 - Total interest expense $ 524 $ 544 |
Note 8 - Stock Options and St17
Note 8 - Stock Options and Stock-based Employee Compensation (Tables) | 3 Months Ended |
Mar. 31, 2017 | |
Notes Tables | |
Disclosure of Share-based Compensation Arrangements by Share-based Payment Award [Table Text Block] | (in thousands, except for weighted-average data) Stock Options Shares Weighted- Average Exercise Price Weighted- Average Remaining Contractual Term (In Yrs) Outstanding at January 1, 2017 1,142 $ 14.66 Granted 822 1.23 Forfeited or expired (1 ) 112.42 Outstanding at March 31, 2017 1,963 $ 8.96 8.7 Vested and exercisable at March 31, 2017 486 $ 29.89 6.2 Vested and expected to vest at March 31, 2017 1,798 $ 9.07 8.6 |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | Three Months Ended March 31, 2017 2016 Weighted average expected volatility 79% 79% Weighted average expected term (in years) 6.6 5.7 Weighted average risk-free interest rate 2.22% 1.40% Expected dividends - - |
Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Table Text Block] | Three Months Ended March 31, (in thousands) 2017 2016 Research and development $ 159 $ 182 Selling, general and administrative 141 421 Total $ 300 $ 603 |
Note 2 - Liquidity Risks and 18
Note 2 - Liquidity Risks and Management's Plans (Details Textual) - USD ($) $ in Thousands | Feb. 15, 2017 | Mar. 31, 2017 | Mar. 31, 2016 | Dec. 31, 2016 |
Cash and Cash Equivalents, at Carrying Value | $ 8,022 | $ 5,588 | ||
Accounts Payable and Accrued Liabilities, Current | 24,800 | |||
Long-term Debt, Current Maturities | 12,500 | |||
Long-term Debt, Excluding Current Maturities | $ 12,500 | $ 25,000 | ||
Common Stock, Shares Authorized | 60,000,000 | 60,000,000 | ||
Proposal, Common Stock, Shares Authorized | 120,000,000 | |||
Revenue from Grants | $ 219 | $ 75 | ||
Preferred Stock, Shares Authorized | 5,000,000 | 5,000,000 | ||
Common Stock Capital Shares Available for Issuance | 25,700,000 | |||
Preferred Stock Capital Shares Available for Issuance | 5,000,000 | |||
Phase II Small Business Innovation Research Grant from the NHLBI [Member] | ||||
Grant Award | $ 2,600 | |||
Revenue from Grants | 1,000 | |||
Private Placement [Member] | ||||
Convertible Preferred Stock, Shares Issued upon Conversion | 1,000 | |||
Private Placement [Member] | Series A Units [Member] | ||||
Gross Proceeds From Issuance Of Units | $ 10,500 | |||
Non-cash Consideration Received | $ 1,600 | |||
Stock Issued During Period, Shares, New Issues | 7,049 | |||
Registered Public Offerings [Member] | ||||
Gross Proceeds From Issuance Of Units | $ 1,000 | |||
July 2015 Public Offering [Member] | Prefunded Warrants [Member] | ||||
Class of Warrant or Right, Outstanding | 2,900,000 |
Note 4 - Stockholders' Equity (
Note 4 - Stockholders' Equity (Details Textual) - USD ($) | Feb. 15, 2017 | Mar. 31, 2017 | Mar. 31, 2016 | Dec. 31, 2016 |
Preferred Stock, Par or Stated Value Per Share | $ 0.001 | $ 0.001 | $ 0.001 | |
Proceeds from Issuance of Common Stock | $ 990,000 | |||
Private Placement [Member] | ||||
Convertible Preferred Stock Units, Price Per Unit | $ 1,495 | |||
Private Placement [Member] | Series A Units [Member] | ||||
Stock Issued During Period, Shares, New Issues | 7,049 | |||
Gross Proceeds From Issuance Of Units | $ 10,500,000 | |||
Non-cash Consideration Received | $ 1,600,000 | |||
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right | 1 | |||
Private Placement [Member] | Series A Warrant [Member] | ||||
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right | 1,000 | |||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 1.37 | |||
Stifel ATM Program [Member] | ||||
Stock Issued During Period, Shares, New Issues | 805,916 | |||
Stock Issued During Period, Value, New Issues | $ 1,034,000 | |||
Proceeds from Issuance of Common Stock | 990,000 | |||
Common Stock, Remaining Shares Available under Program, Value | $ 21,300,000 |
Note 5 - Summary of Significa20
Note 5 - Summary of Significant Accounting Policies (Details Textual) - USD ($) $ in Thousands, shares in Millions | Mar. 31, 2017 | Feb. 01, 2016 | Sep. 30, 2017 | Mar. 31, 2017 | Mar. 31, 2016 |
Number of Shares of Common Stock Potentially Issuable upon the Exercise of Stock Options and Warrants | 24.3 | 9.2 | |||
Preferred Stock Dividends, Income Statement Impact | $ 3,604 | ||||
Cash, Cash Equivalents, Restricted Cash and Restricted Cash Equivalents, Period Increase (Decrease), Including Exchange Rate Effect | 2,434 | $ (9,322) | |||
Accounting Standards Update 2016-18 [Member] | |||||
Cash, Cash Equivalents, Restricted Cash and Restricted Cash Equivalents, Period Increase (Decrease), Including Exchange Rate Effect | 200 | ||||
Reclassification of Cash and Cash Equivalents to Cash, Cash Equivalents, Restricted Cash and Restricted Cash Equivalents [Member] | Quarter Ended March 31, 2016 [Member] | |||||
Prior Period Reclassification Adjustment | $ 200 | ||||
Former CEO's Employment Agreement [Member] | |||||
Payments for Restructuring | $ 800 | ||||
Former CEO's Employment Agreement [Member] | Scenario, Forecast [Member] | |||||
Payments for Restructuring | $ 200 | ||||
Former CEO's Employment Agreement [Member] | Stock Option Expense [Member] | |||||
Severance Costs | $ 200 | ||||
Former CEO's Employment Agreement [Member] | Not Related to Stock-based Compensation [Member] | |||||
Severance Costs | 1,000 | ||||
Selling, General and Administrative Expenses [Member] | Former CEO's Employment Agreement [Member] | |||||
Severance Costs | $ 1,200 |
Note 6 - Fair Value of Financ21
Note 6 - Fair Value of Financial Measurements (Details Textual) - Deerfield Loan [Member] $ in Millions | Mar. 31, 2017USD ($) |
Estimate of Fair Value Measurement [Member] | |
Long-term Debt, Fair Value | $ 21.4 |
Reported Value Measurement [Member] | |
Long-term Debt, Fair Value | $ 25 |
Note 6 - Fair Value of Financ22
Note 6 - Fair Value of Financial Measurements - Assets and Liabilities Measured at Fair Value (Details) - Fair Value, Measurements, Recurring [Member] - USD ($) $ in Thousands | Mar. 31, 2017 | Dec. 31, 2016 |
Assets: | ||
Cash and cash equivalents | $ 8,022 | $ 5,588 |
Total Assets | 8,247 | 5,813 |
Certificates of Deposit [Member] | ||
Assets: | ||
Certificate of deposit | 225 | 225 |
Fair Value, Inputs, Level 1 [Member] | ||
Assets: | ||
Cash and cash equivalents | 8,022 | 5,588 |
Total Assets | 8,247 | 5,813 |
Fair Value, Inputs, Level 1 [Member] | Certificates of Deposit [Member] | ||
Assets: | ||
Certificate of deposit | 225 | 225 |
Fair Value, Inputs, Level 2 [Member] | ||
Assets: | ||
Cash and cash equivalents | ||
Total Assets | ||
Fair Value, Inputs, Level 2 [Member] | Certificates of Deposit [Member] | ||
Assets: | ||
Certificate of deposit | ||
Fair Value, Inputs, Level 3 [Member] | ||
Assets: | ||
Cash and cash equivalents | ||
Total Assets | ||
Fair Value, Inputs, Level 3 [Member] | Certificates of Deposit [Member] | ||
Assets: | ||
Certificate of deposit |
Note 6 - Fair Value of Financ23
Note 6 - Fair Value of Financial Measurements - Level 3 Rollforward (Details) - Fair Value, Inputs, Level 3 [Member] - Derivative Financial Instruments, Liabilities [Member] $ in Thousands | 3 Months Ended |
Mar. 31, 2016USD ($) | |
Balance | $ 223 |
Change in fair value of common stock warrant liability | (223) |
Balance |
Note 7 - Long-term Debt (Detail
Note 7 - Long-term Debt (Details Textual) - Deerfield Loan [Member] - USD ($) $ in Millions | 3 Months Ended | 12 Months Ended |
Mar. 31, 2017 | Dec. 31, 2016 | |
Debt Instrument Repayment of Principal Portion Number of Installments | 2 | |
Long-term Debt, Maturities, Repayments of Principal in Year Two | $ 12.5 | |
Deferred Period for Loan Payment | 1 year | |
Debt Instrument, Threshold for Potential One-year Deferral, Market Capitalization | $ 250 | |
Debt Instrument, Periodic Payment, Principal | $ 5 | |
Debt Instrument, Periodic Payment, Interest | $ 5 | |
Debt Instrument, Interest Rate, Stated Percentage | 8.75% | |
Debt Instrument, Interest Rate During Period | 8.25% | |
Long-term Debt, Maturities, Repayments of Principal in Year Three | $ 12.5 |
Note 7 - Long-term Debt - Long-
Note 7 - Long-term Debt - Long-term Debt (Details) - USD ($) $ in Thousands | Mar. 31, 2017 | Dec. 31, 2016 |
Long-term debt, current portion | $ 12,500 | |
Long-term debt, non-current portion | 12,500 | 25,000 |
Deerfield Loan [Member] | ||
Long-term debt, current portion | 12,500 | |
Long-term debt, non-current portion | 12,500 | 25,000 |
Total Deerfield Loan | $ 25,000 | $ 25,000 |
Note 7 - Long-term Debt - Lon26
Note 7 - Long-term Debt - Long-term Debt Interest Expense (Details) - Deerfield Loan [Member] - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2017 | Mar. 31, 2016 | |
Amortization of prepaid interest expense | $ 270 | $ 544 |
Cash interest expense | 254 | |
Total interest expense | $ 524 | $ 544 |
Note 8 - Stock Options and St27
Note 8 - Stock Options and Stock-based Employee Compensation (Details Textual) | 3 Months Ended |
Mar. 31, 2017 | |
2011 Long-term Incentive Plan [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award, Award Requisite Service Period | 3 years |
Note 8 - Stock Options and St28
Note 8 - Stock Options and Stock-based Employee Compensation - Summary of Stock Option Activity (Details) shares in Thousands | 3 Months Ended |
Mar. 31, 2017$ / sharesshares | |
Shares Outstanding, Beginning Balance (in shares) | shares | 1,142 |
Weighted Average Exercise Price, Outstanding, at Beginning Period (in dollars per share) | $ / shares | $ 14.66 |
Shares Granted (in shares) | shares | 822 |
Weighted Average Exercise Price, Granted (in dollars per share) | $ / shares | $ 1.23 |
Shares Forfeited or Expired (in shares) | shares | (1) |
Weighted Average Exercise Price, Forfeited or Expired (in dollars per share) | $ / shares | $ 112.42 |
Shares Outstanding, Ending Balance (in shares) | shares | 1,963 |
Weighted Average Exercise Price, Outstanding, at Ending Period (in dollars per share) | $ / shares | $ 8.96 |
Weighted Average Remaining Contractual Life, Outstanding (Year) | 8 years 255 days |
Shares Vested and Exercisable (in shares) | shares | 486 |
Weighted Average Exercise Price, Vested and Exercisable (in dollars per share) | $ / shares | $ 29.89 |
Weighted Average Remaining Contractual Life, Vested and Exercisable (Year) | 6 years 73 days |
Vested and expected to vest (in shares) | shares | 1,798 |
Weighted Average Exercise Price, Vested and Expected to Vest (in dollars per share) | $ / shares | $ 9.07 |
Weighted Average Remaining Contractual Life, Vested and Expected to Vest (Year) | 8 years 219 days |
Note 8 - Stock Options and St29
Note 8 - Stock Options and Stock-based Employee Compensation - Stock Options Valuation Assumptions (Details) | 3 Months Ended | |
Mar. 31, 2017 | Mar. 31, 2016 | |
Weighted average expected volatility | 79.00% | 79.00% |
Weighted average expected term (in years) (Year) | 6 years 219 days | 5 years 255 days |
Weighted average risk-free interest rate | 2.22% | 1.40% |
Expected dividends |
Note 8 - Stock Options and St30
Note 8 - Stock Options and Stock-based Employee Compensation - Stock-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2017 | Mar. 31, 2016 | |
Stock-based compensation expense | $ 300 | $ 603 |
Research and Development Expense [Member] | ||
Stock-based compensation expense | 159 | 182 |
Selling, General and Administrative Expenses [Member] | ||
Stock-based compensation expense | $ 141 | $ 421 |