Document And Entity Information
Document And Entity Information - shares | 6 Months Ended | |
Jun. 30, 2023 | Aug. 07, 2023 | |
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 | Q2 | |
Document Fiscal Year Focus | 2023 | |
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2023 | |
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, $0.001 par value | |
Trading Symbol | WINT | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 5,148,219 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Current Period Unaudited) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Current Assets: | ||
Cash and cash equivalents | $ 11,467 | $ 6,172 |
Prepaid expenses and other current assets | 1,852 | 1,205 |
Total current assets | 13,319 | 7,377 |
Property and equipment, net | 216 | 262 |
Restricted cash | 150 | 154 |
Operating lease right-of-use assets | 1,640 | 1,853 |
Intangible assets | 25,250 | 25,250 |
Goodwill | 0 | 3,058 |
Total assets | 40,575 | 37,954 |
Current Liabilities: | ||
Accounts payable | 964 | 249 |
Accrued expenses | 1,731 | 1,552 |
Operating lease liabilities - current portion | 399 | 404 |
Loans payable | 700 | 252 |
Total current liabilities | 3,794 | 2,457 |
Operating lease liabilities - non-current portion | 1,397 | 1,624 |
Restructured debt liability - contingent milestone payments | 15,000 | 15,000 |
Other liabilities | 3,800 | 3,800 |
Deferred tax liabilities | 4,980 | 5,061 |
Total liabilities | 28,971 | 27,942 |
Stockholders’ Equity: | ||
Preferred stock, $0.001 par value; 5,000,000 and 4,960,000 shares authorized; 0 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively | 0 | 0 |
Common stock, $0.001 par value; 120,000,000 shares authorized at June 30, 2023 and December 31, 2022; 5,148,220 and 772,203 shares issued at June 30, 2023 and December 31, 2022, respectively; 5,148,219 and 772,202 shares outstanding at June 30, 2023 and December 31, 2022, respectively | 5 | 0 |
Additional paid-in capital | 849,897 | 837,598 |
Accumulated deficit | (835,244) | (824,532) |
Treasury stock (at cost); 1 share | (3,054) | (3,054) |
Total stockholders’ equity | 11,604 | 10,012 |
Total liabilities, mezzanine equity & stockholders’ equity | 40,575 | 37,954 |
Series A Preferred Stock [Member] | ||
Current Liabilities: | ||
Series A redeemable preferred stock, $0.001 par value; 0 and 40,000 shares authorized; 0 and 38,610.119 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively | $ 0 | $ 0 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Current Period Unaudited) (Parentheticals) - $ / shares | Jun. 30, 2023 | Dec. 31, 2022 |
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 5,000,000 | 4,960,000 |
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) | 5,148,220 | 772,203 |
Common stock, shares outstanding (in shares) | 5,148,219 | 772,202 |
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) | 0 | 40,000 |
Temporary equity, shares issued (in shares) | 0 | 38,610.119 |
Temporary equity, shares outstanding (in shares) | 0 | 38,610.119 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Research and development | $ 1,763 | $ 2,995 | $ 3,178 | $ 8,340 |
General and administrative | 2,420 | 2,907 | 4,712 | 5,895 |
Loss on impairment of goodwill | 2,574 | 11,636 | 3,058 | 11,636 |
Total operating expenses | 6,757 | 17,538 | 10,948 | 25,871 |
Operating loss | (6,757) | (17,538) | (10,948) | (25,871) |
Interest income | 108 | 17 | 152 | 18 |
Interest expense | (13) | (13) | (25) | (26) |
Other income, net | 61 | 201 | 109 | 419 |
Total other income, net | 156 | 205 | 236 | 411 |
Net loss | $ (6,601) | $ (17,333) | $ (10,712) | $ (25,460) |
Net loss per common share | ||||
Basic and diluted (in dollars per share) | $ (1.64) | $ (29.68) | $ (4.36) | $ (44.28) |
Weighted average number of common shares outstanding | ||||
Basic and diluted (in shares) | 4,030 | 584 | 2,455 | 575 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Changes in Stockholders' Equity (Unaudited) - USD ($) shares in Thousands, $ 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, Common [Member] | ATM Program [Member] | Series A Preferred Stock, Mezzanine Equity [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | Treasury Stock, Common [Member] | Total |
Balance (in shares) at Dec. 31, 2021 | 0 | 565 | 0 | |||||||||
Balance at Dec. 31, 2021 | $ 0 | $ 0 | $ 830,259 | $ (785,324) | $ (3,054) | $ 41,881 | ||||||
Net loss | 0 | 0 | 0 | (8,127) | 0 | (8,127) | ||||||
Stock-based compensation expense | $ 0 | $ 0 | 770 | 0 | $ 0 | 770 | ||||||
Issuance of common stock, ATM Program, net of issuance costs (in shares) | 0 | 4 | 0 | |||||||||
Issuance of common stock, ATM Program, net of issuance costs | $ 0 | $ 0 | $ 205 | $ 0 | $ 0 | $ 205 | ||||||
Balance (in shares) at Mar. 31, 2022 | 0 | 569 | 0 | |||||||||
Balance at Mar. 31, 2022 | $ 0 | $ 0 | 831,234 | (793,451) | $ (3,054) | 34,729 | ||||||
Balance (in shares) at Dec. 31, 2021 | 0 | 565 | 0 | |||||||||
Balance at Dec. 31, 2021 | $ 0 | $ 0 | 830,259 | (785,324) | $ (3,054) | 41,881 | ||||||
Net loss | (25,460) | |||||||||||
Balance (in shares) at Jun. 30, 2022 | 0 | 588 | 0 | |||||||||
Balance at Jun. 30, 2022 | $ 0 | $ 0 | 833,035 | (810,784) | $ (3,054) | 19,197 | ||||||
Balance (in shares) at Mar. 31, 2022 | 0 | 569 | 0 | |||||||||
Balance at Mar. 31, 2022 | $ 0 | $ 0 | 831,234 | (793,451) | $ (3,054) | 34,729 | ||||||
Net loss | 0 | 0 | 0 | (17,333) | 0 | (17,333) | ||||||
Stock-based compensation expense | $ 0 | $ 0 | 781 | 0 | $ 0 | 781 | ||||||
Issuance of common stock, ATM Program, net of issuance costs (in shares) | 0 | 19 | 0 | |||||||||
Issuance of common stock, ATM Program, net of issuance costs | $ 0 | $ 0 | $ 1,020 | $ 0 | $ 0 | $ 1,020 | ||||||
Balance (in shares) at Jun. 30, 2022 | 0 | 588 | 0 | |||||||||
Balance at Jun. 30, 2022 | $ 0 | $ 0 | 833,035 | (810,784) | $ (3,054) | 19,197 | ||||||
Balance (in shares) at Dec. 31, 2022 | 39 | 772 | 0 | |||||||||
Balance at Dec. 31, 2022 | $ 0 | $ 0 | 837,598 | (824,532) | $ (3,054) | 10,012 | ||||||
Net loss | 0 | 0 | 0 | (4,111) | 0 | (4,111) | ||||||
Stock-based compensation expense | $ 0 | $ 0 | 285 | 0 | $ 0 | 285 | ||||||
Redemption of Series A Preferred Stock (in shares) | (39) | 0 | 0 | |||||||||
Vesting of restricted stock units (in shares) | 0 | 2 | 0 | |||||||||
Exercise of common stock warrants, net of expenses of $276 (in shares) | 0 | 118 | 0 | |||||||||
Exercise of common stock warrants, net of expenses of $276 | $ 0 | $ 1 | 842 | 0 | $ 0 | 843 | ||||||
Reverse split adjustments - fractional share round ups (in shares) | 0 | 17 | 0 | |||||||||
Balance (in shares) at Mar. 31, 2023 | 0 | 909 | 0 | |||||||||
Balance at Mar. 31, 2023 | $ 0 | $ 1 | 838,725 | (828,643) | $ (3,054) | 7,029 | ||||||
Balance (in shares) at Dec. 31, 2022 | 39 | 772 | 0 | |||||||||
Balance at Dec. 31, 2022 | $ 0 | $ 0 | 837,598 | (824,532) | $ (3,054) | 10,012 | ||||||
Net loss | (10,712) | |||||||||||
Balance (in shares) at Jun. 30, 2023 | 0 | 5,148 | 0 | |||||||||
Balance at Jun. 30, 2023 | $ 0 | $ 5 | 849,897 | (835,244) | $ (3,054) | 11,604 | ||||||
Balance (in shares) at Mar. 31, 2023 | 0 | 909 | 0 | |||||||||
Balance at Mar. 31, 2023 | $ 0 | $ 1 | 838,725 | (828,643) | $ (3,054) | 7,029 | ||||||
Net loss | 0 | 0 | 0 | (6,601) | 0 | (6,601) | ||||||
Stock-based compensation expense | $ 0 | $ 0 | 382 | 0 | $ 0 | 382 | ||||||
Issuance of common stock, ATM Program, net of issuance costs (in shares) | 0 | 4,239 | 0 | |||||||||
Issuance of common stock, ATM Program, net of issuance costs | $ 0 | $ 4 | 10,790 | 0 | $ 0 | 10,794 | ||||||
Balance (in shares) at Jun. 30, 2023 | 0 | 5,148 | 0 | |||||||||
Balance at Jun. 30, 2023 | $ 0 | $ 5 | $ 849,897 | $ (835,244) | $ (3,054) | $ 11,604 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Changes in Stockholders' Equity (Unaudited) (Parentheticals) - USD ($) | 3 Months Ended | |||
Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2022 | Mar. 31, 2022 | |
ATM Program [Member] | ||||
Adjustments to Additional Paid in Capital, Stock Issued, Issuance Costs | $ 32 | $ 6 | ||
Adjustments to Additional Paid in Capital, Stock Issued, Issuance Costs | $ 1,630 | |||
Adjustments to Additional Paid in Capital, Stock Issued, Issuance Costs, Exercise of Warrants Cost | $ 276 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Cash flows from operating activities: | ||
Net loss | $ (10,712) | $ (25,460) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 46 | 488 |
Stock-based compensation | 667 | 1,551 |
Non-cash lease expense | 213 | 307 |
Loss on impairment of goodwill | 3,058 | 11,636 |
Loss on sale and disposal of property and equipment | 0 | 19 |
Unrealized gain on foreign exchange rate changes | (85) | (485) |
Changes in assets and liabilities: | ||
Prepaid expenses and other current assets | 132 | 496 |
Accounts payable | 715 | 379 |
Accrued expenses | 182 | (576) |
Operating lease liabilities | (232) | (328) |
Net cash used in operating activities | (6,016) | (11,973) |
Cash flows from investing activities: | ||
Proceeds from sale of property and equipment | 0 | 210 |
Purchase of property and equipment | 0 | (13) |
Net cash provided by investing activities | 0 | 197 |
Cash flows from financing activities: | ||
Proceeds from issuance of common stock and warrants, net of issuance costs | 10,794 | 0 |
Proceeds from exercise of common stock warrants, net of expenses | 843 | 0 |
Principal payments on loans payable | (330) | (419) |
Proceeds from ATM Program, net of issuance costs | 0 | 1,225 |
Net cash provided by financing activities | 11,307 | 806 |
Net increase (decrease) in cash, cash equivalents, and restricted cash | 5,291 | (10,970) |
Cash, cash equivalents, and restricted cash - beginning of period | 6,326 | 22,502 |
Cash, cash equivalents, and restricted cash - end of period | 11,617 | 11,532 |
Supplementary disclosure of non-cash activity: | ||
Prepayment of insurance through third-party financing | 778 | 1,132 |
January 2023 Existing Warrants [Member] | ||
Supplementary disclosure of non-cash activity: | ||
Fair value of warrant modifications related to the warrant exercise inducement | 1,238 | 0 |
February 2023 Existing Warrants [Member] | ||
Supplementary disclosure of non-cash activity: | ||
Fair value of warrant modifications related to the warrant exercise inducement | $ 274 | $ 0 |
Note 1 - The Company and Descri
Note 1 - The Company and Description of Business | 6 Months Ended |
Jun. 30, 2023 | |
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 increase blood pressure and improve cardiac function in patients with cardiogenic shock and to improve cardiac function in patients with acute heart failure, or AHF, and reverse the hypotension and hypoperfusion associated with heart failure that deteriorates to cardiogenic shock. We also plan to demonstrate that istaroxime can produce a therapeutic benefit in these settings with a differentiated safety profile compared to drugs currently used in these patients. Istaroxime demonstrated significant improvement in both systolic and diastolic 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, or the SEISMiC Study, to evaluate istaroxime for the treatment of early cardiogenic shock (Society for Cardiovascular Angiography and Interventions, or SCAI, 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 the SEISMiC 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 SEISMiC 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. A second manuscript comparing the two doses used in the trial was published in the Journal of Cardiac Failure in April 2023. 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 the SEISMiC Study supports continued development in both cardiogenic shock and AHF. We are currently initiating an extension to the SEISMiC Study, or the SEISMiC Extension, to evaluate a longer dosing period and to continue to characterize the effects of istaroxime, including activation of sarco endoplasmic reticulum Ca2+ -ATPase 2a, or SERCA2a. The SEISMiC Extension trial is expected to enroll up to 30 subjects with SCAI Stage B cardiogenic shock with data anticipated in the second quarter of 2024. Additionally, we are exploring the possibility of commencing a study in more severe SCAI Stage C cardiogenic shock. Our heart failure cardiovascular portfolio also includes SERCA2a activators. 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 rostafuroxin without securing such an arrangement or partnership. 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. The reader is referred to, and encouraged to read in its entirety, “Item 1 – Business” in our Annual Report on Form 10-K for the year ended December 31, 2022 that we filed with the Securities and Exchange Commission, or the SEC, on March 31, 2023 , which contains a discussion of our business and business plans, as well as information concerning our proprietary technologies and our current and planned development programs. |
Note 2 - Basis of Presentation
Note 2 - Basis of Presentation | 6 Months Ended |
Jun. 30, 2023 | |
Notes to Financial Statements | |
Basis of Accounting [Text Block] | Note 2 – Basis of Presentation The interim unaudited condensed consolidated financial statements are prepared in accordance with accounting principles generally accepted in the U.S., or US GAAP, for interim financial information in accordance with the instructions to Form 10-Q and include accounts of Windtree Therapeutics, Inc. and its wholly owned subsidiaries. Accordingly, they do not include all of the information and footnotes required by US GAAP for complete consolidated financial statements. Intercompany balances and transactions have been eliminated in consolidation. All adjustments (consisting of normally recurring accruals) considered for fair presentation have been included. Operating results for the three and six months ended June 30, 2023 are not necessarily indicative of the results that may be expected for the year ending December 31, 2023 . The consolidated balance sheet at December 31, 2022 has been derived from the Company’s audited consolidated financial statements. There have been no changes to our significant accounting policies since December 31, 2022 . The accompanying interim unaudited condensed consolidated financial statements should be read in conjunction with our annual audited consolidated financial statements and related notes as of and for the year ended December 31, 2022 contained in our Annual Report on Form 10-K for the year ended December 31, 2022 . The accompanying condensed 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 - Going Concern and Mana
Note 3 - Going Concern and Management's Plans | 6 Months Ended |
Jun. 30, 2023 | |
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 $6.6 million and $10.7 million, respectively, for the three and six months ended June 30, 2023 . Our net loss was $17.3 million and $25.5 million, respectively, for the three and six months ended June 30, 2022 . Included in our net loss for the three and six months ended June 30, 2023 is a $2.6 million and $3.1 million loss on impairment of goodwill, respectively. three and six months ended June 30, 2022 is an $11.6 million loss on impairment of goodwill (See the section titled, “ Note 4 – Summary of Significant Accounting Policies ”). We expect to continue to incur operating losses for at least the next several years. As of June 30, 2023 , we had an accumulated deficit of $835.2 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 six months ended June 30, 2022 , we sold 22,745 shares of our common stock under the ATM Program $1.2 million. For the three and six months ended June 30, 2023 , we did not Note 8 – 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 August 7, 2023 , we have sold substantially all 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 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. On April 20, 2023, we entered into an underwriting agreement with Ladenburg as the sole underwriter relating to a public offering, or the April 2023 Offering, of an aggregate of 3,686,006 units with each unit consisting of one share of common stock and a $2.93 per share and expire five years from the date of issuance. The shares of common stock and the April 2023 Warrants were immediately separable and were issued separately in the April 2023 Offering. In addition, Ladenburg exercised in full a 45-day option, or the Overallotment Option, to purchase up to 552,900 additional shares of common stock and/or warrants to purchase up to 552,900 additional shares of common stock. The closing of the April 2023 Offering occurred on April 24, 2023, inclusive of the Overallotment Option. The offering price to the public was $2.93 per unit resulting in gross proceeds to us of approximately $12.4 million. After deducting underwriting discounts and commissions and other estimated offering expenses payable by us, and excluding the proceeds, if any, from the exercise of the April 2023 Warrants issued pursuant to this April 2023 Offering, the net proceeds to us were approximately $10.8 million. As of June 30, 2023 , we had cash and cash equivalents of $11.5 million and current liabilities of $3.8 million. We believe that we have sufficient resources available to support our development activities and fund our business operations through the first quarter of 2024. However, we do not have sufficient cash and cash equivalents as of the date of this Quarterly Report on Form 10-Q 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 - Summary of Significant
Note 4 - Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2023 | |
Notes to Financial Statements | |
Significant Accounting Policies [Text Block] | Note 4 – Summary of Significant Accounting Policies Principles of Consolidation The interim unaudited condensed consolidated financial statements are prepared in accordance with US GAAP and include accounts of Windtree Therapeutics, Inc. and its wholly owned subsidiaries, CVie Investments Limited and its wholly owned subsidiary, CVie Therapeutics Limited; 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. During the three and six months ended June 30, 2023 , no events or changes in circumstances occurred indicating that our IPR&D intangible assets were more likely than not impaired. 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 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 amount, 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. Since early 2022, we have experienced a declining trend in the closing share price of our common stock, on a split-adjusted basis. During each of the first and second quarters of 2023, 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 interim goodwill impairment test consistent with the methodology that we use when performing our annual goodwill impairment assessment and determined that the fair value of our reporting unit was more likely than not less than its carrying value. W e recorded a loss on impairment of goodwill of million in the first quarter of 2023 and an additional loss of $2.6 million, representing the remaining balance of goodwill, in the second quarter of 2023. For the six months ended June 30, 2023 , the aggregate loss on impairment of goodwill is $3.1 million, recognized within operating expenses in our condensed consolidated statements of operations. As of June 30, 2023 , goodwill was written down to zero on our condensed consolidated balances sheet. The following table represents identifiable intangible assets and goodwill as of June 30, 2023 and December 31, 2022 : June 30, December 31, (in thousands) 2023 2022 Istaroxime drug candidate $ 22,340 $ 22,340 Rostafuroxin drug candidate 2,910 2,910 Intangible assets 25,250 25,250 Goodwill $ - $ 3,058 Foreign Currency Transactions The functional currency for our foreign subsidiaries is U.S. Dollars. 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 other income, net . Foreign currency transactions resulted in net gains of approximately $0.1 million and $0.2 million for the three-month periods ended June 30, 2023 and 2022 , respectively. $0.1 million and $0.4 million for the six -month periods ended June 30, 2023 and 2022 , respectively. 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, including intangible assets and goodwill, at the date of the financial statements and the reported amounts of 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 three and six months ended June 30, 2023 or the year ended December 31, 2022 . Severance In June 2023, we implemented certain reductions in headcount. The total severance cost for impacted employees is approximately $0.2 million, which was accrued at the date of the separations and will be paid ratably through December 2023. We incurred approximately $0.2 million of expense related to these severance arrangements during the three months ended June 30, 2023 , which is included in research and development expense. The related liability as of June 30, 2023 is approximately $0.2 million and is included as part of accrued expenses. In January 2022, in order to focus our resources on the development of our istaroxime program, we began to reduce costs related to KL4 surfactant that were not already transferred to our licensee, Lee’s Pharmaceutical (HK) Ltd., or Lee’s (HK), and 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. 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 active pharmaceutical ingredients 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 30, 2022. We incurred approximately $0.3 million of expense related to these severance arrangements during the six months ended June 30, 2022 , which was included in research and development expense. The related liability as of June 30, 2022 was $0.2 million and was included as part of accrued expenses. All amounts due were paid in 2022. 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 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 six months ended June 30, 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 7 – Restructured Debt Liability ”), we 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 the Exchange and Termination Agreement, between ourselves and affiliates of Deerfield Management Company L.P., or Deerfield. The liability was 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. 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 Accounting Standards Codification, or ASC, Topic 730, Research and Development 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. 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. As of June 30, 2023 and 2022 , the number of shares of common stock potentially issuable upon the exercise of certain stock options and warrants, as well as the vesting of restricted stock units, was 4.8 million and 0.4 million shares, respectively. For the three and six months ended June 30, 2023 and 2022 , all potentially dilutive securities were anti-dilutive and therefore have been excluded from the computation of diluted net loss per share. We do not have any components of other comprehensive (loss) income. Recent Accounting Pronouncements In May 2021, the Financial Accounting Standards Board issued Accounting Standards Update, or ASU, 2021-04, Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options |
Note 5 - Fair Value Measurement
Note 5 - Fair Value Measurements | 6 Months Ended |
Jun. 30, 2023 | |
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 for the periods presented: Fair Value Fair value measurement using June 30, (in thousands) 2023 Level 1 Level 2 Level 3 Cash equivalents: Money market funds $ 10,362 $ 10,362 $ - $ - Total Assets $ 10,362 $ 10,362 $ - $ - 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 on a Non-Recurring Basis Certain of our assets were measured at fair value on a non-recurring basis during the six months ended June 30, 2023 and the year ended December 31, 2022 . 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. Our goodwill was also recorded at its estimated fair value as a result of the impairment tests performed in 2022 and during the six months ended June 30, 2023 , which resulted in the goodwill being written down to zero as of June 30, 2023 . (See the section titled, “ Note 4 – Summary of Significant Accounting Policies – 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 both periods. |
Note 6 - Loans Payable
Note 6 - Loans Payable | 6 Months Ended |
Jun. 30, 2023 | |
Notes to Financial Statements | |
Short-Term Debt [Text Block] | Note 6 – Loans Payable In June 2023, we entered into an insurance premium financing and security agreement with IPFS Corporation. Under the agreement, we financed $0.8 million of certain premiums at a 7.24% fixed annual interest rate. Payments of approximately $77,000 are due monthly from July 2023 through March 2024. As of June 30, 2023 , the outstanding principal of the loan was $0.7 million. In June 2022, we entered into an insurance premium financing and security agreement with 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 were due monthly from July 2022 through March 2023. As of December 31, 2022, the outstanding principal of the loan was $0.3 million. The balance of the loan was repaid during the first quarter of 2023. |
Note 7 - Restructured Debt Liab
Note 7 - Restructured Debt Liability | 6 Months Ended |
Jun. 30, 2023 | |
Notes to Financial Statements | |
Long-Term Debt [Text Block] | Note 7 – 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, 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 (See the section titled, “ Note 4 – Summary of Significant Accounting Policies ”). The liability was 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 June 30, 2023 and December 31, 2022 , the restructured debt liability balance was $15.0 million. |
Note 8 - Mezzanine Equity and S
Note 8 - Mezzanine Equity and Stockholders' Equity | 6 Months Ended |
Jun. 30, 2023 | |
Notes to Financial Statements | |
Equity [Text Block] | Note 8 – Mezzanine Equity and Stockholders’ Equity April 2023 Public Offering On April 20, 2023, we commenced the April 2023 Offering for a public offering of an aggregate of 3,686,006 units with each unit consisting of one share of common stock and a warrant, or the April 2023 Warrants. The April 2023 Warrants are immediately exercisable for shares of common stock at a price of $2.93 per share and expire five years from the date of issuance. The shares of common stock and the April 2023 Warrants were immediately separable and were issued separately in the April 2023 Offering. In addition, Ladenburg exercised in full the Overallotment Option to purchase up to 552,900 additional shares of common stock and/or warrants to purchase up to 552,900 additional shares of common stock. The closing of the April 2023 Offering occurred on April 24, 2023, inclusive of the Overallotment Option. The offering price to the public was $2.93 per unit resulting in gross proceeds to us of approximately $12.4 million. After deducting underwriting discounts and commissions and other estimated offering expenses payable by us, and excluding the proceeds, if any, from the exercise of the April 2023 Warrants issued pursuant to this April 2023 Offering, the net proceeds to us were approximately $10.8 million. We have determined that the appropriate accounting treatment under ASC 480, Distinguishing Liabilities from Equity, or ASC 480, is to classify the shares of common stock and the April 2023 Warrants issued in the April 2023 Offering as equity. We have also determined that the April 2023 Warrants are not in their entirety a derivative under the scope of ASC 815, Derivatives and Hedging, or ASC 815, due to the scope exception under ASC 815-10-15-74, nor are there any material embedded derivatives that require separate accounting. We allocated the net proceeds from the April 2023 Offering based on the relative fair value of the common stock and the April 2023 Warrants. 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 and net proceeds of approximately $1.0 million and $0.7 million, respectively, 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. The amendment of the January 2023 Existing Warrants by lowering the exercise price and issuing the January 2023 New Warrants is considered a modification of the January 2023 Existing Warrants under the guidance of ASU 2021-04. The modification is consistent with the “Equity Issuance” classification under that guidance as the reason for the modification was to induce the holders of the January 2023 Existing Warrants to cash exercise their warrants, resulting in the imminent exercise of the January 2023 Existing Warrants, which raised equity capital and generated net proceeds for us of approximately $0.7 million. The total fair value of the consideration of the modification includes the incremental fair value of the January 2023 Existing Warrants (determined by comparing the fair value immediately prior to and immediately after the modification) and the initial fair value of the January 2023 New Warrants. The fair values were calculated using the Black-Scholes model and we determined that the total fair value of the consideration related to the modification of the January 2023 Existing Warrants, including the initial fair value of the January 2023 New Warrants, was $1.2 million. February 2023 Warrant Exercise Inducement Offer Letter On February 21, 2023, we entered into a warrant exercise inducement offer letter with Panacea Venture Healthcare Fund I, L.P., a holder 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, Panacea 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 Panacea 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 and net proceeds of approximately $0.2 million and $0.1 million, respectively, from the exercise of the February 2023 Existing Warrants by Panacea. 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. The amendment of the February 2023 Existing Warrants by lowering the exercise price and issuing the February 2023 New Warrants is considered a modification of the February 2023 Existing Warrants under the guidance of ASU 2021-04. The modification is consistent with the “Equity Issuance” classification under that guidance as the reason for the modification was to induce Panacea to cash exercise their warrants, resulting in the imminent exercise of the February 2023 Existing Warrants, which raised equity capital and generated net proceeds for us of approximately $0.1 million. The total fair value of the consideration of the modification includes the incremental fair value of the February 2023 Existing Warrants (determined by comparing the fair value immediately prior to and immediately after the modification) and the initial fair value of the February 2023 New Warrants. The fair values were calculated using the Black-Scholes model and we determined that the total fair value of the consideration related to the modification of the February 2023 Existing Warrants, including the initial fair value of the February 2023 New Warrants, was $0.3 million. 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 were 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 through 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 of 1933, as amended, 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 six months ended June 30, 2022 , we sold 22,745 shares of our common stock under the ATM Program $1.2 million . For the three and six months ended June 30, 2023 , we did not 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 our public float during any 12-month period, and as of August 7, 2023 , we have sold substantially all 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 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. |
Note 9 - Stock-based Compensati
Note 9 - Stock-based Compensation | 6 Months Ended |
Jun. 30, 2023 | |
Notes to Financial Statements | |
Share-Based Payment Arrangement [Text Block] | Note 9 – Stock-Based Compensation We recognize expense in our interim unaudited condensed consolidated financial statements related to all stock-based awards granted to employees and non-employee directors based on their fair value on the date of grant. Compensation expense related to stock options is calculated using the Black-Scholes option-pricing model and is recognized ratably over the vesting period, which is typically three one three A summary of activity under our long-term incentive plans is presented below: (in thousands, except for weighted-average data) Stock Options Shares Weighted- Average Exercise Price Weighted- Average Remaining Contractual Term (In Yrs) Outstanding at January 1, 2023 78 $ 381.00 Forfeited or expired (10 ) 299.70 Outstanding at June 30, 2023 68 $ 381.92 6.8 Vested and exercisable at June 30, 2023 53 $ 447.82 6.5 Vested and expected to vest at June 30, 2023 66 $ 382.01 6.8 (in thousands, except for weighted-average data) Restricted Stock Units Shares Weighted- Average Grant Date Fair Value Outstanding at January 1, 2023 11 $ 49.50 Vested (3 ) 48.55 Cancelled (2 ) 48.85 Outstanding at June 30, 2023 6 $ 50.55 The table below summarizes the total stock-based compensation expense included in the interim unaudited condensed consolidated statements of operations for the periods presented: Three Months Ended June 30, Six Months Ended June 30, (in thousands) 2023 2022 2023 2022 Research and development $ 58 $ 147 $ 187 $ 382 General and administrative 324 634 480 1,169 Total $ 382 $ 781 $ 667 $ 1,551 The fair value of each option award is estimated on the date of grant 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 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. Six Months Ended June 30, 2022 Weighted average expected volatility 106 % Weighted average expected term (in years) 6.9 Weighted average risk-free interest rate 1.70 % Expected dividends - |
Note 10 - Licensing and Researc
Note 10 - Licensing and Research Funding Agreements | 6 Months Ended |
Jun. 30, 2023 | |
Notes to Financial Statements | |
Corporate Partnership, Licensing and Research Funding Agreements [Text Block] | Note 10 – Licensing and Research Funding Agreements Term Sheet with Lee’s (HK) In March 2020, we entered into a Term Sheet with Lee’s (HK), pursuant to which Lee’s (HK) provided financing for the development of AEROSURF. In August 2020, we entered into a Project Financing Agreement with Lee’s (HK), or the PF Agreement, formalizing the terms of the Term Sheet, and under which we received payments totaling $2.8 million through October 2020. In November 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 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 were due under the PF Agreement. 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 June 30, 2023 , the liability balance related to the payments under the PF Agreement was $3.8 million and is recorded in other liabilities. A&R License Agreement with Lee s (HK) Previously, we were developing a 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 program, 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 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. 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. |
Significant Accounting Policies
Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2023 | |
Accounting Policies [Abstract] | |
Consolidation, Policy [Policy Text Block] | Principles of Consolidation The interim unaudited condensed consolidated financial statements are prepared in accordance with US GAAP and include accounts of Windtree Therapeutics, Inc. and its wholly owned subsidiaries, CVie Investments Limited and its wholly owned subsidiary, CVie Therapeutics Limited; 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. During the three and six months ended June 30, 2023 , no events or changes in circumstances occurred indicating that our IPR&D intangible assets were more likely than not impaired. 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 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 amount, 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. Since early 2022, we have experienced a declining trend in the closing share price of our common stock, on a split-adjusted basis. During each of the first and second quarters of 2023, 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 interim goodwill impairment test consistent with the methodology that we use when performing our annual goodwill impairment assessment and determined that the fair value of our reporting unit was more likely than not less than its carrying value. W e recorded a loss on impairment of goodwill of million in the first quarter of 2023 and an additional loss of $2.6 million, representing the remaining balance of goodwill, in the second quarter of 2023. For the six months ended June 30, 2023 , the aggregate loss on impairment of goodwill is $3.1 million, recognized within operating expenses in our condensed consolidated statements of operations. As of June 30, 2023 , goodwill was written down to zero on our condensed consolidated balances sheet. The following table represents identifiable intangible assets and goodwill as of June 30, 2023 and December 31, 2022 : June 30, December 31, (in thousands) 2023 2022 Istaroxime drug candidate $ 22,340 $ 22,340 Rostafuroxin drug candidate 2,910 2,910 Intangible assets 25,250 25,250 Goodwill $ - $ 3,058 |
Foreign Currency Transactions and Translations Policy [Policy Text Block] | Foreign Currency Transactions The functional currency for our foreign subsidiaries is U.S. Dollars. 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 other income, net . Foreign currency transactions resulted in net gains of approximately $0.1 million and $0.2 million for the three-month periods ended June 30, 2023 and 2022 , respectively. $0.1 million and $0.4 million for the six -month periods ended June 30, 2023 and 2022 , respectively. |
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, including intangible assets and goodwill, at the date of the financial statements and the reported amounts of 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 three and six months ended June 30, 2023 or the year ended December 31, 2022 . |
Severance Cost [Policy Text Block] | Severance In June 2023, we implemented certain reductions in headcount. The total severance cost for impacted employees is approximately $0.2 million, which was accrued at the date of the separations and will be paid ratably through December 2023. We incurred approximately $0.2 million of expense related to these severance arrangements during the three months ended June 30, 2023 , which is included in research and development expense. The related liability as of June 30, 2023 is approximately $0.2 million and is included as part of accrued expenses. In January 2022, in order to focus our resources on the development of our istaroxime program, we began to reduce costs related to KL4 surfactant that were not already transferred to our licensee, Lee’s Pharmaceutical (HK) Ltd., or Lee’s (HK), and 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. 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 active pharmaceutical ingredients 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 30, 2022. We incurred approximately $0.3 million of expense related to these severance arrangements during the six months ended June 30, 2022 , which was included in research and development expense. The related liability as of June 30, 2022 was $0.2 million and was included as part of accrued expenses. All amounts due were paid in 2022. |
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 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 six months ended June 30, 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 7 – Restructured Debt Liability ”), we 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 the Exchange and Termination Agreement, between ourselves and affiliates of Deerfield Management Company L.P., or Deerfield. The liability was 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. |
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 Accounting Standards Codification, or ASC, Topic 730, Research and Development |
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. |
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. As of June 30, 2023 and 2022 , the number of shares of common stock potentially issuable upon the exercise of certain stock options and warrants, as well as the vesting of restricted stock units, was 4.8 million and 0.4 million shares, respectively. For the three and six months ended June 30, 2023 and 2022 , all potentially dilutive securities were anti-dilutive and therefore have been excluded from the computation of diluted net loss per share. We do not have any components of other comprehensive (loss) income. |
New Accounting Pronouncements, Policy [Policy Text Block] | Recent Accounting Pronouncements In May 2021, the Financial Accounting Standards Board issued Accounting Standards Update, or ASU, 2021-04, Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options |
Note 4 - Summary of Significa_2
Note 4 - Summary of Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Notes Tables | |
Schedule of Intangible Assets and Goodwill [Table Text Block] | June 30, December 31, (in thousands) 2023 2022 Istaroxime drug candidate $ 22,340 $ 22,340 Rostafuroxin drug candidate 2,910 2,910 Intangible assets 25,250 25,250 Goodwill $ - $ 3,058 |
Note 5 - Fair Value Measureme_2
Note 5 - Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Notes Tables | |
Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis [Table Text Block] | Fair Value Fair value measurement using June 30, (in thousands) 2023 Level 1 Level 2 Level 3 Cash equivalents: Money market funds $ 10,362 $ 10,362 $ - $ - Total Assets $ 10,362 $ 10,362 $ - $ - 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 $ - $ - |
Note 9 - Stock-based Compensa_2
Note 9 - Stock-based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Notes Tables | |
Disclosure of Share-Based Compensation Arrangements by Share-Based Payment Award [Table Text Block] | (in thousands, except for weighted-average data) Stock Options Shares Weighted- Average Exercise Price Weighted- Average Remaining Contractual Term (In Yrs) Outstanding at January 1, 2023 78 $ 381.00 Forfeited or expired (10 ) 299.70 Outstanding at June 30, 2023 68 $ 381.92 6.8 Vested and exercisable at June 30, 2023 53 $ 447.82 6.5 Vested and expected to vest at June 30, 2023 66 $ 382.01 6.8 |
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, 2023 11 $ 49.50 Vested (3 ) 48.55 Cancelled (2 ) 48.85 Outstanding at June 30, 2023 6 $ 50.55 |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Table Text Block] | Three Months Ended June 30, Six Months Ended June 30, (in thousands) 2023 2022 2023 2022 Research and development $ 58 $ 147 $ 187 $ 382 General and administrative 324 634 480 1,169 Total $ 382 $ 781 $ 667 $ 1,551 |
Schedule of Share-Based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | Six Months Ended June 30, 2022 Weighted average expected volatility 106 % Weighted average expected term (in years) 6.9 Weighted average risk-free interest rate 1.70 % Expected dividends - |
Note 2 - Basis of Presentation
Note 2 - Basis of Presentation (Details Textual) | Feb. 24, 2023 |
Reverse Stock Split [Member] | |
Stockholders' Equity Note, Stock Split, Conversion Ratio | 50 |
Note 3 - Going Concern and Ma_2
Note 3 - Going Concern and Management's Plans (Details Textual) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | |||||||
Apr. 24, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | Sep. 17, 2020 | |
Net Income (Loss) Attributable to Parent | $ (6,601) | $ (4,111) | $ (17,333) | $ (8,127) | $ (10,712) | $ (25,460) | |||
Goodwill, Impairment Loss | 2,574 | $ 500 | $ 11,636 | 3,058 | 11,636 | ||||
Retained Earnings (Accumulated Deficit) | (835,244) | (835,244) | $ (824,532) | ||||||
Proceeds from Issuance of Common Stock | 0 | $ 1,225 | |||||||
Equity Issued During Period, Units, New Issues (in shares) | 3,686,006 | ||||||||
Units, Number of Warrants Called by Each Unit (in shares) | 1 | ||||||||
Units, Number of Securities Called by Each Unit (in shares) | 1 | ||||||||
Shares Issued, Price Per Share (in dollars per share) | $ 2.93 | ||||||||
Proceeds from Issuance or Sale of Equity, Gross | $ 12,400 | ||||||||
Proceeds from Issuance or Sale of Equity | $ 10,800 | ||||||||
Cash and Cash Equivalents, at Carrying Value | 11,467 | 11,467 | 6,172 | ||||||
Liabilities, Current | $ 3,794 | $ 3,794 | $ 2,457 | ||||||
April 2023 Warrant [Member] | |||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 2.93 | ||||||||
Warrants and Rights Outstanding, Term (Year) | 5 years | ||||||||
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) | 0 | 0 | 0 | 22,745 | |||||
Proceeds from Issuance of Common Stock | $ 1,200 | ||||||||
Over-Allotment Option [Member] | |||||||||
Overallotment, Potential Issuable Shares (in shares) | 552,900 | ||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 552,900 |
Note 4 - Summary of Significa_3
Note 4 - Summary of Significant Accounting Policies (Details Textual) $ in Thousands, shares in Millions | 3 Months Ended | 6 Months Ended | 9 Months Ended | ||||||
Jun. 30, 2023 USD ($) shares | Mar. 31, 2023 USD ($) | Jun. 30, 2022 USD ($) shares | Mar. 31, 2022 USD ($) | Jun. 30, 2023 USD ($) shares | Jun. 30, 2022 USD ($) shares | Sep. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) | Nov. 01, 2017 USD ($) | |
Number of Reporting Units | 1 | ||||||||
Goodwill, Impairment Loss | $ 2,574 | $ 500 | $ 11,636 | $ 3,058 | $ 11,636 | ||||
Goodwill | 0 | 0 | $ 3,058 | ||||||
Foreign Currency Transaction Gain, before Tax | 100 | 200 | 100 | 400 | |||||
Severance Costs | 200 | 300 | $ 400 | ||||||
Supplemental Unemployment Benefits, Severance Benefits | 200 | $ 200 | 200 | 200 | |||||
Depreciation | 46 | $ 488 | |||||||
Liability for Contingent Milestone Payment, Noncurrent | $ 15,000 | $ 15,000 | $ 15,000 | ||||||
Number of Shares of Common Stock Potentially Issuable upon the Exercise of Stock Options and Warrants (in shares) | shares | 4.8 | 0.4 | 4.8 | 0.4 | |||||
Deerfield Loan [Member] | Exchange and Termination Agreement [Member] | Deerfield Management, L.P. [Member] | |||||||||
Liability for Contingent Milestone Payment, Noncurrent | $ 15,000 | ||||||||
Manufacturing and Laboratory Equipment [Member] | |||||||||
Depreciation | $ 400 | ||||||||
Minimum [Member] | |||||||||
Property, Plant and Equipment, Useful Life (Year) | 3 years | 3 years | |||||||
Maximum [Member] | |||||||||
Property, Plant and Equipment, Useful Life (Year) | 10 years | 10 years |
Note 4 - Summary of Significa_4
Note 4 - Summary of Significant Accounting Policies - Intangible Assets (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Intangible assets | $ 25,250 | $ 25,250 |
Goodwill | 0 | 3,058 |
Istaroxime Drug Candidate [Member] | ||
Intangible assets | 22,340 | 22,340 |
Rostafuroxin Drug Candidate [Member] | ||
Intangible assets | $ 2,910 | $ 2,910 |
Note 5 - Fair Value Measureme_3
Note 5 - Fair Value Measurements (Details Textual) $ in Thousands | Jun. 30, 2023 USD ($) | Dec. 31, 2022 USD ($) |
Goodwill | $ 0 | $ 3,058 |
Measurement Input, Discount Rate [Member] | ||
Indefinite Lived Intangible Assets, Measurement Input | 0.200 | |
Measurement Input, Tax Rate [Member] | ||
Indefinite Lived Intangible Assets, Measurement Input | 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 | Jun. 30, 2023 | Dec. 31, 2022 |
Total Assets | $ 10,362 | $ 4,212 |
Fair Value, Inputs, Level 1 [Member] | ||
Total Assets | 10,362 | 4,212 |
Money Market Funds [Member] | ||
Cash equivalents | 10,362 | 4,212 |
Money Market Funds [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Cash equivalents | $ 10,362 | $ 4,212 |
Note 6 - Loans Payable (Details
Note 6 - Loans Payable (Details Textual) - USD ($) | 1 Months Ended | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | |
Loans Payable With IPFS Corporation [Member] | |||
Debt Instrument, Face Amount | $ 800,000 | ||
Debt Instrument, Interest Rate, Stated Percentage | 7.24% | ||
Debt Instrument, Periodic Payment | $ 77,000 | ||
Loans Payable to Bank | $ 700,000 | ||
Loan payable to Bank Direct Capital Finance [Member] | Loans Payable [Member] | |||
Debt Instrument, Face Amount | $ 1,100,000 | ||
Debt Instrument, Interest Rate, Stated Percentage | 3.90% | ||
Debt Instrument, Periodic Payment | $ 126,000 | ||
Loans Payable to Bank | $ 300,000 |
Note 7 - Restructured Debt Li_2
Note 7 - Restructured Debt Liability (Details Textual) - USD ($) $ / shares in Units, $ in Millions | Oct. 27, 2017 | Jun. 30, 2023 | Dec. 31, 2022 |
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 8 - Mezzanine Equity and_2
Note 8 - Mezzanine Equity and Stockholders' Equity (Details Textual) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||||||||
Apr. 24, 2023 USD ($) $ / shares shares | Feb. 21, 2023 USD ($) $ / shares shares | Jan. 20, 2023 USD ($) $ / shares shares | Nov. 17, 2022 $ / shares shares | Sep. 17, 2020 USD ($) | Jun. 30, 2023 $ / shares shares | Mar. 31, 2023 USD ($) shares | Jun. 30, 2023 USD ($) $ / shares shares | Jun. 30, 2022 USD ($) shares | Dec. 31, 2022 $ / shares shares | |
Equity Issued During Period, Units, New Issues (in shares) | 3,686,006 | |||||||||
Units, Number of Warrants Called by Each Unit (in shares) | 1 | |||||||||
Units, Number of Securities Called by Each Unit (in shares) | 1 | |||||||||
Shares Issued, Price Per Share (in dollars per share) | $ / shares | $ 2.93 | |||||||||
Proceeds from Issuance or Sale of Equity, Gross | $ | $ 12,400 | |||||||||
Proceeds from Issuance or Sale of Equity | $ | $ 10,800 | |||||||||
Stock Issued During Period, Value, Exercise Of Warrants | $ | $ 843 | |||||||||
Proceeds from Warrant Exercises | $ | $ 843 | $ 0 | ||||||||
Preferred Stock, Shares Authorized (in shares) | 5,000,000 | 5,000,000 | 5,000,000 | 4,960,000 | ||||||
Preferred Stock, Par or Stated Value Per Share (in dollars per share) | $ / shares | $ 0.001 | $ 0.001 | $ 0.001 | $ 0.001 | ||||||
Proceeds from Issuance of Common Stock | $ | $ 0 | $ 1,225 | ||||||||
Series A Preferred Stock [Member] | ||||||||||
Preferred Stock, Shares Authorized (in 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) | 38,610 | |||||||||
Preferred Stock, Convertible, Conversion Price (in dollars per share) | $ / shares | $ 0.01 | |||||||||
Over-Allotment Option [Member] | ||||||||||
Overallotment, Potential Issuable Shares (in shares) | 552,900 | |||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 552,900 | |||||||||
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) | 0 | 0 | 0 | 22,745 | ||||||
Proceeds from Issuance of Common Stock | $ | $ 1,200 | |||||||||
April 2023 Warrant [Member] | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ / shares | $ 2.93 | |||||||||
Warrants and Rights Outstanding, Term (Year) | 5 years | |||||||||
December 2019 Warrants [Member] | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ / shares | $ 604.50 | $ 604.50 | ||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 5,519 | 1,573 | ||||||||
May 2020 Warrants [Member] | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ / shares | $ 398.75 | $ 398.75 | ||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 5,517 | 5,598 | ||||||||
March 2021 Warrants [Member] | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ / shares | $ 180 | |||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 89,001 | |||||||||
January 2023 Existing Warrants [Member] | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ / shares | $ 10 | |||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 96,172 | |||||||||
Stock Issued During Period, Value, Exercise Of Warrants | $ | $ 1,000 | |||||||||
Proceeds from Warrant Exercises | $ | 700 | |||||||||
Fair Value of Warrant Modifications Related to Warrant Exercise Inducement | $ | $ 1,200 | $ 1,238 | 0 | |||||||
January 2023 Existing Warrants [Member] | Ladenburg [Member] | ||||||||||
Placement Agent Payment, Percent | 8% | |||||||||
Management Fee, Percent | 1% | |||||||||
January 2023 New Warrants [Member] | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ / shares | $ 10.76 | |||||||||
Warrants and Rights Outstanding, Term (Year) | 5 years | |||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 192,344 | |||||||||
July 2018 Warrants [Member] | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ / shares | $ 600 | |||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 1,250 | |||||||||
December 2018 Warrants [Member] | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ / shares | $ 607.50 | |||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 9,960 | |||||||||
February 2023 Existing Warrants [Member] | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ / shares | $ 7.06 | |||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 22,246 | |||||||||
Stock Issued During Period, Value, Exercise Of Warrants | $ | $ 200 | |||||||||
Proceeds from Warrant Exercises | $ | 100 | |||||||||
Fair Value of Warrant Modifications Related to Warrant Exercise Inducement | $ | $ 300 | $ 274 | $ 0 | |||||||
February 2023 Existing Warrants [Member] | Ladenburg [Member] | ||||||||||
Placement Agent Payment, Percent | 8% | |||||||||
Management Fee, Percent | 1% | |||||||||
February 2023 New Warrants [Member] | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ / shares | $ 10.76 | |||||||||
Warrants and Rights Outstanding, Term (Year) | 5 years | |||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 44,492 |
Note 9 - Stock-based Compensa_3
Note 9 - Stock-based Compensation (Details Textual) | 6 Months Ended |
Jun. 30, 2023 | |
Restricted Stock Units (RSUs) [Member] | Minimum [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award, Award Requisite Service Period (Year) | 1 year |
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, Award Requisite Service Period (Year) | 3 years |
Note 9 - Stock-based Compensa_4
Note 9 - Stock-based Compensation - Summary Stock Option Activity (Details) shares in Thousands | 6 Months Ended |
Jun. 30, 2023 $ / shares shares | |
Shares Outstanding, Beginning Balance (in shares) | shares | 78 |
Weighted Average Exercise Price, Outstanding, at Beginning Period (in dollars per share) | $ / shares | $ 381 |
Shares Forfeited or Expired (in shares) | shares | (10) |
Weighted Average Exercise Price, Forfeited or Expired (in dollars per share) | $ / shares | $ 299.70 |
Shares Outstanding, Ending Balance (in shares) | shares | 68 |
Weighted Average Exercise Price, Outstanding, at Ending Period (in dollars per share) | $ / shares | $ 381.92 |
Weighted Average Remaining Contractual Life, Outstanding (Year) | 6 years 9 months 18 days |
Shares Vested and Exercisable (in shares) | shares | 53 |
Weighted Average Exercise Price, Vested and Exercisable (in dollars per share) | $ / shares | $ 447.82 |
Weighted Average Remaining Contractual Life, Vested and Exercisable (Year) | 6 years 6 months |
Vested and expected to vest (in shares) | shares | 66 |
Weighted Average Exercise Price, Vested and Expected to Vest (in dollars per share) | $ / shares | $ 382.01 |
Weighted Average Remaining Contractual Life, Vested and Expected to Vest (Year) | 6 years 9 months 18 days |
Note 9 - Stock-based Compensa_5
Note 9 - Stock-based Compensation - Restricted Stock Units (Details) - Restricted Stock Units (RSUs) [Member] shares in Thousands | 6 Months Ended |
Jun. 30, 2023 $ / shares shares | |
Balance (in shares) | shares | 11 |
Weighted- Average Grant Date Fair Value, Outstanding, Beginning Balance (in dollars per share) | $ / shares | $ 49.50 |
Vested (in shares) | shares | (3) |
Vested Weighted- Average Grant Date Fair Value, Outstanding (in dollars per share) | $ / shares | $ 48.55 |
Cancelled (in shares) | shares | (2) |
Cancelled, Weighted- Average Grant Date Fair Value, Outstanding (in dollars per share) | $ / shares | $ 48.85 |
Balance (in shares) | shares | 6 |
Weighted- Average Grant Date Fair Value, Outstanding (in dollars per share) | $ / shares | $ 50.55 |
Note 9 - Stock-based Compensa_6
Note 9 - Stock-based Compensation - Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Stock-based compensation expense | $ 382 | $ 781 | $ 667 | $ 1,551 |
Research and Development Expense [Member] | ||||
Stock-based compensation expense | 58 | 147 | 187 | 382 |
Selling, General and Administrative Expenses [Member] | ||||
Stock-based compensation expense | $ 324 | $ 634 | $ 480 | $ 1,169 |
Note 9 - Stock-based Compensa_7
Note 9 - Stock-based Compensation - Stock Options Valuation Assumptions (Details) | 6 Months Ended |
Jun. 30, 2023 | |
Weighted average expected volatility | 106% |
Weighted average expected term (Year) | 6 years 10 months 24 days |
Weighted average risk-free interest rate | 1.70% |
Note 10 - Licensing and Resea_2
Note 10 - Licensing and Research Funding Agreements (Details Textual) - USD ($) $ in Millions | 3 Months Ended | 12 Months Ended | ||||
Aug. 17, 2022 | Jun. 30, 2019 | Dec. 31, 2021 | Jun. 30, 2023 | Oct. 31, 2020 | Mar. 18, 2020 | |
AEROSURF Funding Term Sheet [Member] | Lee’s Pharmaceutical Holdings Limited [Member] | ||||||
Nonrefundable Payments, Maximum Financing to Be Received Under Special Circumstances | $ 2.8 | |||||
Term Sheet With Lee [Member] | ||||||
Proceeds for Payments to Develop Product | $ 1 | |||||
Financing of Product, Percent of Financing That Must be Repaid to Discontinue Revenue Sharing | 125% | |||||
Financing of Product, Percent of Revenue Shared With Financer | 50% | |||||
Term Sheet With Lee [Member] | Other Liabilities [Member] | ||||||
Contractual Obligation, Total | $ 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 |