Document And Entity Information
Document And Entity Information - USD ($) | 12 Months Ended | |||
Dec. 31, 2022 | Dec. 31, 2021 | Mar. 30, 2023 | Jun. 30, 2022 | |
Document Information [Line Items] | ||||
Entity Central Index Key | 0000946486 | |||
Entity Registrant Name | WINDTREE THERAPEUTICS INC /DE/ | |||
Amendment Flag | false | |||
Current Fiscal Year End Date | --12-31 | |||
Document Fiscal Period Focus | FY | |||
Document Fiscal Year Focus | 2022 | |||
Document Type | 10-K | |||
Document Annual Report | true | |||
Document Period End Date | Dec. 31, 2022 | |||
Document Transition Report | false | |||
Entity File Number | 001-39290 | |||
Entity Incorporation, State or Country Code | DE | |||
Entity Tax Identification Number | 94-3171943 | |||
Entity Address, Address Line One | 2600 Kelly Road, Suite 100 | |||
Entity Address, City or Town | Warrington | |||
Entity Address, State or Province | PA | |||
Entity Address, Postal Zip Code | 18976-3622 | |||
City Area Code | 215 | |||
Local Phone Number | 488-9300 | |||
Title of 12(b) Security | Common Stock, $0.001 par value | |||
Trading Symbol | WINT | |||
Security Exchange Name | NASDAQ | |||
Entity Well-known Seasoned Issuer | No | |||
Entity Voluntary Filers | No | |||
Entity Current Reporting Status | Yes | |||
Entity Interactive Data Current | Yes | |||
Entity Filer Category | Non-accelerated Filer | |||
Entity Small Business | true | |||
Entity Emerging Growth Company | false | |||
ICFR Auditor Attestation Flag | false | |||
Entity Shell Company | false | |||
Entity Public Float | $ 9,200,000 | |||
Entity Common Stock, Shares Outstanding | 909,013 | |||
Auditor Firm ID | 274 | 42 | ||
Auditor Name | EisnerAmper LLP | Ernst & Young LLP | ||
Auditor Location | Philadelphia, Pennsylvania | Philadelphia, Pennsylvania |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Current Assets: | ||
Cash and cash equivalents | $ 6,172 | $ 22,348 |
Prepaid expenses and other current assets | 1,205 | 1,143 |
Total current assets | 7,377 | 23,491 |
Property and equipment, net | 262 | 1,011 |
Restricted cash | 154 | 154 |
Operating lease right-of-use assets | 1,853 | 2,381 |
Intangible assets | 25,250 | 32,070 |
Goodwill | 3,058 | 15,682 |
Total assets | 37,954 | 74,789 |
Current Liabilities: | ||
Accounts payable | 249 | 693 |
Accrued expenses | 1,552 | 3,408 |
Operating lease liabilities - current portion | 404 | 528 |
Loans payable - current portion | 252 | 294 |
Total current liabilities | 2,457 | 4,923 |
Operating lease liabilities - non-current portion | 1,624 | 2,071 |
Restructured debt liability - contingent milestone payments | 15,000 | 15,000 |
Other liabilities | 3,800 | 3,800 |
Deferred tax liabilities | 5,061 | 7,114 |
Total liabilities | 27,942 | 32,908 |
Stockholders’ Equity: | ||
Preferred stock, $0.001 par value; 4,960,000 and 5,000,000 shares authorized; 0 shares issued and outstanding at December 31, 2022 and 2021, respectively | 0 | 0 |
Common stock, $0.001 par value; 120,000,000 shares authorized; 772,203 and 565,379 shares issued at December 31, 2022 and 2021, respectively; 772,202 and 565,378 shares outstanding at December 31, 2022 and 2021, respectively | 0 | 0 |
Additional paid-in capital | 837,598 | 830,259 |
Accumulated deficit | (824,532) | (785,324) |
Treasury stock (at cost); 1 share | (3,054) | (3,054) |
Total stockholders’ equity | 10,012 | 41,881 |
Total liabilities, mezzanine equity & stockholders’ equity | 37,954 | 74,789 |
Series A Preferred Stock [Member] | ||
Current Liabilities: | ||
Series A redeemable preferred stock, $0.001 par value; 40,000 and 0 shares authorized; 38,610.119 and 0 shares issued and outstanding at December 31, 2022 and 2021, respectively | $ 0 | $ 0 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parentheticals) - $ / shares | Dec. 31, 2022 | Dec. 31, 2021 |
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 4,960,000 | 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) | 120,000,000 | 120,000,000 |
Common stock, shares issued (in shares) | 772,203 | 565,379 |
Common stock, shares outstanding (in shares) | 772,202 | 565,378 |
Treasury stock, shares (in shares) | 1 | 1 |
Series A Preferred Stock [Member] | ||
Temporary equity, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Temporary equity, shares authorized (in shares) | 40,000 | 0 |
Temporary equity, shares issued (in shares) | 38,610 | 0 |
Temporary equity, shares outstanding (in shares) | 38,610 | 0 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Expenses: | ||
Research and development | $ 11,099 | $ 17,787 |
General and administrative | 10,790 | 14,473 |
Loss on impairment of goodwill | 12,624 | 0 |
Loss on impairment of intangible assets | 6,820 | 45,020 |
Total operating expenses | 41,333 | 77,280 |
Operating loss | (41,333) | (77,280) |
Interest income | 109 | 91 |
Interest expense | (53) | (114) |
Other income (expense), net | 702 | (320) |
Total other income (expense), net | 758 | (343) |
Loss before income taxes | (40,575) | (77,623) |
Deferred income tax benefit | 1,367 | 9,987 |
Net loss | $ (39,208) | $ (67,636) |
Net loss per common share | ||
Basic and diluted (in dollars per share) | $ (62.23) | $ (136.64) |
Weighted average number of common shares outstanding | ||
Basic and diluted (in shares) | 630 | 495 |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' Equity - USD ($) $ in Thousands | ATM Program [Member] Series A Preferred Stock, Mezzanine Equity [Member] | ATM Program [Member] Common Stock [Member] | ATM Program [Member] Additional Paid-in Capital [Member] | ATM Program [Member] Retained Earnings [Member] | ATM Program [Member] Treasury Stock [Member] | ATM Program [Member] | Series A Preferred Stock [Member] Series A Preferred Stock, Mezzanine Equity [Member] | Series A Preferred Stock [Member] Common Stock [Member] | Series A Preferred Stock [Member] Additional Paid-in Capital [Member] | Series A Preferred Stock [Member] Retained Earnings [Member] | Series A Preferred Stock [Member] Treasury Stock [Member] | Series A Preferred Stock [Member] | Share Purchase Agreement, December 2019 [Member] Series A Preferred Stock, Mezzanine Equity [Member] | Share Purchase Agreement, December 2019 [Member] Common Stock [Member] | Share Purchase Agreement, December 2019 [Member] Additional Paid-in Capital [Member] | Share Purchase Agreement, December 2019 [Member] Retained Earnings [Member] | Share Purchase Agreement, December 2019 [Member] Treasury Stock [Member] | Share Purchase Agreement, December 2019 [Member] | Series A Preferred Stock, Mezzanine Equity [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | Treasury Stock [Member] | Total |
Balance (in shares) at Dec. 31, 2020 | 0 | 338,000 | 0 | |||||||||||||||||||||
Balance at Dec. 31, 2020 | $ 0 | $ 0 | $ 790,294 | $ (717,688) | $ (3,054) | $ 69,552 | ||||||||||||||||||
Net loss | $ 0 | $ 0 | 0 | (67,636) | $ 0 | (67,636) | ||||||||||||||||||
Issuance of common stock and common stock warrants, net of issuance costs (in shares) | 0 | 185,000 | 0 | |||||||||||||||||||||
Issuance of common stock and common stock warrants, net of issuance costs | $ 0 | $ 0 | 27,390 | 0 | $ 0 | $ 27,390 | ||||||||||||||||||
Issuance of common stock, ATM Program, net of issuance costs (in shares) | 0 | 42,000 | 0 | 42,339 | ||||||||||||||||||||
Issuance of common stock, ATM Program, net of issuance costs | $ 0 | $ 0 | $ 4,843 | $ 0 | $ 0 | $ 4,843 | $ 4,800 | |||||||||||||||||
Issuance of common stock warrants, equity consideration for service agreement | $ 0 | $ 0 | $ 494 | $ 0 | $ 0 | $ 494 | ||||||||||||||||||
Stock-based compensation expense | $ 0 | $ 0 | 7,238 | 0 | $ 0 | 7,238 | ||||||||||||||||||
Balance (in shares) at Dec. 31, 2021 | 0 | 565,000 | 0 | |||||||||||||||||||||
Balance at Dec. 31, 2021 | $ 0 | $ 0 | 830,259 | (785,324) | $ (3,054) | 41,881 | ||||||||||||||||||
Net loss | $ 0 | $ 0 | 0 | (39,208) | $ 0 | (39,208) | ||||||||||||||||||
Issuance of common stock, ATM Program, net of issuance costs (in shares) | 39,000 | 0 | 0 | 0 | 207,000 | 0 | ||||||||||||||||||
Issuance of common stock, ATM Program, net of issuance costs | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | 4,253 | 0 | $ 0 | 4,253 | ||||||||||||
Stock-based compensation expense | $ 0 | $ 0 | 3,086 | 0 | $ 0 | 3,086 | ||||||||||||||||||
Balance (in shares) at Dec. 31, 2022 | 39,000 | 772,000 | 0 | |||||||||||||||||||||
Balance at Dec. 31, 2022 | $ 0 | $ 0 | $ 837,598 | $ (824,532) | $ (3,054) | $ 10,012 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Cash flows from operating activities: | ||
Net loss | $ (39,208) | $ (67,636) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 533 | 192 |
Stock-based compensation | 3,086 | 7,238 |
Non-cash lease expense | 528 | 677 |
Non-cash expense related to equity consideration for a service agreement | 0 | 494 |
Loss on impairment of goodwill | 12,624 | 0 |
Loss on impairment of intangible assets | 6,820 | 45,020 |
Loss on sale and disposal of property and equipment | 19 | 0 |
Deferred income tax benefit | (1,367) | (9,987) |
Unrealized (gain) loss on foreign exchange rate changes | (710) | 396 |
Changes in assets and liabilities: | ||
Prepaid expenses and other current assets | 1,076 | 1,365 |
Accounts payable | (444) | (468) |
Accrued expenses | (1,838) | (407) |
Operating lease liabilities | (571) | (548) |
Net cash used in operating activities | (19,452) | (23,664) |
Cash flows from investing activities: | ||
Proceeds from sale of property and equipment | 210 | 0 |
Purchase of property and equipment | (13) | (279) |
Net cash provided by (used in) investing activities | 197 | (279) |
Cash flows from financing activities: | ||
Proceeds from Issuance of Common Stock | 4,253 | 4,843 |
Principal payments on loans payable | (1,174) | (3,872) |
Proceeds from issuance of common stock and warrants, net of issuance costs | 0 | 27,390 |
Proceeds from research and development funding arrangement | 0 | 1,000 |
Net cash provided by financing activities | 3,079 | 29,361 |
Net (decrease) increase in cash, cash equivalents, and restricted cash | (16,176) | 5,418 |
Cash, cash equivalents, and restricted cash - beginning of year | 22,502 | 17,084 |
Cash, cash equivalents, and restricted cash - end of year | 6,326 | 22,502 |
Supplementary disclosure of non-cash activity: | ||
Operating lease liabilities arising from obtaining right-of-use assets | 0 | 2,141 |
Prepayment of insurance through third-party financing | $ 1,132 | $ 1,321 |
Note 1 - The Company and Descri
Note 1 - The Company and Description of Business | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Organization, Consolidation and Presentation of Financial Statements Disclosure [Text Block] | Note 1 – The Company and Description of Business We are a clinical-stage biopharmaceutical company focused on the development of novel therapeutics intended to address significant unmet medical needs in important cardiovascular care markets. Our development programs are primarily focused on the treatment of cardiovascular diseases. Our lead product candidate, istaroxime, is a first-in-class, dual-acting agent being developed to improve cardiac function in patients with acute heart failure, or AHF, with a potentially differentiated safety profile from existing treatments. Istaroxime demonstrated significant improvement in both diastolic and systolic aspects of cardiac function and was generally well tolerated in three Phase 2 clinical trials. Istaroxime has been granted Fast Track designation for the treatment of AHF by the U.S. Food and Drug Administration, or FDA. Based on the profile observed in our Phase 2 clinical studies in AHF, where istaroxime significantly improved cardiac function and systolic blood pressure, or SBP, in acute decompensated heart failure patients, we initiated a Phase 2 global clinical study to evaluate istaroxime for the treatment of early cardiogenic shock (Society for Cardiovascular Angiography and Interventions Stage B shock), a severe form of AHF characterized by very low blood pressure and risk for hypoperfusion to critical organs and mortality. We completed this Phase 2 global clinical study and, in April 2022, announced positive topline results. Istaroxime rapidly and significantly increased SBP while also improving cardiac function and preserving renal function. In May 2022, we presented the study results at the European Society of Cardiology Heart Failure Meeting in Madrid, Spain and, in September 2022, the results were published in the European Journal of Heart Failure. We believe that istaroxime has the potential to fulfill an unmet need in early and potentially more severe cardiogenic shock. We further believe that the data from our recently completed Phase 2 global clinical study in early cardiogenic shock not only supports that program’s continued development but also supports the continued development of our AHF program as well. Our heart failure cardiovascular portfolio also includes sarco endoplasmic reticulum Ca2+ -ATPase 2a, or SERCA2a, activators which activate SERCA2a. This research program is evaluating these preclinical product candidates, including oral and intravenous SERCA2a activator heart failure compounds. These candidates would potentially be developed for both acute decompensated and chronic out-patient heart failure. In addition, our cardiovascular drug product candidates include rostafuroxin, a novel product candidate for the treatment of hypertension in patients with a specific genetic profile. We are pursuing potential licensing arrangements and/or other strategic partnerships and do not intend to advance this product candidate without securing such an arrangement or partnership. Previously, we were developing our KL4 surfactant platform, including AEROSURF (lucinactant for inhalation), to address a range of serious respiratory conditions in children and adults. In order to focus our resources on the development of our istaroxime pipeline, we suspended internal AEROSURF clinical activities in November 2020, and, in January 2022 we began to reduce all other costs related to the KL4 surfactant platform that were not already being performed by our licensee, Lee’s Pharmaceutical (HK) Ltd., or Lee’s (HK), and its affiliate, Zhaoke Pharmaceutical (Hefei) Co. Ltd., or Zhaoke, under the terms of our License, Development and Commercialization Agreement between us and Lee’s (HK) dated as of June 12, 2017, as amended, or the Original License Agreement. On August 17, 2022, we entered into an Amended and Restated License, Development and Commercialization Agreement, or the A&R License Agreement, with Lee’s (HK) and Zhaoke effective as of August 9, 2022. We refer to Zhaoke and Lee’s (HK) together as the “Licensee.” The A&R License Agreement amends, restates, and supersedes the Original License Agreement. Under the A&R License Agreement, we granted to Licensee an exclusive license, with a right to sublicense, to develop, register, make, use, sell, offer for sale, import, distribute, and otherwise commercialize our KL4 surfactant products, including SURFAXIN®, the lyophilized dosage form of SURFAXIN, and aerosolized KL4 surfactant, in each case for the prevention, mitigation, and/or treatment of any respiratory disease, disorder, or condition in humans worldwide, except for Andorra, Greece, and Italy (including the Republic of San Marino and Vatican City), Portugal, and Spain, or the Licensed Territory, which countries are currently exclusively licensed to Laboratorios Del Dr. Esteve, S.A., or Esteve. Under the Original License Agreement, previously made an upfront payment to us of $1.0 million. Pursuant to the terms of the A&R License Agreement, we may also receive up to $78.9 million in potential clinical, regulatory, and commercial milestone payments. We are also entitled to receive a low double-digit percentage of Licensee’s non-royalty sublicense income. Further, under the A&R License Agreement, Licensee is solely and exclusively responsible for all costs and activities related to the development, manufacturing, regulatory approval, and commercialization of licensed products in the Licensed Territory, including all royalties payable in respect of third-party intellectual property rights sublicensed by us to Licensee and all intellectual property prosecution, maintenance and defense activities and costs. Our ability to advance our development programs is dependent upon our ability to secure additional capital in both the near and long-term, through public or private securities offerings; convertible debt financings; and/or potential strategic opportunities, including licensing agreements, drug product development, and marketing collaboration arrangements, pharmaceutical research cooperation arrangements, and/or other similar transactions in geographic markets, including the U.S., and/or through potential grants and other funding commitments from U.S. government agencies, in each case, if available. We have engaged with potential counterparties in various markets and will continue to pursue non-dilutive sources of capital as well as potential private and public securities offerings. There can be no assurance, however, that we will be able to identify and enter into public or private securities offerings on acceptable terms and in amounts sufficient to meet our needs or qualify for non-dilutive funding opportunities under any grant programs sponsored by U.S. government agencies, private foundations, and/or leading academic institutions, or identify and enter into any strategic transactions that will provide the additional capital that we will require. If none of these alternatives is available, or if available and we are unable to raise sufficient capital through such transactions, we potentially could be forced to limit or cease our development activities, which would have a material adverse effect on our business, financial condition, and results of operations. |
Note 2 - Basis of Presentation
Note 2 - Basis of Presentation | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Basis of Accounting [Text Block] | Note 2 – Basis of Presentation The consolidated financial statements are prepared in accordance with accounting principles generally accepted in the U.S., or US GAAP, and include accounts of Windtree Therapeutics, Inc. and its wholly owned subsidiaries. Intercompany balances and transactions have been eliminated in consolidation. All adjustments (consisting of normally recurring accruals) considered for fair presentation have been included. The accompanying consolidated financial statements reflect the 1-for-50 reverse split of our common stock that was approved by our Board of Directors and stockholders and made effective on February 24, 2023. All share and per share information herein that relates to our common stock prior to the effective date has been retroactively restated to reflect the reverse stock split. |
Note 3 - Liquidity Risks and Ma
Note 3 - Liquidity Risks and Management's Plans | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Liquidity Disclosures [Text Block] | Note 3 – Going Concern and Management s Plans We are subject to risks common to companies in the biotechnology industry, including but not limited to, the need for additional capital, risks of failure of preclinical and clinical studies, the need to obtain marketing approval and reimbursement for any drug product candidate that we may identify and develop, the need to successfully commercialize and gain market acceptance of our product candidates, dependence on key personnel, protection of proprietary technology, compliance with government regulations, development of technological innovations by competitors, and risks associated with our international operations in Taiwan and activities abroad, including but not limited to having foreign suppliers, manufacturers, and clinical sites in support of our development activities. We have incurred net losses since inception. Our net loss was $39.2 million and $67.6 million, respectively, for the years ended December 31, 2022 and 2021 . Included in our net loss for the year ended December 31, 2022 are non-cash items such as a $12.6 million loss on impairment of goodwill and a $6.8 million loss on impairment of intangible assets related to rostafuroxin and a related $1.4 million deferred income tax benefit. Included in our net loss for the year ended December 31, 2021 are non-cash items such as a $45.0 million loss on impairment of intangible assets related to rostafuroxin and a related $10.0 million deferred income tax benefit (See the section titled, Note 4 – Accounting Policies and Recent Accounting Pronouncements ”). We expect to continue to incur operating losses for at least the next several years. As of December 31, 2022 , we had an accumulated deficit of $824.5 million. Our future success is dependent on our ability to fund and develop our product candidates, and ultimately upon our ability to attain profitable operations. We have devoted substantially all of our financial resources and efforts to research and development and general and administrative expense to support such research and development. Net losses and negative cash flows have had, and will continue to have, an adverse effect on our stockholders’ equity and working capital, and accordingly, our ability to execute our future operating plans. We are party to an At-The-Market Offering Agreement with Ladenburg Thalmann & Co. Inc., or Ladenburg, pursuant to which we may offer and sell, from time to time at our sole discretion, up to a maximum of $10.0 million of shares of our common stock through Ladenburg as agent and/or principal through an at-the-market program, or the ATM Program. For the year ended December 31, 2022 , we sold 206,824 shares of our common stock under the ATM Program resulting in aggregate gross proceeds to us of approximately $4.4 million and net proceeds of approximately $4.3 million (See the section titled , Note 10 – Mezzanine Equity and Stockholders’ Equity ”). The shares of common stock issued and sold under the ATM Program are registered under our registration statement on Form S-3 (File No. 333-248874), which was declared effective by the SEC on September 29, 2020. We are currently subject to the limitations contained in General Instruction I.B.6 of Form S-3. As a result, we are limited to selling no more than one-third of the aggregate market value of the equity held by non-affiliates, or the public float, during any 12-month period, and as of December 31, 2022, we have sold the full amount we are permitted to sell under the Form S-3 pursuant to General Instruction I.B.6. If our public float increases, we will have additional availability under such limitations, and if our public float increases to $75.0 million or more, we will no longer be subject to such limitations. There can be no assurance that our public float will increase or that we will no longer be subject to such limitations. As of December 31, 2022 , we had cash and cash equivalents of $6.2 million and current liabilities of $2.5 million. We believe that we have sufficient resources available to support our development activities and fund our business operations into the second quarter of 2023. However, we do not have sufficient cash and cash equivalents as of the date of this Annual Report on Form 10-K to support our operations for at least the 12 months following the date that the financial statements are issued. These conditions raise substantial doubt about our ability to continue as a going concern for at least 12 months after the date that the financial statements are issued. To alleviate the conditions that raise substantial doubt about our ability to continue as a going concern, management plans to secure additional capital, potentially through a combination of public or private securities offerings, convertible debt financings, and/or strategic transactions, including potential licensing arrangements, alliances, and drug product collaborations focused on specified geographic markets; however, none of these alternatives are committed at this time. There can be no assurance that we will be successful in obtaining sufficient funding on terms acceptable to us to fund continuing operations, if at all, or identify and enter into any strategic transactions that will provide the capital that we will require. The failure to obtain sufficient capital on acceptable terms when needed would have a material adverse effect on our business, results of operations, and financial condition. Accordingly, management has concluded that substantial doubt exists with respect to our ability to continue as a going concern for at least 12 months after the issuance of the accompanying financial statements. 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. |
Note 4 - Accounting Policies an
Note 4 - Accounting Policies and Recent Accounting Pronouncements | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Significant Accounting Policies [Text Block] | Note 4 – Accounting Policies and Recent Accounting Pronouncements Principles of Consolidation The consolidated financial statements are prepared in accordance with US GAAP and include accounts of Windtree Therapeutics, Inc. and our wholly owned subsidiary, CVie Investments Limited and its wholly owned subsidiary, CVie Therapeutics Limited, or CVie Therapeutics, and a presently inactive subsidiary, Discovery Laboratories, Inc. (formerly known as Acute Therapeutics, Inc.). Intangible Assets and Goodwill We record acquired intangible assets and goodwill based on estimated fair value. The identifiable intangible assets resulting from the CVie Therapeutics acquisition in December 2018 relate to in-process research and development, or IPR&D, of istaroxime and rostafuroxin. The IPR&D assets are considered indefinite-lived intangible assets until completion or abandonment of the associated research and development efforts. IPR&D is not amortized but reviewed for impairment at least annually, or when events or changes in the business environment indicate the carrying value may be impaired. When testing our indefinite-lived intangible assets and goodwill for impairment, we can elect to perform a qualitative assessment to determine if it is more likely than not that the fair values of our indefinite-lived intangible assets and our reporting unit are less than their respective carrying values. Such qualitative factors can include, among others, industry and market conditions, overall financial performance, and relevant entity-specific events. If we conclude based on our qualitative assessment that it is more likely than not that the fair value of our indefinite-lived intangible assets or reporting unit are less than their respective carrying values, we perform a quantitative assessment. When conducting our annual impairment test of indefinite-lived intangible assets and goodwill as of December 1, 2022 , we elected to perform a quantitative assessment. When performing the quantitative impairment assessment for our indefinite-lived IPR&D intangible assets, we estimate the fair values of the assets using the multi-period excess earnings method, or MPEEM. MPEEM is a variation of the income approach which estimates the fair value of an intangible asset based on the present value of the incremental after-tax cash flows attributable to the intangible asset. Significant factors considered in the calculation of IPR&D intangible assets include the risks inherent in the development process, including the likelihood of achieving commercial success and the cost and related time to complete the remaining development. Future cash flows for each project were estimated based on forecasted revenue and costs, taking into account the expected product life cycles, market penetration, and growth rates. Other significant estimates and assumptions inherent in this approach include (i) the amount and timing of the projected net cash flows associated with the IPR&D assets, (ii) the discount rate, which seeks to reflect the various risks inherent in the projected cash flows; and (iii) the tax rate, which considers geographic diversity of the projected cash flows. While we use the best available information to prepare our cash flows and discount rate assumptions, actual future cash flows could differ significantly based on the commercial success of the related drug candidates and market conditions which could result in future impairment charges related to our indefinite-lived intangible asset balances. During 2021, we concluded an initial process to test the industry’s interest in investing in our rostafuroxin drug candidate and were not able to secure a licensing transaction or other strategic opportunity at that time. Based on feedback received from potential licensing partners, we have determined that there is a need for an additional Phase 2 clinical trial. Due to these developments, we recorded a loss on impairment of intangible assets of $37.8 million during the second quarter of 2021. Further, in connection with our annual quantitative impairment assessment of indefinite-lived IPR&D intangible assets as of December 1, 2021, we reassessed certain assumptions related to our rostafuroxin drug candidate due to the current macroeconomic conditions which have made it harder to secure the funding needed to conduct the additional Phase 2 clinical trial and had therefore delayed our intended development of rostafuroxin. As a result, we recorded an additional loss on impairment of intangible assets of $7.2 million in the fourth quarter of 2021. When combined with the loss on impairment of intangible assets recorded during the second quarter, we recorded a loss on impairment of intangible assets totaling $45.0 million within operating expenses in our consolidated statements of operations during the year ended December 31, 2021. As part of our annual quantitative impairment assessment of indefinite-lived IPR&D intangible assets as of December 1, 2022, we again reassessed certain assumptions related to our rostafuroxin drug candidate due to the continued difficulties in current macroeconomic conditions which have continued to make it more challenging to secure the funding needed to conduct the additional Phase 2 clinical trial and have therefore further delayed our intended development of rostafuroxin. As a result, we concluded that the fair value of the IPR&D related to our rostafuroxin drug candidate was less than its carrying value. We estimated the fair value of the asset using MPEEM and determined that the fair value as of December 1, 2022 was approximately $2.9 $6.8 Goodwill represents the excess of the purchase price over the fair value of assets acquired and liabilities assumed in a business combination and is not amortized. It is reviewed for impairment at least annually or when events or changes in the business environment indicate that its carrying value may be impaired. Our company consists of one In accordance with applicable accounting standards, we are required to review intangible assets and goodwill for impairment on an annual basis, or more frequently where there is an indication of impairment. Throughout the year, we consider whether any events or changes in the business environment have occurred which indicate that goodwill may be impaired. For example, a significant decline in the closing share price of our common stock and market capitalization may suggest that the fair value of our reporting unit has fallen below its carrying value, indicating that an interim goodwill impairment test is required. Accordingly, we monitor changes in our share price during interim periods between annual impairment tests and consider overall stock market conditions, the underlying reasons for the decline in our share price, the significance of the decline, and the duration of time that our securities have been trading at a lower value. We have experienced a declining trend in the closing share price of our common stock, on a split-adjusted basis, following the announcement in April 2022 of positive topline results in our Phase 2 global clinical study of istaroxime for the treatment of early cardiogenic shock. During each of the second and third quarters of 2022, the continued declining trend in the closing share price of our common stock, on a split-adjusted basis, suggested that the fair value of our reporting unit was more likely than not less than its carrying value. As a result, in each quarter we performed the required interim goodwill impairment test consistent with the methodology described above. Based on the quantitative tests performed, we recorded losses on impairment of goodwill of $11.6 million and $0.5 million, respectively, in the second and third quarters of 2022. We performed our annual goodwill quantitative test as of December 1, 2022 and determined that the fair value of our reporting unit was more likely than not less than its carrying value. As a result, we recorded a loss on impairment of goodwill of $0.5 million in the fourth quarter of 2022. When combined with the losses on impairment of goodwill recorded during the second and third quarters of 2022, we recorded a loss on impairment of intangible assets totaling $12.6 million within operating expenses in our consolidated statements of operations during the year ended December 31, 2022. The closing share price of our common stock, on a split-adjusted basis, has continued to decline subsequent to the end of 2022. If our share price continues to decline, we may be at risk for future impairment to goodwill in the near term. The following table represents identifiable intangible assets and goodwill as of : December 31, (in thousands) 2022 2021 Istaroxime drug candidate $ 22,340 $ 22,340 Rostafuroxin drug candidate 2,910 9,730 Intangible assets 25,250 32,070 Goodwill $ 3,058 $ 15,682 Foreign Currency Transactions The functional currency for our foreign subsidiaries is the US Dollar. We remeasure monetary assets and liabilities that are not denominated in the functional currency at exchange rates in effect at the end of each period. Gains and losses from the remeasurement of foreign currency transactions are recognized in . Foreign currency transactions resulted in of approximately million and of million, respectively, for the years ended . Use of Estimates The preparation of financial statements in conformity with US GAAP 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. Cash and Cash Equivalents Cash and cash equivalents are held at domestic and foreign financial institutions and consist of liquid investments and money market funds that are readily convertible into cash. Concentration of Credit Risk Financial instruments, which potentially subject us to credit risk, consist principally of cash and cash equivalents. All cash and cash equivalents are held in U.S. financial institutions and money market funds. At times, we may maintain cash balances in excess of the federally insured amount of $250,000 per depositor, per insured bank, for each account ownership category. Although we currently believe that the financial institutions with whom we do business will be able to fulfill their commitments to us, there is no assurance that those institutions will be able to continue to do so. We have not experienced any credit losses associated with our balances in such accounts for the years ended December 31, 2022 and 2021 . Fair Value of Financial Instruments Our financial instruments consist principally of cash and cash equivalents and restricted cash. The fair values of our cash equivalents are based on quoted market prices. The carrying value of cash equivalents is equal to their respective fair values at December 31, 2022 and 2021 , respectively. Accounts payable and accrued expenses are carried at cost, which approximates fair value because of their short maturity. The carrying value of loans payable (including current installments) approximates fair value based on a comparison of interest rates on the loan to current market rates considering our credit risk. Property and Equipment Property and equipment are recorded at cost and depreciated using the straight-line method over the estimated useful lives of the assets (generally three ten Restricted Cash Restricted cash consists principally of a $140,000 certificate of deposit held by our bank as collateral for a letter of credit in the same notional amount held by our landlord to secure our obligations under our lease agreement dated May 26, 2004 for our headquarters location in Warrington, Pennsylvania and $14,000 in deposits held by our landlord for our offices in Taipei, Taiwan. Leases Leases are accounted for under Financial Accounting Standards Board, or FASB, Accounting Standards Codification, or ASC, Topic 842, Leases Operating lease liabilities and their corresponding operating lease right-of-use assets are recorded based on the present value of lease payments over the expected remaining lease term. Certain adjustments to the right-of-use asset may be required for items such as incentives received. The interest rate implicit in our leases is typically not readily determinable. As a result, we utilize our incremental borrowing rate, which reflects the fixed rate at which we could borrow on a collateralized basis the amount of the lease payments in the same currency, for a similar term, in a similar economic environment. At the inception of a contract, we assess whether the contract is, or contains, a lease. The assessment is based on: (i) whether the contract involves the use of a distinct identified asset, (ii) whether we obtain the right to substantially all the economic benefit from the use of the asset throughout the period, and (iii) whether we have the right to direct the use of the asset. We evaluate the classification of our leases as either finance leases or operating leases. A lease is classified as a finance lease if any one of the following criteria are met: the lease transfers ownership of the asset by the end of the lease term, the lease contains an option to purchase the asset that is reasonably certain to be exercised, the lease term is for a major part of the remaining useful life of the asset, the present value of the lease payments equals or exceeds substantially all of the fair value of the asset, or the leased asset is of such a specialized nature that it is expected to have no alternative use to the lessor at the end of the lease. A lease is classified as an operating lease if it does not meet any of these criteria. Currently, all of our leases are classified as operating leases. Lease cost for our operating leases is recognized on a straight-line basis over the lease term. Included in lease cost are any variable lease payments incurred in the period that are not included in the initial lease liability and lease payments incurred in the period for any leases with an initial term of 12 months or less. Long-lived Assets Our long-lived assets, primarily consisting of property and equipment, are reviewed for impairment when events or changes in circumstances indicate that the carrying value of an asset may not be recoverable, or its estimated useful life has changed significantly. When the undiscounted cash flows of an asset are less than its carrying value, an impairment is recorded and the asset is written down to estimated value. No impairment was recorded during the years ended December 31, 2022 and 2021 as management believes there are no circumstances that indicate that the carrying value of the assets will not be recoverable. Collaborative Arrangements We account for collaborative arrangements in accordance with applicable accounting guidance provided in ASC Topic 808, Collaborative Arrangements , Note 12 – Collaboration, Licensing and Research Funding Agreements ”. Severance In January 2022, in order to focus our resources on the development of our istaroxime pipeline, we began to reduce costs related to KL4 surfactant that were not already being performed by our licensee, Lee’s (HK) and its affiliate Zhaoke, under the terms of the Original License Agreement. These costs included certain reductions in headcount dedicated to KL4 surfactant and the decommissioning of both our analytical and technical support laboratory, which previously conducted release testing of active pharmaceutical ingredients, or APIs, and supportive research for our lyophilized and aerosolized KL4 surfactant, and our medical device development laboratory, which was previously used to conduct development activities and testing for our aerosol delivery system technologies. In February 2022, management communicated its commitment to provide severance payments to impacted employees, provided that they remained employed with us through their expected termination dates. The total severance cost for impacted employees was approximately $0.4 million, which was accrued over the service periods of the employees and was paid ratably through September 2022. No further amounts are due as of December 31, 2022. Restructured Debt Liability – Contingent Milestone Payment In conjunction with the November 2017 restructuring and retirement of long-term debt (See the section titled , Note 9 – Restructured Debt Liability ”) , we have established a $15.0 million long-term liability for contingent milestone payments potentially due under the Exchange and Termination Agreement dated as of October 27, 2017, or Exchange and Termination Agreement, between ourselves and affiliates of Deerfield Management Company L.P., or Deerfield. The liability has been recorded at full value of the contingent milestones and will continue to be carried at full value until the milestones are achieved and paid or milestones are not achieved and the liability is written off as a gain on debt restructuring. Research and Development We account for research and development expense by the following categories: (a) product development and manufacturing, (b) clinical, medical, and regulatory operations, and (c) direct clinical and preclinical development programs. Research and development expense includes personnel, facilities, manufacturing and quality operations, pharmaceutical development, research, clinical, regulatory, other preclinical and clinical activities and medical affairs. Research and development costs are charged to operations as incurred in accordance with ASC Topic 730, Research and Development Stock-based Compensation Stock-based compensation is accounted for under the fair value recognition provisions of ASC Topic 718, Stock Compensation , Note 11 – Stock Options and Stock-based Employee Compensation , for a detailed description of our recognition of stock-based compensation expense. The fair value of stock option grants is recognized evenly over the vesting period of the options or over the period between the grant date and the time the option becomes non-forfeitable by the employee, whichever is shorter. Warrant Accounting 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 Income Taxes We account for income taxes in accordance with ASC Topic 740, Accounting for Income Taxes We use a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. Because we have never realized a profit, management has fully reserved the net deferred tax asset since realization is not assured. For the years ended December 31, 2022 and 2021, we recorded a deferred income tax benefit of Net Loss per Common Share Basic net loss per common 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. The number of shares of common stock potentially issuable upon the exercise of certain stock options and warrants was million shares for each of the years ended . As of , all potentially dilutive securities were anti-dilutive and therefore have been excluded from the computation of diluted net loss per common share. We do not have any components of other comprehensive (loss) income. Concentration of Suppliers We currently obtain the APIs of our drug products from a single supplier. In addition, our drug products are produced at one contract manufacturer. These single source providers also perform various studies as well as quality control release and stability testing and other activities related to our development and manufacturing activities. At the present time these providers are located outside of the U.S. The loss of either the supplier of our APIs or our drug product contract manufacturer could have a material adverse effect on our operations. Segment and Geographic Information We currently operate in one operating segment, which is the research and development of products focused on cardiovascular disease. We are managed and operated as one million and goodwill of million, were located outside the U.S. as of . |
Note 5 - Fair Value Measurement
Note 5 - Fair Value Measurements | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Fair Value Disclosures [Text Block] | Note 5 – Fair Value Measurements 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 measured at fair value on a recurring basis as of : Fair Value Fair value measurement using December 31, (in thousands) 2022 Level 1 Level 2 Level 3 Cash equivalents: Money market funds $ 4,212 $ 4,212 $ - $ - Total Assets $ 4,212 $ 4,212 $ - $ - Fair Value Fair value measurement using December 31, (in thousands) 2021 Level 1 Level 2 Level 3 Cash equivalents: Money market funds $ 21,104 $ 21,104 $ - $ - Total Assets $ 21,104 $ 21,104 $ - $ - Fair Value on a Non-Recurring Basis The table below categorizes assets measured at fair value on a non-recurring basis for the periods presented: Fair Value Fair value measurement using December 31, (in thousands) 2022 Level 1 Level 2 Level 3 Intangible assets: Rostafuroxin drug candidate $ 2,910 $ - $ - $ 2,910 Goodwill $ 3,058 $ - $ - $ 3,058 Fair Value Fair value measurement using December 31, (in thousands) 2021 Level 1 Level 2 Level 3 Intangible assets: Rostafuroxin drug candidate $ 9,730 $ - $ - $ 9,730 Certain of our assets were measured at fair value on a non-recurring basis during the years ended December 31, 2022 and 2021 . The IPR&D intangible asset related to our rostafuroxin drug candidate was recorded at its estimated fair value as a result of the impairment tests performed during 2022 and 2021. Our goodwill was also recorded at its estimated fair value as a result of the impairment test performed in 2022 (See the section titled, “ Note 4 – Accounting Policies and Recent Accounting Pronouncements – Intangible Assets and Goodwill Significant factors considered in estimating the fair value of the IPR&D intangible asset related to our rostafuroxin drug candidate include the risks inherent in the development process, including the likelihood of achieving commercial success and the cost and related time to complete the remaining development. Future cash flows for the IPR&D intangible asset were estimated based on forecasted revenue and costs, taking into account the expected product life cycle, market penetration, and growth rates. Other significant estimates and assumptions inherent in this approach include (i) the amount and timing of the projected net cash flows associated with the IPR&D intangible asset; (ii) the discount rate, which seeks to reflect the various risks inherent in the projected cash flows; and (iii) the tax rate, which considers geographic diversity of the projected cash flows. Quantitative information about the significant unobservable inputs used in the fair value measurement of the IPR&D intangible asset included a discount rate of 20.0% In order to perform the goodwill impairment test, we compare the estimated fair value of our reporting unit to its carrying value. Significant factors considered in estimating the fair value of our reporting unit include the use of the quoted market price and related market capitalization of our common stock, adjusted for an estimated control premium based on transactions completed by comparable companies. Quantitative information about the significant unobservable inputs used in the fair value measurement of the reporting unit included an estimated control premium of 50% for 2022. |
Note 6 - Property and Equipment
Note 6 - Property and Equipment | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Property, Plant and Equipment Disclosure [Text Block] | Note 6 – Property and Equipment Property and equipment is comprised of the following: December 31, (in thousands) 2022 2021 Leasehold improvements $ 2,649 $ 2,649 Manufacturing, laboratory & office equipment 881 4,703 Furniture & fixtures 390 390 Subtotal 3,920 7,742 Accumulated depreciation and amortization (3,658 ) (6,731 ) Property and equipment, net $ 262 $ 1,011 Depreciation expense on property and equipment for the years ended December 31, 2022 and 2021 was $0.5 million and $0.2 million, respectively. During the first quarter of 2022, we determined that certain manufacturing and laboratory equipment assets related to the KL4 surfactant platform would be abandoned by March 31, 2022. We accelerated depreciation of these assets during the first quarter of 2022, resulting in $0.4 million of additional depreciation expense for the three months ended March 31, 2022. During the second quarter of 2022, the abandoned assets and certain other KL4 surfactant platform assets were disposed. |
Note 7 - Accrued Expenses
Note 7 - Accrued Expenses | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Accounts Payable, Accrued Liabilities, and Other Liabilities Disclosure, Current [Text Block] | Note 7 – Accrued Expenses Accrued expenses are comprised of the following: December 31, (in thousands) 2022 2021 Research and development $ 786 $ 1,500 Professional fees 459 391 Salaries, bonus and benefits 123 1,218 Manufacturing operations 5 46 Other 179 253 Total accrued expenses $ 1,552 $ 3,408 |
Note 8 - Loans Payable
Note 8 - Loans Payable | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Short-Term Debt [Text Block] | Note 8 - Loans Payable In June 2022, we entered into an insurance premium financing and security agreement with Bank Direct Capital Finance, or Bank Direct. Under the agreement, we financed $1.1 million of certain premiums at a 3.90% fixed annual interest rate. Payments of approximately $126,000 are due monthly from July 2022 through March 2023. As of December 31, 2022 , the outstanding principal of the loan was $0.3 million. In June 2021, we entered into an insurance premium financing and security agreement with Bank Direct. Under the agreement, we financed $1.3 million of certain premiums at a 3.37% fixed annual interest rate. Payments of approximately $147,000 were due monthly from July 2021 through March 2022. As of December 31, 2021, the outstanding principal of the loan was $0.3 million. The balance of the loan was repaid during the first quarter of 2022. |
Note 9 - Restructured Debt Liab
Note 9 - Restructured Debt Liability | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Long-Term Debt [Text Block] | Note 9 – Restructured Debt Liability On October 27, 2017, we and Deerfield entered into the Exchange and Termination Agreement pursuant to which (i) promissory notes evidencing a loan with affiliates of Deerfield Management Company L.P., or the Deerfield Loan, in the aggregate principal amount of $25.0 million and (ii) warrants to purchase up to 167 shares of our common stock at an exercise price of $118,020.00 per share held by Deerfield were cancelled in consideration for (x) a cash payment in the aggregate amount of $2.5 million, (y) 474 shares of common stock, representing 2% of fully-diluted shares outstanding (as defined in the Exchange and Termination Agreement) on the closing date, and (z) the right to receive certain milestone payments based on achievement of specified AEROSURF development and commercial milestones, which, if achieved, could potentially total up to $15.0 million. In addition, a related security agreement, pursuant to which Deerfield held a security interest in substantially all of our assets, was terminated. We established a $15.0 million long-term liability for the contingent milestone payments potentially due to Deerfield under the Exchange and Termination Agreement. The liability has been recorded at the full value of the contingent milestones and will continue to be carried at full value until the milestones are achieved and paid or the milestones are not achieved and the liability is written off as a gain on debt restructuring. As of December 31, 2022 and 2021 , the restructured debt liability balance was $15.0 million. |
Note 10 - Mezzanine Equity and
Note 10 - Mezzanine Equity and Stockholders' Equity | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Stockholders' Equity Note Disclosure [Text Block] | Note 10 – Mezzanine Equity and Stockholders’ Equity Preferred Stock We are authorized to issue 5,000,000 shares of preferred stock, with a par value of $0.001 per share. On November 17, 2022, our Board of Directors declared a dividend of one one-thousandth ( 1/1,000th 38,610.119 All shares of Series A Preferred Stock that are not present in person or by proxy at any meeting of stockholders held to vote on the Reverse Stock Split and the adjournment proposal as of immediately prior to the opening of the polls at such meeting, or the Initial Redemption Time, will automatically be redeemed in whole, but not in part, by the Company at the Initial Redemption Time. All shares that were not redeemed pursuant to the Initial Redemption Time will be redeemed if ordered by the Board of Directors or automatically upon the approval by our stockholders of the Reverse Stock Split at any meeting of the stockholders held for the purpose of voting on such proposal. Each share of Series A Preferred Stock is entitled to receive $0.01 in cash for each 10 whole shares of Series A Preferred Stock immediately prior to the redemption. Upon issuance of the Series A Preferred Stock, the Company was not solely in control of the redemption of the shares of Series A Preferred Stock since the holders had the option of deciding whether to attend or return a proxy card for the Special Meeting, which determined whether a given holder’s shares of Series A Preferred Stock were redeemed at the Initial Redemption Time. Since the redemption of the Series A Preferred Stock was not solely in the control of the Company, the shares of Series A Preferred Stock are classified within mezzanine equity. The shares of Series A Preferred Stock were recorded at redemption value, which approximates fair value. On February 7, 2023, we held a Special Meeting of Stockholders, or the Special Meeting, where our stockholders voted on and approved an amendment to our Amended and Restated Certificate of Incorporation, as amended, to effect the Reverse Stock Split and adjourn the Special Meeting, at which point all shares of Series A Preferred Stock were redeemed, and were no longer issued and outstanding as of such date. At-The-Market Program On September 17, 2020, we entered into an At-The-Market Offering Agreement with Ladenburg pursuant to which we may offer and sell, from time to time at our sole discretion, up to a maximum of $10.0 million of shares of our common stock through Ladenburg as agent and/or principal under the ATM Program. When we issue sales notices to Ladenburg, we designate the maximum amount of shares to be sold by Ladenburg daily and the minimum price per share at which shares may be sold. Ladenburg may sell shares by any method permitted by law deemed to be an “at-the-market offering” as defined in Rule 415(a)(4) under the Securities Act, or in privately negotiated transactions. We agreed to pay Ladenburg a commission of 3% of the gross sales price of any shares sold pursuant to the ATM Program. The rate of compensation will not apply when Ladenburg acts as principal. For the year ended December 31, 2022 , we sold 206,824 shares of our common stock under the ATM Program resulting in aggregate gross proceeds to us of approximately $4.4 million and net proceeds of approximately $4.3 million. For the year ended December 31, 2021, we sold 42,339 shares of our common stock under the ATM Program resulting in aggregate gross proceeds to us of approximately $5.0 million and net proceeds of approximately $4.8 million. The shares of common stock issued and sold under the ATM Program are registered under our registration statement on Form S-3 (File No. 333-248874), which was declared effective by the SEC on September 29, 2020. We are currently subject to the limitations contained in General Instruction I.B.6 of Form S-3. As a result, we are limited to selling no more than one-third of the aggregate market value of the equity held by non-affiliates, or the public float, during any 12-month period, and as of December 31, 2022, we have sold the full amount we are permitted to sell under the Form S-3 pursuant to General Instruction I.B.6. If our public float increases, we will have additional availability under such limitations, and if our public float increases to $75.0 million or more, we will no longer be subject to such limitations. There can be no assurance that our public float will increase or that we will no longer be subject to such limitations. March 2021 Public Offering On March 23, 2021, we entered into an underwriting agreement with Oppenheimer & Co. Inc. as representative for the several underwriters named therein, relating to a public offering, or the March 2021 Offering, of an aggregate of 184,610 units with each unit consisting of one $180.00 per share and expire five The closing of the March 2021 Offering occurred on March 25, 2021. The offering price to the public was $162.50 per unit resulting in gross proceeds to us of $30.0 million. After deducting underwriting discounts and commissions and estimated offering expenses payable by us, and excluding the proceeds, if any, from the exercise of the March 2021 Warrants issued pursuant to the March 2021 Offering, the net proceeds to us were approximately $27.4 million. We have determined that the appropriate accounting treatment under ASC 480, Distinguishing Liabilities from Equity Derivatives and Hedging Common Shares Reserved for Future Issuance Common shares reserved for potential future issuance upon exercise of warrants The chart below summarizes shares of our common stock reserved for future issuance upon the exercise of warrants: December 31, Expiration (in thousands, except price per share data) 2022 2021 Exercise Price Date Investors - March 2021 financing 185 185 $ 180.00 03/25/26 Service Agreement - 2021 warrants 3 3 $ 412.50 02/09/24 Investors - May 2020 financing 63 63 $ 399.00 05/22/25 Investors - December 2019 financing 29 29 $ 604.50 12/06/24 Investors - AEROSURF 20 20 $ - 02/14/24 Investors - December 2018 financing - long-term 26 26 $ 607.50 12/04/23 Battelle - 2018 payables restructuring agreement (1) 1 1 $ 975.00 12/07/23 Panacea Venture Management Company Ltd. 1 1 $ 600.00 07/02/23 LPH II Investments Limited 1 1 $ 828.00 04/04/25 Investors - February 2017 financing 2 2 $ 4,110.00 02/15/24 Investors - July 2015 financing - 2 $ 29,400.00 07/22/22 Battelle - 2014 collaboration agreement 1 1 $ 210,000.00 10/10/24 Total 332 334 (1) See the section titled , “ Note 12 – Collaboration, Licensing and Research Funding Agreements , ” for further details on the Battelle collaboration agreement. Common shares reserved for potential future issuance upon granting of additional equity incentive awards The 2020 Equity Incentive Plan, or the 2020 Plan, initially provided for up to a maximum of approximately 31,000 , “ Note 11 – Stock Options and Stock-based Employee Compensation . ” As of December 31, 2022 , we had approximately 12,000 shares available for potential future issuance under the 2020 Plan. |
Note 11 - Stock Options and Sto
Note 11 - Stock Options and Stock-Based Employee Compensation | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Share-Based Payment Arrangement [Text Block] | Note 11 – Stock Options and Stock-based Employee Compensation Long-term Incentive Plans On November 23, 2020, our Board of Directors adopted our 2020 Plan, which was subsequently approved on December 24, 2020 by written consent of our majority stockholders and became effective on January 20, 2021, or the Effective Date. On the Effective Date, the 2020 Plan replaced our 2011 long-term incentive plan, or the 2011 Plan, and the 2020 Plan became our primary plan for providing equity-based compensation to our eligible employees, consultants, and non-employee directors. Awards under the 2020 Plan may include stock options, stock appreciation rights, or SARs, restricted stock awards, or RSAs, restricted stock units, or RSUs, other performance and stock-based awards, and dividend equivalents. As of December 31, 2022 , there were approximately 62,000 shares of our common stock authorized under the 2020 Plan, of which approximately 12,000 shares remained available for issuance as of December 31, 2022 . The 2020 Plan is subject to automatic annual increases on January 1 of each year of the lesser of (i) 4% of the number of shares of our common stock issued and outstanding on the last day of the immediately preceding fiscal year, and (ii) such smaller number of shares as determined by our board. The annual increase on January 1, 2023 was approximately 31,000 shares. An administrative committee, currently the Compensation Committee of the Board of Directors, or Committee delegates, may determine the types, the number of shares covered by, and the terms and conditions of, such awards. Eligible participants may include any of our employees, directors, advisors or consultants. Stock options and RSUs outstanding and available for future issuance are as follows: December 31, (in thousands) 2022 2021 Stock Options and RSUs Outstanding 2020 Plan 50 25 2011 Plan 30 32 Non-Plan 9 11 Total Outstanding 89 68 Available for Future Grants under the 2020 Plan 12 13 No SARs, RSAs, other performance and stock-based awards, or dividend equivalents have been granted under the 2020 Plan. Although individual grants may vary, option awards generally have a 10-year term, are exercisable upon vesting, and vest with respect to one-twelfth of the total number of shares subject to the options on a quarterly basis (every three third three 10 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 Years) Outstanding at January 1, 2022 68 $ 487.00 Granted 18 49.50 Forfeited or expired (8 ) 551.50 Outstanding at December 31, 2022 78 $ 381.00 7.6 Vested and exercisable at December 31, 2022 48 $ 510.00 7.0 Vested and expected to vest at December 31, 2022 74 $ 382.00 7.6 (in thousands, except for weighted-average data) Restricted Stock Units Shares Weighted- Average Grant Date Fair Value Outstanding at January 1, 2022 - $ - Awarded 12 49.50 Cancelled (1 ) 51.00 Outstanding at December 31, 2022 11 $ 49.50 Vested and exercisable at December 31, 2022 - $ - Vested and expected to vest at December 31, 2022 11 $ 49.50 Based upon application of the Black-Scholes option-pricing formula described below, the weighted-average grant-date fair value of options granted during the years ended December 31, 2022 and 2021 was $42.00 and $201.50 , respectively. The weighted-average grant-date fair value of RSUs granted during the year ended December 31, 2022 was $49.50 . The total intrinsic value of options outstanding, vested, and exercisable as of December 31, 2022 are each $0 . Stock-Based Compensation We recognized stock-based compensation expense in accordance with ASC Topic 718 of $3.1 million and $7.2 million, respectively, for each of the years ended December 31, 2022 and 2021 . Stock-based compensation expense was classified as follows: Year Ended December 31, (in thousands) 2022 2021 Research and development $ 807 $ 2,940 General and administrative 2,279 4,298 Total $ 3,086 $ 7,238 The fair value of each option award is estimated on the grant date using the Black-Scholes option-pricing formula that uses assumptions noted in the following table. Expected volatilities are based upon the historical volatility of our common stock and other factors. We also use historical data and other factors to estimate option exercises, employee terminations and forfeiture rates. The risk-free interest rates are based upon the U.S. Treasury yield curve in effect at the time of the grant. Year Ended December 31, 2022 2021 Weighted average expected volatility 106 % 104 % Weighted average expected term 6.9 6.7 Weighted average risk-free interest rate 1.70 % 0.49 % Expected dividends - - The total fair value of the underlying shares of the options vested during 2022 and 2021 is $3.8 million and $6.7 million, respectively. As of December 31, 2022 , there was $2.3 million of total unrecognized compensation cost related to non-vested share-based compensation arrangements granted under the 2020 Plan and the 2011 Plan. That cost is expected to be recognized over a weighted-average vesting period of 1.3 years. |
Note 12 - Collaboration, Licens
Note 12 - Collaboration, Licensing and Research Funding Agreements | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Corporate Partnership, Licensing and Research Funding Agreements [Text Block] | Note 12 – Collaboration, Licensing and Research Funding Agreements Collaboration Agreement Battelle Memorial Institute In October 2014, we entered into a Collaboration Agreement with Battelle, or, as amended, the Battelle Collaboration Agreement, for the development of our ADS for use in a potential Phase 3 program. We had previously worked with Battelle, which has expertise in developing and integrating aerosol devices using innovative and advanced technologies, in connection with development of our Phase 2 ADS used in the AEROSURF Phase 2b clinical trial. Under the Battelle Collaboration Agreement, we and Battelle shared the costs of development for a three-stage development plan that included planning, executing the project plan and testing and completing verification and documentation of a new Phase 3 ADS, putting us in a position to manufacture a new Phase 3 ADS for use in the remaining AEROSURF development activities, including a potential Phase 3 clinical program, and, if approved, initial commercial activities. We retained final decision-making authority over all matters related to the design, registration, manufacture, packaging, marketing, distribution and sale of the Phase 3 ADS. We and Battelle shared the costs of the project plan equally. Battelle agreed to bear the cost of any cost overruns associated with the project plan and we agreed to bear the cost of any increase in cost resulting from changes in the scope of the product requirements. We also agreed that, if Battelle successfully completed the project plan in a timely manner, we would pay Battelle royalties equal to a low single-digit percentage of the worldwide net sales and license royalties on sales of AEROSURF for the treatment of RDS in premature infants, up to an initial aggregate limit of $25.0 million, which under a payment restructuring agreement (discussed below), was increased to $35.0 million. The Battelle Collaboration Agreement will end at the time we fulfill our payment obligations to Battelle, unless sooner terminated by a party as provided therein. Pursuant to the A&R License Agreement described below, Licensee has agreed to assume certain of our obligations under the Battelle Collaboration Agreement. Li censing and Research Funding Agreements Lee’s Pharmaceutical (HK) Ltd. Term Sheet and Project Financing Agreement On March 18, 2020, we entered into the Term Sheet with Lee’s (HK) pursuant to which Lee’s (HK) agreed to provide financing to fund the development of AEROSURF for the period April 1, 2020 through September 30, 2020 and make payments of up to $3.9 million (which was reduced to $2.8 million under specified circumstances) prior to September 1, 2020. In August 2020, we entered into a Project Financing Agreement with Lee’s (HK), or the PF Agreement with Lee’s (HK), formalizing the terms of the Term Sheet, and under which we received payments totaling $2.8 million through October 2020. Pursuant to the PF Agreement, Lee’s (HK) agreed to pay additional amounts to be set forth in an updated development budget to be agreed between the parties by September 1, 2020 and updated every six months thereafter, to fund the continued development of AEROSURF and to be paid with the payment schedule to be set forth in each updated development budget. In partial satisfaction of our obligations under the PF Agreement, we agreed to pay Lee’s (HK) 50% of any Commercialization Net Revenues (as defined in the PF Agreement) up to an amount that is equal to 125% of the Project Expenses (as defined in the PF Agreement) funded by Lee’s (HK). On November 12, 2020, Lee’s (HK) provided notice of termination of additional funding under the PF Agreement, and we and Lee’s (HK) revised our plans for the continued development of AEROSURF. Lee’s (HK) agreed to continue the development of AEROSURF in Asia at its own cost. Lee’s (HK) agreed to fund an additional $1.0 million to us in 2021 for certain transition and analytical services to be provided by us with respect to the development of AEROSURF, which will be considered “Project Expenses” under the terms of the PF Agreement. In 2021, we received payments totaling $1.0 million from Lee’s (HK) and no further amounts are due under the PF Agreement. Since the 2018 acquisition of CVie Investments Limited and CVie Therapeutics, istaroxime has become our primary focus for investment and execution due to what we believe represents a greater potential value opportunity for us and our stockholders. Since completing our Phase 2 study of lucinactant (KL4 surfactant) for patients with severe COVID-19 associated ARDS and lung injury in January 2022, in order to preserve resources for the highest priority programs, we have begun to reduce costs not already being performed by our licensee, Lee’s (HK) and Zhaoke, under the terms of our Original License Agreement. These costs include certain reductions in headcount dedicated to KL4 surfactant and the decommissioning of both our analytical and technical support laboratory, which previously conducted release testing of APIs and supportive research for our lyophilized and aerosolized KL4 surfactant, and our medical device development laboratory, which was previously used to conduct development activities and testing for our ADS technologies. To support the future development of our KL4 surfactant platform in markets outside of Asia, including the U.S., we are pursuing one or more licensing transactions. To repay the funds provided under the terms of the PF Agreement, until such time as we have repaid 125% of the amounts funded by Lee’s (HK) for the development of AEROSURF, we will pay to Lee’s (HK) 50% of all revenue amounts and payments received by us for any sale, divestiture, license or other development and/or commercialization of the KL4/AEROSURF patent portfolio, excluding (i) payments for bona fide research and development services; (ii) reimbursement of patent expenses and (iii) all amounts paid to us under the Original License Agreement, minus certain deductions and certain reductions for any payments made by us with respect to third party intellectual property not previously funded by Lee’s (HK). As of December 31, 2022 and 2021 , the liability balance related to the payments under the PF Agreement was $3.8 million and is recorded in other liabilities. We have determined that the Term Sheet and the PF Agreement are within the scope of ASC 730-20, Research and Development Arrangements We have determined that the appropriate accounting treatment under ASC 730-20 is to record the proceeds received from Lee’s (HK) as cash and cash equivalents, as we have the ability to direct the usage of funds, and a long-term liability on our consolidated balance sheet when received. The liability will remain on the balance sheet until we repay such amounts as a result of any revenues and payments received by us for any sale, divestiture, license or other development and/or commercialization of the KL4/AEROSURF patent portfolio. We have also determined that the Term Sheet and the PF Agreement are not in their entirety a derivative under the scope of ASC 815, due to the scope exception under ASC 815-10-15-59, nor are there any embedded derivatives that require separate accounting. A&R License Agreement Previously, we were developing our KL4 surfactant platform, including AEROSURF (lucinactant for inhalation), to address a range of serious respiratory conditions in children and adults. In order to focus our resources on the development of our istaroxime pipeline, we suspended all internal AEROSURF clinical activities in November 2020, and, in January 2022 we began to reduce all other costs related to the KL4 surfactant platform that were not already being performed by our licensee, Lee’s (HK) and Zhaoke, under the terms of the Original License Agreement. On August 17, 2022, we entered into the A&R License Agreement, with Lee’s (HK) and Zhaoke effective as of August 9, 2022. We refer to Zhaoke and Lee’s (HK) together as the “Licensee.” The A&R License Agreement amends, restates, and supersedes the Original License Agreement. The Original License Agreement previously granted Lee’s (HK) an exclusive license to develop, market and sell non-aerosolized KL4 surfactant for the treatment of human diseases and aerosolized KL4 surfactant (including AEROSURF®, our investigative combination drug/device product) for the treatment of human respiratory diseases, in each case in Greater China, Japan, South Korea and certain other Southeast Asia countries. Under the A&R License Agreement, we granted to Licensee an exclusive license, with a right to sublicense, to develop, register, make, use, sell, offer for sale, import, distribute, and otherwise commercialize our KL4 surfactant products, including SURFAXIN®, the lyophilized dosage form of SURFAXIN, and aerosolized KL4 surfactant, in each case for the prevention, mitigation and/or treatment of any respiratory disease, disorder, or condition in humans worldwide, except for Andorra, Greece, and Italy (including the Republic of San Marino and Vatican City), Portugal, and Spain, or the Licensed Territory, which countries are currently exclusively licensed to Esteve. If and when the exclusive license granted to Esteve terminates as to any country, such country automatically becomes part of the Licensed Territory of Licensee. Under the Original License Agreement, Lee’s (HK) previously made an upfront payment to us of $1.0 million. Pursuant to the terms of the A&R License Agreement, we may also receive up to $78.9 million in potential clinical, regulatory and commercial milestone payments. We are also entitled to receive a low double-digit percentage of Licensee’s non-royalty sublicense income. We are also eligible to receive tiered royalties based on a percentage of Net Sales (as defined in the A&R License Agreement) that ranges from low single digit to low teen percentages, depending on the product. Royalties are payable on a product-by-product and country-by-country basis until the latest of (i) the expiration of the last valid patent claim covering the product in the country of sale, (ii) the expiration or revocation of any applicable regulatory exclusivity in the country of sale, and (iii) ten years after the first commercial sale of the product in the country of sale. Thereafter, in consideration of licensed rights other than patent rights, royalties shall continue for the commercial life of each product but at substantially reduced rates. In addition, the royalty rates are subject to reduction by as much as 50% in a given country based on generic competition in such country. The A&R License Agreement is considered to be a contract modification in accordance with ASC Topic 606. No additional performance obligations were identified in the contract modification, and no future material performance obligations are due. All revenue related to the $1.0 million upfront payment under the Original License Agreement was appropriately recognized as of the second quarter of 2019. Regulatory and commercialization milestones under the A&R License Agreement were excluded from the transaction price, as all milestone amounts were fully constrained under the guidance. Consideration related to sales-based milestones and royalties under the A&R License Agreement will be recognized when the related sales occur, provided that the reported sales are reliably measurable and that we have no remaining performance obligations, as such sales were determined to relate predominantly to the license granted to Licensee and therefore have also been excluded from the transaction price. We will re-evaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur. Under the A&R License Agreement, Licensee will be solely and exclusively responsible for all costs and activities related to the development, manufacturing, regulatory approval and commercialization of licensed products in the Licensed Territory including all royalties payable in respect of third-party intellectual property rights sublicensed by us to Licensee and all intellectual property prosecution, maintenance and defense activities and costs. Licensee may sublicense certain activities under the A&R License Agreement to an affiliate of Licensee but may not grant sublicenses to unaffiliated third parties without our prior consent and, if the proposed sublicense will cover the U.S., without first complying with rights of first offer and rights to match granted to us under the A&R License Agreement. A sublicensee and a subcontractor may not be a competitor identified by us. Sublicenses under the A&R License Agreement do not include the right to further sublicense. The term of the A&R License Agreement will continue on a country-by-country basis for the commercial life of the products. Either party may terminate the A&R License Agreement in the event of bankruptcy or a material breach of the A&R License Agreement by the other party that remains uncured for a period of sixty (60) days (or within 30 days after delivery of a Default Notice (as defined in the A&R License Agreement) if such material breach is solely based on the breaching party’s failure to pay amount due under the A&R License Agreement). At any time after the second anniversary of the A&R License Agreement, Licensee may terminate the A&R License Agreement in its entirety or on a product-by-product basis. In addition, either party may terminate the A&R License Agreement with respect to any individual product in a country if a regulatory authority in such country terminates, suspends or discontinues development of such product and such termination, suspension or discontinuance persists for a period in excess of eighteen (18) months. Upon termination of the A&R License Agreement in its entirety or with respect to a particular product or country, generally all related rights and licenses granted to Licensee will terminate, all rights under our technology will revert to us, and Licensee will cease all use of our technology, in each case in relation to the terminated product(s) and country(ies), as applicable. Philip Morris USA Inc. and Philip Morris Products S.A. Under license agreements with Philip Morris USA Inc., or PMUSA, and Philip Morris Products S.A., or PMPSA, we hold exclusive worldwide licenses to the ADS technology for use with pulmonary surfactants (alone or in combination with any other pharmaceutical compound(s)) for all respiratory diseases and conditions (the foregoing uses in each territory, the Exclusive Field), and an exclusive license in the U.S. for use with certain non-surfactant drugs to treat specified respiratory indications in humans in designated hospital settings. The license agreements with PMUSA and PMPSA provide for payment of royalties at a rate equal to a low single-digit percent of sales of products sold in the Exclusive Field (as defined in the license agreements) in the territories, including sales of aerosol devices that are not based on the ADS technology (unless we exercise our right to terminate the license with respect to a specific indication). While there is no legal obligation under the agreements to make minimum royalty payments, in the event we do not make quarterly minimum royalty payments, PMUSA and PMPSA can terminate the agreements. In making such payments, we are entitled to a reduction of future royalties in an amount equal to the excess of any minimum royalty paid over royalties actually earned in prior periods. Pursuant to the A&R License Agreement described above, Licensee has agreed to assume certain of our obligations under our license agreement with PMUSA and PMPSA. Johnson & Johnson and Ortho Pharmaceutical Corporation We, Johnson & Johnson, or J&J, and its wholly owned subsidiary, Ortho Pharmaceutical Corporation, are parties to a license agreement granting to us an exclusive worldwide license to the J&J KL4 surfactant technology. Under the license agreement, we are obligated to pay fees of up to $2.5 million in the aggregate upon our achievement of certain milestones, primarily upon receipt of marketing regulatory approvals for certain designated products. We have paid $1.0 million to date for milestones that have been achieved. In addition, the license agreement requires that we make royalty payments at different rates, depending upon type of revenue and country, in amounts in the range of a high single-digit percent of net sales (as defined in the license agreement) of licensed products sold by us or sublicensees, or, if greater, a percentage of royalty income from sublicensees in the low double digits. Pursuant to the A&R License Agreement described above, Licensee has agreed to assume certain of our obligations under our license agreement with J&J. Laboratorios del Dr. Esteve, S.A. We have a strategic alliance with Esteve for the development, marketing and sales of a broad portfolio of potential KL4 surfactant products in Andorra, Greece, and Italy (including the Republic of San Marino and Vatican City) Portugal, and Spain, or, collectively, the Territory. Antonio Esteve, Ph.D., a principal of Esteve, served as a member of our Board of Directors from May 2002 until January 2013. Under the alliance, Esteve will pay us a transfer price on sales of our KL4 surfactant products. We are responsible for the manufacture and supply of all of the covered products and Esteve will be responsible for all sales and marketing in the Territory. Esteve is obligated to make stipulated cash payments to us upon our achievement of certain milestones, primarily upon receipt of marketing regulatory approvals for the covered products. In addition, Esteve has agreed to contribute to Phase 3 clinical trials for the covered products by conducting and funding development performed in the Territory. As part of a 2004 restructuring, Esteve returned certain rights to us in certain territories, or the Former Esteve Territories, and we agreed to pay Esteve 10% of any cash up front and milestone fees (up to a maximum aggregate of $20.0 million) that we receive in connection with any strategic collaborations for the development and/or commercialization of certain of our KL4 surfactant products in the Former Esteve Territories. Universita degli Studi di Milano-Bicocca Effective April 13, 2015, CVie Therapeutics, entered into an Agreement for Scientific Collaboration with the Universita degli Studi di Milano-Bicocca, or Bicocca, in Milan, Italy, focused on defining the role of SERCA2a and phospholamban, or PLN, in modulating cardiac contraction, and discovering new small molecules to modulate SERCA2a activity or new drugs for treating chronic and acute human heart failure. The term of the collaboration agreement would have expired after three years but was extended for approximately an additional year, with option for further renewal. Under the collaboration agreement, intellectual property resulting from the collaboration, including patents and know-how, will be jointly owned by the parties. For the development of any new SERCA2a compounds and diagnostic products suitable for further clinical development, we have the option to purchase Bicocca’s interest for up to 12 months after the filing of a patent application. If the option is not exercised, then the parties shall remain joint owners and each can use the intellectual property with consent of the other on terms to be defined. If we exercise an option, we have agreed to pay Bicocca (corresponding to stage of development): (i) € 0.1 million upon completion and the proof of concept of biological efficacy for new compounds modulating the SERCA2a activity caused by PLN mutations; and (ii) € 1.5 million upon obtaining marketing authorization in the U.S., EU, or China of new compounds with the corresponding companion diagnostic assay. We have also agreed to pay royalties for any purchased intellectual property arising out of the collaboration in the range of a low- to mid-single digit percent of net sales for any products sold in any country for a period of ten years from the date of the first commercial sale. On March 19, 2021, we entered into an Agreement for Scientific Collaboration, or the New SERCA2a Agreement, with Bicocca, which extends our collaboration. The New SERCA2a Agreement amends and restates the recently expired terms of the prior collaboration agreement. Under the New SERCA2a Agreement, we will provide Bicocca with approximately € 0.2 million for research activities and to cover laboratory space and operation costs. Results obtained from the collaboration will be jointly owned by the parties. However, Bicocca will assign to us its interest in patent applications and patents covering any new SERCA2a compounds and diagnostic products suitable for further clinical development. We have agreed to pay Bicocca (corresponding to stage of development): (i) € 25,000 for execution of an assignment to us of Bicocca’s interest in the patent at issue, (ii) € 75,000 for new SERCA2a compounds developed up to Phase 1 studies in humans upon the completion and availability of the proof of concept of biological efficacy of new compounds on modulating the SERCA2a activity in cell-free systems, or its functional counterpart in isolated cells and (iii) € 1.5 million upon obtaining marketing authorization in the U.S., EU, or China of new compounds with the corresponding companion diagnostic assay. We have also agreed to pay royalties on products generated from the collaboration in the range of a fraction of a single digit to a low single digit percent of net sales for any products sold in any country for a period of ten years from the date of the first commercial sale or until the expiry of patent(s) covering the products. In connection with our research activities, Bicocca agreed to provide us exclusive use of a research laboratory for the collaboration, and nonexclusive access to a physiology laboratory within the university. Bicocca served as our primary location in Milan, Italy. Our agreement with Universita Degli Studi di Milano-Bicocca, the institution that has performed many preclinical studies with istaroxime and our preclinical families of compounds, expired on July 31, 2022. If additional preclinical work is required for any reason, we will need to re-engage with Bicocca or find another vendor to provide those services. |
Note 13 - Related Party Transac
Note 13 - Related Party Transactions | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Related Party Transactions Disclosure [Text Block] | Note 13 – Related Party Transactions Lee’s Holdings As of December 31, 2022 and 2021 , Lee’s Holdings’ beneficial ownership of our issued and outstanding shares of common stock was 13% and 17% , respectively. We entered into the following transactions with Lee’s Holdings during 2022 and 2021 : ● On August 17, 2022, we entered into the A&R License Agreement, with Lee’s (HK) and Zhaoke, effective as of August 9, 2022. We may receive up to $78.9 million in potential clinical, regulatory, and commercial milestone payments under the A&R License Agreement. We are also entitled to receive a low double-digit percentage of Licensee’s non-royalty sublicense income (See the section titled, “ Note 12 – Collaboration, Licensing and Research Funding Agreements – Lee’s Pharmaceutical (HK) Ltd.)”); ● In March 2020, we entered into the Term Sheet, with Lee’s (HK), pursuant to which Lee’s (HK) had agreed to provide financing for the development of AEROSURF. In August 2020, we entered into the PF Agreement with Lee’s (HK), formalizing the terms of the Term Sheet, under which we received payments of $1.0 million in 2021. As of December 31, 2022 and 2021 , the liability balance related to the payments under the PF Agreement was $3.8 million and is recorded in other liabilities. The liability will remain on the balance sheet until we repay such amounts as a result of any revenues and payments received by us for any sale, divestiture, license or other development and/or commercialization of the KL4/AEROSURF patent portfolio. No December 31, 2022 (See the section titled, “ Note 12 – Collaboration, Licensing and Research Funding Agreements – Lee’s Pharmaceutical (HK) Ltd.)”); ● During 2022, we incurred $0.4 million in research and development expenses for services provided by an affiliate of Lee’s Holdings, $0.3 million of which is in accrued expenses as of December 31, 2022; and ● On December 31, 2021, we entered into a Master Manufacturing and Supply Agreement with an affiliate of Lee’s Holdings for the manufacture of our istaroxime drug product candidate. Panacea Venture Management Company Ltd. As of December 31, 2022 and 2021 , Panacea Venture Management Company Ltd.’s, or Panacea’s, beneficial ownership of our issued and outstanding shares of common stock was 9% and 8% , respectively. James Huang, who in connection with the CVie Acquisition in December 2018 was appointed as a director and Chairman of our Board, is a founding and Managing Partner to Panacea. |
Note 14 - Litigation
Note 14 - Litigation | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Legal Matters and Contingencies [Text Block] | Note 14 – Litigation We are not aware of any pending or threatened legal actions that would, if determined adversely to us, have a material adverse effect on our business and operations. We have from time to time been involved in disputes and proceedings arising in the ordinary course of business, including in connection with the conduct of our clinical trials. In addition, as a public company, we are also potentially susceptible to litigation, such as claims asserting violations of securities laws. Any such claims, with or without merit, if not resolved, could be time-consuming and result in costly litigation. There can be no assurance that an adverse result in any future proceeding would not have a potentially material adverse effect on our business, results of operations and financial condition. |
Note 15 - Income Taxes
Note 15 - Income Taxes | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Income Tax Disclosure [Text Block] | Note 15 – Income Taxes The components of the benefit for income taxes for the years ended December 31, 2022 and 2021 is as follows: December 31, (in thousands) 2022 2021 Deferred expense (benefit): Foreign $ (1,367 ) $ (9,987 ) Total deferred expense (benefit) (1,367 ) (9,987 ) Total income tax expense (benefit) $ (1,367 ) $ (9,987 ) For the years ended December 31, 2022 and 2021 , we recorded a deferred income tax benefit of $1.4 million and $10.0 million, respectively The reconciliation of the income tax benefit computed at the federal statutory rates to our recorded tax benefit for the years ended December 31, 2022 and 2021 is as follows: December 31, (in thousands) 2022 2021 Income tax benefit, statutory rates $ (8,521 ) $ (16,301 ) State taxes on income, net of federal benefit 903 (1,390 ) Net operating loss expirations 3,485 2,184 Intangibles 2,561 - Research and development tax credit 825 94 Foreign rate differential 196 462 Employee related and other 467 (186 ) Other (17 ) - Income tax expense / (benefit), statutory rates (101 ) (15,137 ) Valuation allowance (1,266 ) 5,150 Income tax benefit, net $ (1,367 ) $ (9,987 ) The tax effects of temporary differences that give rise to deferred tax assets and deferred tax liabilities as of December 31, 2022 and 2021 , are as follows: December 31, (in thousands) 2022 2021 Long-term deferred assets: Net operating loss carryforwards (federal and state) $ 185,591 $ 187,905 Research and development tax credit 17,671 18,538 Compensation expense on stock 4,166 4,568 Other accrued 1,293 2,006 Capitalized R&D expenses 2,369 - Depreciation 191 115 Total long-term deferred tax assets 211,281 213,132 Long-term deferred liabilities: IPR&D (5,061 ) (7,114 ) Total long-term deferred tax liabilities (5,061 ) (7,114 ) Valuation allowance (211,281 ) (213,132 ) Deferred tax liabilities, net $ (5,061 ) $ (7,114 ) We are in a net deferred tax liability position as of December 31, 2022 and 2021 . Because we have never realized a profit, management has fully reserved the net deferred tax asset since realization is not assured. It is our policy to classify interest and penalties recognized on uncertain tax positions as a component of income tax expense. There was neither interest nor penalties accrued as of December 31, 2022 and 2021 , nor were any incurred in 2022 or 2021 . At December 31, 2022 and 2021 , we had available carryforward net operating losses for federal tax purposes of $637.4 million and $644.6 million, respectively, research and development tax credit carryforward of $17.0 million and $17.4 million, respectively and orphan drug tax credit carryforwards of $0.6 million and $1.1 million, respectively. Of the of $637.4 million of federal net operating loss carryforwards, $90.2 million can be carried forward indefinitely. The remaining Federal net operating loss, research and development tax credit carryforwards and orphan drug credit carryforward will continue to expire through 2042 . At December 31, 2022 and 2021 , we had available carryforward losses of approximately $593.3 million and $598.9 million, respectively, for state tax purposes. Of the $593.3 million state tax carryforward losses, $589.7 million is associated with the state of Pennsylvania, with the remainder associated with the other seven ( 7 ) states within which we have established tax nexus. The Tax Cuts and Jobs Act resulted in significant changes to the treatment of research and development, or R&D, expenditures under Internal Revenue Code Section 174. For tax years beginning after December 31, 2021, taxpayers are required to capitalize and amortize all R&D expenditures that are paid or incurred in connection with their trade or business for tax purposes. Specifically, costs for U.S.-based R&D activities must be amortized over five years and costs for foreign R&D activities must be amortized over 15 years, both using a midyear convention. During the year ended December 31, 2022 , we capitalized $6.4 million and $3.9 million of domestic and foreign R&D expenses, respectively. Future realization of the tax benefits of existing temporary differences and net operating loss carryforwards ultimately depends on the existence of sufficient taxable income within the carryforward period. As of December 31, 2022 and 2021 , we performed an evaluation to determine whether a valuation allowance was needed. We considered all available evidence, both positive and negative, which included the results of operations for the current and preceding years. We determined that it was not possible to reasonably quantify future taxable income and determined that it is more likely than not that all of the deferred tax assets will not be realized. Accordingly, we maintained a full valuation allowance as of December 31, 2022 and 2021 . Under Internal Revenue Code Section 382, if a corporation undergoes an “ownership change,” the corporation’s ability to use its pre-change NOL carryforwards and other pre-change tax attributes to offset its post-change income may be limited. We have not completed a study to assess whether an “ownership change” has occurred or whether there have been multiple ownership changes since we became a “loss corporation” as defined in Section 382. Future changes in our stock ownership, which may be outside of our control, may trigger an “ownership change.” In addition, future equity offerings or acquisitions that have equity as a component of the purchase price could result in an “ownership change.” If an “ownership change” has occurred or does occur in the future, utilization of the NOL carryforwards or other tax attributes may be limited, which could potentially result in increased future tax liability to us. Utilization of net operating loss, or NOL, and R&D credit carryforwards may be subject to a substantial annual limitation under Section 382 of the Internal Revenue Code of 1986 due to ownership change limitations that have occurred previously or that could occur in the future. These ownership changes may limit the amount of NOL and R&D credit carryforwards that can be utilized annually to offset future taxable income and tax, respectively. There also could be additional ownership changes in the future, which may result in additional limitations in the utilization of the carryforward NOLs and credits. A full valuation allowance has been provided against our deferred tax assets and, if a future assessment requires an adjustment, an adjustment would be offset by an adjustment to the valuation allowance. Thus, there would be no impact to the consolidated balance sheets or statements of operations if an adjustment were required. |
Note 16 - Leases
Note 16 - Leases | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Lessee, Operating Leases [Text Block] | Note 16 – Leases Our operating leases consist primarily of facility leases for our operations in Warrington, Pennsylvania and Taipei, Taiwan. We maintain our corporate headquarters and operations in Warrington, Pennsylvania. The facility serves as the main operating facility for drug development, regulatory, research and development, and administration. We also maintain offices in Taipei, Taiwan where we perform certain manufacturing development and preclinical activities. In January 2021, we entered into a lease amendment to extend the term of our Warrington, Pennsylvania lease for a period of five Throughout the term of our leases, we are responsible for paying certain variable lease costs, in addition to the rent, as specified in the lease, including a proportionate share of applicable taxes, operating expenses and utilities. The following table contains a summary of the lease costs recognized under ASC 842 and other information pertaining to our operating leases for the years ended December 31, 2022 and 2021 : Year Ended December 31, (in thousands) 2022 2021 Operating lease cost $ 692 $ 857 Variable lease cost 9 45 Total lease cost $ 701 $ 902 Other Information Operating cash flows used for operating leases $ 730 $ 734 Operating lease liabilities arising from obtaining right-of-use assets $ - $ 2,141 Weighted average remaining lease term (in years) 4.1 4.8 Weighted average incremental borrowing rate 7.08 % 7.12 % Future minimum lease payments under our non-cancelable operating leases as of December 31, 2022 , are as follows: (in thousands) December 31, 2022 2023 $ 529 2024 560 2025 570 2026 581 2027 97 Thereafter - Total lease payments 2,337 Less imputed interest (309 ) Total operating lease liabilities $ 2,028 |
Note 17 - Subsequent Events
Note 17 - Subsequent Events | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Subsequent Events [Text Block] | Note 17 – Subsequent Events January 2023 Warrant Exercise Inducement Offer Letters On January 20, 2023, we entered into warrant exercise inducement offer letters, with certain holders of certain of our: (i) warrants issued in December 2019 to purchase 1,573 shares of common stock with an exercise price of $604.50 per share; (ii) warrants issued in May 2020 to purchase 5,598 shares of common stock with an exercise price of $398.75 per share, and (iii) warrants issued in March 2021 to purchase 89,001 shares of common stock with an exercise price of $180.00 per share (collectively, the January 2023 Existing Warrants). Pursuant to the terms of the inducement letters, we agreed to amend the January 2023 Existing Warrants by lowering the exercise price of the January 2023 Existing Warrants to $10.00 per share. Additionally, the exercising holders agreed to exercise for cash all of their January 2023 Existing Warrants to purchase an aggregate of 96,172 shares of common stock in exchange for our agreement to issue to such exercising holders new warrants, or the January 2023 New Warrants, to purchase up to an aggregate of 192,344 shares of common stock. We received aggregate gross proceeds of approximately $1.0 million from the exercise of the January 2023 Existing Warrants by the exercising holders. Each January 2023 New Warrant is exercisable into shares of common stock at a price per share of $10.76, will initially be exercisable six months following its date of issuance, or the January 2023 Initial Exercise Date, and will expire on the fifth We engaged Ladenburg as our exclusive placement agent in connection with these transactions and paid Ladenburg a fee equal to 8% of its gross proceeds from the exercise of the January 2023 Existing Warrants. We also paid Ladenburg a management fee equal to 1% of the gross proceeds from the exercise of the January 2023 Existing Warrants. We also agreed to file a registration statement covering the resale of the shares of common stock underlying the January 2023 New Warrants no later than 90 calendar days following the date of the inducement letter. February 2023 Warrant Exercise Inducement Offer Letter On February 21, 2023, we entered into a warrant exercise inducement offer letter wit of certain of our: (i) warrants issued in July 2018 to purchase 1,250 shares of common stock with an exercise price of $600.00 per share; (ii) warrants issued in December 2018 to purchase 9,960 shares of common stock with an exercise price of $607.50 per share; (iii) warrants issued in December 2019 to purchase 5,519 shares of common stock with an exercise price of $604.50 per share; and (iv) warrants issued in May 2020 to purchase 5,517 shares of common stock with an exercise price of $398.75 per share (collectively, the February 2023 Existing Warrants. Pursuant to the terms of the inducement letter, we agreed to amend the February 2023 Existing Warrants by lowering the exercise price of the February 2023 Existing Warrants to $7.06 per share. Additionally, the exercising holder agreed to exercise for cash all of their February 2023 Existing Warrants to purchase an aggregate of 22,246 shares of common stock in exchange for our agreement to issue to such exercising holder new warrants, or the February 2023 New Warrants, to purchase up to an aggregate of 44,492 shares of common stock. We received aggregate gross proceeds of approximately $157,000 from the exercise of the February 2023 Existing Warrants by the exercising holders. Each February 2023 New Warrant is exercisable into shares of common stock at a price per share of $10.76, will initially be exercisable six months following its date of issuance, or the February 2023 Initial Exercise Date, and will expire on the fifth We engaged Ladenburg as our exclusive placement agent in connection with these transactions and paid Ladenburg a fee equal to 8% of its gross proceeds from the exercise of the February 2023 Existing Warrants. We also paid Ladenburg a management fee equal to 1% of the gross proceeds from the exercise of the February 2023 Existing Warrants. We also agreed to file a registration statement covering the resale of the shares of common stock underlying the February 2023 New Warrants no later than 90 calendar days following the date of the inducement letter. |
Significant Accounting Policies
Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Consolidation, Policy [Policy Text Block] | Principles of Consolidation The consolidated financial statements are prepared in accordance with US GAAP and include accounts of Windtree Therapeutics, Inc. and our wholly owned subsidiary, CVie Investments Limited and its wholly owned subsidiary, CVie Therapeutics Limited, or CVie Therapeutics, and a presently inactive subsidiary, Discovery Laboratories, Inc. (formerly known as Acute Therapeutics, Inc.). |
Goodwill and Intangible Assets, Policy [Policy Text Block] | Intangible Assets and Goodwill We record acquired intangible assets and goodwill based on estimated fair value. The identifiable intangible assets resulting from the CVie Therapeutics acquisition in December 2018 relate to in-process research and development, or IPR&D, of istaroxime and rostafuroxin. The IPR&D assets are considered indefinite-lived intangible assets until completion or abandonment of the associated research and development efforts. IPR&D is not amortized but reviewed for impairment at least annually, or when events or changes in the business environment indicate the carrying value may be impaired. When testing our indefinite-lived intangible assets and goodwill for impairment, we can elect to perform a qualitative assessment to determine if it is more likely than not that the fair values of our indefinite-lived intangible assets and our reporting unit are less than their respective carrying values. Such qualitative factors can include, among others, industry and market conditions, overall financial performance, and relevant entity-specific events. If we conclude based on our qualitative assessment that it is more likely than not that the fair value of our indefinite-lived intangible assets or reporting unit are less than their respective carrying values, we perform a quantitative assessment. When conducting our annual impairment test of indefinite-lived intangible assets and goodwill as of December 1, 2022 , we elected to perform a quantitative assessment. When performing the quantitative impairment assessment for our indefinite-lived IPR&D intangible assets, we estimate the fair values of the assets using the multi-period excess earnings method, or MPEEM. MPEEM is a variation of the income approach which estimates the fair value of an intangible asset based on the present value of the incremental after-tax cash flows attributable to the intangible asset. Significant factors considered in the calculation of IPR&D intangible assets include the risks inherent in the development process, including the likelihood of achieving commercial success and the cost and related time to complete the remaining development. Future cash flows for each project were estimated based on forecasted revenue and costs, taking into account the expected product life cycles, market penetration, and growth rates. Other significant estimates and assumptions inherent in this approach include (i) the amount and timing of the projected net cash flows associated with the IPR&D assets, (ii) the discount rate, which seeks to reflect the various risks inherent in the projected cash flows; and (iii) the tax rate, which considers geographic diversity of the projected cash flows. While we use the best available information to prepare our cash flows and discount rate assumptions, actual future cash flows could differ significantly based on the commercial success of the related drug candidates and market conditions which could result in future impairment charges related to our indefinite-lived intangible asset balances. During 2021, we concluded an initial process to test the industry’s interest in investing in our rostafuroxin drug candidate and were not able to secure a licensing transaction or other strategic opportunity at that time. Based on feedback received from potential licensing partners, we have determined that there is a need for an additional Phase 2 clinical trial. Due to these developments, we recorded a loss on impairment of intangible assets of $37.8 million during the second quarter of 2021. Further, in connection with our annual quantitative impairment assessment of indefinite-lived IPR&D intangible assets as of December 1, 2021, we reassessed certain assumptions related to our rostafuroxin drug candidate due to the current macroeconomic conditions which have made it harder to secure the funding needed to conduct the additional Phase 2 clinical trial and had therefore delayed our intended development of rostafuroxin. As a result, we recorded an additional loss on impairment of intangible assets of $7.2 million in the fourth quarter of 2021. When combined with the loss on impairment of intangible assets recorded during the second quarter, we recorded a loss on impairment of intangible assets totaling $45.0 million within operating expenses in our consolidated statements of operations during the year ended December 31, 2021. As part of our annual quantitative impairment assessment of indefinite-lived IPR&D intangible assets as of December 1, 2022, we again reassessed certain assumptions related to our rostafuroxin drug candidate due to the continued difficulties in current macroeconomic conditions which have continued to make it more challenging to secure the funding needed to conduct the additional Phase 2 clinical trial and have therefore further delayed our intended development of rostafuroxin. As a result, we concluded that the fair value of the IPR&D related to our rostafuroxin drug candidate was less than its carrying value. We estimated the fair value of the asset using MPEEM and determined that the fair value as of December 1, 2022 was approximately $2.9 $6.8 Goodwill represents the excess of the purchase price over the fair value of assets acquired and liabilities assumed in a business combination and is not amortized. It is reviewed for impairment at least annually or when events or changes in the business environment indicate that its carrying value may be impaired. Our company consists of one In accordance with applicable accounting standards, we are required to review intangible assets and goodwill for impairment on an annual basis, or more frequently where there is an indication of impairment. Throughout the year, we consider whether any events or changes in the business environment have occurred which indicate that goodwill may be impaired. For example, a significant decline in the closing share price of our common stock and market capitalization may suggest that the fair value of our reporting unit has fallen below its carrying value, indicating that an interim goodwill impairment test is required. Accordingly, we monitor changes in our share price during interim periods between annual impairment tests and consider overall stock market conditions, the underlying reasons for the decline in our share price, the significance of the decline, and the duration of time that our securities have been trading at a lower value. We have experienced a declining trend in the closing share price of our common stock, on a split-adjusted basis, following the announcement in April 2022 of positive topline results in our Phase 2 global clinical study of istaroxime for the treatment of early cardiogenic shock. During each of the second and third quarters of 2022, the continued declining trend in the closing share price of our common stock, on a split-adjusted basis, suggested that the fair value of our reporting unit was more likely than not less than its carrying value. As a result, in each quarter we performed the required interim goodwill impairment test consistent with the methodology described above. Based on the quantitative tests performed, we recorded losses on impairment of goodwill of $11.6 million and $0.5 million, respectively, in the second and third quarters of 2022. We performed our annual goodwill quantitative test as of December 1, 2022 and determined that the fair value of our reporting unit was more likely than not less than its carrying value. As a result, we recorded a loss on impairment of goodwill of $0.5 million in the fourth quarter of 2022. When combined with the losses on impairment of goodwill recorded during the second and third quarters of 2022, we recorded a loss on impairment of intangible assets totaling $12.6 million within operating expenses in our consolidated statements of operations during the year ended December 31, 2022. The closing share price of our common stock, on a split-adjusted basis, has continued to decline subsequent to the end of 2022. If our share price continues to decline, we may be at risk for future impairment to goodwill in the near term. The following table represents identifiable intangible assets and goodwill as of : December 31, (in thousands) 2022 2021 Istaroxime drug candidate $ 22,340 $ 22,340 Rostafuroxin drug candidate 2,910 9,730 Intangible assets 25,250 32,070 Goodwill $ 3,058 $ 15,682 |
Foreign Currency Transactions and Translations Policy [Policy Text Block] | Foreign Currency Transactions The functional currency for our foreign subsidiaries is the US Dollar. We remeasure monetary assets and liabilities that are not denominated in the functional currency at exchange rates in effect at the end of each period. Gains and losses from the remeasurement of foreign currency transactions are recognized in . Foreign currency transactions resulted in of approximately million and of million, respectively, for the years ended . |
Use of Estimates, Policy [Policy Text Block] | Use of Estimates The preparation of financial statements in conformity with US GAAP 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. |
Cash and Cash Equivalents, Policy [Policy Text Block] | Cash and Cash Equivalents Cash and cash equivalents are held at domestic and foreign financial institutions and consist of liquid investments and money market funds that are readily convertible into cash. |
Concentration Risk, Credit Risk, Policy [Policy Text Block] | Concentration of Credit Risk Financial instruments, which potentially subject us to credit risk, consist principally of cash and cash equivalents. All cash and cash equivalents are held in U.S. financial institutions and money market funds. At times, we may maintain cash balances in excess of the federally insured amount of $250,000 per depositor, per insured bank, for each account ownership category. Although we currently believe that the financial institutions with whom we do business will be able to fulfill their commitments to us, there is no assurance that those institutions will be able to continue to do so. We have not experienced any credit losses associated with our balances in such accounts for the years ended December 31, 2022 and 2021 . |
Fair Value of Financial Instruments, Policy [Policy Text Block] | Fair Value of Financial Instruments Our financial instruments consist principally of cash and cash equivalents and restricted cash. The fair values of our cash equivalents are based on quoted market prices. The carrying value of cash equivalents is equal to their respective fair values at December 31, 2022 and 2021 , respectively. Accounts payable and accrued expenses are carried at cost, which approximates fair value because of their short maturity. The carrying value of loans payable (including current installments) approximates fair value based on a comparison of interest rates on the loan to current market rates considering our credit risk. |
Property, Plant and Equipment, Policy [Policy Text Block] | Property and Equipment Property and equipment are recorded at cost and depreciated using the straight-line method over the estimated useful lives of the assets (generally three ten |
Cash and Cash Equivalents, Restricted Cash and Cash Equivalents, Policy [Policy Text Block] | Restricted Cash Restricted cash consists principally of a $140,000 certificate of deposit held by our bank as collateral for a letter of credit in the same notional amount held by our landlord to secure our obligations under our lease agreement dated May 26, 2004 for our headquarters location in Warrington, Pennsylvania and $14,000 in deposits held by our landlord for our offices in Taipei, Taiwan. |
Lessee, Leases [Policy Text Block] | Leases Leases are accounted for under Financial Accounting Standards Board, or FASB, Accounting Standards Codification, or ASC, Topic 842, Leases Operating lease liabilities and their corresponding operating lease right-of-use assets are recorded based on the present value of lease payments over the expected remaining lease term. Certain adjustments to the right-of-use asset may be required for items such as incentives received. The interest rate implicit in our leases is typically not readily determinable. As a result, we utilize our incremental borrowing rate, which reflects the fixed rate at which we could borrow on a collateralized basis the amount of the lease payments in the same currency, for a similar term, in a similar economic environment. At the inception of a contract, we assess whether the contract is, or contains, a lease. The assessment is based on: (i) whether the contract involves the use of a distinct identified asset, (ii) whether we obtain the right to substantially all the economic benefit from the use of the asset throughout the period, and (iii) whether we have the right to direct the use of the asset. We evaluate the classification of our leases as either finance leases or operating leases. A lease is classified as a finance lease if any one of the following criteria are met: the lease transfers ownership of the asset by the end of the lease term, the lease contains an option to purchase the asset that is reasonably certain to be exercised, the lease term is for a major part of the remaining useful life of the asset, the present value of the lease payments equals or exceeds substantially all of the fair value of the asset, or the leased asset is of such a specialized nature that it is expected to have no alternative use to the lessor at the end of the lease. A lease is classified as an operating lease if it does not meet any of these criteria. Currently, all of our leases are classified as operating leases. Lease cost for our operating leases is recognized on a straight-line basis over the lease term. Included in lease cost are any variable lease payments incurred in the period that are not included in the initial lease liability and lease payments incurred in the period for any leases with an initial term of 12 months or less. |
Impairment or Disposal of Long-Lived Assets, Policy [Policy Text Block] | Long-lived Assets Our long-lived assets, primarily consisting of property and equipment, are reviewed for impairment when events or changes in circumstances indicate that the carrying value of an asset may not be recoverable, or its estimated useful life has changed significantly. When the undiscounted cash flows of an asset are less than its carrying value, an impairment is recorded and the asset is written down to estimated value. No impairment was recorded during the years ended December 31, 2022 and 2021 as management believes there are no circumstances that indicate that the carrying value of the assets will not be recoverable. |
Collaborative Arrangement, Accounting Policy [Policy Text Block] | Collaborative Arrangements We account for collaborative arrangements in accordance with applicable accounting guidance provided in ASC Topic 808, Collaborative Arrangements , Note 12 – Collaboration, Licensing and Research Funding Agreements ”. |
Severance Cost [Policy Text Block] | Severance In January 2022, in order to focus our resources on the development of our istaroxime pipeline, we began to reduce costs related to KL4 surfactant that were not already being performed by our licensee, Lee’s (HK) and its affiliate Zhaoke, under the terms of the Original License Agreement. These costs included certain reductions in headcount dedicated to KL4 surfactant and the decommissioning of both our analytical and technical support laboratory, which previously conducted release testing of active pharmaceutical ingredients, or APIs, and supportive research for our lyophilized and aerosolized KL4 surfactant, and our medical device development laboratory, which was previously used to conduct development activities and testing for our aerosol delivery system technologies. In February 2022, management communicated its commitment to provide severance payments to impacted employees, provided that they remained employed with us through their expected termination dates. The total severance cost for impacted employees was approximately $0.4 million, which was accrued over the service periods of the employees and was paid ratably through September 2022. No further amounts are due as of December 31, 2022. |
Restructured Debt Liability, Contingent Milestone Payment, Policy [Policy Text Block] | Restructured Debt Liability – Contingent Milestone Payment In conjunction with the November 2017 restructuring and retirement of long-term debt (See the section titled , Note 9 – Restructured Debt Liability ”) , we have established a $15.0 million long-term liability for contingent milestone payments potentially due under the Exchange and Termination Agreement dated as of October 27, 2017, or Exchange and Termination Agreement, between ourselves and affiliates of Deerfield Management Company L.P., or Deerfield. The liability has been recorded at full value of the contingent milestones and will continue to be carried at full value until the milestones are achieved and paid or milestones are not achieved and the liability is written off as a gain on debt restructuring. |
Research and Development Expense, Policy [Policy Text Block] | Research and Development We account for research and development expense by the following categories: (a) product development and manufacturing, (b) clinical, medical, and regulatory operations, and (c) direct clinical and preclinical development programs. Research and development expense includes personnel, facilities, manufacturing and quality operations, pharmaceutical development, research, clinical, regulatory, other preclinical and clinical activities and medical affairs. Research and development costs are charged to operations as incurred in accordance with ASC Topic 730, Research and Development |
Share-Based Payment Arrangement [Policy Text Block] | Stock-based Compensation Stock-based compensation is accounted for under the fair value recognition provisions of ASC Topic 718, Stock Compensation , Note 11 – Stock Options and Stock-based Employee Compensation , for a detailed description of our recognition of stock-based compensation expense. The fair value of stock option grants is recognized evenly over the vesting period of the options or over the period between the grant date and the time the option becomes non-forfeitable by the employee, whichever is shorter. |
Derivatives, Policy [Policy Text Block] | Warrant Accounting 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 |
Income Tax, Policy [Policy Text Block] | Income Taxes We account for income taxes in accordance with ASC Topic 740, Accounting for Income Taxes We use a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. Because we have never realized a profit, management has fully reserved the net deferred tax asset since realization is not assured. For the years ended December 31, 2022 and 2021, we recorded a deferred income tax benefit of |
Earnings Per Share, Policy [Policy Text Block] | Net Loss per Common Share Basic net loss per common 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. The number of shares of common stock potentially issuable upon the exercise of certain stock options and warrants was million shares for each of the years ended . As of , all potentially dilutive securities were anti-dilutive and therefore have been excluded from the computation of diluted net loss per common share. We do not have any components of other comprehensive (loss) income. |
Concentration of Suppliers [Policy Text Block] | Concentration of Suppliers We currently obtain the APIs of our drug products from a single supplier. In addition, our drug products are produced at one contract manufacturer. These single source providers also perform various studies as well as quality control release and stability testing and other activities related to our development and manufacturing activities. At the present time these providers are located outside of the U.S. The loss of either the supplier of our APIs or our drug product contract manufacturer could have a material adverse effect on our operations. |
Segment Reporting, Policy [Policy Text Block] | Segment and Geographic Information We currently operate in one operating segment, which is the research and development of products focused on cardiovascular disease. We are managed and operated as one million and goodwill of million, were located outside the U.S. as of . |
Note 4 - Accounting Policies _2
Note 4 - Accounting Policies and Recent Accounting Pronouncements (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Notes Tables | |
Schedule of Intangible Assets and Goodwill [Table Text Block] | December 31, (in thousands) 2022 2021 Istaroxime drug candidate $ 22,340 $ 22,340 Rostafuroxin drug candidate 2,910 9,730 Intangible assets 25,250 32,070 Goodwill $ 3,058 $ 15,682 |
Note 5 - Fair Value Measureme_2
Note 5 - Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Notes Tables | |
Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis [Table Text Block] | Fair Value Fair value measurement using December 31, (in thousands) 2022 Level 1 Level 2 Level 3 Cash equivalents: Money market funds $ 4,212 $ 4,212 $ - $ - Total Assets $ 4,212 $ 4,212 $ - $ - Fair Value Fair value measurement using December 31, (in thousands) 2021 Level 1 Level 2 Level 3 Cash equivalents: Money market funds $ 21,104 $ 21,104 $ - $ - Total Assets $ 21,104 $ 21,104 $ - $ - |
Fair Value Measurements, Nonrecurring [Table Text Block] | Fair Value Fair value measurement using December 31, (in thousands) 2022 Level 1 Level 2 Level 3 Intangible assets: Rostafuroxin drug candidate $ 2,910 $ - $ - $ 2,910 Goodwill $ 3,058 $ - $ - $ 3,058 Fair Value Fair value measurement using December 31, (in thousands) 2021 Level 1 Level 2 Level 3 Intangible assets: Rostafuroxin drug candidate $ 9,730 $ - $ - $ 9,730 |
Note 6 - Property and Equipme_2
Note 6 - Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Notes Tables | |
Property, Plant and Equipment [Table Text Block] | December 31, (in thousands) 2022 2021 Leasehold improvements $ 2,649 $ 2,649 Manufacturing, laboratory & office equipment 881 4,703 Furniture & fixtures 390 390 Subtotal 3,920 7,742 Accumulated depreciation and amortization (3,658 ) (6,731 ) Property and equipment, net $ 262 $ 1,011 |
Note 7 - Accrued Expenses (Tabl
Note 7 - Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Notes Tables | |
Schedule of Accrued Liabilities [Table Text Block] | December 31, (in thousands) 2022 2021 Research and development $ 786 $ 1,500 Professional fees 459 391 Salaries, bonus and benefits 123 1,218 Manufacturing operations 5 46 Other 179 253 Total accrued expenses $ 1,552 $ 3,408 |
Note 10 - Mezzanine Equity an_2
Note 10 - Mezzanine Equity and Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Notes Tables | |
Common Shares Reserved for Future Issuance, Warrants [Table Text Block] | December 31, Expiration (in thousands, except price per share data) 2022 2021 Exercise Price Date Investors - March 2021 financing 185 185 $ 180.00 03/25/26 Service Agreement - 2021 warrants 3 3 $ 412.50 02/09/24 Investors - May 2020 financing 63 63 $ 399.00 05/22/25 Investors - December 2019 financing 29 29 $ 604.50 12/06/24 Investors - AEROSURF 20 20 $ - 02/14/24 Investors - December 2018 financing - long-term 26 26 $ 607.50 12/04/23 Battelle - 2018 payables restructuring agreement (1) 1 1 $ 975.00 12/07/23 Panacea Venture Management Company Ltd. 1 1 $ 600.00 07/02/23 LPH II Investments Limited 1 1 $ 828.00 04/04/25 Investors - February 2017 financing 2 2 $ 4,110.00 02/15/24 Investors - July 2015 financing - 2 $ 29,400.00 07/22/22 Battelle - 2014 collaboration agreement 1 1 $ 210,000.00 10/10/24 Total 332 334 |
Note 11 - Stock Options and S_2
Note 11 - Stock Options and Stock-Based Employee Compensation (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Notes Tables | |
Schedule of Share Based Compensation Arrangement by Stock Options and Restricted Stock Units Outstanding and Available for Future Issuance [Table Text Block] | December 31, (in thousands) 2022 2021 Stock Options and RSUs Outstanding 2020 Plan 50 25 2011 Plan 30 32 Non-Plan 9 11 Total Outstanding 89 68 Available for Future Grants under the 2020 Plan 12 13 |
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 Years) Outstanding at January 1, 2022 68 $ 487.00 Granted 18 49.50 Forfeited or expired (8 ) 551.50 Outstanding at December 31, 2022 78 $ 381.00 7.6 Vested and exercisable at December 31, 2022 48 $ 510.00 7.0 Vested and expected to vest at December 31, 2022 74 $ 382.00 7.6 |
Share-Based Payment Arrangement, Restricted Stock Unit, Activity [Table Text Block] | (in thousands, except for weighted-average data) Restricted Stock Units Shares Weighted- Average Grant Date Fair Value Outstanding at January 1, 2022 - $ - Awarded 12 49.50 Cancelled (1 ) 51.00 Outstanding at December 31, 2022 11 $ 49.50 Vested and exercisable at December 31, 2022 - $ - Vested and expected to vest at December 31, 2022 11 $ 49.50 |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Table Text Block] | Year Ended December 31, (in thousands) 2022 2021 Research and development $ 807 $ 2,940 General and administrative 2,279 4,298 Total $ 3,086 $ 7,238 |
Schedule of Share-Based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | Year Ended December 31, 2022 2021 Weighted average expected volatility 106 % 104 % Weighted average expected term 6.9 6.7 Weighted average risk-free interest rate 1.70 % 0.49 % Expected dividends - - |
Note 15 - Income Taxes (Tables)
Note 15 - Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Notes Tables | |
Schedule of Components of Income Tax Expense (Benefit) [Table Text Block] | December 31, (in thousands) 2022 2021 Deferred expense (benefit): Foreign $ (1,367 ) $ (9,987 ) Total deferred expense (benefit) (1,367 ) (9,987 ) Total income tax expense (benefit) $ (1,367 ) $ (9,987 ) |
Schedule of Effective Income Tax Rate Reconciliation [Table Text Block] | December 31, (in thousands) 2022 2021 Income tax benefit, statutory rates $ (8,521 ) $ (16,301 ) State taxes on income, net of federal benefit 903 (1,390 ) Net operating loss expirations 3,485 2,184 Intangibles 2,561 - Research and development tax credit 825 94 Foreign rate differential 196 462 Employee related and other 467 (186 ) Other (17 ) - Income tax expense / (benefit), statutory rates (101 ) (15,137 ) Valuation allowance (1,266 ) 5,150 Income tax benefit, net $ (1,367 ) $ (9,987 ) |
Schedule of Deferred Tax Assets and Liabilities [Table Text Block] | December 31, (in thousands) 2022 2021 Long-term deferred assets: Net operating loss carryforwards (federal and state) $ 185,591 $ 187,905 Research and development tax credit 17,671 18,538 Compensation expense on stock 4,166 4,568 Other accrued 1,293 2,006 Capitalized R&D expenses 2,369 - Depreciation 191 115 Total long-term deferred tax assets 211,281 213,132 Long-term deferred liabilities: IPR&D (5,061 ) (7,114 ) Total long-term deferred tax liabilities (5,061 ) (7,114 ) Valuation allowance (211,281 ) (213,132 ) Deferred tax liabilities, net $ (5,061 ) $ (7,114 ) |
Note 16 - Leases (Tables)
Note 16 - Leases (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Notes Tables | |
Lease, Cost [Table Text Block] | Year Ended December 31, (in thousands) 2022 2021 Operating lease cost $ 692 $ 857 Variable lease cost 9 45 Total lease cost $ 701 $ 902 Other Information Operating cash flows used for operating leases $ 730 $ 734 Operating lease liabilities arising from obtaining right-of-use assets $ - $ 2,141 Weighted average remaining lease term (in years) 4.1 4.8 Weighted average incremental borrowing rate 7.08 % 7.12 % |
Lessee, Operating Lease, Liability, Maturity [Table Text Block] | (in thousands) December 31, 2022 2023 $ 529 2024 560 2025 570 2026 581 2027 97 Thereafter - Total lease payments 2,337 Less imputed interest (309 ) Total operating lease liabilities $ 2,028 |
Note 1 - The Company and Desc_2
Note 1 - The Company and Description of Business (Details Textual) - USD ($) $ in Millions | 3 Months Ended | 12 Months Ended | |
Aug. 17, 2022 | Jun. 30, 2019 | Dec. 31, 2022 | |
Original Agreement With Lee [Member] | |||
Proceeds for Payments to Develop Product | $ 1 | ||
A&R License Agreement With Lee [Member] | |||
Proceeds for Payments to Develop Product | $ 1 | ||
Maximum Amount May be Received for Potential Milestone Payments | $ 78.9 |
Note 2 - Basis of Presentation
Note 2 - Basis of Presentation (Details Textual) | Feb. 24, 2023 |
Reverse Stock Split [Member] | Subsequent Event [Member] | |
Stockholders' Equity Note, Stock Split, Conversion Ratio | 1 |
Note 3 - Liquidity Risks and _2
Note 3 - Liquidity Risks and Management's Plans (Details Textual) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | ||||||
Dec. 31, 2022 | Sep. 30, 2022 | Jun. 30, 2022 | Dec. 31, 2021 | Jun. 30, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | Sep. 17, 2020 | |
Net Income (Loss) Attributable to Parent, Total | $ (39,208) | $ (67,636) | ||||||
Goodwill, Impairment Loss | $ 500 | $ 500 | $ 11,600 | 12,624 | 0 | |||
Impairment of Intangible Assets (Excluding Goodwill), Total | $ 7,200 | $ 37,800 | 6,820 | 45,020 | ||||
Deferred Income Tax Expense (Benefit), Total | (1,367) | (9,987) | ||||||
Retained Earnings (Accumulated Deficit), Total | (824,532) | (785,324) | (824,532) | $ (785,324) | ||||
Stock Issued During Period, Shares, New Issues (in shares) | 42,339 | |||||||
Stock Issued During Period, Value, New Issues | 4,253 | $ 4,800 | ||||||
Proceeds from Issuance of Common Stock | 4,253 | 4,843 | ||||||
Cash and Cash Equivalents, at Carrying Value, Total | 6,172 | 22,348 | 6,172 | 22,348 | ||||
Liabilities, Current, Total | 2,457 | $ 4,923 | $ 2,457 | 4,923 | ||||
ATM Program [Member] | ||||||||
Shares Authorized to Be Offered and Sold Under Offering Agreement, Value | $ 10,000 | |||||||
Stock Issued During Period, Shares, New Issues (in shares) | 206,824 | |||||||
Stock Issued During Period, Value, New Issues | $ 4,400 | |||||||
Proceeds from Issuance of Common Stock | 4,300 | |||||||
Stock Offering Agreement, Public Float Limitation Amount | $ 75,000 | 75,000 | ||||||
Rostafuroxin Drug Candidate [Member] | ||||||||
Impairment of Intangible Assets (Excluding Goodwill), Total | 6,800 | 45,000 | ||||||
Deferred Income Tax Expense (Benefit), Total | $ (1,400) | $ (10,000) |
Note 4 - Accounting Policies _3
Note 4 - Accounting Policies and Recent Accounting Pronouncements (Details Textual) shares in Millions | 3 Months Ended | 12 Months Ended | ||||||
Dec. 31, 2022 USD ($) | Sep. 30, 2022 USD ($) | Jun. 30, 2022 USD ($) | Dec. 31, 2021 USD ($) | Jun. 30, 2021 USD ($) | Dec. 31, 2022 USD ($) shares | Dec. 31, 2021 USD ($) | Nov. 01, 2017 USD ($) | |
Impairment of Intangible Assets (Excluding Goodwill), Total | $ 7,200,000 | $ 37,800,000 | $ 6,820,000 | $ 45,020,000 | ||||
Indefinite-Lived Intangible Assets (Excluding Goodwill), Fair Value Disclosure | $ 2,900,000 | 2,900,000 | ||||||
Intangible Assets, Net (Excluding Goodwill), Total | 9,700,000 | $ 9,700,000 | ||||||
Number of Reporting Units | 1 | |||||||
Goodwill, Impairment Loss | 500,000 | $ 500,000 | $ 11,600,000 | $ 12,624,000 | 0 | |||
Foreign Currency Transaction Gain, before Tax | 700,000 | |||||||
Foreign Currency Transaction Loss, before Tax | 300,000 | |||||||
Severance Costs | 400,000 | |||||||
Supplemental Unemployment Benefits, Severance Benefits | 0 | 0 | ||||||
Liability for Contingent Milestone Payment, Noncurrent | 15,000,000 | 15,000,000 | 15,000,000 | 15,000,000 | ||||
Deferred Income Tax Expense (Benefit), Total | $ (1,367,000) | (9,987,000) | ||||||
Number of Shares of Common Stock Potentially Issuable upon the Exercise of Stock Options and Warrants (in shares) | shares | 0.4 | |||||||
Number of Operating Segments | 1 | |||||||
Goodwill, Ending Balance | 3,058,000 | $ 15,682,000 | $ 3,058,000 | $ 15,682,000 | ||||
Non-US [Member] | ||||||||
Intangible Assets, Net (Excluding Goodwill), Total | 25,300,000 | 25,300,000 | ||||||
Goodwill, Ending Balance | 3,100,000 | 3,100,000 | ||||||
Deerfield Loan [Member] | Exchange and Termination Agreement [Member] | Deerfield Management, L.P. [Member] | ||||||||
Liability for Contingent Milestone Payment, Noncurrent | $ 15,000,000 | |||||||
Restricted Cash for Headquarters in Warrington, Pennsylvania [Member] | ||||||||
Security Deposit | 140,000 | 140,000 | ||||||
Restricted Cash for Offices in Taipei, Taiwan [Member] | ||||||||
Security Deposit | $ 14,000 | $ 14,000 | ||||||
Minimum [Member] | ||||||||
Property, Plant and Equipment, Useful Life (Year) | 3 years | |||||||
Maximum [Member] | ||||||||
Property, Plant and Equipment, Useful Life (Year) | 10 years |
Note 4 - Summary of Significant
Note 4 - Summary of Significant Accounting Policies - Intangible Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Intangible assets | $ 25,250 | $ 32,070 |
Goodwill, Ending Balance | 3,058 | 15,682 |
Istaroxime Drug Candidate [Member] | ||
Intangible assets | 22,340 | 22,340 |
Rostafuroxin Drug Candidate [Member] | ||
Intangible assets | $ 2,910 | $ 9,730 |
Note 5 - Fair Value Measureme_3
Note 5 - Fair Value Measurements (Details Textual) | Dec. 31, 2022 | Dec. 31, 2021 |
Measurement Input, Discount Rate [Member] | ||
Indefinite Lived Intangible Assets, Measurement Input | 0.200 | 0.190 |
Measurement Input, Tax Rate [Member] | ||
Indefinite Lived Intangible Assets, Measurement Input | 0.300 | 0.300 |
Note 5 - Fair Value Measureme_4
Note 5 - Fair Value Measurements - Assets and Liabilities Measured at Fair Value on a Recurring Basis (Details) - Fair Value, Recurring [Member] - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Total Assets | $ 4,212 | $ 21,104 |
Fair Value, Inputs, Level 1 [Member] | ||
Total Assets | 4,212 | 21,104 |
Money Market Funds [Member] | ||
Cash equivalents | 4,212 | 21,104 |
Money Market Funds [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Cash equivalents | $ 4,212 | $ 21,104 |
Note 5 - Fair Value Measureme_5
Note 5 - Fair Value Measurements - Assets Measured at Fair Value on a Non-recurring Basis (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Indefinite-Lived Intangible Assets (Excluding Goodwill), Fair Value Disclosure | $ 2,900 | |
Fair Value, Nonrecurring [Member] | ||
Goodwill | 3,058 | |
Fair Value, Nonrecurring [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Goodwill | 3,058 | |
Fair Value, Nonrecurring [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Goodwill | 0 | |
Fair Value, Nonrecurring [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Goodwill | 0 | |
Fair Value, Nonrecurring [Member] | Rostafuroxin Drug Candidate [Member] | ||
Indefinite-Lived Intangible Assets (Excluding Goodwill), Fair Value Disclosure | 2,910 | $ 9,730 |
Fair Value, Nonrecurring [Member] | Rostafuroxin Drug Candidate [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Indefinite-Lived Intangible Assets (Excluding Goodwill), Fair Value Disclosure | 2,910 | $ 9,730 |
Fair Value, Nonrecurring [Member] | Rostafuroxin Drug Candidate [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Indefinite-Lived Intangible Assets (Excluding Goodwill), Fair Value Disclosure | 0 | |
Fair Value, Nonrecurring [Member] | Rostafuroxin Drug Candidate [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Indefinite-Lived Intangible Assets (Excluding Goodwill), Fair Value Disclosure | $ 0 |
Note 6 - Property and Equipme_3
Note 6 - Property and Equipment (Details Textual) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Depreciation, Total | $ 400 | $ 533 | $ 192 |
Note 6 - Property and Equipme_4
Note 6 - Property and Equipment - Property and Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Property and equipment, gross | $ 3,920 | $ 7,742 |
Accumulated depreciation and amortization | (3,658) | (6,731) |
Property and equipment, net | 262 | 1,011 |
Leasehold Improvements [Member] | ||
Property and equipment, gross | 2,649 | 2,649 |
Manufacturing, Laboratory, and Office Equipment [Member] | ||
Property and equipment, gross | 881 | 4,703 |
Furniture and Fixtures [Member] | ||
Property and equipment, gross | $ 390 | $ 390 |
Note 7 - Accrued Expenses - Acc
Note 7 - Accrued Expenses - Accrued Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Research and development | $ 786 | $ 1,500 |
Professional fees | 459 | 391 |
Salaries, bonus and benefits | 123 | 1,218 |
Manufacturing operations | 5 | 46 |
Other | 179 | 253 |
Total accrued expenses | $ 1,552 | $ 3,408 |
Note 8 - Loans Payable (Details
Note 8 - Loans Payable (Details Textual) - Loan payable to Bank Direct Capital Finance [Member] - Loans Payable [Member] - USD ($) | 1 Months Ended | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2022 | Dec. 31, 2022 | |
Debt Instrument, Face Amount | $ 1,300,000 | $ 1,100,000 | |
Debt Instrument, Interest Rate, Stated Percentage | 3.37% | 3.90% | |
Debt Instrument, Periodic Payment, Total | $ 147,000 | $ 126,000 | |
Loans Payable to Bank, Total | $ 300,000 | $ 300,000 |
Note 9 - Restructured Debt Li_2
Note 9 - Restructured Debt Liability (Details Textual) - USD ($) $ / shares in Units, $ in Millions | Oct. 27, 2017 | Dec. 31, 2022 | Dec. 31, 2021 |
Liability for Contingent Milestone Payment, Noncurrent | $ 15 | $ 15 | |
Deerfield Loan [Member] | Exchange and Termination Agreement [Member] | Deerfield Management, L.P. [Member] | |||
Extinguishment of Debt, Amount | $ 25 | ||
Class of Warrant or Right, Number of Warrants Cancelled (in shares) | 167 | ||
Class of Warrant or Right, Exercise Price of Cancelled Warrants (in dollars per share) | $ 118,020 | ||
Repayments of Long-term Debt, Total | $ 2.5 | ||
Stock Issued During Period, Shares, Cancellation of Debt and Warrant Obligations (in shares) | 474 | ||
Stock Issued During Period, Shares, Cancellation of Debt and Warrant Obligations, Percentage of Fully-diluted Shares Outstanding | 2% | ||
Liability for Contingent Milestone Payment, Noncurrent | $ 15 | $ 15 | $ 15 |
Note 10 - Mezzanine Equity an_3
Note 10 - Mezzanine Equity and Stockholders' Equity (Details Textual) $ / shares in Units, $ in Thousands | 12 Months Ended | ||||||
Nov. 17, 2022 $ / shares shares | Mar. 25, 2021 USD ($) | Mar. 23, 2021 $ / shares shares | Sep. 17, 2020 USD ($) | Dec. 31, 2022 USD ($) $ / shares shares | Dec. 31, 2021 USD ($) $ / shares shares | Dec. 02, 2022 shares | |
Preferred Stock, Shares Authorized (in shares) | shares | 5,000,000 | 4,960,000 | 5,000,000 | ||||
Preferred Stock, Par or Stated Value Per Share (in dollars per share) | $ / shares | $ 0.001 | $ 0.001 | $ 0.001 | ||||
Stock Issued During Period, Shares, New Issues (in shares) | shares | 42,339 | ||||||
Stock Issued During Period, Value, New Issues | $ | $ 4,253 | $ 4,800 | |||||
Proceeds from Issuance of Common Stock | $ | $ 4,253 | $ 4,843 | |||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ / shares | |||||||
The 2011 Long-term Incentive Plan [Member] | |||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Available for Grant (in shares) | shares | 31,000 | ||||||
The 2020 Equity Incentive Plan [Member] | |||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Available for Grant (in shares) | shares | 12,000 | 13,000 | |||||
Share-based Compensation Plan, Annual Increases to Shares of Common Stock Issued and Outstanding | 4% | ||||||
March 2021 Warrants [Member] | |||||||
Warrants and Rights Outstanding, Term (Year) | 5 years | ||||||
Stock and Warrants Issued, Price Per Share (in dollars per share) | $ / shares | $ 162.50 | ||||||
ATM Program [Member] | |||||||
Shares Authorized to Be Offered and Sold Under Offering Agreement, Value | $ | $ 10,000 | ||||||
Commission Fee, Percent Fee | 3% | ||||||
Stock Issued During Period, Shares, New Issues (in shares) | shares | 206,824 | ||||||
Stock Issued During Period, Value, New Issues | $ | $ 4,400 | ||||||
Proceeds from Issuance of Common Stock | $ | 4,300 | ||||||
Stock Offering Agreement, Public Float Limitation Amount | $ | 75,000 | ||||||
March 2021 Public Offering [Member] | |||||||
Equity Issued During Period, Units, New Issues (in shares) | shares | 184,610 | ||||||
Units, Number of Securities Called by Each Unit (in shares) | shares | 1 | ||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ / shares | $ 180 | ||||||
Proceeds from Issuance or Sale of Equity, Gross Amount | $ | $ 30,000 | ||||||
Proceeds from Issuance or Sale of Equity, Total | $ | $ 27,400 | ||||||
Series A Preferred Stock [Member] | |||||||
Preferred Stock, Shares Authorized (in shares) | shares | 40,000 | ||||||
Preferred Stock, Par or Stated Value Per Share (in dollars per share) | $ / shares | $ 0.001 | ||||||
Common Stock, Dividends, Shares Issued Per Share, Declared | 0.001 | ||||||
Stock Dividends, Shares, Total (in shares) | shares | 38,610 | ||||||
Preferred Stock, Convertible, Conversion Price (in dollars per share) | $ / shares | $ 0.01 | ||||||
Stock Issued During Period, Value, New Issues | $ | $ 0 |
Note 10 - Mezzanine Equity an_4
Note 10 - Mezzanine Equity and Stockholders' Equity - Common Shares Reserved for Future Issuance (Details) - $ / shares shares in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | ||
Common stock, capital shares reserved for future issuance (in shares) | 332 | 334 | |
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | |||
Expiration date | |||
Common stock, capital shares reserved for future issuance (in shares) | 332 | 334 | |
Service Agreement - 2021 warrants (in dollars per share) | |||
Expiration date | |||
Investors - March 2021 Financing [Member] | |||
Common stock, capital shares reserved for future issuance (in shares) | 185 | 185 | |
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 180 | ||
Expiration date | 03/25/26 | ||
Common stock, capital shares reserved for future issuance (in shares) | 185 | 185 | |
Service Agreement - 2021 warrants (in dollars per share) | $ 180 | ||
Expiration date | 03/25/26 | ||
March 2021 Warrants [Member] | |||
Common stock, capital shares reserved for future issuance (in shares) | 3 | 3 | |
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 412.50 | ||
Expiration date | 02/09/24 | ||
Common stock, capital shares reserved for future issuance (in shares) | 3 | 3 | |
Service Agreement - 2021 warrants (in dollars per share) | $ 412.50 | ||
Expiration date | 02/09/24 | ||
Investors - May 2020 Financing [Member] | |||
Common stock, capital shares reserved for future issuance (in shares) | 63 | 63 | |
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 399 | ||
Expiration date | 05/22/25 | ||
Common stock, capital shares reserved for future issuance (in shares) | 63 | 63 | |
Service Agreement - 2021 warrants (in dollars per share) | $ 399 | ||
Expiration date | 05/22/25 | ||
Investors - December 2019 Financing [Member] | |||
Common stock, capital shares reserved for future issuance (in shares) | 29 | 29 | |
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 604.50 | ||
Expiration date | 12/06/24 | ||
Common stock, capital shares reserved for future issuance (in shares) | 29 | 29 | |
Service Agreement - 2021 warrants (in dollars per share) | $ 604.50 | ||
Expiration date | 12/06/24 | ||
Investors - Aerosurf [Member] | |||
Common stock, capital shares reserved for future issuance (in shares) | 20 | 20 | |
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 0 | ||
Expiration date | 02/14/24 | ||
Common stock, capital shares reserved for future issuance (in shares) | 20 | 20 | |
Service Agreement - 2021 warrants (in dollars per share) | $ 0 | ||
Expiration date | 02/14/24 | ||
Investors - December 2018 Financing - Long-term [Member] | |||
Common stock, capital shares reserved for future issuance (in shares) | 26 | 26 | |
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 607.50 | ||
Expiration date | 12/04/23 | ||
Common stock, capital shares reserved for future issuance (in shares) | 26 | 26 | |
Service Agreement - 2021 warrants (in dollars per share) | $ 607.50 | ||
Expiration date | 12/04/23 | ||
Battelle - 2018 Payables Restructuring Agreement [Member] | |||
Common stock, capital shares reserved for future issuance (in shares) | [1] | 1 | 1 |
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | [1] | $ 975 | |
Expiration date | [1] | 12/07/23 | |
Common stock, capital shares reserved for future issuance (in shares) | [1] | 1 | 1 |
Service Agreement - 2021 warrants (in dollars per share) | [1] | $ 975 | |
Expiration date | [1] | 12/07/23 | |
Panacea Venture Management Company Ltd. [Member] | |||
Common stock, capital shares reserved for future issuance (in shares) | 1 | 1 | |
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 600 | ||
Expiration date | 07/02/23 | ||
Common stock, capital shares reserved for future issuance (in shares) | 1 | 1 | |
Service Agreement - 2021 warrants (in dollars per share) | $ 600 | ||
Expiration date | 07/02/23 | ||
LPH II Investments Limited [Member] | |||
Common stock, capital shares reserved for future issuance (in shares) | 1 | 1 | |
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 828 | ||
Expiration date | 04/04/25 | ||
Common stock, capital shares reserved for future issuance (in shares) | 1 | 1 | |
Service Agreement - 2021 warrants (in dollars per share) | $ 828 | ||
Expiration date | 04/04/25 | ||
Investors - February 2017 Financing [Member] | |||
Common stock, capital shares reserved for future issuance (in shares) | 2 | 2 | |
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 4,110 | ||
Expiration date | 02/15/24 | ||
Common stock, capital shares reserved for future issuance (in shares) | 2 | 2 | |
Service Agreement - 2021 warrants (in dollars per share) | $ 4,110 | ||
Expiration date | 02/15/24 | ||
Investors - July 2015 Financing [Member] | |||
Common stock, capital shares reserved for future issuance (in shares) | 0 | 2 | |
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 29,400 | ||
Expiration date | 07/22/22 | ||
Common stock, capital shares reserved for future issuance (in shares) | 0 | 2 | |
Service Agreement - 2021 warrants (in dollars per share) | $ 29,400 | ||
Expiration date | 07/22/22 | ||
Battelle 2014 Collaboration Agreement [Member] | |||
Common stock, capital shares reserved for future issuance (in shares) | 1 | 1 | |
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 210,000 | ||
Expiration date | 10/10/24 | ||
Common stock, capital shares reserved for future issuance (in shares) | 1 | 1 | |
Service Agreement - 2021 warrants (in dollars per share) | $ 210,000 | ||
Expiration date | 10/10/24 | ||
[1]See, Note 14 - Collaboration, Licensing and Research Funding Agreements, for further details on the Battelle collaboration agreement. |
Note 11 - Stock Options and S_3
Note 11 - Stock Options and Stock-Based Employee Compensation (Details Textual) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Jan. 01, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Authorized (in shares) | 12,000 | ||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value (in dollars per share) | $ 42 | $ 201.50 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Intrinsic Value | $ 0 | ||
Share-Based Payment Arrangement, Expense | 3,086 | $ 7,238 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Vested in Period, Fair Value | 3,800 | $ 6,700 | |
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount, Total | $ 2,300 | ||
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition (Year) | 1 year 3 months 18 days | ||
Restricted Stock Units (RSUs) [Member] | |||
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Grants in Period, Intrinsic Value, Amount Per Share (in dollars per share) | $ 49.50 | ||
Restricted Stock Units (RSUs) [Member] | Maximum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Award Requisite Service Period (Year) | 3 years | ||
The 2020 Equity Incentive Plan [Member] | |||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Authorized (in shares) | 62,000 | ||
Share-based Compensation Plan, Annual Increases to Shares of Common Stock Issued and Outstanding | 4% | ||
Share-Based Compensation Arrangement by Share-Based Payment Award, Expiration Period (Year) | 10 years | ||
Share-based Compensation Arrangement by Share-based Payment Award, Award Requisite Service Period (Year) | 3 years | ||
The 2011 Long-term Incentive Plan [Member] | Subsequent Event [Member] | |||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Additional Shares Authorized (in shares) | 31,000 | ||
Non-plan Stock Options [Member] | Executive Officers and Employees [Member] | |||
Share-Based Compensation Arrangement by Share-Based Payment Award, Expiration Period (Year) | 10 years | ||
Share-based Compensation Arrangement by Share-based Payment Award, Award Requisite Service Period (Year) | 3 years |
Note 11 - Stock Options and S_4
Note 11 - Stock Options and Stock-Based Employee Compensation - Stock Options and Restricted Stock Units (RSUs) Outstanding and Available for Future Issuance (Details) - shares | Dec. 31, 2022 | Dec. 02, 2022 | Dec. 31, 2021 |
Stock Options and RSUs Outstanding (in shares) | 89,000 | 68,000 | |
Stock Options and RSUs Outstanding (in shares) | 89,000 | 68,000 | |
The 2020 Equity Incentive Plan [Member] | |||
Stock Options and RSUs Outstanding (in shares) | 50,000 | 25,000 | |
Stock Options and RSUs Outstanding (in shares) | 50,000 | 25,000 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Available for Grant (in shares) | 12,000 | 13,000 | |
The 2011 Long-term Incentive Plan [Member] | |||
Stock Options and RSUs Outstanding (in shares) | 30,000 | 32,000 | |
Stock Options and RSUs Outstanding (in shares) | 30,000 | 32,000 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Available for Grant (in shares) | 31,000 | ||
Non-Plan [Member] | |||
Stock Options and RSUs Outstanding (in shares) | 9,000 | 11,000 | |
Stock Options and RSUs Outstanding (in shares) | 9,000 | 11,000 |
Note 11 - Stock Option and Stoc
Note 11 - Stock Option and Stock-Based Employee Compensation - Summary Stock Option Activity (Details) shares in Thousands | 12 Months Ended |
Dec. 31, 2022 $ / shares shares | |
Shares Outstanding, Beginning Balance (in shares) | shares | 68 |
Weighted Average Exercise Price, Outstanding, at Beginning Period (in dollars per share) | $ / shares | $ 487 |
Shares Granted (in shares) | shares | 18 |
Weighted Average Exercise Price, Granted (in dollars per share) | $ / shares | $ 49.50 |
Shares Forfeited or Expired (in shares) | shares | (8) |
Weighted Average Exercise Price, Forfeited or Expired (in dollars per share) | $ / shares | $ 551.50 |
Shares Outstanding, Ending Balance (in shares) | shares | 78 |
Weighted Average Exercise Price, Outstanding, at Ending Period (in dollars per share) | $ / shares | $ 381 |
Weighted Average Remaining Contractual Life, Outstanding (Year) | 7 years 7 months 6 days |
Shares Vested and Exercisable (in shares) | shares | 48 |
Weighted Average Exercise Price, Vested and Exercisable (in dollars per share) | $ / shares | $ 510 |
Weighted Average Remaining Contractual Life, Vested and Exercisable (Year) | 7 years |
Vested and expected to vest (in shares) | shares | 74 |
Weighted Average Exercise Price, Vested and Expected to Vest (in dollars per share) | $ / shares | $ 382 |
Weighted Average Remaining Contractual Life, Vested and Expected to Vest (Year) | 7 years 7 months 6 days |
Note 11 - Stock Options and S_5
Note 11 - Stock Options and Stock-Based Employee Compensation - Restricted Stock Units (Details) - Restricted Stock Units (RSUs) [Member] shares in Thousands | 12 Months Ended |
Dec. 31, 2022 $ / shares shares | |
Balance (in shares) | shares | 0 |
Weighted- Average Grant Date Fair Value, Outstanding, Beginning Balance (in dollars per share) | $ / shares | $ 0 |
Awarded (in shares) | shares | 12 |
Awarded, Weighted- Average Grant Date Fair Value, Outstanding (in dollars per share) | $ / shares | $ 49.50 |
Cancelled (in shares) | shares | (1) |
Cancelled, Weighted- Average Grant Date Fair Value, Outstanding (in dollars per share) | $ / shares | $ 51 |
Balance (in shares) | shares | 11 |
Weighted- Average Grant Date Fair Value, Outstanding (in dollars per share) | $ / shares | $ 49.50 |
Vested and exercisable at December 31, 2022 (in shares) | shares | 0 |
Vested and exercisable Weighted- Average Grant Date Fair Value (in dollars per share) | $ / shares | $ 0 |
Vested and expected to vest at December 31, 2022 (in shares) | shares | 11 |
Vested and expected to vest Weighted- Average Grant Date Fair Value (in dollars per share) | $ / shares | $ 49.50 |
Note 11 - Stock Options and S_6
Note 11 - Stock Options and Stock-Based Employee Compensation - Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share-Based Payment Arrangement, Expense | $ 3,086 | $ 7,238 |
Research and Development Expense [Member] | ||
Share-Based Payment Arrangement, Expense | 807 | 2,940 |
Selling, General and Administrative Expenses [Member] | ||
Share-Based Payment Arrangement, Expense | $ 2,279 | $ 4,298 |
Note 11 - Stock Options and S_7
Note 11 - Stock Options and Stock-Based Employee Compensation - Stock Options Valuation Assumptions (Details) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Weighted average expected volatility | 106% | 104% |
Weighted average expected term (Year) | 6 years 10 months 24 days | 6 years 8 months 12 days |
Weighted average risk-free interest rate | 1.70% | 0.49% |
Note 12 - Collaboration, Lice_2
Note 12 - Collaboration, Licensing and Research Funding Agreements (Details Textual) $ in Millions | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||||||
Aug. 17, 2022 USD ($) | Mar. 19, 2021 EUR (€) | Oct. 31, 2014 USD ($) | Oct. 31, 2022 USD ($) | Jun. 30, 2019 USD ($) | Dec. 31, 2021 USD ($) | Dec. 31, 2019 USD ($) | Dec. 31, 2019 EUR (€) | Dec. 31, 2022 USD ($) | Sep. 30, 2020 USD ($) | Mar. 18, 2020 | |
Term Sheet With Lee [Member] | |||||||||||
Financing of Product, Percent of Revenue Shared With Financer | 50% | ||||||||||
Financing of Product, Percent of Financing That Must be Repaid to Discontinue Revenue Sharing | 125% | ||||||||||
Proceeds for Payments to Develop Product | $ 1 | ||||||||||
Term Sheet With Lee [Member] | Other Liabilities [Member] | |||||||||||
Contractual Obligation, Total | 3.8 | $ 3.8 | |||||||||
A&R License Agreement With Lee [Member] | |||||||||||
Proceeds for Payments to Develop Product | $ 1 | ||||||||||
Maximum Amount May be Received for Potential Milestone Payments | $ 78.9 | ||||||||||
Johnson and Johnson - License Agreement [Member] | |||||||||||
Potential License Fee Payable | $ 2.5 | ||||||||||
Payment of License Cost Subject to Regulatory Approval | $ 1 | ||||||||||
Percent of Cash Upfront and Milestone Fees Payable to Esteve | 10% | ||||||||||
Maximum Aggregate Cash Upfront and Milestone Fees Payable to Esteve | $ 20 | ||||||||||
Universita Degli Studi Do Miano-Biocca [Member] | |||||||||||
Payment of License Cost for New Compounds Modulating | € | € 100,000 | ||||||||||
Payment of License Cost Upon Obtaining Marketing Authorization | € | € 1,500,000 | ||||||||||
Agreement for Scientific Collaboration, or the New SERCA2a Agreement, with Bicocca [Member] | |||||||||||
Payment of License Cost for Research Activities and to Cover Laboratory Space and Operation Costs | € | € 200,000 | ||||||||||
Payment of License Cost for Execution of an Assignment | € | 25,000 | ||||||||||
Payment of License Cost for New Compounds Developed | € | 75,000 | ||||||||||
Payment of License Cost upon Obtaining Marketing Authorization in the U.S., EU, or China of New Compounds | € | € 1,500,000 | ||||||||||
Battelle Applies [Member] | |||||||||||
Maximum Royalty Paid on Completion of Activities Under the Agreement | $ 25 | $ 35 | |||||||||
Lee’s Pharmaceutical Holdings Limited [Member] | AEROSURF Funding Term Sheet [Member] | |||||||||||
Nonrefundable Payments, Maximum Financing to Be Received | $ 3.9 | ||||||||||
Nonrefundable Payments, Maximum Financing to Be Received Under Special Circumstances | $ 2.8 | ||||||||||
Nonrefundable Payments | $ 2.8 |
Note 13 - Related Party Trans_2
Note 13 - Related Party Transactions (Details Textual) - USD ($) $ in Thousands | 12 Months Ended | ||
Aug. 17, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
AEROSURF Funding Term Sheet [Member] | Lee’s Pharmaceutical Holdings Limited [Member] | |||
Nonrefundable Payments | $ 1,000 | ||
Due to Related Parties, Total | 3,800 | ||
Contractual Obligation, Total | $ 0 | ||
Research and Development Expenses for Services Provided [Member] | Lee’s Pharmaceutical Holdings Limited [Member] | |||
Due to Related Parties, Total | $ 300 | ||
Related Party Transaction, Expenses from Transactions with Related Party | $ 400 | ||
A&R License Agreement With Lee [Member] | |||
Maximum Amount May be Received for Potential Milestone Payments | $ 78,900 | ||
Lee’s Pharmaceutical Holdings Limited [Member] | Windtree Therapeutics [Member] | |||
Ownership Percentage | 13% | 17% | |
Panacea [Member] | Windtree Therapeutics [Member] | |||
Ownership Percentage | 9% | 8% |
Note 15 - Income Taxes (Details
Note 15 - Income Taxes (Details Textual) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Deferred Income Tax Expense (Benefit), Total | $ (1,367) | $ (9,987) |
Operating Loss Carryforwards | 637,400 | 644,600 |
Operating Loss Carryforwards Not Subject to Expiration | 90,200 | |
UNITED STATES | ||
Capitalized Research and Development Expense | 6,400 | |
Non-US [Member] | ||
Capitalized Research and Development Expense | 3,900 | |
State and Local Jurisdiction [Member] | ||
Operating Loss Carryforwards | 593,300 | 598,900 |
State and Local Jurisdiction [Member] | PA Department of Revenue [Member] | ||
Operating Loss Carryforwards | 589,700 | |
Research Tax Credit Carryforward [Member] | ||
Tax Credit Carryforward, Amount | 17,000 | 17,400 |
Orphan Drug Tax Credit [Member] | ||
Tax Credit Carryforward, Amount | $ 600 | $ 1,100 |
Note 15 - Income Taxes - Benefi
Note 15 - Income Taxes - Benefit for Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Foreign | $ (1,367) | $ (9,987) |
Total deferred expense (benefit) | (1,367) | (9,987) |
Income tax benefit, net | $ (1,367) | $ (9,987) |
Note 15 - Income Taxes - Income
Note 15 - Income Taxes - Income Tax Reconciliation (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income tax benefit, statutory rates | $ (8,521) | $ (16,301) |
State taxes on income, net of federal benefit | 903 | (1,390) |
Net operating loss expirations | 3,485 | 2,184 |
Intangibles | 2,561 | 0 |
Research and development tax credit | 825 | 94 |
Foreign rate differential | 196 | 462 |
Employee related and other | 467 | (186) |
Other | (17) | 0 |
Income tax expense / (benefit), statutory rates | (101) | (15,137) |
Valuation allowance | (1,266) | 5,150 |
Income tax benefit, net | $ (1,367) | $ (9,987) |
Note 15 - Income Taxes - Deferr
Note 15 - Income Taxes - Deferred Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Net operating loss carryforwards (federal and state) | $ 185,591 | $ 187,905 |
Research and development tax credit | 17,671 | 18,538 |
Compensation expense on stock | 4,166 | 4,568 |
Other accrued | 1,293 | 2,006 |
Capitalized R&D expenses | 2,369 | 0 |
Depreciation | 191 | 115 |
Total long-term deferred tax assets | 211,281 | 213,132 |
IPR&D | (5,061) | (7,114) |
Total long-term deferred tax liabilities | (5,061) | (7,114) |
Valuation allowance | (211,281) | (213,132) |
Deferred tax liabilities, net | $ (5,061) | $ (7,114) |
Note 16 - Leases (Details Textu
Note 16 - Leases (Details Textual) | 1 Months Ended |
Jan. 31, 2022 | |
Amendment to Extend Warrington, Pennsylvania Lease [Member] | |
Lessee, Operating Lease, Extended Term (Year) | 5 years |
Note 16 - Leases - Lease Costs
Note 16 - Leases - Lease Costs (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Operating lease cost | $ 692 | $ 857 |
Variable lease cost | 9 | 45 |
Total lease cost | 701 | 902 |
Operating cash flows used for operating leases | 730 | 734 |
Operating lease liabilities arising from obtaining right-of-use assets | $ 0 | $ 2,141 |
Weighted average remaining lease term (in years) (Year) | 4 years 1 month 6 days | 4 years 9 months 18 days |
Weighted average incremental borrowing rate | 7.08% | 7.12% |
Note 16 - Leases - Future Minim
Note 16 - Leases - Future Minimum Lease Payments (Details) $ in Thousands | Dec. 31, 2022 USD ($) |
2023 | $ 529 |
2024 | 560 |
2025 | 570 |
2026 | 581 |
2027 | 97 |
Thereafter | 0 |
Total lease payments | 2,337 |
Less imputed interest | (309) |
Total operating lease liabilities | $ 2,028 |
Note 17 - Subsequent Events (De
Note 17 - Subsequent Events (Details Textual) - USD ($) | Feb. 21, 2023 | Jan. 20, 2023 | Dec. 31, 2022 | Mar. 23, 2021 |
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | ||||
March 2021 Warrants [Member] | ||||
Warrants and Rights Outstanding, Term (Year) | 5 years | |||
Subsequent Event [Member] | December 2019 Warrants [Member] | ||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 5,519 | 1,573 | ||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 604.50 | $ 604.50 | ||
Subsequent Event [Member] | May 2020 Warrants [Member] | ||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 5,517 | 5,598 | ||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 398.75 | $ 398.75 | ||
Subsequent Event [Member] | March 2021 Warrants [Member] | ||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 89,001 | |||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 180 | |||
Subsequent Event [Member] | January 2023 Existing Warrants [Member] | ||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 96,172 | |||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 10 | |||
Proceeds from Warrant Exercises | $ 1,000,000 | |||
Subsequent Event [Member] | January 2023 Existing Warrants [Member] | Ladenburg [Member] | ||||
Placement Agent Payment, Percent | 8% | |||
Management Fee, Percent | 1% | |||
Subsequent Event [Member] | January 2023 New Warrants [Member] | ||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 192,344 | |||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 10.76 | |||
Warrants and Rights Outstanding, Term (Year) | 5 years | |||
Subsequent Event [Member] | July 2018 Warrants [Member] | ||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 1,250 | |||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 600 | |||
Subsequent Event [Member] | December 2018 Warrants [Member] | ||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 9,960 | |||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 607.50 | |||
Subsequent Event [Member] | February 2023 Existing Warrants [Member] | ||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 22,246 | |||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 7.06 | |||
Proceeds from Warrant Exercises | $ 157,000 | |||
Subsequent Event [Member] | February 2023 Existing Warrants [Member] | Ladenburg [Member] | ||||
Placement Agent Payment, Percent | 8% | |||
Management Fee, Percent | 1% | |||
Subsequent Event [Member] | February 2023 New Warrants [Member] | ||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 44,492 | |||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 10.76 | |||
Warrants and Rights Outstanding, Term (Year) | 5 years |