[10-Q] WINDTREE THERAPEUTICS INC /DE/ Quarterly Earnings Report
Windtree Therapeutics (WINT) reported a net loss of $28,085 for the quarter and $42,761 for the nine months ended September 30, 2025, driven largely by a $16,130 impairment of intangible assets. Operating expenses rose sharply to $19,882 in the quarter, reflecting that write-down, while research and development and general and administrative spending remained significant.
Cash and cash equivalents were $204 at quarter end against total liabilities of $27,584 and negative stockholders’ equity of $(11,610), underscoring heavy leverage and dependence on external financing, including convertible notes and an ELOC commitment note.
The company adopted a new strategy to generate revenue via acquisitions of small companies with FDA-approved products and entered manufacturing arrangements, while continuing its cardiovascular pipeline with partner Lee’s. It terminated the SEISMiC C cardiogenic shock trial and, after being delisted from Nasdaq in August 2025, now trades on the OTC market.
- None.
- Net losses widened sharply, with a quarterly loss of $28,085 and nine‑month loss of $42,761, significantly above prior‑year levels.
- Large non-cash impairment of intangible assets of $16,130 in Q3 2025 reduced asset values and contributed heavily to the period’s loss.
- Very limited cash versus liabilities, with $204 of cash and cash equivalents against $27,584 of total liabilities and negative equity of $(11,610).
- Heavy dependence on complex financing, including convertible notes, an ELOC commitment note, derivative liabilities and preferred stock history, rather than operating cash flow.
- Delisting from Nasdaq in August 2025, with the stock now trading on OTCID, may reduce liquidity and visibility for shareholders.
- Termination of the SEISMiC C cardiogenic shock trial halts development in that more severe segment, narrowing near-term clinical optionality.
Insights
Large loss, asset impairment, thin cash, and delisting increase risk.
Windtree Therapeutics posted a quarterly net loss of
On the balance sheet, cash and cash equivalents of only
Operationally, the company is pivoting toward acquiring FDA‑approved products and acting as a manufacturing sourcing agent while continuing its cardiovascular pipeline via partnerships. It terminated the SEISMiC C cardiogenic shock study and its common stock was delisted from Nasdaq on
Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
| | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
or
| | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from _____ to _____
Commission File Number:
WINDTREE THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
| (State or other jurisdiction of incorporation or organization) | (I.R.S. Employer |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including area code: (
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading symbol(s) | Name of each exchange on which registered |
| | | OTCID |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| Large accelerated filer ☐ | Accelerated filer ☐ |
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| Emerging growth company |
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes
As of November 14, 2025, there were
Table of Contents
PART I - FINANCIAL INFORMATION
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Financial Statements |
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CONDENSED CONSOLIDATED BALANCE SHEETS |
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As of September 30, 2025 (unaudited) and December 31, 2024 |
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) |
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For the Three and Nine Months Ended September 30, 2025 and 2024 |
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CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN MEZZANINE EQUITY AND STOCKHOLDERS’ EQUITY (unaudited) For the Three and Nine Months Ended September 30, 2025 and 2024 |
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CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited) |
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For the Nine Months Ended September 30, 2025 and 2024 |
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Notes to Condensed Consolidated Financial Statements (unaudited) |
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Management’s Discussion and Analysis of Financial Condition and Results of Operations |
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Quantitative and Qualitative Disclosures about Market Risk |
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Controls and Procedures |
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PART II - OTHER INFORMATION
| Item 1. |
Legal Proceedings |
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Risk Factors |
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Unregistered Sales of Equity Securities and Use of Proceeds |
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| Item 3. |
Defaults Upon Senior Securities |
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| Item 4. |
Mine Safety Disclosures |
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| Item 5. |
Other Information |
56 |
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| Item 6. |
Exhibits |
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| Signatures |
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Unless the context otherwise requires, all references to “we,” “us,” “our,” and the “Company” include Windtree Therapeutics, Inc., and its consolidated subsidiaries.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. These forward-looking statements provide our current expectations or forecasts of future events and financial performance and may be identified by the use of forward-looking terminology, including such terms as “anticipates,” “believes,” “contemplates,” “continues,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “targets,” or “will” or, in each case, their negative, or other variations or comparable terminology, though the absence of these words does not necessarily mean that a statement is not forward-looking.
We intend that all forward-looking statements be subject to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to many risks and uncertainties that could cause actual results to differ materially from any future results expressed or implied by the forward-looking statements. We caution you therefore against relying on any of these forward-looking statements. They are neither statements of historical fact nor guarantees or assurances of future performance. Examples of such risks and uncertainties, which potentially could have a material adverse effect on our development programs, business and/or operations, include, but are not limited to the following:
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our estimates regarding future results of operations, financial position, research and development costs, capital requirements, and our needs for additional financing; |
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how long we can continue to fund our operations with our existing cash and cash equivalents; |
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| ● | the impact of the delisting of our Common Stock from the Nasdaq Stock Market ("Nasdaq"); | |
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changes in market conditions, general economic conditions, and the banking sector, and potential constraints in accessing capital or credit if and when needed with favorable terms, if at all; |
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the potential impairment of our intangible assets on our condensed consolidated balance sheet, which could lead to material impairment charges in the future; |
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our ability to repay indebtedness; |
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potential delays and uncertainties in our anticipated timelines and milestones and additional costs associated with the impact of the evolving events in the Israel-Gaza region, the ongoing military conflict between Russian and Ukraine, and trade and political tensions between the United States and the People’s Republic of China on our clinical trial operations; |
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the costs, timing, and results, of our preclinical studies and clinical trials, as well as the number of required trials for regulatory approval and the criteria for success in such trials; |
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legal and regulatory developments in the U.S. and foreign countries, including any actions or advice that may affect the design, initiation, timing, continuation, progress or outcome of clinical trials or result in the need for additional clinical trials; |
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the difficulties and expenses associated with obtaining and maintaining regulatory approval of our product candidates, and the indication and labeling under any such approval; |
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risks related to manufacturing active pharmaceutical ingredients, drug product, and other materials we need; |
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delays, interruptions or failures in the manufacture and supply of our product candidates; |
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the plans of our licensee, Lee’s Pharmaceutical (HK) Ltd., and its affiliate, Zhaoke Pharmaceutical (Hefei) Co. Ltd., and their ability to successfully source materials, execute necessary clinical and regulatory activities in a timely manner, if at all, to support development and commercialization of the licensed product candidates; |
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the performance of third parties, both foreign and domestic, upon which we depend, including contract research organizations, contract manufacturing organizations, contract laboratories, and independent contractors; |
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the size and growth of the potential markets for our product candidates, the regulatory requirements in such markets, the rate and degree of market acceptance of our product candidates, and our ability to serve those markets; |
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the success of competing therapies and products that are or may become available; |
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our ability to limit our exposure under product liability lawsuits; |
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our ability to obtain and maintain intellectual property protection for our product candidates; |
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recently enacted and future legislation, including but not limited to, the Inflation Reduction Act of 2022, regarding the healthcare system in the U.S. or the healthcare systems in foreign jurisdictions; |
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our ability to recruit or retain key scientific, commercial or management personnel or to retain our executive officers; |
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our ability to secure electronically stored work product, including clinical data, analyses, research, communications, and other materials necessary to gain regulatory approval of our product candidates, including those acquired from third parties, and assure the integrity, proper functionality, and security of our internal computer and information systems and prevent or avoid cyber-attacks, malicious intrusion, breakdown, destruction, security incidents, data privacy violations, or other significant disruption; |
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economic uncertainty resulting from inflation and interest rate fluctuations, including concerns involving liquidity, defaults or other non-performance by financial institutions; |
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our expectations regarding the use of proceeds from sales under our equity line of credit, if any; |
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economic uncertainty resulting from geopolitical instability, including the ongoing conflict between Russia and Ukraine, the People’s Republic of China and the Republic of China (Taiwan), and the Middle East, including any escalation or expansion; |
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our ability to successfully implement our new business strategy to generate revenue through acquisitions of small companies and their FDA-approved products; and |
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| ● | other risks and uncertainties, including those listed under the caption “Risk Factors.” |
Pharmaceutical, biotechnology, and medical technology companies have suffered significant setbacks conducting clinical trials, even after obtaining promising earlier preclinical and clinical data. In addition, data obtained from clinical trials are susceptible to varying interpretations, which could delay, limit or prevent regulatory approval. After gaining approval of a drug product, pharmaceutical and biotechnology companies face considerable challenges in marketing and distributing their products and may never become profitable.
The forward-looking statements contained in this Quarterly Report on Form 10-Q, or the documents incorporated by reference herein, speak only as of their respective dates. Factors or events that could cause our actual results to differ may emerge from time to time and it is not possible for us to predict them all. Except to the extent required by applicable laws, rules or regulations, we do not undertake any obligation to publicly update any forward-looking statements or to publicly announce revisions to any of the forward-looking statements, whether as a result of new information, future events or otherwise.
You should also read carefully the factors described in the “Risk Factors” included in Part II, Item 1A of this Quarterly Report on Form 10-Q in conjunction with Part I, Item 1A of our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, as supplemented by our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2025 and June 30, 2025, to better understand the significant risks and uncertainties inherent in our business and underlying any forward-looking statements.
Trademark Notice
AEROSURF®, AFECTAIR®, SURFAXIN®, SURFAXIN LS™, WINDTREE THERAPEUTICS® (logo), WINDTREE THERAPEUTICS™, and WINDTREE™ are registered and common law trademarks of Windtree Therapeutics, Inc. (Warrington, PA).
ITEM 1. Financial Statements
WINDTREE THERAPEUTICS, INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
| (in thousands, except share and per share data) |
| September 30, 2025 | December 31, 2024 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | $ | ||||||
| Prepaid expenses and other current assets | ||||||||
| Note receivable, net | ||||||||
| Total current assets | ||||||||
| Property and equipment, net | ||||||||
| Restricted cash | ||||||||
| Operating lease right-of-use assets | ||||||||
| Intangible assets | ||||||||
| Total assets | $ | $ | ||||||
| LIABILITIES, MEZZANINE EQUITY & STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | $ | ||||||
| Accrued expenses | ||||||||
| Operating lease liabilities - current portion | ||||||||
| Convertible notes payable | ||||||||
| ELOC commitment note payable | ||||||||
| Derivative liability - ELOC commitment note | ||||||||
| Common stock warrant liability | ||||||||
| Loans payable | ||||||||
| Other current liabilities | ||||||||
| Total current liabilities | ||||||||
| Operating lease liabilities - non-current portion | ||||||||
| Other liabilities | ||||||||
| Deferred tax liabilities | ||||||||
| Total liabilities | ||||||||
| Mezzanine equity: | ||||||||
| Series B redeemable preferred stock, $0.001 par value; 5,500 shares authorized; 0 shares issued and outstanding at September 30, 2025 and December 31, 2024, respectively | ||||||||
| Series C redeemable preferred stock, $0.001 par value; 18,820 shares authorized; 6 and 11,757 shares issued and outstanding at September 30, 2025 and December 31, 2024, respectively | ||||||||
| Series D redeemable preferred stock, $0.001 par value; 5,000 shares authorized; 4 and 0 shares issued and outstanding at September 30, 2025 and December 31, 2024, respectively | ||||||||
| Total mezzanine equity | ||||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, $0.001 par value; 4,970,680 shares authorized; 0 shares issued and outstanding at September 30, 2025 and December 31, 2024, respectively | ||||||||
| Common stock, $0.001 par value; 120,000,000 shares authorized; 33,634,221 and 256,397 shares issued and 33,634,220 and 256,396 shares outstanding at September 30, 2025 and December 31, 2024, respectively | ||||||||
| Additional paid-in capital | ||||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Treasury stock (at cost); 1 share | ( | ) | ( | ) | ||||
| Total stockholders’ equity | ( | ) | ||||||
| Total liabilities, mezzanine equity & stockholders’ equity | $ | $ | ||||||
| See notes to condensed consolidated financial statements |
WINDTREE THERAPEUTICS, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Operations
(Unaudited)
| (in thousands, except share and per share data) |
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Expenses: | ||||||||||||||||
| Research and development | $ | $ | $ | $ | ||||||||||||
| General and administrative | ||||||||||||||||
| Impairment of intangible assets | ||||||||||||||||
| Total operating expenses | ||||||||||||||||
| Operating loss | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Loss on debt issuances | (14,965 | ) | - | (22,402 | ) | - | ||||||||||
| Gain on debt extinguishment, net | ||||||||||||||||
| Loss on deposit settlement | ( | ) | ( | ) | ||||||||||||
| Change in fair value of convertible notes payable | ||||||||||||||||
| Change in fair value of common stock warrant liability | ||||||||||||||||
| Change in fair value of derivative liabilities | ||||||||||||||||
| Interest income | ||||||||||||||||
| Interest expense | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Other income (expense), net | 204 | (446 | ) | (338 | ) | (563 | ) | |||||||||
| Total other (expense) income, net | ( | ) | ( | ) | ||||||||||||
| Loss before income taxes | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Income tax benefit (expense) | ( | ) | ||||||||||||||
| Net loss | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Extinguishment of Series B preferred stock | ||||||||||||||||
| Dividends on Series C preferred stock | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Dividends on Series D preferred stock | ( | ) | ( | ) | ||||||||||||
| Dividends on warrants | ( | ) | ||||||||||||||
| Net loss attributable to common stockholders | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Net loss per share attributable to common stockholders | ||||||||||||||||
| Basic and diluted | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Weighted average number of common shares outstanding | ||||||||||||||||
| Basic and diluted | ||||||||||||||||
| See notes to condensed consolidated financial statements |
WINDTREE THERAPEUTICS, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Changes in Mezzanine Equity and Stockholders’ Equity
(Unaudited)
| (in thousands) |
| Mezzanine Equity | Stockholders’ Equity | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Series B Preferred Stock | Series C Preferred Stock | Series D Preferred Stock | Common Stock | Treasury Stock | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Shares | Amount | Total | Shares | Amount | Additional Paid-in Capital | Accumulated Deficit | Shares | Amount | Total | |||||||||||||||||||||||||||||||||||||||||||
| Balance - December 31, 2023 | $ | $ | $ | $ | $ | $ | $ | ( | ) | - | $ | ( | ) | $ | ||||||||||||||||||||||||||||||||||||||||||
| Net income | - | - | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||||||||
| Issuance of common stock, ATM Program, net of issuance costs of $44 | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Issuance of common stock, equity consideration in debt extinguishment | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Stock-based compensation expense | - | - | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||||||||
| Balance - March 31, 2024 | $ | $ | $ | $ | $ | $ | $ | ( | ) | - | $ | ( | ) | $ | ||||||||||||||||||||||||||||||||||||||||||
| Net loss | - | - | - | - | ( | ) | - | ( | ) | |||||||||||||||||||||||||||||||||||||||||||||||
| Issuance of preferred stock, net of issuance costs of $68 | 6 | - | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||||||||
| Reverse split adjustments - fractional share round ups | - | - | - | - | - | - | - | - | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||
| Stock-based compensation expense | - | - | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||||||||
| Balance - June 30, 2024 | $ | $ | $ | $ | $ | $ | $ | ( | ) | - | $ | ( | ) | $ | ||||||||||||||||||||||||||||||||||||||||||
| Net loss | - | - | - | - | ( | ) | - | ( | ) | |||||||||||||||||||||||||||||||||||||||||||||||
| ELOC sales, net of issuance costs of $156 | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Exchange of Series B preferred stock | ( | ) | ( | ) | (5,962 | ) | - | |||||||||||||||||||||||||||||||||||||||||||||||||
| Issuance of Series C preferred stock for cash proceeds, net of issuance costs of $172 | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Issuance of Series C preferred stock to extinguish debt | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Issuance of Series C preferred stock as consideration for services | - | - | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||||||||
| Conversions of Series C preferred stock | ( | ) | ( | ) | (154 | ) | - | |||||||||||||||||||||||||||||||||||||||||||||||||
| Redemptions of Series C preferred stock | ( | ) | ( | ) | (74 | ) | ( | ) | - | ( | ) | |||||||||||||||||||||||||||||||||||||||||||||
| Deemed dividends on Series C preferred stock | - | - | - | - | ( | ) | - | ( | ) | |||||||||||||||||||||||||||||||||||||||||||||||
| Deemed cash dividends on Series C preferred stock | - | - | - | - | ( | ) | - | ( | ) | |||||||||||||||||||||||||||||||||||||||||||||||
| Stock-based compensation expense | - | - | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||||||||
| Balance - September 30, 2024 | $ | $ | $ | $ | $ | $ | $ | ( | ) | - | $ | ( | ) | $ | ||||||||||||||||||||||||||||||||||||||||||
| Mezzanine Equity | Stockholders’ Equity | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Series B Preferred Stock | Series C Preferred Stock | Series D Preferred Stock | Common Stock | Treasury Stock | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Shares | Amount | Total | Shares | Amount | Additional Paid-in Capital | Accumulated Deficit | Shares | Amount | Total | |||||||||||||||||||||||||||||||||||||||||||
| Balance - December 31, 2024 | $ | $ | $ | $ | $ | $ | $ | ( | ) | - | $ | ( | ) | $ | ||||||||||||||||||||||||||||||||||||||||||
| Net loss | - | - | - | - | - | ( | ) | - | ( | ) | ||||||||||||||||||||||||||||||||||||||||||||||
| Series C preferred stock conversions | ( | ) | ( | ) | ( | ) | - | |||||||||||||||||||||||||||||||||||||||||||||||||
| Series C preferred stock redemptions | ( | ) | ( | ) | ( | ) | - | ( | ) | |||||||||||||||||||||||||||||||||||||||||||||||
| Deemed dividends on Series C preferred stock | - | - | - | - | - | ( | ) | - | ( | ) | ||||||||||||||||||||||||||||||||||||||||||||||
| Cash dividends on Series C preferred stock | - | - | - | - | - | ( | ) | - | ( | ) | ||||||||||||||||||||||||||||||||||||||||||||||
| Issuance of common stock, ELOC | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Issuance of common stock, equity consideration in debt extinguishment | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Exercise of common stock warrants | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Settlement of common stock warrant liability | - | - | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Stock-based compensation expense | - | - | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Balance - March 31, 2025 | $ | $ | $ | $ | $ | $ | $ | ( | ) | - | $ | ( | ) | $ | ||||||||||||||||||||||||||||||||||||||||||
| Net loss | - | - | - | - | - | ( | ) | - | ( | ) | ||||||||||||||||||||||||||||||||||||||||||||||
| Series C preferred stock conversions | ( | ) | ( | ) | ( | ) | - | |||||||||||||||||||||||||||||||||||||||||||||||||
| Deemed dividends on Series C preferred stock | - | - | - | - | - | ( | ) | - | ( | ) | ||||||||||||||||||||||||||||||||||||||||||||||
| Deemed dividends on warrants | - | - | - | - | - | ( | ) | - | ( | ) | ||||||||||||||||||||||||||||||||||||||||||||||
| Cash dividends on Series C preferred stock | - | - | - | - | - | ( | ) | - | ( | ) | ||||||||||||||||||||||||||||||||||||||||||||||
| Issuance of Series D preferred stock, net of issuance costs | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Issuance of June 2025 warrants | - | - | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Deemed dividends on Series D preferred stock | - | - | - | 74 | - | ( | ) | - | ( | ) | ||||||||||||||||||||||||||||||||||||||||||||||
| Cash dividends on Series D preferred stock | - | - | - | - | - | ( | ) | - | ( | ) | ||||||||||||||||||||||||||||||||||||||||||||||
| Issuance of common stock, ELOC | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Exercise of common stock warrants | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Settlement of common stock warrant liability | - | - | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Stock-based compensation expense | - | - | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Balance - June 30, 2025 | $ | $ | $ | $ | $ | $ | $ | ( | ) | - | $ | ( | ) | $ | ||||||||||||||||||||||||||||||||||||||||||
| Net income | - | - | - | - | ( | ) | - | ( | ) | |||||||||||||||||||||||||||||||||||||||||||||||
| Series C preferred stock conversions | ( | ) | ( | ) | ( | ) | - | |||||||||||||||||||||||||||||||||||||||||||||||||
| Series C preferred stock redemptions | ( | ) | ( | ) | ( | ) | ( | ) | - | ( | ) | |||||||||||||||||||||||||||||||||||||||||||||
| Series D preferred stock conversions | ( | ) | ( | ) | ( | ) | - | |||||||||||||||||||||||||||||||||||||||||||||||||
| Series D preferred stock redemptions | ( | ) | ( | ) | ( | ) | ( | ) | - | ( | ) | |||||||||||||||||||||||||||||||||||||||||||||
| Deemed dividends on Series C preferred stock | - | - | - | - | - | ( | ) | - | ( | ) | ||||||||||||||||||||||||||||||||||||||||||||||
| Cash dividends on Series C preferred stock | - | - | - | - | - | ( | ) | - | ( | ) | ||||||||||||||||||||||||||||||||||||||||||||||
| Deemed dividends on Series D preferred stock | - | - | - | 81 | - | ( | ) | - | ( | ) | ||||||||||||||||||||||||||||||||||||||||||||||
| Cash dividends on Series D preferred stock | - | - | - | - | - | ( | ) | - | ( | ) | ||||||||||||||||||||||||||||||||||||||||||||||
| Issuance of Common stock, note conversions | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| ELOC sales, net of issuance costs | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Exercise of common stock warrants | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Stock-based compensation expense | - | - | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||||||||
| Balance - September 30, 2025 | $ | $ | $ | $ | $ | $ | $ | ( | ) | - | $ | ( | ) | $ | ( | ) | ||||||||||||||||||||||||||||||||||||||||
| See notes to condensed consolidated financial statements |
WINDTREE THERAPEUTICS, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Cash Flows
(Unaudited)
| (in thousands) |
| Nine Months Ended | ||||||||
| September 30, | ||||||||
| 2025 | 2024 | |||||||
| Cash flows from operating activities: | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| In-process research and development expenses in connection with the Varian asset acquisition | ||||||||
| Depreciation and amortization | ||||||||
| Stock-based compensation | ||||||||
| Non-cash lease expense | ||||||||
| Accretion of discount on senior note receivable | ( | ) | ||||||
| Amortization of debt discount and debt issuance costs | ||||||||
| Non-cash expense related to equity consideration for services | ||||||||
| Loss on ELOC commitment note and derivative liability | ||||||||
| Loss on impairment of intangible assets | ||||||||
| Loss on sale and disposal of property and equipment | ||||||||
| Loss on settlement of deposit | ||||||||
| Loss on debt issuances | ||||||||
| Gain on debt extinguishment | ( | ) | ( | ) | ||||
| Deferred income tax benefit | ( | ) | ||||||
| Unrealized loss (gain) on foreign exchange rate changes | ( | ) | ||||||
| Change in fair value of convertible notes | ( | ) | ||||||
| Change in fair value of derivative liabilities | ( | ) | ( | ) | ||||
| Change in fair value of senior secured notes | ||||||||
| Change in fair value of warrant liability | ( | ) | ( | ) | ||||
| Changes in assets and liabilities: | ||||||||
| Prepaid expenses and other current assets | ( | ) | ||||||
| Accounts payable | ( | ) | ||||||
| Accrued expenses | ||||||||
| Operating lease liabilities | ( | ) | ( | ) | ||||
| Other current liabilities | ( | ) | ( | ) | ||||
| Net cash used in operating activities | ( | ) | ( | ) | ||||
| Cash flows from investing activities: | ||||||||
| Issuance of senior note | ( | ) | ||||||
| Deposit | ( | ) | ||||||
| Proceeds from sale of property and equipment | ||||||||
| Purchase of property and equipment | ( | ) | ||||||
| Net cash used in investing activities | ( | ) | ( | ) | ||||
| Cash flows from financing activities: | ||||||||
| Proceeds from convertible notes | ||||||||
| Proceeds from private placement of Series D preferred stock, net of issuance costs | ||||||||
| Proceeds from ELOC Purchase Agreement, net of issuance costs | ||||||||
| Proceeds from private placements, net of issuance costs | ||||||||
| Proceeds from senior secured notes payable | ||||||||
| Proceeds from exercise of common stock warrants | ||||||||
| Principal payments on senior secured notes payable | ( | ) | ||||||
| Principal payments on loans payable | ( | ) | ( | ) | ||||
| Redemptions of Series C preferred stock | ( | ) | ( | ) | ||||
| Cash dividend payments on Series C preferred stock | ( | ) | ( | ) | ||||
| Redemptions of Series D preferred stock | ( | ) | ||||||
| Proceeds from ATM Program, net of issuance costs | ||||||||
| Proceeds from senior convertible notes payable, net of issuance costs | ||||||||
| Principal payments on senior convertible notes payable | ( | ) | ( | ) | ||||
| Proceeds from senior secured and unsecured notes, net of issuance costs | ||||||||
| Issuance costs related to Series B Preferred Stock | ( | ) | ||||||
| Payments on debt extinguishment | ( | ) | ||||||
| Net cash provided by financing activities | ||||||||
| Net decrease in cash, cash equivalents, and restricted cash | ( | ) | ( | ) | ||||
| Cash, cash equivalents, and restricted cash - beginning of period | ||||||||
| Cash, cash equivalents, and restricted cash - end of period | $ | $ | ||||||
| Supplementary disclosure of non-cash activity: | ||||||||
| Private placement proceeds allocated to common stock warrant liability | $ | $ | ||||||
| Non-cash issuance costs allocated to Series C preferred stock | ||||||||
| Conversions of Series C preferred stock | ||||||||
| Deemed dividends on Series C preferred stock | ||||||||
| Deemed dividends on Series D preferred stock | | - | ||||||
| Deemed dividends on warrants | ||||||||
| Cash dividends payable | ||||||||
| Cash dividends converted into common stock | ||||||||
| Issuance of common stock, note conversions | ||||||||
| Fair value upon issuance of common stock warrant liability | ||||||||
| Fair value upon issuance of convertible notes | ||||||||
| Fair value upon issuance of June 2025 warrants | ||||||||
| Fair value of common stock consideration related to ELOC commitment note extinguishment | ||||||||
| Fair value upon issuance of March 2025 senior secured notes | ||||||||
| Settlement of common stock warrant liability | ||||||||
| Fair value of Series B Preferred Stock issued in connection with the Varian asset acquisition | ||||||||
| Fair value upon issuance of derivative liability related to senior convertible notes payable | ||||||||
| Fair value upon issuance of derivative liability related to ELOC commitment note | ||||||||
| Fair value of common stock consideration related to debt extinguishment | ||||||||
| Prepayment of insurance through third-party financing | ||||||||
| See notes to condensed consolidated financial statements |
Notes to Condensed Consolidated Financial Statements (unaudited)
Note 1 – The Company and Description of Business
We are a diversified company focused on seeking partnerships and becoming a revenue-generating company through various initiatives. We became the manufacturing sourcing agent for Evofem’s FDA-approved product Phexxi® in March 2025 and signed the manufacturing deal with Zhoake (Hong Kong) Ophthalmology Pharmaceutical Limited in June 2025 to produce the approved product at lower cost.
Our portfolio of product candidates includes istaroxime, a Phase 2 candidate that inhibits the sodium-potassium ATPase and also activates sarco endoplasmic reticulum Ca2+ -ATPase 2a, or SERCA2a, for acute heart failure and/or associated cardiogenic shock; preclinical SERCA2a activators for heart failure; rostafuroxin for the treatment of hypertension in patients with a specific genetic profile; and a preclinical atypical protein kinase C iota, or aPKCi, inhibitor (topical and oral formulations), being developed for potential application in rare and broad oncology indications. We also have a licensing business model with partnership out-licenses currently in place.
Our lead product candidate, istaroxime, is a first-in-class, dual-mechanism 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. Istaroxime demonstrated significant improvement in both systolic and diastolic aspects of cardiac function and was generally well tolerated in four Phase 2 clinical trials and 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 and had a favorable renal profile, 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. In April 2022, we announced our observations in the SEISMiC Study that istaroxime rapidly and significantly increased SBP while also improving cardiac function and preserving renal function. 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. In September 2024, we announced positive topline results from our Phase 2b SEISMiC Extension Study, or the SEISMiC Extension, which demonstrated that istaroxime infused intravenously significantly improves cardiac function and blood pressure without increasing heart rate or clinically significant cardiac rhythm disturbances. Additionally, we initiated a study in more severe SCAI Stage C cardiogenic shock, or the SEISMiC C Study, to evaluate the safety and efficacy of istaroxime in cardiogenic shock patients who are also receiving standard of care rescue therapy for shock. A planned interim analysis review of the data from the first 20 subjects occurred in July 2025. The review of the preliminary interim data suggests that the responses to istaroxime in SCAI Stage C patients, many of whom were also treated with currently available inotropes and vasopressors, is similar to that seen in our previous clinical trials. Because our ability to complete this study with its intended sample size is dependent upon our ability to secure adequate resourcing for the program through financing efforts or business development activities we have decided to terminate the SEISMiC C clinical trial and pursue further development with istaroxime in the much larger market of less severe patients with acute decompensated heart failure with our licensing partner, Lee’s Pharmaceutical (HK) Ltd., who is planning a global phase 3 study in that indication.
Our heart failure cardiovascular portfolio also includes other SERCA2a activators. One family of compounds has the dual mechanism of action that includes inhibition of the sodium-potassium ATPase as well as activation of SERCA2a. The other family of compounds are considered selective SERCA2a activators and are devoid of activity against the sodium-potassium ATPase. 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 the development of rostafuroxin without securing such an arrangement or partnership.
Our cardiovascular assets and programs are associated with a regional licensed partnership with Lee’s Pharmaceutical (HK) Ltd., or Lee’s (HK), for the development and commercialization of our product candidate, istaroxime, in Greater China. In addition to istaroxime, the agreement also licenses our preclinical next-generation dual mechanism SERCA2a activators, and rostafuroxin. In addition, we are supporting the efforts of Lee’s (HK) in starting a Phase 3 trial in AHF with istaroxime.
On August 19, 2025, we were notified by Nasdaq that as a result of the Company’s previously disclosed noncompliance with Nasdaq Listing Rule 5550(a)(2), Nasdaq has determined to delist our common stock from the Nasdaq Capital Market. We began trading publicly on the over-the-counter market (“OTCID”) on August 22, 2025, under our existing symbol “WINT.”
In January 2025, we launched a new corporate strategy to become a revenue generating biotech company through acquisitions of small companies and their FDA-approved products while the Company continues to seek partnership to progress its cardiovascular and oncology development pipeline. The Company will seek acquisition targets to achieve the Company’s new corporate strategy. To capitalize on this opportunity, we plan to become a parent company acquiring strategic subsidiaries utilizing equity and debt. The number of deals, if any, over time will depend upon the valuation and growth potential of the subsidiary companies.
On July 16, 2025, we announced our agreement to launch of a crypto treasury strategy utilizing the native token of the BNB chain commonly referred to as “BNB,” including a $
On April 2, 2024, we entered into an Asset Purchase Agreement, or the Asset Purchase Agreement, with Varian Biopharmaceuticals, Inc., or Varian. Pursuant to the Asset Purchase Agreement, we purchased all of the assets of Varian’s business associated with a license agreement, dated as of July 5, 2019, by and between Varian and Cancer Research Technology Limited, or the License Agreement, which includes the License Agreement, all rights in molecules and compounds subject to the License Agreement, know-how and inventory of drug substance, or the Transferred Assets. The Transferred Assets include a novel, potential high-potency, specific, aPKCi inhibitor with possible broad use in oncology as well as certain rare malignant diseases. The asset platform includes two formulations (topical and oral) of an aPKCi inhibitor.
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, 2024 that we filed with the Securities and Exchange Commission, or the SEC, on April 15, 2025, 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
The interim unaudited condensed consolidated financial statements are prepared in accordance with accounting principles generally accepted in the U.S., or U.S. 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 U.S. 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 nine months ended September 30, 2025 are not necessarily indicative of the results that may be expected for the year ending December 31, 2025. The consolidated balance sheet at December 31, 2024 has been derived from the Company’s audited consolidated financial statements. There have been no changes to our significant accounting policies since December 31, 2024. 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, 2024 contained in our Annual Report on Form 10-K for the year ended December 31, 2024.
The accompanying condensed consolidated financial statements reflect the 1-for-
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.
With the exception of certain non-recurring items such as gain on debt extinguishment or change in fair value of financial instruments, we have incurred net losses since inception. Our net loss was $
In July 2025, we entered into a Common Stock Purchase Agreement, or the 2025 ELOC Purchase Agreement, establishing an equity line of credit with the purchaser, or the Purchaser, whereby we have the right, but not the obligation, to sell to the Purchaser, and the Purchaser is obligated to purchase, up to $
In June 2024, we entered into a Common Stock Purchase Agreement, or the 2024 ELOC Purchase Agreement, establishing an equity line of credit with the purchaser, or the Purchaser, whereby we have the right, but not the obligation, to sell to the Purchaser, and the Purchaser is obligated to purchase, up to $
As of September 30, 2025, we had cash and cash equivalents of $
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. If we fail to raise sufficient capital, we potentially could be forced to limit or cease our development activities, as well as modify or cease our operations, either of which would have a material adverse effect on our business, financial condition, and results of operations.
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 Accounting Policies
Principles of Consolidation
The interim unaudited condensed consolidated financial statements are prepared in accordance with U.S. GAAP and include accounts of Windtree Therapeutics, Inc. and its wholly owned subsidiaries, WINT Real Estate, LLC; 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
We record acquired intangible assets based on estimated fair value. The identifiable intangible assets resulting from the CVie Therapeutics acquisition in December 2018 relate to in-process research and development, or IPR&D, of istaroxime and rostafuroxin. The IPR&D assets are considered indefinite-lived intangible assets until completion or abandonment of the associated research and development efforts. IPR&D is not amortized but reviewed for impairment at least annually, or when events or changes in the business environment indicate the carrying value may be impaired.
When testing our indefinite-lived intangible assets for impairment, we can elect to perform a qualitative assessment to determine if it is more likely than not that the fair values of our indefinite-lived intangible assets and our reporting unit are less than their respective carrying values. Such qualitative factors can include, among others, industry and market conditions, overall financial performance, and relevant entity-specific events. If we conclude based on our qualitative assessment that it is more likely than not that the fair value of our indefinite-lived intangible assets or reporting unit are less than their respective carrying values, we perform a quantitative assessment. When conducting our annual impairment test of indefinite-lived intangible assets as of December 1, 2025, we elect to perform a quantitative assessment.
When performing the quantitative impairment assessment for our indefinite-lived IPR&D intangible assets, we estimate the fair values of the assets using the multi-period excess earnings method, or MPEEM. MPEEM is a variation of the income approach which estimates the fair value of an intangible asset based on the present value of the incremental after-tax cash flows attributable to the intangible asset. Significant factors considered in the calculation of IPR&D intangible assets include the risks inherent in the development process, including the likelihood of achieving commercial success and the cost and related time to complete the remaining development. Future cash flows for each project were estimated based on forecasted revenue and costs, taking into account the expected product life cycles, market penetration, and growth rates. Other significant estimates and assumptions inherent in this approach include (i) the amount and timing of the projected net cash flows associated with the IPR&D assets, (ii) the discount rate, which seeks to reflect the various risks inherent in the projected cash flows; and (iii) the tax rate, which considers geographic diversity of the projected cash flows. While we use the best available information to prepare our cash flows and discount rate assumptions, actual future cash flows could differ significantly based on the commercial success of the related drug candidates and market conditions which could result in future impairment charges related to our indefinite-lived intangible asset balances.
In accordance with applicable accounting standards, we are required to review intangible assets for impairment on an annual basis, or more frequently where there is an indication of impairment. During the third quarter of 2025, the continued declining trend in the closing share price of our common stock, on a split-adjusted basis, and subsequent delisting from Nasdaq and the strategic decision to cease internal commercialization efforts for ISTA suggested that the fair value of our intangible asset related to istaroxime was more likely than not less than its carrying value. As a result, we performed the required interim asset impairment test consistent with the methodology described above. Based on the quantitative tests performed, we recorded losses on impairment of long-lived intangible assets of $16.1 million within operating expenses in our consolidated statements of operations during the three months ended September 30, 2025.
The closing share price of our common stock, on a split-adjusted basis, has continued to decline subsequent to the end of 2022. If our share price continues to decline, we may be at risk for future impairment to identifiable intangible assets in the near term.
The following table represents identifiable intangible assets as of September 30, 2025 and December 31, 2024:
| September 30, | December 31, | |||||||
| (in thousands) | 2025 | 2024 | ||||||
| Istaroxime drug candidate | $ | $ | ||||||
| Rostafuroxin drug candidate | ||||||||
| Intangible assets | $ | $ | ||||||
Convertible Debt and Equity Instruments
We review the terms of convertible debt and equity instruments to determine whether there are conversion features or embedded derivative instruments including embedded conversion options that are required to be bifurcated and accounted for separately as derivative financial instruments under ASC Topic 815, Derivatives and Hedging.
In circumstances where the convertible instrument contains more than one embedded derivative instrument, including conversion options that are required to be bifurcated, the bifurcated derivative instruments are accounted for as a single compound instrument. Also, in connection with the sale of convertible debt and equity instruments, we may issue free standing warrants that may, depending on their terms, be accounted for as derivative instrument liabilities, rather than as equity. When convertible debt or equity instruments contain embedded derivative instruments that are to be bifurcated and accounted for separately, the total proceeds allocated to the convertible host instruments are first allocated to the fair value of the bifurcated derivative instrument. The remaining proceeds, if any, are then allocated to the convertible instruments themselves, usually resulting in those instruments being recorded at a discount from their face amount. When we issue debt securities, which bear interest at rates that are lower than market rates, we recognize a discount, which is offset against the carrying value of the debt. Such discount from the face value of the debt, together with the stated interest on the instrument, is amortized over the life of the instrument through periodic charges to income.
Derivative Financial Instruments
Derivatives are recorded on the consolidated balance sheet at fair value. The conversion features of the convertible notes are embedded derivatives and are separately valued and accounted for on the consolidated balance sheet with changes in fair value recognized during the period of change as a separate component of other income (expense). Fair values for exchange-traded securities and derivatives are based on quoted market prices. The pricing model we use for determining the fair value of non-exchange traded derivatives is the Monte Carlo Model. Valuations derived from this model are subject to ongoing internal and external verification and review. The model uses market-sourced inputs such as interest rates and stock price volatilities.
Foreign Currency Transactions
The functional currency for our foreign subsidiaries is the U.S. Dollar. We remeasure monetary assets and liabilities that are not denominated in the functional currency at exchange rates in effect at the end of each period. Gains and losses from the remeasurement of foreign currency transactions are recognized in other (expense) income, net. Foreign currency transactions resulted in a net gain of approximately $
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, including intangible assets and fair value of certain debt and equity instruments, at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates.
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.
Research and Development
We account for research and development expense by the following categories: (a) direct clinical and preclinical development programs, (b) product development and manufacturing, and (c) clinical, medical, and regulatory operations. Research and development expense includes personnel, facilities, manufacturing and quality, pharmaceutical development, research, clinical, regulatory, and other preclinical and clinical activities. Research and development costs are charged to operations as incurred in accordance with Accounting Standards Codification, or ASC, Topic 730, Research and Development.
Warrant Accounting
We account for common stock warrants in accordance with applicable accounting guidance provided in ASC Topic 815, Derivatives and Hedging – Contracts in Entity’s Own Equity, or ASC Topic 815, as either derivative liabilities or equity instruments depending on the specific terms of the warrant agreement.
Income Taxes
We account for income taxes in accordance with ASC Topic 740, Accounting for Income Taxes, which requires the recognition of deferred tax liabilities and assets for the expected future tax consequences of temporary differences between financial statement carrying amounts and the tax basis of assets and liabilities.
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 Share Attributable to Common Stockholders
Net loss is adjusted for any deemed dividends to preferred stockholders to compute net loss attributable to common stockholders. Net loss is also adjusted for any impact to retained earnings related to the extinguishment of equity securities. The Series C preferred stock is a participating security. Accordingly, in any period in which we report net income attributable to common stockholders, basic earnings per share is computed using the “two-class” method. Under this method, net income is reduced by any dividends earned and the remaining earnings (undistributed earnings) are allocated to common stock and each series of participating securities to the extent that each participating security may share in earnings as if all of the earnings for the period had been distributed. The total earnings allocated to common stock is then divided by the number of outstanding shares to which the earnings are allocated to determine the earnings per share. The two-class method is not applicable during periods with a net loss, as the holders of the participating securities have no obligation to fund losses. Diluted net income per common share is computed under the two-class method by using the weighted-average number of shares of common stock outstanding, plus the effect of any other potentially dilutive securities outstanding for the period. In addition, the Company analyzes the potential dilutive effect of the outstanding participating securities under the “if-converted” method when calculating diluted earnings per share, in which it assumes that the outstanding participating securities convert into common stock at the beginning of the period, or when issued if later. The Company reports the more dilutive of the approaches (two class or “if-converted”) as their diluted net income per share during the period.
For periods in which a net loss exists, basic net loss per share attributable to common stockholders is computed by dividing net loss attributable to common stockholders by the weighted average number of common shares outstanding for the period. Diluted net loss per share attributable to common stockholders is computed by giving effect to all potentially dilutive securities outstanding for the period.
As of September 30, 2025 and 2024, the number of shares of common stock potentially issuable upon the exercise of certain stock options and warrants, the vesting of restricted stock units, and the conversion of preferred stock and convertible notes payable was
We do not have any components of other comprehensive (loss) income.
Segment and Geographic Information
Operating segments are defined as components of an enterprise for which separate and discrete financial information is available for evaluation by the chief operating decision-maker (the “CODM”) in deciding how to allocate resources and assess performance. The Company has one reportable segment primarily focused on the research and development of cardiovascular diseases. The Company’s CODM is the Chief Executive Officer who manages the Company’s operations on a consolidated basis for the purpose of making operating decisions, assessing financial performance, and allocating resources. When evaluating the Company’s financial performance, the CODM regularly reviews the details of research and development expenses, including program-related and unallocated costs, and general and administrative costs, as part of the overall review of the Company’s consolidated net loss and cash flows as compared to prior quarters and the Company’s operating budget. This financial information assists the CODM in his decision-making process to allocate resources based on the Company’s available cash resources, as well its forecasted expenditures. This information in conjunction with his assessment of the probability of the success of the Company’s research and development activities is used to plan the timing and size of future capital raises. The measure of segment assets is reported on the balance sheet as total consolidated assets. Other segment items included in consolidated net loss consist of gain on debt extinguishment, change in fair value of common stock warrant liability, loss on impairment of goodwill, interest income, interest expense, other income, net and income tax benefit (expense) which are reflected in the consolidated statements of operations.
Recently Adopted Accounting Pronouncements
In December 2023, the FASB issued Accounting Standards Update, or ASU, 2023-09, Income Taxes (ASC 740): Improvements to Income Tax Disclosures, which requires disaggregated information about a reporting entity’s effective tax rate reconciliation as well as information on income taxes paid. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024. The Company adopted this standard on January 1, 2025, which will expand our disclosures beginning with our annual consolidated financial statements for the year ended December 31, 2025. ASU 2023-09 is not expected to have an impact on the consolidated financial results of the Company.
Recently Issued Accounting Pronouncements
In November 2024, the FASB issued ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, which is intended to provide more detailed information about specified categories of expenses (purchases of inventory, employee compensation, depreciation and amortization) included in certain expense captions presented on the consolidated statement of operations. The guidance in this ASU is effective for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027. Early adoption is permitted. The amendments may be applied either (1) prospectively to financial statements issued for periods after the effective date of this ASU or (2) retrospectively to all prior periods presented in the consolidated financial statements. The Company is currently evaluating the impact that the adoption of ASU 2024-03 will have on its consolidated financial statements and disclosures.
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 and liabilities measured at fair value on a recurring basis for the periods presented:
| Fair Value | Fair value measurement using | |||||||||||||||
| September 30, | ||||||||||||||||
| (in thousands) | 2025 | Level 1 | Level 2 | Level 3 | ||||||||||||
| Assets: | ||||||||||||||||
| Money market funds | $ | $ | $ | $ | ||||||||||||
| Total Assets | $ | $ | $ | $ | ||||||||||||
| Liabilities: | ||||||||||||||||
| Convertible notes payable | $ | ( | ) | $ | $ | $ | ( | ) | ||||||||
| Derivative liability - ELOC commitment note | ( | ) | ( | ) | ||||||||||||
| Common stock warrant liability | ( | ) | ( | ) | ||||||||||||
| Total Liabilities | $ | ( | ) | $ | $ | $ | ( | ) | ||||||||
| Fair Value | Fair value measurement using | |||||||||||||||
| December 31, | ||||||||||||||||
| (in thousands) | 2024 | Level 1 | Level 2 | Level 3 | ||||||||||||
| Assets: | ||||||||||||||||
| Money market funds | $ | $ | $ | $ | ||||||||||||
| Total Assets | $ | $ | $ | $ | ||||||||||||
| Liabilities: | ||||||||||||||||
| Derivative liability - ELOC commitment note | $ | ( | ) | $ | $ | $ | ( | ) | ||||||||
| Common stock warrant liability | ( | ) | ( | ) | ||||||||||||
| Total Liabilities | $ | ( | ) | $ | $ | $ | ( | ) | ||||||||
The money market funds were classified as cash and cash equivalents on the consolidated balance sheets and were within Level 1 of the fair value hierarchy. The aggregate fair value of the Company’s money market funds approximated amortized cost.
The fair value of the convertible notes payable is based on significant unobservable inputs, which represent Level 3 measurements within the fair value hierarchy. The following table provides a summary of the change in the estimated fair value of the convertible notes payable:
| Nine Months Ended September 30, 2025 | ||||
| Issuance of convertible notes payable | ||||
| Principal payments | ( | ) | ||
| Change in fair value | ( | ) | ||
| Balance at September 30, 2025 | $ | |||
In determining the initial fair value of the convertible notes payable at their respective issuance dates as well as for the subsequent remeasurement at September 30, 2025, we used a Black Scholes pricing model. The following table provides a summary of the significant inputs used in these valuations:
| June 5, 2025 Issuance Date | September 30, 2025 | |||||||
| Fair value of underlying equity | $ | $ | ||||||
| Conversion price | $ | $ | ||||||
| Volatility | % | % | ||||||
| Risk-free interest rate | % | % | ||||||
| Expected term (in years) | ||||||||
| Discounting factor | ||||||||
The fair value of the common stock warrant liability is based on significant unobservable inputs, which represent Level 3 measurements within the fair value hierarchy. The following table provides a summary of the change in the estimated fair value of the common stock warrant liability:
| Nine Months Ended September 30, 2025 | ||||
| Balance at December 31, 2024 | $ | |||
| Change in fair value | ( | ) | ||
| Settlement of common stock warrant liability | ( | ) | ||
| Deemed dividend | ||||
| Balance at September 30, 2025 | $ | |||
In determining the initial fair value of the common stock warrants at their respective issuance dates as well as for the subsequent remeasurement at September 30, 2025, we used a Black Scholes pricing model. For the measurement at December 31, 2024, we used a Monte Carlo simulation. The following table provides a summary of the significant inputs used in these valuations:
| September 30, 2025 | December 31, 2024 | |||||||
| Fair value of underlying equity | $ | $ | ||||||
| Exercise price | $ | $ | ||||||
| Volatility | % | n/a | ||||||
| Risk-free interest rate | % | % | ||||||
| Expected term (in years) | ||||||||
| Discounting factor | n/a | |||||||
The fair value of the derivative liability - ELOC commitment note is also based on significant unobservable inputs, which represent Level 3 measurements within the fair value hierarchy. The following table provides a summary of the change in the estimated fair value of the derivative liability:
| Nine Months Ended September 30, 2025 | ||||
| Balance at December 31, 2024 | $ | |||
| Change in fair value of June 2024 ELOC commitment note | ( | ) | ||
| Extinguishment of derivative of June 2024 ELOC commitment note | ( | ) | ||
| Initial recognition of derivative liability of July 2025 ELOC commitment note | ||||
| Change in fair value of July 2025 ELOC commitment note | ( | ) | ||
| Balance at September 30, 2025 | $ | |||
In determining the initial fair value of the derivative liability and for the subsequent measurement at September 30, 2025, we used a Monte Carlo simulation. The following table provides a summary of the significant inputs used in these valuations:
| September 30, 2025 | ||||
| Fair value of underlying equity | $ | |||
| Volatility | ||||
| Risk-free interest rate | % | |||
| Conversion price discount | % | |||
| Discounting period (in years) | ||||
| Discount rate | % | |||
| Discounting factor | ||||
Certain of our assets were measured at fair value on a non-recurring basis during the nine months ended September 30, 2025 and during the year ended December 31, 2024. 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 2024. There was
| Fair Value | Fair value measurement using | |||||||||||||||
| December 31, | ||||||||||||||||
| (in thousands) | 2024 | Level 1 | Level 2 | Level 3 | ||||||||||||
| Intangible assets: | ||||||||||||||||
| Rostafuroxin drug candidate | $ | $ | $ | $ | ||||||||||||
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
Note 6 - Note Receivable, Net
On June 5, 2025, the Company issued a senior note to Standard Waste Services, LLC, or Standard Waste, in the principal amount of $
During the quarter ended September 30, 2025, the Company made the decision to not pursue the acquisition of Titan.
Note 7 - Deposit
On April 19, 2025, WINT Real Estate, LLC, or WINT LLC, a wholly owned subsidiary of Windtree Therapeutics, Inc., entered into an Assignment and Conditional Assumption Agreement, or the Assignment with Way Maker Growth Fund, LLC, or Way Maker, relating to that certain Purchase and Sale Agreement dated June 28, 2024, or the Original Purchase Agreement, as amended by that certain First Amendment to Purchase and Sale Agreement, dated December 19, 2024, or the First Amendment, and that certain Second Amendment to Purchase and Sale Agreement, dated March 25, 2025, the Second Amendment (the Original Purchase Agreement, as amended by the First Amendment and the Second Amendment, is referred to hereafter as the Purchase Agreement), and that certain development services agreement, dated February 4, 2025, or the Development Agreement, and together with the Purchase Agreement, collectively, the Assigned Agreements, each between Way Maker and TBB Crescent Park Drive LLC, or TBB CPD. Pursuant to the Purchase Agreement, TBB CPD agreed to sell to Way Maker real property commonly known as The Aubrey, located at 11755 Southlake, Houston, Texas, or the Property.
On April 30, 2025 WINT LLC advanced $
On September 30, 2025, WINT LLC and TBB CPD entered into a Settlement and Mutual Release Agreement which instructs the Escrow Holder to release $
Note 8 - Convertible Notes Payable
On July 2, 2025, we entered into note purchase agreements (the “July Note Purchase Agreements”) with two purchasers (the “July Purchasers,” and each a “July Purchaser”) who are also a holders of the Company's Series C Preferred Stock and Series D Preferred Stock as well as a holder of certain of our convertible notes payable. Pursuant to the July Note Purchase Agreements, we issued two Convertible Promissory Notes to the July Purchasers, each in a principal amount of $
Pursuant to the June and July Note Purchase Agreements, each of the June Purchasers and July Purchasers warrants to purchase shares of our common stock in an amount equal to
The June and July Promissory Notes and the Note Warrants were sold in reliance upon an exemption from the registration requirement of the Securities Act of 1933, as amended (the “Securities Act”), pursuant to Section 4(a)(2) thereof and/or Rule 506(b) of Regulation D promulgated thereunder. We received gross proceeds of $
Subject to certain limitations under the First June 2025 Note Purchase Agreement and the Additional June 2025 Purchase Agreements, or together the Purchase Agreements, while any portion of the First June 2025 Convertible Note and Additional June 2025 Convertible Notes is outstanding, or together the Convertible Notes, we must inform the Purchasers of any proceeds we receive from the issuance of our securities. After receipt of this notice, the Purchasers have ten trading days to require that we apply all proceeds received from the sale of our securities to repay any or all of the amounts outstanding under the Convertible Notes.
The Note Purchase Agreements contain certain covenants and customary representations and warranties of the Company and the parties, piggyback registration rights, restrictions on variable rate transactions, participation rights, indemnification obligations of the parties, termination provisions, and other obligations and rights of the parties.
The Purchasers may exercise their conversion rights under their respective convertible note agreements at any time after the Issue Date, as defined therein, until all amounts owed under the Convertible Notes have been satisfied. The First June 2025 Convertible Note is a senior, unsecured obligation of the Company, with priority over all existing and future indebtedness; the Additional June 2025 Purchasers will not be entitled to any payments of principal or interest until the company has repaid all outstanding obligations under the First June 2025 Convertible Note. Interest for the Convertible Notes will be payable in cash or, at the holder’s election beginning
The holders may not exercise their conversion rights if the conversion would result in the holders (and their affiliates) beneficially owning in excess of
The number of shares of Common Stock to be issued upon each conversion is determined by dividing the Conversion Amount, as defined therein, by the applicable conversion price then in effect on the date specified in the notice of conversion. The Conversion Amount is the sum of the principal to be converted plus, at the holder’s election, any accrued and unpaid interest. The initial conversion price, subject to adjustment, was $
In connection with the Note Financings, we issued the June 2025 Purchasers the June 2025 Warrants to purchase an aggregate of $
We elected to apply the fair value option for all of the June 2025 Notes and June 2025 Warrants as of their issuance date. The fair value of the June 2025 Notes on the dates of issuance was $
On June 5, 2025, we entered into a note purchase agreement, or the First June 2025 Purchase Agreement, pursuant to which we issued a convertible promissory note, or the First June 2025 Convertible Note, to an investor, the First June 2025 Purchaser, in the principal amount of $
In July 2025, holders of the June 5 and June 9 notes converted $
| ● | June 5, 2025 senior unsecured convertible promissory note issued to DFU, LLC with the principal amount of $ |
| ● | June 9, 2025 senior unsecured convertible notes issued to each of Keystone Capital Partners, LLC and Seven Knots, LLC in the principal amount of $ |
| ● | June 9, 2025 senior unsecured convertible notes issued to C/M Capital Master Fund LP in the principal amount of $ |
| ● | June 9, 2025 senior unsecured convertible notes issued to WVP Emerging Manager Onshore Fund in the principal amount of $ |
| ● | June 24, 2025 senior unsecured convertible promissory note issued to certain purchasers for the aggregate purchase price of $ |
| ● | June 27, 2025 Convertible Promissory Notes to Purchasers in the principal amount of $ |
| ● | July 2, 2025 Convertible Promissory Notes to the July Purchasers, each in a principal amount of $ |
| ● | July 23, 2025 convertible promissory note issued to Seven Knots as consideration for it entering into the 2025 ELOC Purchase Agreement for the principal amount of $ |
Note 9 – ELOC Commitment Note Payable
July 2025 Commitment Note Payable
In July 2025, we entered into a common stock purchase agreement, or the 2025 ELOC Purchase Agreement, establishing an ELOC for the right to sell shares of our common stock to the purchaser named therein. The Purchaser is also a holder of the Company's Series C Preferred Stock and Series D Preferred Stock as well as a holder of certain of our convertible notes payable. As consideration for the Purchaser’s irrevocable commitment to purchase shares of our common stock upon the terms of and subject to satisfaction of the conditions set forth in the 2025 ELOC Purchase Agreement, concurrently with the execution and delivery of the ELOC Purchase Agreement, we issued a convertible promissory note, or the ELOC Commitment Note, to the Purchaser in the amount of $
The ELOC Commitment Note in its entirety had an estimated fair value of $
June 2024 Commitment Note Payable
In June 2024, we entered into a common stock purchase agreement, or the 2024 ELOC Purchase Agreement, establishing an ELOC for the right to sell shares of our common stock to the purchaser, or the Purchaser. The Purchaser is also a holder of the Company's Series C Preferred Stock and Series D Preferred Stock as well as a holder of certain of our convertible notes payable. As consideration for the Purchaser’s irrevocable commitment to purchase shares of our common stock upon the terms of and subject to satisfaction of the conditions set forth in the 2024 ELOC Purchase Agreement, concurrently with the execution and delivery of the 2024 ELOC Purchase Agreement, we issued a convertible promissory note, or the ELOC Commitment Note, to the Purchaser in the amount of $
The ELOC Commitment Note in its entirety had an estimated fair value of $
The derivative was adjusted to fair value at each reporting period, with the change in the fair value recorded in change in fair value of derivatives, which is a component of other income (expense) in our condensed consolidated statement of operations. During the three months ended March 31, 2025, the Purchaser converted the ELOC Commitment Note and its related accrued interest into
Note 10 - Senior Secured Notes Payable
April 2025 Convertible Senior Secured Notes
On April 4, 2025, we issued convertible senior secured notes, or the April 2025 Notes, with an aggregate principal amount of $
On May 2, 2025, the holders of the March 2025 Notes and the April 2025 Notes accepted in writing the Company’s payoff letter, pursuant to which the Company made a one-time payment to the foregoing holders in the aggregate amount of $
Note 11 – Common Stock Warrant Liability
In July 2024, we completed two private placements of Series C Preferred Stock and common stock warrants, or the July 2024 Warrants (Refer to Note 13, “Mezzanine Equity and Stockholders' Equity - Accounting for the First and Second Private Placements” for additional details). The July 2024 Warrants were exercisable upon the six month and one day anniversary of the issuance date, or the Initial Exercisability Date, and expire on the fifth anniversary of the Initial Exercisability Date and had an initial exercise price of $
The July 2024 warrants had an initial fair value of $
Note 12 – Loans Payable
In August 2025, we entered into an insurance premium financing and security agreement with AFCO Direct. Under the agreement, we financed $
Note 13 - Other Current Liabilities
In 2008, we entered into an Amended and Restated License Agreement with Philip Morris USA, Inc., or PMUSA, with respect to the U.S., or the U.S. License Agreement, and, as PMUSA had assigned its ex-U.S. rights to Philip Morris Products S.A., or PMPSA, effective on the same date and on substantially the same terms and conditions, we entered into a license agreement with PMPSA with respect to rights outside of the U.S., which we refer to, together with the U.S. License Agreement, as the PM License Agreements. Under amendment no. 2 to each of these agreements, we owe $
Note 14 – Restructured Debt Liability
On October 27, 2017, we and Deerfield entered into the Milestone Agreement pursuant to which (i) promissory notes evidencing a loan with affiliates of Deerfield in the aggregate principal amount of $
On January 24, 2024, we and Deerfield entered into an Exchange and Termination Agreement wherein Deerfield agreed to terminate its rights to receive the Milestone Payments.
Pursuant to the Exchange and Termination Agreement, Deerfield agreed to terminate its rights to receive the Milestone Payments and all related rights and obligations in respect of such Milestone Payments in exchange for (i) cash in the aggregate amount of $
Contemporaneously with the execution of the Exchange and Termination Agreement, we and Deerfield entered into a Registration Rights Agreement pursuant to which we agreed to, among other matters, register for resale with the SEC the shares of the common stock issued to Deerfield pursuant to the Exchange and Termination Agreement. On February 14, 2024, we filed a resale registration statement on Form S-3 (File No. 333-277073) with respect to
The Exchange and Termination Agreement was accounted for as an extinguishment of debt in accordance with ASC Topic 470, Debt – Modifications and Extinguishments, and, as a result, we recognized a $
Note 15 – Mezzanine Equity and Stockholders’ Equity
Securities Purchase Agreements
Subsequent to the execution of the Treasury Strategy Securities Purchase Agreement, management made the decision not to move the cryptocurrency treasury strategy forward and to focus on other businesses in our new corporate strategy.
Private Placement of Series D Preferred Stock
On April 29, 2025, we entered into a Securities Purchase Agreement, or the Purchase Agreement, with the buyers named therein, or the Initial Buyers, pursuant to which we agreed to the private placement of
During May 2025, certain additional buyers, or the Additional Buyers, each executed a joinder to the Purchase Agreement, pursuant to which the Additional Buyers agreed to purchase, and the Company agreed to sell, an aggregate of
We agreed to seek stockholder approval for the issuance of all of the shares of our common stock issuable upon conversion of the Series D Preferred Stock in connection with the above private placements in accordance with the rules and regulations of The Nasdaq Stock Market.
Series D Preferred Stock
The terms of the Series D Preferred Stock are as set forth in the Certificate of Designation of Series D Convertible Preferred Stock, or the Series D Certificate of Designation, as filed with the Delaware Secretary of State and effective on April 30, 2025. The Series D Certificate of Designation authorizes a total of
From and after April 29, 2025, each holder of a share of Series D Preferred Stock is entitled to receive dividends, which are computed on the basis of a 360-day year and twelve 30-day months and will increase the stated value of the Series D Preferred Stock on each dividend date (as defined in the Series D Certificate of Designation).
Dividends on the Series D Preferred Stock will accrue at
The Series D Preferred Conversion Price is subject to adjustment upon the occurrence of specified events and subject to price-based adjustment in the event of any stock split, stock dividend, stock combination, recapitalization or other similar transactions involving our common stock at a price below the then-applicable Series D Preferred Conversion Price, as described in further detail in the Series D Certificate of Designation. In July 2025, due to an inducement related to the Series C preferred stock, the conversion price of the Series D Preferred Stock was adjusted to $
In addition, pursuant to the Purchase Agreement, the Company agreed (i) in lieu of the payments required pursuant to Sections 10, 6 and 2(d) of the that certain certificate of designation (as amended, modified, or supplemented, the “Series C COD”) filed by the Company with the Secretary of State of the State of Delaware on July 19, 2024, for the purpose of establishing and designating the Company’s Series C Convertible Preferred Stock, par value $
January 2025 Series C Preferred Stock Inducement
On January 24, 2025, the Company made an inducement offer to all holders of the Company’s Series C Convertible Preferred Stock, par value $
Pursuant to the Transaction, approximately
April 2025 Down Round
During April 2025, the Company issued the April 2025 Notes with a conversion price of $
The Company calculated the value of the conversion feature before and after the adjustment and recorded the incremental value as an increase to the carrying value of the affected Series C Preferred Stock of $
May 2025 Series C Preferred Stock Inducement
In May 2025, the Company made an inducement offer to certain holders of its Series C Preferred Stock (the “May 2025 Inducement”) to reduce the conversion price from the previously effective price of $
In connection with the May 2025 Inducement, the converted Series C Preferred Stock was converted into
July 2025 Series C and Series D Preferred Stock Inducement
In July 2025, the Company made an inducement offer to certain holders of its Series C and Series D Preferred Stock (the “July 2025 Inducement”) to reduce the conversion price from the previously effective price of $0.45 per share down to an induced rate of $0.30 per share in exchange for the such holders agreeing to waive the Triggering Event Redemption Premium for a period of fifteen (15) business days. This inducement was accepted by eight holders of the Series C Preferred Stock, resulting in the induced conversion of
In connection with the July 2025 Inducement, the converted Series C Preferred Stock was converted into
July 2024 Warrant Exercises
During the three and nine months ended September 30, 2025,
First Private Placement
On July 18, 2024, we entered into a Securities Purchase Agreement, or the First Purchase Agreement, with the buyers named therein, pursuant to which we agreed to the private placement, or the First PIPE, of (i)
Additionally, we issued
We agreed to seek stockholder approval for the issuance of all of the shares of our common stock issuable upon conversion of the Preferred Shares and exercise of the July 2024 Warrants in connection with the First PIPE in accordance with the rules and regulations of The Nasdaq Stock Market, which approval was obtained on September 24, 2024.
Series C Preferred Stock
The terms of the Series C Preferred Stock are as set forth in the Series C Certificate of Designation of Series C Preferred Stock, as filed with the Delaware Secretary of State and effective on July 19, 2024. The Series C Certificate of Designation authorizes a total of
From and after July 19, 2024, each holder of a share of Series C Preferred Stock is entitled to receive dividends, which are computed on the basis of a 360-day year and twelve 30-day months and will increase the stated value of the Series C Preferred Stock on each dividend date (as defined in the Series C Certificate of Designation).
Dividends on the Series C Preferred Stock will accrue at
The Preferred Conversion Price is subject to adjustment upon the occurrence of specified events and subject to price-based adjustment in the event of any stock split, stock dividend, stock combination, recapitalization or other similar transactions involving our common stock at a price below the then-applicable Preferred Conversion Price, as described in further detail in the Series C Certificate of Designation. In July 2025, due to an inducement related to the Series C preferred stock, the conversion price was adjusted to $
July 2024 Warrants
The July 2024 Warrants were exercisable upon the six month and one day anniversary of the issuance date, or the Initial Exercisability Date, and expire on the fifth anniversary of the Initial Exercisability Date and had an initial exercise price of $
Related Party Participation
Our former CEO and our CMO each participated in the First PIPE, with Mr. Fraser making a $
Second Private Placement
On July 26, 2024, we entered into a Securities Purchase Agreement, or the Second Purchase Agreement, with the buyer named therein, pursuant to which we agreed to a second tranche of the private placement, or the Second PIPE, of (i)
Additionally, we issued
We agreed to seek stockholder approval for the issuance of all of the shares of our common stock issuable upon conversion of the Preferred Shares and exercise of the July 2024 Warrants in connection with the Second PIPE in accordance with the rules and regulations of The Nasdaq Stock Market, which approval was obtained on September 24, 2024.
The rights and preferences of the Series C Preferred Stock issued in connection with the Second PIPE, including the terms pursuant to which they are convertible into our common stock, are consistent with the rights and preferences of the Series C Preferred Stock issued in connection with the First PIPE. Similarly, the terms of the warrants issued in connection with the Second PIPE are consistent with the terms of the warrants issued in connection with the First PIPE.
Accounting for the First and Second Private Placements
The July 2024 Warrants are considered a freestanding financial instrument as they are separable and legally detachable from the Series C Preferred Stock. These warrants have been classified as a liability in the Company’s condensed consolidated balance sheet due to the inclusion of put option election available to the holders that is contingently exercisable if the Company enters into a change of control transaction, or the Change of Control Put (the "Put"). If the Put is exercised by the holder of a July 2024 Warrant, they may elect to receive cash as determined by the Black Scholes pricing model, based on terms and timing specified in the July 2024 Warrants. The potential for a cash settlement for the July 2024 Warrants is outside the control of the Company requiring the July 2024 Warrants to be treated as financial liabilities measured at fair value through profit or loss.
Cash proceeds from the issuance of
Upon issuance of the Series C Preferred Stock, the Company was not solely in control of the redemption of the shares due to them having multiple redemption features that are outside of our control, including time-based maturity redemption and change of control redemption. As a result, the shares of Series C Preferred Stock are classified within mezzanine equity.
In connection with the First PIPE, we issued
In addition, we issued
Also in connection with the First PIPE, we issued
We incurred approximately $
Conversions of Series C Preferred Stock
During the three months ended September 30, 2025,
Conversions of Series D Preferred Stock
During the three and nine months ended September 30, 2025,
Common Stock Purchase Agreement
In July 2025, we entered into a Common Stock Purchase Agreement, or the 2025 ELOC Purchase Agreement, establishing an equity line of credit with the purchaser, or the Purchaser, whereby we have the right, but not the obligation, to sell to the Purchaser, and the Purchaser is obligated to purchase, up to $
In June 2024, we entered into the ELOC Purchase Agreement establishing an equity line of credit with the Purchaser, whereby we have the right, but not the obligation, to sell to the Purchaser, and the Purchaser is obligated to purchase, up to $
is also a holder of the Company's Series C Preferred Stock and Series D Preferred Stock as well as a holder of certain of our convertible notes payable.
Over the 36-month period from and after the Commencement Date, we will control the timing and amount of any sales of common stock to the Purchaser. Actual sales of shares of our common stock to the Purchaser under the ELOC Purchase Agreement will depend on a variety of factors to be determined by us from time to time, including, among others, market conditions, the trading price of our common stock and determinations by us as to the appropriate sources of funding and our operations. For the nine months ended September 30, 2025, we sold
We have determined that the put option in the ELOC Purchase Agreement is a derivative within the scope of ASC Topic 815, Derivatives and Hedging, to be initially measured and recorded at fair value with subsequent changes in fair value to be recorded in earnings. However, as the exercise price is floating and is a discounted price to the exercise date fair value of the common stock, we have determined that the put option has a de minimis value (effectively zero value) and will not be recorded.
Series B Preferred Stock
The terms of the Series B Preferred Stock are as set forth in the Series B Certificate of Designation of Series B Preferred Stock, as filed with the Delaware Secretary of State and effective on April 3, 2024. The Series B Certificate of Designation authorizes a total of
Upon issuance of the Series B Preferred Stock, the Company was not solely in control of the redemption of the shares of Series B Preferred Stock due to multiple redemption features that are outside of our control, including time-based maturity redemption and change of control redemption. Accordingly, the shares of Series B Preferred Stock are classified within mezzanine equity at their fair value of $
As of September 30, 2025 and December 31, 2024, there are no shares of Series B Preferred Stock outstanding as all shares were exchanged in the First PIPE. (See the section titled, Note 15 “Mezzanine Equity and Stockholders’ Equity - First Private Placement”).
At-The-Market Program
On November 9, 2023, we entered into the 2023 ATM Program with Ladenburg. We were not obligated to make any sales under the 2023 ATM Program.
Sales under the 2023 ATM Program were made pursuant to our “shelf” registration statement on Form S-3 (No. 333-261878) filed with the SEC on December 23, 2021, and declared effective on January 3, 2022, and a prospectus supplement related thereto, and subsequently expired on January 3, 2025.
During the three months ended March 31, 2024, we sold
Note 16 – 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 grant date. Compensation expense related to stock options is calculated using the Black-Scholes option-pricing model and is recognized ratably over the vesting period. While individual grants may vary, option awards generally have a
A summary of activity under our long-term incentive plans is presented below:
| (in whole numbers) | ||||||||||||
| Stock Options | Shares | Weighted- Average Exercise Price | Weighted- Average Remaining Contractual Term (In Yrs) | |||||||||
| Outstanding at January 1, 2025 | $ | |||||||||||
| Forfeited or expired | ( | ) | ||||||||||
| Outstanding at September 30, 2025 | $ | |||||||||||
| Vested and exercisable at September 30, 2025 | $ | |||||||||||
| Vested and expected to vest at September 30, 2025 | $ | |||||||||||
During the nine months ended September 30, 2025, there were no RSUs granted or forfeited. As of September 30, 2025, there were
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 September 30, | Nine Months Ended September 30, | |||||||||||||||
| (in thousands) | 2025 | 2024 | 2025 | 2024 | ||||||||||||
| Research and development | $ | $ | $ | $ | ||||||||||||
| General and administrative | ||||||||||||||||
| Total | $ | $ | $ | $ | ||||||||||||
The fair value of each option award is estimated on the grant date using the Black-Scholes option-pricing formula. Expected volatilities are based upon the historical volatility of our common stock and other factors. We also use historical data and other factors to estimate option exercises, employee terminations and forfeiture rates. The risk-free interest rates are based upon the U.S. Treasury yield curve in effect at the time of the grant.
Note 17 – Licensing and Research Funding Agreements
License and Supply Agreement with Evofem Biosciences, Inc.
On March 20, 2025, we entered into a License and Supply Agreement, as amended on March 28, 2025, or the L&S Agreement, with Evofem Biosciences, Inc., a Delaware corporation, or Evofem. Pursuant to the L&S Agreement, we will act as the supplier to Evofem of its Phexxi® product outside of the United States. The term of the L&S Agreement is for an initial three-year period and is automatically renewed thereafter for successive two-year periods unless either party provides 180 days’ notice of non-renewal or the L&S Agreement is otherwise terminated in accordance with the termination provisions provided therein. Our manufacturing and supply obligations under the L&S Agreement will commence the later of the termination of Evofem’s exclusivity obligations with its current supplier or within 90 days of the our notification to Evofem that we have established manufacturing capabilities for the Products (as defined in the L&S Agreement). We may subcontract, with any third party including an affiliate of the Company, to perform any of our obligations under the L&S Agreement without the prior written consent of Evofem.
Evofem is generally obligated to purchase the Products from us at a specified price during the first three years of the Term (as defined in the L&S Agreement). Evofem also granted us a limited, nonexclusive, royalty-free right to use Evofem’s Intellectual Property Rights (as defined in the L&S Agreement) solely as necessary to manufacture the Products exclusively for Evofem during the Term, subject to the terms of the L&S Agreement. The L&S Agreement contains representations and warranties of both parties, insurance requirements, mutual indemnification provisions, and confidentiality provisions.
Term Sheet and Project Financing Agreement with Lee’s (HK)
In March 2020, we entered into the 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 $
Since the 2018 acquisition of CVie Investments Limited and CVie Therapeutics, istaroxime has become our primary focus for investment and execution due to what we believe represents a greater potential value opportunity for us and our stockholders. Since completing our Phase 2 study of lucinactant (KL4 surfactant) for patients with severe COVID-19 associated ARDS and lung injury in January 2022, in order to preserve resources for the highest priority programs, we have begun to reduce costs not already being performed by our licensee, Lee’s (HK) and Zhaoke, under the terms of our Original License Agreement. These costs include certain reductions in headcount dedicated to KL4 surfactant and the decommissioning of both our analytical and technical support laboratory, which previously conducted release testing of APIs and supportive research for our lyophilized and aerosolized KL4 surfactant, and our medical device development laboratory, which was previously used to conduct development activities and testing for our ADS technologies. To support the future development of our KL4 surfactant platform in markets outside of Asia, including the U.S., we are pursuing one or more licensing transactions.
To repay the funds provided under the terms of the PF Agreement, until such time as we have repaid
As of September 30, 2025, the liability balance related to the payments under the PF Agreement was $
Note 18 – Income Taxes
During the third quarter of 2025, the Company recorded an income tax benefit primarily related to the treatment of domestic research and experimental expenditures under Internal Revenue Code Section 174. In connection with the enactment of the One Big Beautiful Bill Act (“OBBBA”), the Company elected not to capitalize certain domestic research and experimental costs on its 2024 federal income tax return. This election resulted in an increase in deductible expenses for prior periods and a corresponding reduction in taxable income, which generated the income tax benefit of $
For the three months and nine months ended September 30, 2025, we realized an income tax benefit of $
Note 19 – Subsequent Events
Senior Convertible Promissory Notes
On October 9, 2025, the Company issued to certain institutional investors an aggregate principal amount of $
The 2026 Commitment Notes must be prepaid by the Company in an amount equal to
If the Company completes a qualified equity financing with total gross proceeds to the Company of $
The 2026 Commitment Notes provide for a beneficial ownership limitation of
The 2026 Commitment Notes are convertible at the Holders’ option into shares of common stock at a conversion price equal to
Pursuant to the terms of the 2026 Commitment Notes, the Company filed a resale registration statement on Form S-1 on October 24, 2025 for the resale of all registrable securities under the 2026 Commitment Note.
On November 14, 2025, the Company issued to Seven Knots a senior convertible promissory note in the principal amount of $750,000 due in November 2026 (the “2026 Note”). The 2026 Note was issued in connection with a letter of intent by the Company to acquire all of the issued and outstanding securities of CommLoan, Inc. and related note receivable with Commloan (see Note 19 - Subsequent events - Note Receivable). Seven Knots is also a holder of the 2026 Commitment Notes as well as the Company’s Series C and Series D Preferred Shares. The 2026 Note matures on November 13, 2026 and will bear interest at 10% per annum on a 360-day basis, due and payable on such maturity date. Accrued and unpaid interest is payable in arrears and due on the fifth calendar day of each month beginning December 2025.
The 2026 Note must be prepaid by the Company in an amount equal to 25% of the gross proceeds received by the Company from that certain Common Stock Purchase Agreement dated June 26, 2024 by and between Seven Knots and the Company, with a mandatory prepayment premium of 115%.
If the Company completes a qualified equity financing with total gross proceeds to the Company of $
The 2026 Note provides for a beneficial ownership limitation of
The 2026 Note is convertible at the Holders’ option into shares of common stock at a conversion price equal to
Note Receivable
On November 12, 2025, the Company issued a senior convertible promissory note to Commloan in the principal amount of $
By mutual written agreement of the Company and Commloan, the outstanding principal and accrued interest may be converted into equity securities issued in the Company’s next qualified financing round at a fixed price equal to the price per share of such financing, less a fifteen percent (
Termination of the Letter of Intent with Titan Environmental Services, Inc.
On November 11, 2025, the Company entered into a Letter Agreement (the “Agreement”) with Titan Environmental Services, Inc (“TESI”) in connection with the previously disclosed Letter of Intent (“LOI”) from June 6, 2025. The LOI contemplated that the Company would acquire all of the issued and outstanding securities of TESI on the terms and conditions set forth in the LOI and in an acquisition agreement to be entered into by the parties. Pursuant to that LOI, the Company had advanced $
The Letter Agreement releases The Company and TESI from any and all reciprocal surviving obligations under the LOI and establishes an arrangement for the return of the $
The Company shall use at least
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report on Form 10-Q, including information with respect to our plans and strategy for our business and related financing activities, includes forward-looking statements that involve risks, uncertainties and assumptions. These statements are based on our beliefs and expectations about future outcomes and are subject to risks and uncertainties that could cause our actual results to differ materially from anticipated results. We undertake no obligation to publicly update these forward-looking statements, whether as a result of new information, future events or otherwise. The reader should review the section titled “Forward-Looking Statements” and any risk factors discussed elsewhere in this Quarterly Report on Form 10-Q, which are in addition to and supplement the risk factors discussed in our Annual Report on Form 10-K for the year ended December 31, 2024 that we filed with the Securities and Exchange Commission, or SEC, on April 15, 2025, as supplemented by our Quarterly Reports on Form 10-Q for the three months ended March 31, 2025 and the three and six months ended June 30, 2025 filed thereafter, and our other filings with the SEC, and any amendments thereto, for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis or elsewhere in this Quarterly Report on Form 10-Q.
This Management’s Discussion and Analysis, or MD&A, is provided as a supplement to the accompanying interim unaudited Condensed Consolidated Financial Statements (including the notes thereto) to help provide an understanding of our financial condition and changes in our financial condition and our results of operations. This item should be read in connection with our accompanying interim unaudited Condensed Consolidated Financial Statements (including the notes thereto) and our Annual Report on Form 10-K for the year ended December 31, 2024. Unless otherwise specified, references to Notes in this MD&A refer to the Notes to Condensed Consolidated Financial Statements (unaudited) in this Quarterly Report on Form 10-Q.
OVERVIEW
We are a diversified company focused on seeking partnerships and becoming a revenue-generating company through various initiatives. We became the manufacturing sourcing agent for Evofem’s FDA-approved product Phexxi® in March 2025 and signed the manufacturing deal with Zhoake (Hong Kong) Ophthalmology Pharmaceutical Limited in June 2025 to produce the approved product at lower cost.
Our portfolio of product candidates includes istaroxime, a Phase 2 candidate that inhibits the sodium-potassium ATPase and also activates sarco endoplasmic reticulum Ca2+ -ATPase 2a, or SERCA2a, for acute heart failure and/or associated cardiogenic shock; preclinical SERCA2a activators for heart failure; rostafuroxin for the treatment of hypertension in patients with a specific genetic profile; and a preclinical atypical protein kinase C iota, or aPKCi, inhibitor (topical and oral formulations), being developed for potential application in rare and broad oncology indications. We also have a licensing business model with partnership out-licenses currently in place.
Our lead product candidate, istaroxime, is a first-in-class, dual-mechanism 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. Istaroxime demonstrated significant improvement in both systolic and diastolic aspects of cardiac function and was generally well tolerated in four Phase 2 clinical trials and 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 and had a favorable renal profile, 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. In April 2022, we announced our observations in the SEISMiC Study that istaroxime rapidly and significantly increased SBP while also improving cardiac function and preserving renal function. 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. In September 2024, we announced positive topline results from our Phase 2b SEISMiC Extension Study, or the SEISMiC Extension, which demonstrated that istaroxime infused intravenously significantly improves cardiac function and blood pressure without increasing heart rate or clinically significant cardiac rhythm disturbances. Additionally, we initiated a study in more severe SCAI Stage C cardiogenic shock, or the SEISMiC C Study, to evaluate the safety and efficacy of istaroxime in cardiogenic shock patients who are also receiving standard of care rescue therapy for shock. A planned interim analysis review of the data from the first 20 subjects occurred in July 2025. The review of the preliminary interim data suggests that the responses to istaroxime in SCAI Stage C patients, many of whom were also treated with currently available inotropes and vasopressors, is similar to that seen in our previous clinical trials. Because our ability to complete this study with its intended sample size is dependent upon our ability to secure adequate resourcing for the program through financing efforts or business development activities we have decided to terminate the SEISMiC C clinical trial and pursue further development with istaroxime in the much larger market of less severe patients with acute decompensated heart failure with our licensing partner, Lee’s Pharmaceutical (HK) Ltd., who is planning a global Phase 3 study in that indication.
Our heart failure cardiovascular portfolio also includes next generation SERCA2a activators. One family of compounds has the dual mechanism of action that includes inhibition of the sodium-potassium ATPase as well as activation of SERCA2a. The other family of compounds are considered selective SERCA2a activators and are devoid of activity against the sodium-potassium ATPase. This research program is evaluating these preclinical product candidates that includes oral and intravenous administration . 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 the development of rostafuroxin without securing such an arrangement or partnership.
Our cardiovascular assets and programs are associated with a regional licensed partnership with Lee’s Pharmaceutical (HK) Ltd., or Lee’s (HK), for the development and commercialization of our product candidate, istaroxime, in Greater China. In addition to istaroxime, the agreement also licenses our preclinical next-generation dual mechanism SERCA2a activators, and rostafuroxin. We are supporting the efforts of Lee’s (HK) in starting a Phase 3 trial in acute heart failure with istaroxime.
In addition, in January 2025, we launched a new corporate strategy to become a revenue generating biotech company through acquisitions of small companies and their FDA-approved products while the Company continues to seek partnership to progress its cardiovascular and oncology development pipeline. The Company will seek acquisition targets to achieve the Company’s new corporate strategy. To capitalize on this opportunity, we plan to become a parent company acquiring strategic subsidiaries utilizing equity and debt. The number of deals, if any, over time will depend upon the valuation and growth potential of the subsidiary companies.
We will seek acquisition targets to achieve our new corporate strategy. We believe there is an opportunity in the market: the acquisition of small companies with FDA-approved products from the many small biotech companies that struggle to maximize their commercialization potential. To capitalize on this opportunity, we plan to become a parent company acquiring strategic subsidiaries with FDA-approved products. Our management team has commercialization expertise in both large pharmaceutical and small biotech companies across multiple therapeutic areas, potentially enabling them to leverage synergies and optimize commercial performance across future subsidiaries. We will seek to use equity to acquire subsidiaries. The number of deals, if any, over time will depend upon the valuation and growth potential of the subsidiary companies.
On April 2, 2024, we entered into an Asset Purchase Agreement, or the Asset Purchase Agreement, with Varian Biopharmaceuticals, Inc., or Varian. Pursuant to the Asset Purchase Agreement, we purchased all of the assets of Varian’s business associated with a license agreement, dated as of July 5, 2019, by and between Varian and Cancer Research Technology Limited, or the License Agreement, which includes the License Agreement, all rights in molecules and compounds subject to the License Agreement, know-how and inventory of drug substance, or the Transferred Assets. The Transferred Assets include a novel, potential high-potency, specific, aPKCi inhibitor with possible broad use in oncology as well as certain rare malignant diseases. The asset platform includes two formulations (topical and oral) of an aPKCi inhibitor. We plan to advance investigational new drug enabling activities and are in the process of determining the expected clinical development plan for the platform.
We have incurred net losses since inception. Our net loss was $28.1 million and $42.8 million for the three and nine months ended September 30, 2025. For the three and nine months ended September 30, 2024, our net loss was $2.7 million and $4.6 million. As of September 30, 2025, we had an accumulated deficit of $889.4 million. To date, we have financed our operations primarily through private placements and public offerings of our common and preferred stock, warrants to purchase common stock, and borrowings from investors and financial institutions.
We intend to seek partnership to continue development of our biotechnology pipeline to reduce research and clinical development, regulatory, and other expenses as we (i) continue to develop our product candidates; (ii) seek regulatory clearances or approvals for our product candidates; (iii) conduct clinical trials on our product candidates; and (iv) manufacture, market, and sell any product candidates for which we may obtain regulatory approval.
Our ability to advance our development programs is dependent upon our ability to secure partnerships for additional capital. We may also consider public or private securities offerings; convertible debt financings; and/or potential strategic opportunities, including licensing agreements, drug product development, 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, as well as modify or cease our operations, either of which would have a material adverse effect on our business, financial condition, and results of operations.
Business and Program Updates
We became the manufacturing sourcing agent for Evofem’s FDA-approved product Phexxi® in March 2025 and signed the manufacturing deal with Zhoake (Hong Kong) Ophthalmology Pharmaceutical Limited in June 2025 to produce the approved product at lower cost.
For our biotechnology pipeline, a key element of our business strategy is to seek and establish strategic collaborations, licensing arrangements, and other partnerships that can support the advancement and commercialization of our product candidates. We expect partnerships to be an important focus for the Company as such relationships have the potential to provide resources for development that may in turn lower or potentially eliminate costs. We continue to evaluate and pursue potential partnerships with biotechnology and pharmaceutical companies, investors and other strategic partners to access complementary expertise, technologies, funding, and commercialization capabilities. While we are actively engaged in discussions with potential partners, there can be no assurance that any such collaborations will be successfully completed or that they will yield the anticipated benefits.
Istaroxime (Cardiogenic Shock)
In September 2020, we initiated a Phase 2 clinical study of istaroxime for the acute treatment of cardiogenic shock in more severe heart failure patients than previously studied to evaluate the potential to improve blood pressure (primary measure) and cardiac function (secondary measure). The study also evaluated the safety and side effect profile of istaroxime in this patient population. In April 2022, we announced positive topline results with istaroxime in rapidly and significantly raising SBP. In May 2022, we presented data from our positive Phase 2 study of istaroxime in early cardiogenic shock in a late-breaker presentation 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. There is a significant unmet medical need in the area of early cardiogenic shock and severe heart failure. Istaroxime demonstrated a meaningful increase in blood pressure while simultaneously increasing cardiac output and preserving renal function in clinical trials of this condition.
In September 2024, we announced positive topline results from our SEISMiC Extension study which enrolled 30 patients with SCAI Stage B cardiogenic shock and demonstrated significant improvement in systolic blood pressure and cardiac function as well as improving pulmonary congestion and renal function. This study evaluated lower doses and longer duration of dosing than in previous studies. These data were presented at the Heart Failure Society of America meeting in September 2024. This study contributed to optimizing the istaroxime dosing regimen and extended the favorable safety and tolerability profile for the istaroxime program. Multiple secondary endpoints supported the positive outcome on the primary endpoint of systolic blood pressure AUC over the first 6 hours of study drug infusion. These included assessments from invasive hemodynamics (from a pulmonary artery catheter), echocardiography and Holter monitoring. The most commonly reported adverse events were gastrointestinal (nausea and vomiting) and infusion site discomfort, both known to occur with istaroxime administration from previous clinical trials. Additionally, we initiated a study in more severe SCAI Stage C cardiogenic shock, or the SEISMiC C Study, to evaluate the safety and efficacy of istaroxime in cardiogenic shock patients who are also receiving standard of care rescue therapy for shock. The SEISMiC C Study was planned to enroll up to 100 subjects with SCAI Stage C cardiogenic shock. A planned unblinded review of the data from the first 20 subjects occurred in July 2025. The review of the preliminary interim data suggests that the responses to istaroxime in SCAI Stage C patients, many of whom were also treated with currently available inotropes and vasopressors, is similar to that seen in our previous clinical trials. Because our ability to complete this study with its intended sample size is dependent upon our ability to secure adequate resourcing for the program through financing efforts or business development activities we have decided to terminate the SEISMiC C clinical trial and pursue further development with istaroxime in the much larger market of less severe patients with acute decompensated heart failure with our licensing partner, Lee’s Pharmaceutical (HK) Ltd., who is planning a global phase 3 study in that indication. We believe that the SEISMiC Extension and SEISMiC C studies have contributed to dose selection and to the characterization of the effects associated with SERCA2a activation and will support our clinical and regulatory strategy for istaroxime.
Istaroxime (AHF)
There is substantial potential synergy between our clinical trial program in early cardiogenic shock and our development program in acute decompensated heart failure. Both programs are focused on treating heart failure patients with acute congestion and low blood pressure requiring hospitalization. We believe that this category of heart failure patients (whether they are in shock or not) could particularly benefit from the unique profile and potential ability of istaroxime to improve cardiac function and increase blood pressure while maintaining or improving renal function. Our strategy has been to advance istaroxime in cardiogenic shock as the lead indication and utilize this data and experience, along with the positive Phase 2a and 2b AHF studies, already completed, to potentially enter Phase 3 for acute decompensated heart failure in the normal to low SBP population. Our licensing partner, Lee’s (HK) is preparing to initiate a phase 3 study in less severe patients with acute decompensated heart failure in China. We believe we can join that study and create a global phase 3 program in this population that may or may not include patients with cardiogenic shock. We currently do not have sufficient capital to execute our clinical trial in AHF and are seeking partnership opportunities to advance our portion of the program.
SERCA2a Activators – Preclinical Oral, Chronic, and Acute Heart Failure Product Candidates
We are pursuing several early exploratory research programs to assess potential product candidates, including oral and intravenous dual mechanism or selective SERCA2a activator heart failure compounds, and believe that we can add value to our cardiovascular portfolio by advancing these SERCA2a activator candidates through preclinical studies. In April 2023, we announced that the European Patent Office has granted Patent No. 3599243, providing patent coverage for the dual mechanism SERCA2a Activator class of drug candidates. This patent provides protection until July 2038 for the family of compounds with a dual mechanism of action. To further advance these product candidates, we are actively exploring potential licensing transactions, research partnership arrangements, or other strategic opportunities. Additionally, the United States Patent and Trademark Office has issued U.S. Patent No. 11,730,746 covering our dual mechanism SERCA2a activators. The new composition of matter patent provides patent protection through late 2039. Further, the European Patent Office has granted Patent No. 3805243, providing composition of matter patent coverage for the pure SERCA2a Activator class of drug candidates. The pure SERCA2a Activators are one of two families of preclinical drug candidates that act on SERCA2a in the Company’s pipeline. The pure SERCA2a Activators are devoid of action on the Na+/K+ pump while activating SERCA2a. The new European patent provides patent protection until October 9, 2039 for the family of compounds with the pure SERCA2a mechanism of action.
Rostafuroxin
Rostafuroxin has demonstrated efficacy in Caucasian patients in treatment naïve hypertension in a Phase 2b trial. During the second quarter of 2021, we concluded an initial process to test the industry’s interest in investing in our product candidate. We currently have not been able to secure a licensing transaction or other strategic opportunity. Based on feedback received from potential licensing partners, we have determined that there is a need for an additional Phase 2 clinical trial to demonstrate efficacy in African American patients in treatment resistant hypertension. We are continuing to pursue licensing arrangements and/or other strategic partnerships for rostafuroxin. We do not intend to conduct the additional Phase 2 clinical trial without securing such an arrangement or partnership.
aPKCi inhibitor (topical formulation previously designated as VAR-101)
The topical (cutaneous) formulation is a small molecule that may have potential for the treatment of basal cell carcinoma, or BCC. The active pharmaceutical ingredient, or API, in aPKCi inhibitor (topical) has demonstrated dose dependent anti-tumor activity in murine and human BCC cell lines, in studies performed at Cancer Research UK, or CRUK, a charity registered in England and Scotland, and based in London, United Kingdom. CRUK collaborators, including Stanford University under a sponsored research agreement with CRUK, completed the preclinical tumor cell line data and the BCC cell line data that formed the basis for additional “method of use” patents that are included in the License Agreement. These types of in vitro studies in tumor cell lines are typical early-stage models of activity or efficacy when testing a new chemical compound, the data from which is used in regulatory filings for first-in-man clinical trials. These mouse models of BCC and lung cancer were performed by CRUK and their collaborators.
aPKCi inhibitor (oral formulation previously designated as VAR-102)
The oral formulation is a small molecule that may have potential for the treatment of solid tumors. The API in the aPKCi inhibitor (oral) is the same as the API in aPKCi inhibitor (topical). In the scientific literature, the presence and activation of aPKCi has been implicated in the growth of multiple human cancers including non-small cell lung cancer, or NSCLC, pancreatic, and ovarian cancer. The API in aPKCi inhibitor (oral) has demonstrated dose dependent anti-tumor activity in a mouse model of NSCLC (squamous cell lung carcinoma), in studies performed at CRUK and with its collaborators. Preclinical experiments of the API in aPKCi inhibitor (oral), appears to show dose dependent anti-tumor activity in a xenograft NSCLC model.
Delisting from the Nasdaq Capital Market
December 2024 Deficiency
June 2025 Deficiency
On June 18, 2025, we received a deficiency letter from the Nasdaq Listing Qualifications Department, or the Nasdaq Staff, notifying the Company that, for the last 30 consecutive business days, the closing bid price our common stock had been below the minimum $1.00 per share required for continued listing on The Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2), or the Minimum Bid Price Requirement.
Normally, a company would be afforded a 180-calendar day period to demonstrate compliance with the Minimum Bid Price Requirement. However, as disclosed above, the Company is subject to a Discretionary Panel Monitor until March 20, 2026, pursuant to Listing Rule 5815(4)(A). Moreover, pursuant to Listing Rule 5810(c)(3)(A)(iv), the Company is not eligible for any compliance period specified in Rule 5810(c)(3)(A) because the Company effected two reverse stock splits over the prior two-year period with a cumulative ratio of more than 250 shares to one.
On August 19, 2025, we were notified by The Nasdaq Stock Market LLC that as a result of the Company’s previously disclosed noncompliance with Nasdaq Listing Rule 5550(a)(2), Nasdaq has determined to delist our common stock from the Nasdaq Capital Market.
We began trading publicly on the over-the-counter market (“OTCID”) on August 22, 2025, under our existing symbol “WINT.”
Increase in Authorized Shares
On August 28, 2025, we obtained stockholder approval at the Special Meeting of Stockholders to, among other things, amend our Amended and Restated Certificate of Incorporation to increase the number of authorized shares of capital stock from 125,000,000 shares to 1,000,000,000 shares. On October 23, 2025, we filed an amendment to our Amended and Restated Certificate of Incorporation, as amended, with the Secretary of State of the State of Delaware to increase the number of authorized shares of capital stock from 125,000,000 shares to 1,000,000,000 shares, consisting of 995,000,000 shares of common stock and 5,000,000 shares of preferred stock, par value $0.001 per share. The amendment was affected at 5:30 p.m. Eastern Time on October 23, 2025.
CRITICAL ACCOUNTING POLICIES
For a discussion of our accounting policies, see the section titled, “Note 4 – Summary of Significant Accounting Policies” and, in the Notes to Consolidated Financial Statements in our Annual Report on Form 10-K for the year ended December 31, 2024, Note 4 – Accounting Policies and Recent Accounting Pronouncements. Readers are encouraged to review those disclosures in conjunction with this Quarterly Report on Form 10-Q.
Intangible Assets
We record acquired intangible assets based on estimated fair value. The identifiable intangible assets resulting from the CVie Therapeutics acquisition in December 2018 relate to in-process research and development, or IPR&D, of istaroxime and rostafuroxin. The IPR&D assets are considered indefinite-lived intangible assets until completion or abandonment of the associated research and development efforts. IPR&D is not amortized but reviewed for impairment at least annually, or when events or changes in the business environment indicate the carrying value may be impaired.
When testing our indefinite-lived intangible assets for impairment, we can elect to perform a qualitative assessment to determine if it is more likely than not that the fair values of our indefinite-lived intangible assets and our reporting unit are less than their respective carrying values. Such qualitative factors can include, among others, industry and market conditions, overall financial performance, and relevant entity-specific events. If we conclude based on our qualitative assessment that it is more likely than not that the fair value of our indefinite-lived intangible assets or reporting unit are less than their respective carrying values, we perform a quantitative assessment. When conducting our annual impairment test of indefinite-lived intangible assets as of December 1, 2022, we elected to perform a quantitative assessment.
When performing the quantitative impairment assessment for our indefinite-lived IPR&D intangible assets, we estimate the fair values of the assets using the multi-period excess earnings method, or MPEEM. MPEEM is a variation of the income approach which estimates the fair value of an intangible asset based on the present value of the incremental after-tax cash flows attributable to the intangible asset. Significant factors considered in the calculation of IPR&D intangible assets include the risks inherent in the development process, including the likelihood of achieving commercial success and the cost and related time to complete the remaining development. Future cash flows for each project were estimated based on forecasted revenue and costs, taking into account the expected product life cycles, market penetration, and growth rates. Other significant estimates and assumptions inherent in this approach include (i) the amount and timing of the projected net cash flows associated with the IPR&D assets, (ii) the discount rate, which seeks to reflect the various risks inherent in the projected cash flows; and (iii) the tax rate, which considers geographic diversity of the projected cash flows. While we use the best available information to prepare our cash flows and discount rate assumptions, actual future cash flows could differ significantly based on the commercial success of the related drug candidates and market conditions which could result in future impairment charges related to our indefinite-lived intangible asset balances.
In accordance with applicable accounting standards, we are required to review intangible assets for impairment on an annual basis, or more frequently where there is an indication of impairment. Throughout the year, we consider whether any events or changes in the business environment have occurred which indicate that goodwill may be impaired. For example, a significant decline in the closing share price of our common stock and market capitalization may suggest that the fair value of our reporting unit has fallen below its carrying value, indicating that an interim impairment test is required. Accordingly, we monitor changes in our share price during interim periods between annual impairment tests and consider overall stock market conditions, the underlying reasons for the decline in our share price, the significance of the decline, and the duration of time that our securities have been trading at a lower value. We have experienced a declining trend in the closing share price of our common stock, on a split-adjusted basis, following the announcement August 2025 of our delisting from the Nasdaq Capital Market.
During the third quarter of 2025, the continued declining trend in the closing share price of our common stock, on a split-adjusted basis, and subsequent delisting from Nasdaq and the strategic decision to cease internal commercialization efforts for ISTA suggested that the fair value of our intangible asset related to istaroxime was more likely than not less than its carrying value. As a result, we performed the required interim asset impairment test consistent with the methodology described above. Based on the quantitative tests performed, we recorded losses on impairment of long-lived intangible assets of $16.1 million within operating expenses in our consolidated statements of operations during the three months ended September 30, 2025.
The following table represents identifiable intangible assets as of September 30, 2025 and December 31, 2024:
| September 30, | December 31, | |||||||
| (in thousands) |
2025 |
2024 |
||||||
| Istaroxime drug candidate |
$ | 6,210 | $ | 22,340 | ||||
| Rostafuroxin drug candidate |
1,790 | 1,790 | ||||||
| Intangible assets |
$ | 8,000 | $ | 24,130 | ||||
Convertible Debt and Equity Instruments
We review the terms of convertible debt and equity instruments to determine whether there are conversion features or embedded derivative instruments including embedded conversion options that are required to be bifurcated and accounted for separately as derivative financial instruments under ASC Topic 815, Derivatives and Hedging.
In circumstances where the convertible instrument contains more than one embedded derivative instrument, including conversion options that are required to be bifurcated, the bifurcated derivative instruments are accounted for as a single compound instrument. Also, in connection with the sale of convertible debt and equity instruments, we may issue free standing warrants that may, depending on their terms, be accounted for as derivative instrument liabilities, rather than as equity. When convertible debt or equity instruments contain embedded derivative instruments that are to be bifurcated and accounted for separately, the total proceeds allocated to the convertible host instruments are first allocated to the fair value of the bifurcated derivative instrument. The remaining proceeds, if any, are then allocated to the convertible instruments themselves, usually resulting in those instruments being recorded at a discount from their face amount. When we issue debt securities, which bear interest at rates that are lower than market rates, we recognize a discount, which is offset against the carrying value of the debt. Such discount from the face value of the debt, together with the stated interest on the instrument, is amortized over the life of the instrument through periodic charges to income.
RESULTS OF OPERATIONS
As we continue to explore commercial opportunities, and plan to work with business partners, in both U.S. and international markets, we remain attentive to evolving global economic conditions, including uncertainties related to international trade policies, tariffs, and supply chain dynamics. Although these factors have not had a material impact on our operations to date, future changes in trade regulations, tariff structures, or logistical constraints could include the cost, availability, or timing of materials, services and other components associated with the development of our tablet vaccines and manufacturing capabilities. We continue to monitor these developments closely to maintain operational efficiency and help mitigate potential future impacts.
Comparison of the Three and Nine Months Ended September 30, 2025 and 2024
| Three Months Ended |
Nine Months Ended |
|||||||||||||||||||||||
| September 30, |
September 30, |
|||||||||||||||||||||||
| (in thousands) |
2025 |
2024 |
Change |
2025 |
2024 |
Change |
||||||||||||||||||
| Expenses: |
||||||||||||||||||||||||
| Research and development |
$ | 1,897 | $ | 1,968 | $ | (71 | ) | $ | 6,349 | $ | 14,084 | $ | (7,735 | ) | ||||||||||
| General and administrative |
1,855 | 2,773 | (918 | ) | 5,477 | 6,514 | (1,037 | ) | ||||||||||||||||
| Impairment of intangible assets |
16,130 | - | 16,130 | 16,130 | - | 16,130 | ||||||||||||||||||
| Total operating expenses |
19,882 | 4,741 | 15,141 | 27,956 | 20,598 | 7,358 | ||||||||||||||||||
| Operating loss |
(19,882 | ) | (4,741 | ) | (15,141 | ) | (27,956 | ) | (20,598 | ) | (7,358 | ) | ||||||||||||
| Other income (expense): |
||||||||||||||||||||||||
| Loss on debt issuance |
(14,965 | ) | - | (14,965 | ) | (22,402 | ) | - | (22,402 | ) | ||||||||||||||
| Gain on debt extinguishment |
- | 71 | (71 | ) | 52 | 14,591 | (14,539 | ) | ||||||||||||||||
| Loss on deposit settlement |
(650 | ) | - | (650 | ) | (650 | ) | - | (650 | ) | ||||||||||||||
| Change in fair value of convertible notes payable |
2,684 | - | 2,684 | 3,473 | - | 3,473 | ||||||||||||||||||
| Change in fair value of common stock warrant liability |
50 | 2,166 | (2,116 | ) | 292 | 2,166 | (1,874 | ) | ||||||||||||||||
| Change in fair value of derivative liabilities |
613 | - | 613 | 801 | 33 | 768 | ||||||||||||||||||
| Interest income |
758 | 12 | 746 | 963 | 62 | 901 | ||||||||||||||||||
| Interest expense |
(328 | ) | (51 | ) | (277 | ) | (427 | ) | (174 | ) | (253 | ) | ||||||||||||
| Other income (expense), net |
204 | (446 | ) | 650 | (338 | ) | (563 | ) | 225 | |||||||||||||||
| Total other (expense) income, net |
(11,634 | ) | 1,752 | (13,386 | ) | (18,236 | ) | 16,115 | (34,351 | ) | ||||||||||||||
| Loss before income taxes |
(31,516 | ) | (2,989 | ) | (28,527 | ) | (46,192 | ) | (4,483 | ) | (41,709 | ) | ||||||||||||
| Income tax benefit (expense) |
3,431 | 240 | 3,191 | 3,431 | (71 | ) | 3,502 | |||||||||||||||||
| Net loss |
$ | (28,085 | ) | $ | (2,749 | ) | $ | (25,336 | ) | $ | (42,761 | ) | $ | (4,554 | ) | $ | (38,207 | ) | ||||||
Research and Development Expenses
Our research and development expenses are charged to operations as incurred and we incur both direct and indirect expenses for each of our programs. We track direct research and development expenses by preclinical and clinical programs, which include third-party costs such as contract research organization, contract manufacturing organizations, contract laboratories, consulting, and clinical trial costs. We do not allocate indirect research and development expenses, which include product development and manufacturing expenses and clinical, medical, and regulatory operations expenses, to specific programs. We also account for research and development and report annually by major expense category as follows: (i) contracted services; (ii) salaries and benefits; (iii) rents and utilities; (iv) stock-based compensation; (v) depreciation; and (vi) other. We expect that our research and development expenses related to the istaroxime – cardiogenic shock program will continue to increase to the extent that we continue the SEISMiC C study in patients with more severe SCAI Stage C cardiogenic shock. We currently do not have sufficient capital to fully complete this clinical trial. At this time, we cannot reasonably estimate or know the nature, timing, and estimated costs of the efforts that will be necessary to complete the development of our product candidates. We are also unable to predict when, if ever, material net cash inflows will commence from sales of our product candidates.
Research and development expenses are as follows:
| Three Months Ended September 30, |
Increase |
Nine Months Ended September 30, |
Increase |
|||||||||||||||||||||
| (in thousands) |
2025 |
2024 |
(Decrease) |
2025 |
2024 |
(Decrease) |
||||||||||||||||||
| Acquired IPR&D from Varian asset purchase |
$ | - | $ | - | $ | - | $ | - | $ | 7,495 | $ | (7,495 | ) | |||||||||||
| Istaroxime – cardiogenic shock program |
1,283 | 1,254 | $ | 29 | 4,242 | 4,413 | (171 | ) | ||||||||||||||||
| Istaroxime – AHF |
- | 25 | (25 | ) | - | 25 | (25 | ) | ||||||||||||||||
| Total direct clinical and preclinical programs |
1,283 | 1,279 | 4 | 4,242 | 4,438 | (196 | ) | |||||||||||||||||
| Product development and manufacturing |
208 | 221 | (13 | ) | 725 | 660 | 65 | |||||||||||||||||
| Clinical, medical, and regulatory operations |
406 | 468 | (62 | ) | 1,382 | 1,491 | (109 | ) | ||||||||||||||||
| Total research and development expenses |
$ | 1,897 | $ | 1,968 | $ | (71 | ) | $ | 6,349 | $ | 14,084 | $ | (7,735 | ) | ||||||||||
For the three and nine months ended September 30, 2024, research and development expenses include non-cash charges of $7.5 million associated with the acquired IPR&D related to the Asset Purchase Agreement with Varian Biopharmaceuticals in the second quarter of 2024.
Direct Clinical and Preclinical Programs
Direct clinical and preclinical programs include: (i) activities associated with conducting clinical trials, including contract research organization costs, patient enrollment costs, clinical site costs, clinical drug supply, and related external costs, such as consultant fees and expenses; and (ii) development activities, toxicology studies, and other preclinical studies.
Total direct clinical and preclinical programs expenses decreased $0.2 million for the nine months ended September 30, 2025 compared to the same period in 2024 primarily due to the winddown of costs related to the istaroxime – cardiogenic shock program as described below.
Istaroxime – cardiogenic shock program costs decreased $0.2 million for the nine months ended September 30, 2025 compared to the same period in 2024 due to the winddown of trial costs for the istaroxime - cardiogenic shock program, which included clinical trial costs for the SEISMiC C study in patients with more severe SCAI Stage C cardiogenic shock in 2025 and clinical trial costs for the SEISMiC Extension study in 2024.
Istaroxime – AHF costs have been limited as we focus our resources on the execution of the istaroxime – cardiogenic shock program.
Product Development and Manufacturing
Product development and manufacturing includes (i) manufacturing operations with our contract manufacturing organization, validation activities, quality assurance; and (ii) pharmaceutical and manufacturing development activities of our drug product candidates, including development of istaroxime. These costs include employee expenses, facility-related costs, depreciation, costs of drug substances (including raw materials), supplies, quality assurance activities, and expert consultants and outside services to support pharmaceutical development activities.
Product development and manufacturing expenses increased $0.1 million for the nine months ended September 30, 2025 compared to the same period in 2024 due to an increase in quality assurance costs related to a GMP server validation during the first quarter of 2025.
Clinical, Medical, and Regulatory Operations
Clinical, medical, and regulatory operations include medical, scientific, preclinical and clinical, regulatory, data management, and biostatistics activities in support of our research and development programs. These costs include personnel, expert consultants, outside services to support regulatory and data management, symposiums at key medical meetings, facilities-related costs, and other costs for the management of clinical trials.
Clinical, medical, and regulatory operations expenses decreased $0.1 million for the three and nine months ended September 30, 2025 compared to the same period in 2024 due to a $0.2 million decrease in personnel costs related to the reduction in headcount during the quarter, partially offset by a $0.1 increase in regulatory CMC consulting during the first quarter of 2025.
General and Administrative Expenses
General and administrative expenses consist of costs for executive management, business development, intellectual property, finance and accounting, legal, insurance, human resources, information technology, facilities, and other administrative costs.
General and administrative expenses decreased $0.9 million for the three months ended September 30, 2025 due to (i) a decrease of $0.8 million in professional fees, primarily related to costs associated with the First and Second PIPEs that were allocated to the July 2024 Warrants and expensed immediately; (ii) a decrease of $0.1 million in insurance costs related to a lower D&O premium. General and Administrative expenses decreased $1.0 million for the nine months ended September 30, 2025 compared to the same periods in 2024 due to a decrease of $0.8 million in professional fees, primarily related to costs associated with the First and Second PIPEs that were allocated to the July 2024 Warrants and expensed immediately and a decrease of $0.2 million in insurance costs related to a lower D&O premium.
Other (Expense) Income, Net
Other (Expense) Income increased $13.4 million mainly due to a loss on debt issuance of $15.0 million related to the $10.0 million July 2025 ELOC commitment note. Other (Expense) Income increased $32.4 million for the nine months ended September 30, 2025 mainly due to losses on debt issuance of $22.4 related to the July 2025 ELOC commitment note and the June and July 2025 Note Purchase agreements.
In June 2025, we entered into certain Note Purchase Agreements for which we elected to apply the fair value option for all of the June 2025 Notes and June 2025 Warrants as of their issuance date. The fair value of the June 2025 Notes on the dates of issuance was $8.6 million and $7.8 million at June 30, 2025. In July 2025, we entered into two additional Note Purchase Agreements for which we also elected to apply the fair value option for the July 2025 Notes. The fair value of the June 2025 and July 2025 as of September 30, 2025 was $2.6 million. Accordingly, a change in fair value adjustment of $2.7 million and $3.5 million is reflected in other income (expense) for the three and nine months ended September 30, 2025.
The fair value of the June 2025 Warrants on the dates of issuance was $2.9 million. The June 2025 Warrants are considered permanent equity and do not need to be remeasured. Given the fair value at issuance of the June 2025 Notes and June 2025 Warrants were in excess of the cash proceeds received, we incurred a loss on debt issuance of $7.3 million for the nine months ended September 30, 2025. The loss on debt issuance of $7.4 million for the nine months ended September 30, 2025 also includes an additional $0.1 million loss related to the issuance of the March 2025 Notes.
On January 24, 2024, we and affiliates of Deerfield Management Company L.P., or Deerfield, entered into an Exchange and Termination Agreement, or the Exchange and Termination Agreement, wherein Deerfield agreed to terminate its rights to receive certain milestone payments in exchange for (i) cash in the aggregate amount of $0.2 million and (ii) an aggregate of 676 shares of our common stock, par value $0.001 per share (See the section titled, “Note 14 - Restructured Debt Liability”). This transaction was accounted for as an extinguishment of debt in accordance with ASC 470, Debt-Modifications and Extinguishments, and as a result, we recognized a $14.5 million non-cash gain on debt extinguishment.
Change in fair value of common stock warrant liability relates to the change in fair value of the July 2024 Warrants, which are classified as a liability on our condensed consolidated balance sheet and are recorded at fair value at the end of each period. For the three and nine months ended September 30, 2025, the change in the estimated fair value of the July 2024 warrants was $0.1 million and $0.3 million, respectively. For further details, refer to “Note 11 - Common Stock Warrant Liability.”
For the nine months ended September 30, 2025, change in fair value of derivative liabilities is related to the final remeasurement of the fair value of the derivative liability associated with our ELOC commitment note.
Interest income relates primarily to interest related to the accretion of the debt discount for our note receivable with Standard Waste for the three and nine months ended September 30, 2025 and 2024.
For the three and nine months ended September 30, 2025, interest expense consists primarily of interest expense associated with our ELOC commitment note and the interest accruing related to PMUSA and PMPSA. For the three and nine months ended September 30, 2024, interest expense consists primarily of interest expense associated with the amortization of the issuance costs and the debt discount related to our senior convertible notes payable.
For the three and nine months ended September 30, 2025, other expense, net primarily consists of $0.2 million gain on foreign currency translation and $0.3 million loss on foreign currency translation. For the three and nine months ended September 30, 2024, other (expense) income, net primarily consists of initial recognition and remeasurement changes in the fair value of derivative liabilities associated with our senior convertible notes payable and our ELOC commitment note, partially offset by net gains on foreign currency translation. Foreign currency gains and losses are primarily due to changes in the New Taiwan dollar exchange rate related to activities of our wholly-owned subsidiary, CVie Therapeutics Limited, in Taiwan.
Income Tax Expense
For the three months and nine months ended September 30, 2025, we realized an income tax benefit of $3.4 million from the reversal of deferred taxes due to the intangible asset impairment charge of $16.0 million. During the three and nine months ended September 30, 2024, we recorded income tax benefit of $0.2 million and income tax expense of $0.1 million, respectively, related to the tax on our estimated taxable income for the year, primarily due to the gain on debt extinguishment (See the section titled, “Note 12 – Restructured Debt Liability”).
LIQUIDITY AND CAPITAL RESOURCES
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.
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. If we fail to raise sufficient capital, we potentially could be forced to limit or cease our development activities, as well as modify or cease our operations, either of which would have a material adverse effect on our business, financial condition, and results of operations.
Cash Flows
The following table summarizes our sources and uses of cash for each of the periods presented:
| Nine Months Ended |
||||||||
| September 30, |
||||||||
| (in thousands) |
2025 |
2024 |
||||||
| Net cash provided by (used in): |
||||||||
| Operating activities |
$ | (11,436 | ) | $ | (11,717 | ) | ||
| Investing activities |
(5,972 | ) | (12 | ) | ||||
| Financing activities |
15,834 | 9,569 | ||||||
| Change in cash and cash equivalents |
$ | (1,574 | ) | $ | (2,160 | ) | ||
Operating Activities
Cash used in operating activities resulted primarily from our net loss adjusted for non-cash charges and changes in components of working capital. Net cash used in operating activities was $11.4 million for the nine months ended September 30, 2025 compared to $11.7 million for the nine months ended September 30, 2024. The decrease in cash used in operating activities of $0.3 million was primarily attributable to a decrease in cash paid for research and development and general administrative expense offset by an increase in the amount of cash used in working capital primarily related to the settlement of accounts payable.
Investing Activities
Cash used in investing activities resulted from $4.6 million in senior note receivable issuance and $1.4 million in a deposit on the Aubrey property.
Financing Activities
Net cash provided by financing activities was $15.8 million for the nine months ended September 30, 2025. Cash provided by financing activities for the nine months ended September 30, 2025 was attributable to net proceeds from the issuance of private placement notes and Series D Preferred stock of $7.1 million, ELOC Purchase agreement of $15.9 million, proceeds from senior secured notes of $0.5 million, proceeds from warrant exercises of $0.4 million, partially offset by redemption and cash dividend payments on our Series C and Series D Preferred Stock of $4.7 million and $2.2 million in principal payments for senior secured notes payable and loans payable.
Net cash provided by financing activities of $9.6 million for the nine months ended September 30, 2024 was attributable to net proceeds of $1.4 million related to our 2023 ATM Program and $0.3 million in proceeds from the issuance of senior secured notes, and $1.3 million in proceeds from the issuance of senior convertible notes payable, partially offset by $0.2 million in principal payments for loans payable, $0.1 million paid for Series B preferred stock issuance costs, and $0.1 million in payments on debt extinguishment.
The following sections provide a more detailed discussion of our available financing facilities.
Common Stock Purchase Agreements
In July 2025, we entered into a Common Stock Purchase Agreement, or the 2025 ELOC Purchase Agreement, establishing an equity line of credit with the purchaser, or the Purchaser, whereby we have the right, but not the obligation, to sell to the Purchaser, and the Purchaser is obligated to purchase, up to $500 million of newly issued shares of our common stock. The Purchaser is also a holder of the Company's Series C Preferred Stock and Series D Preferred Stock as well as a holder of certain of our convertible notes payable. On October 24, 2025, pursuant to the Common Stock Purchase Agreement, we filed a Form S-1 Registration Statement under the Securities Act of 1933 with the U.S. Securities and Exchange Commission (the “SEC”) SEC registering up to 555,555,556 shares of common stock (the “Purchase Shares”) under the 2025 ELOC Purchase Agreement and (ii) up to 166,687,215 shares of common stock (the “Note Shares,” and together with the Purchase Shares, the “ELOC Shares”), issuable upon the conversion of the outstanding unpaid principal balance, together with all accrued and unpaid interest, if any, of the convertible promissory note (the “Commitment Note”), issued to Seven Knots as consideration for it entering into the ELOC Purchase Agreement.
In June 2024, we entered into the 2024 ELOC Purchase Agreement establishing an equity line of credit with the Purchaser, whereby we have the right, but not the obligation, to sell to the Purchaser, and the Purchaser is obligated to purchase, up to $35 million of newly issued shares of our common stock. The Purchaser
Supplementary Disclosure of Non-Cash Activity
During the nine months ended September 30, 2025, 11,321 shares of Series C Convertible Preferred Stock and $106,000 of accrued and unpaid dividends were converted into 9,856,630 shares of common stock. Upon conversion, the excess of the stated value of $1,000 per share over the current the carrying value of the shares of the Series C Preferred Stock converted was reclassified to common stock $0.001 par value and additional paid-in capital in the aggregate amount of $8.7 million. There was no gain or loss recognized on the transaction as the shares were converted in accordance with the original terms of the Certificate of Designation of Series C Preferred Stock.
The Company accretes to Series C Preferred Stock against additional paid-in capital as a deemed dividend for the difference between the initial net carrying value and the full redemption price of $1,000 per share. The Company uses the effective interest method to calculate the accretion amount for each period. During the nine months ended September 30, 2025, we recognized $5.5 million in deemed dividends on Series C preferred stock.
The Company accretes to Series D Preferred Stock against additional paid-in capital as a deemed dividend for the difference between the initial net carrying value and the full redemption price of $1,000 per share. The Company uses the effective interest method to calculate the accretion amount for each period. During the nine months ended September 30, 2025, we recognized $0.3 million in deemed dividends on Series D preferred stock.
During the nine months ended September 30, 2025, we recognized a fair value upon issuance of the June 2025 Notes of $8.7 million and a fair value upon issuance of the June 2025 Warrants of $2.9 million. The June 2025 Notes will be remeasured at each balance sheet date. The June 2025 Warrants are considered permanent equity and do not need to be remeasured.
During the nine months ended September 30, 2025, the Purchaser converted the ELOC Commitment Note and its related accrued interest into 56,769 shares of our common stock with a fair value of $0.5 million.
During the first quarter of 2025, we issued the March 2025 Notes for aggregate gross proceeds of $0.25 million. The March 2025 Notes include a 20% original issue discount and bear interest at 10% per annum with such interest compounded each calendar month. Certain conversion and redemption features of the March 2025 Notes would typically be considered derivatives that would require bifurcation. In lieu of bifurcating various features in the agreement, we elected the fair value option for the March 2025 Notes and recognized a fair value upon issuance of $0.4 million.
During the nine months ended September 30, 2025, we recorded a $20,000 reduction to our common stock warrant liability related to exercises of July 2024 Warrants during the period.
Off-Balance Sheet Arrangements
We did not have any material off-balance sheet arrangements as of September 30, 2025 or 2024 or during the periods then ended.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Not applicable.
Item 4. Controls and Procedures
Evaluation of disclosure controls and procedures
Our management, including our President and Chief Executive Officer (principal executive officer and principal financial officer), do not expect that our disclosure controls or our internal control over financial reporting will prevent all error and all fraud. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty and that breakdowns can occur because of simple error or mistake. Controls can also be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the controls. The design of any system of controls is based in part on certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate because of changes in conditions or deterioration in the degree of compliance with policies or procedures. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected. In designing and evaluating the disclosure controls and procedures, our management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives and our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
Our President and Chief Executive Officer has evaluated the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rule 13a-15(e) and Rule 15d-15(e) of the Exchange Act) as of the end of the period covered by this Quarterly Report on Form 10-Q. Based on this evaluation, our President and Chief Executive Officer concluded that, as of the end of the period covered by this report, our disclosure controls and procedures were effective to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is accumulated and communicated to our management, including our President and Chief Executive Officer, to allow for timely decisions regarding required disclosures, and recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms.
Changes in internal control
There were no changes in our internal control over financial reporting identified in connection with the evaluation described above that occurred during the quarter ended September 30, 2025 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
PART II – OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
We are not aware of any pending legal actions that would, if determined adversely to us, have a material adverse effect on our business and operations.
We have from time to time been involved in disputes and proceedings arising in the ordinary course of business, including in connection with the conduct of our clinical trials. In addition, as a public company, we are also potentially susceptible to litigation, such as claims asserting violations of securities laws. Any such claims, with or without merit, if not resolved, could be time-consuming and result in costly litigation. There can be no assurance that an adverse result in any future proceeding would not have a potentially material adverse effect on our business, results of operations and financial condition.
ITEM 1A. RISK FACTORS
Investing in our securities involves certain risks. In addition to any risks and uncertainties described elsewhere in this Quarterly Report on Form 10-Q, investors should carefully consider the risks and uncertainties discussed in Part I, Item 1A. "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2024, as supplemented by risk factors included in our Quarterly Reports on Form 10-Q filed thereafter. These risks are not the only risks that could materialize. Other than as set forth below, there have been no material changes in our risk factors from those previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2024 or our Quarterly Reports on Form 10-Q filed thereafter. Additional risks and uncertainties not presently known to us or that we currently consider to be immaterial may also impair our business operations and development activities. Should any of the risks and uncertainties described in our Annual Report on Form 10-K for the year ended December 31, 2024, as supplemented by our subsequent filings with the SEC, actually materialize, our business, financial condition, and/or results of operations could be materially adversely affected, the trading price of our common stock could decline, and an investor could lose all or part of his or her investment. In particular, the reader’s attention is drawn to the discussion in Part I, Item 2 – Management’s Discussion and Analysis of Financial Condition and Results of Operations – Liquidity and Capital Resources.
Our ability to continue as a going concern requires that we obtain sufficient funding to finance our operations in the near term.
We do not have sufficient resources available to fund our business beyond December 2025. To increase our cash runway, 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 and/or potential revenues from any future acquisitions of small companies with FDA approved products as a result of our new corporate strategy
Further, under the terms of the various Note Purchase Agreements, we are subject to certain restrictive covenants that may make it difficult to procure additional financing. As a result of these covenants, our ability to respond to changes in business and economic conditions and engage in beneficial transactions, including to obtain additional debt or equity financing as needed in the future, on favorable terms or at all, may be limited, which could adversely affect our business, financial condition, and results of operations.
If we fail to raise sufficient capital, we potentially could be forced to limit or cease our development activities, as well as modify or cease our operations, either of which would have a material adverse effect on our business, financial condition, and results of operations. In addition, sales of a substantial number of shares of our common stock in the public market or the perception that these sales might occur, including pursuant to our existing equity line of credit, could depress the market price of our common stock and could impair our ability to raise capital through the sale of additional equity securities. These conditions raise substantial doubt regarding our ability to continue as a going concern.
Nasdaq has delisted the our stock from the Nasdaq Capital Market. As a result, our common stock is now listed on the over-the-counter market (‘OTCID’) as of August 22, 2025. We can provide no assurance that we will be able to comply with the continued listing requirements over time and that our common stock will continue to be listed on the OTCID.
On December 4, 2024, we received a deficiency letter from the Nasdaq Listing Qualifications Department, or the Nasdaq Staff, notifying the Company that, for the last 30 consecutive business days, the closing bid price for the Company’s common stock had been below the minimum $1.00 per share required for continued listing on The Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2), or the Minimum Bid Price Requirement. The Company timely requested a hearing before the Hearings Panel, or the Nasdaq Panel. On March 20, 2025, we received written confirmation from Nasdaq notifying us that we had regained compliance with the Minimum Bid Price Requirement. Nasdaq also stated that the Nasdaq Panel was imposing a Discretionary Panel Monitor until March 20, 2026, which generally will require the Nasdaq Staff to issue a Delist Determination Letter in the event that we fail to maintain compliance with any continued listing requirement.
On August 19, 2025, we were notified by Nasdaq that as a result of the Company’s previously disclosed noncompliance with Nasdaq Listing Rule 5550(a)(2), Nasdaq has determined to delist our common stock from the Nasdaq Capital Market. We began trading publicly on the over-the-counter market (“OTCID”) on August 22, 2025, under our existing symbol “WINT.”
The delisting of our securities by Nasdaq could adversely affect the trading market for our securities, as price quotations may not be as readily obtainable, which would likely have a material adverse effect on the market price of our securities and the Company’s ability to raise additional capital.
Moreover, we can provide no assurance that trading in our securities will continue over the counter or otherwise. As a result of the delisting, we could face significant material adverse consequences, including:
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a limited availability of market quotations for our securities; |
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reduced liquidity with respect to our securities; |
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a determination that our shares of common stock are “penny stock”, which will require brokers trading in our shares of common stock to adhere to more stringent rules, possibly resulting in a reduced level of trading activity in the secondary trading market for our shares of common stock; |
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a limited amount of news and analyst coverage for our company; and |
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a decreased ability to issue additional securities or obtain additional financing, including our 2025 ELOC Purchase Agreement, or otherwise, in the future. |
The National Securities Markets Improvement Act of 1996, which is a federal statute, prevents or preempts the states from regulating the sale of certain securities, which are referred to as “covered securities.” Because they have been delisted, our securities would not be covered securities and we would be subject to regulation in each state in which we offer our securities. This state level regulation introduces additional compliance requirements for brokers to consider making markets in our securities and will further negatively impact any trading liquidity in our securities.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
On July 2, 2025, we agreed to issue and sell to certain institutional investors convertible promissory notes in an aggregate principal amount of $81,396 for aggregate gross proceeds of $70,000 (the “July 2 Notes”). In connection with the purchase of the July 2 Notes, the investors received warrants to purchase an aggregate of $17,500 worth of shares of the Company’s common stock. The warrants have an exercise price of $1.10 per share, subject to adjustment, are immediately exercisable and expire upon the earlier of (1) five years from the date of issuance or (2) when the warrant is exercised in full. Interest will accrue at a rate of 14% per annum on the July 2 Notes, provided, however, that for the first 6 months following the issue date, interest on the principal will accrue immediately and be guaranteed. The July 2 Notes have a maturity date of July 2, 2026. Each of the July 2 Notes and associated warrants were issued in a private offering in reliance on exemption from registration provided in Section 4(a)(2) of the Securities Act of 1933, as amended.
On July 16, 2025, we agreed to the private placement of (i) approximately 60,000 shares of Series E Convertible Preferred Stock, par value $0.001 per share (the “Series E Preferred Stock,” and such shares issuable upon the conversion of Series E Preferred Stock, the “Conversion Shares”) at an offering price of $1,000 per share of Series E Preferred Stock (the “Stated Value”), and (ii) warrants, and such shares issuable upon exercise of the warrants, the “Warrant Shares”) to purchase up to an aggregate of 66,000,000 shares of our common stock, for aggregate gross proceeds of approximately $60,000,000, payable in cash, the native token of the BNB chain commonly referred to as “BNB,” or shares of Osprey BNB Chain Trust (“OBNB”). Windtree management decided not to move forward with the cryptocurrency treasury strategy.
On July 23, 2025, we entered into the ELOC Purchase Agreement with Seven Knots, LLC (“Seven Knots”), establishing an equity line of credit (the “Committed Equity Financing”), pursuant to which we may sell shares of common stock to Seven Knots from time to time. Pursuant to the ELOC Purchase Agreement, Seven Knots shall purchase from us up to the lesser of (i) $500 million of newly issued shares of common stock and (ii) 19.99% of the total number of shares of common stock outstanding immediately prior to the execution of the ELOC Purchase Agreement at an average price equal to or in excess of $0.9726; provided however that such limitations will not apply if we obtain stockholder approval to issue additional shares of common stock. On August 28, 2025, we obtained stockholder approval at the Special Meeting of Stockholders to issue up to $500 million of ELOC Shares under the ELOC Purchase Agreement. Such sales of common stock by the Company to Seven Knots will be made in reliance upon the provisions of 4(a)(2) of the Securities Act.
On October 9, 2025, we issued to institutional investors an aggregate principal amount of $1,600,000 in senior convertible promissory notes due 2026 (the “Commitment Notes”). The Commitment Notes were issued in connection with the termination and settlement of the Assignment and Conditional Assumption Agreement between WINT Real Estate, LLC, a wholly owned subsidiary of the Company, and Way Maker Growth Fund, LLC relating to that certain Purchase and Sale Agreement dated June 28, 2024, as amended by that certain First Amendment to Purchase and Sale Agreement, dated December 19, 2024 and that certain Second Amendment to Purchase and Sale Agreement, dated March 25, 2025, and that certain development services agreement, dated February 4, 2025 (each between Way Maker Growth Fund, LLC and TBB Crescent Park Drive LLC), as previously disclosed by the Company on October 6, 2025. The Commitment Notes are junior to the Company’s June 2025 Convertible Promissory Note, which was issued to DFU, LLC and is a senior, unsecured obligation of the Company, with priority over all existing and future indebtedness of the Company. The Company issued the Commitment Notes in reliance upon the exemption from registration provided by Section 4(a)(2) of the Securities Act and/or Rule 506(b) of Regulation D promulgated thereunder.
On November 12, 2025, we issued a senior convertible promissory note to Commloan in the principal amount of $0.6 million (the “Commloan Note”). The Commloan Note matures on November 11, 2026. The Commloan Note accrues interest at the rate of ten percent (10%) per annum. All interest payments will be payable in cash. Accrued and unpaid interest shall be payable in arrears and shall be due on the 10th calendar day of each month beginning December 10, 2025. Interest shall be calculated on the basis of a 360-day year, consisting of twelve 30 calendar day periods, commencing on the November 12, 2025. The Commloan Note must be prepaid by the Commloan in an amount equal to 105% in the event the note is satisfied prior to November 10, 2026. The Company issued the Commloan Note in reliance upon the exemption from registration provided by Section 4(a)(2) of the Securities Act and/or Rule 506(b) of Regulation D promulgated thereunder.
On November 14, 2025, the Company issued to Seven Knots a senior convertible promissory note in the principal amount of $750,000 due in November 2026 (the “2026 Note”). The 2026 Note was issued in connection with a letter of intent by the Company to acquire all of the issued and outstanding securities of CommLoan and related note receivable with Commloan (see Note 19 - Subsequent events - Note Receivable). [GP1] Seven Knots is also a holder of the 2026 Commitment Notes as well as the Company’s Series C and Series D Preferred Shares. The 2026 Note matures on November 13, 2026 and will bear interest at 10% per annum on a 360-day basis, due and payable on such maturity date. Accrued and unpaid interest is payable in arrears and due on the fifth calendar day of each month beginning December 2025. The Company issued the 2026 Note in reliance upon the exemption from registration provided by Section 4(a)(2) of the Securities Act and/or Rule 506(b) of Regulation D promulgated thereunder.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
On August 19, 2025, we were notified by Nasdaq that as a result of the Company’s previously disclosed noncompliance with Nasdaq Listing Rule 5550(a)(2), Nasdaq has determined to delist our common stock from the Nasdaq Capital Market and, accordingly, suspended trading in our common stock effective at the open of trading on August 21, 2025. The delisting of our common stock from Nasdaq constitutes a technical “event of default” for the following securities:
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June 5, 2025 senior unsecured convertible promissory note issued to DFU, LLC with the principal amount of $3,600,000. |
| ● | June 9, 2025 senior unsecured convertible notes issued to each of Keystone Capital Partners, LLC and Seven Knots, LLC in the principal amount of $232,550. |
| ● | June 9, 2025 senior unsecured convertible notes issued to C/M Capital Master Fund LP in the principal amount of $116,280. |
| ● | June 9, 2025 senior unsecured convertible notes issued to WVP Emerging Manager Onshore Fund in the principal amount of $348,837. |
| ● | June 24, 2025 senior unsecured convertible promissory note issued to certain purchasers for the aggregate purchase price of $100,000. |
| ● | June 27, 2025 Convertible Promissory Notes to Purchasers in the principal amount of $58,140 for a purchase price of $50,000 and issued the other June Purchaser a Convertible Promissory Note in the principal amount of $96,899 for a purchase price of $83,333. |
| ● | July 2, 2025 Convertible Promissory Notes to the July Purchasers, each in a principal amount of $40,698 for a purchase price of $35,000; and |
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| ● | July 23, 2025 convertible promissory note issued to Seven Knots as consideration for it entering into the 2025 ELOC Purchase Agreement for the principal amount of $10,000,000 |
ITEM 4. MINE SAFETY DISCLOSURES
Not applicable.
ITEM 5. OTHER INFORMATION
Termination of the Letter of Intent with Titan Environmental Services, Inc.
On November 11, 2025, the Company entered into a Letter Agreement (the “Agreement”) with Titan Environmental Services, Inc (“TESI”) in connection with the previously disclosed Letter of Intent (“LOI”) from June 6, 2025. The LOI contemplated that the Company would acquire all of the issued and outstanding securities of TESI on the terms and conditions set forth in the LOI and in an acquisition agreement to be entered into by the parties. Pursuant to that LOI, the Company had advanced $7.5 million (the “Outstanding Amount”). As mentioned in Note 6 - Note Receivable, net, the Company made the decision to not pursue the acquisition of TESI.
The Letter Agreement releases The Company and TESI from any and all reciprocal surviving obligations under the LOI and establishes an arrangement for the return of the $7.5 million advance in the form of a combination of cash and securities.
The parties also agree that the execution of the Letter Agreement settles all actual and potential obligations of TESI towards the Company and upon payment of the Equity Consideration, each party releases and forever discharges the other party and its foregoing related persons from any and all claims of any kind, whether known or unknown, arising out of or relating to the LOI or the proposed transaction thereunder.
Note Receivable
On November 12, 2025, the Company issued a senior convertible promissory note to Commloan in the principal amount of $0.6 million (the “Commloan Note”). The Commloan Note matures on November 11, 2026. The Commloan Note accrues interest at the rate of ten percent (10%) per annum. All interest payments will be payable in cash. Accrued and unpaid interest shall be payable in arrears and shall be due on the 10th calendar day of each month beginning December 10, 2025. Interest shall be calculated on the basis of a 360-day year, consisting of twelve 30 calendar day periods, commencing on the November 12, 2025. The Commloan Note must be prepaid by the Commloan with a mandatory prepayment premium in the amount equal to 105%, in the event the note is satisfied prior to November 10, 2026.
By mutual written agreement of the Company and Commloan, the outstanding principal and accrued interest may be converted into equity securities issued in the Company’s next qualified financing round at a fixed price equal to the price per share of such financing, less a fifteen percent (15%) discount. If an Event of Default occurs, as defined in the Commloan Note, then we may (i) declare all outstanding principal and other sums payable to be immediately due and payable and (ii) exercise any and all of our other rights under applicable law.
On November 14, 2025, the Company issued to Seven Knots a senior convertible promissory note in the principal amount of $750,000 due in November 2026 (the “2026 Note”). The 2026 Note was issued in connection with a letter of intent by the Company to acquire all of the issued and outstanding securities of CommLoan and related note receivable with Commloan (see Note 19 - Subsequent events - Note Receivable). [GP1] Seven Knots is also a holder of the 2026 Commitment Notes as well as the Company’s Series C and Series D Preferred Shares. The 2026 Note matures on November 13, 2026 and will bear interest at 10% per annum on a 360-day basis, due and payable on such maturity date. Accrued and unpaid interest is payable in arrears and due on the fifth calendar day of each month beginning December 2025.
The 2026 Note must be prepaid by the Company in an amount equal to 25% of the gross proceeds received by the Company from that certain Common Stock Purchase Agreement dated June 26, 2024 by and between Seven Knots and the Company, with a mandatory prepayment premium of 115%.
If the Company completes a qualified equity financing with total gross proceeds to the Company of $1 million or more (excluding the conversion of the notes or other convertible securities issued for capital raising purposes) before the maturity date, the 2026 Note must be repaid in full in an amount equal to the then-outstanding principal amount, any accrued but unpaid interest and a pre-payment premium equal to 115% of the 2026 Note value on November 14, 2025. Such repayment will be due within one business day of the closing such qualified equity financing. The Company shall give written notice to the Holders as soon as practicable, but in no event less than ten days before the anticipated closing date of such qualified equity financing, during which period the Holders shall have the opportunity to convert the 2026 Note pursuant its terms.
The 2026 Note provides for a beneficial ownership limitation of 4.99% of the number of shares of the Company’s common stock immediately after giving effect to the issuance of shares of common stock issuable upon conversion of the 2026 Note held by the Holders (increasable to 9.99% upon 61 days’ notice by the Holders to the Company).
The 2026 Note is convertible at the Holders’ option into shares of common stock at a conversion price equal to 90% of the lowest sale price for the 20 consecutive trading days preceding conversion, subject to adjustment. The Holders are entitled to an amount equal to $1,500 for each conversion of the 2026 Note for the related review and applicable deposit of the related shares. The 2026 Note include customary Events of Default (as defined in the 2026 Note), including non-payment, covenant breaches, bankruptcy, and change of control, and provides for acceleration at 120% of the unpaid principal balance, together with any accrued and unpaid interest, if any.
Rule 10b5-1 and Non-Rule 10b5-1 Trading Arrangements
During the nine months ended September 30, 2025, none of our directors or officers adopted, terminated or modified a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as defined in Item 408(a) of Regulation S-K of the Exchange Act.
ITEM 6. EXHIBITS
Exhibits are listed on the Index to Exhibits at the end of this Quarterly Report on Form 10-Q. The exhibits required by Item 601 of Regulation S-K, listed on such Index in response to this Item, are incorporated herein by reference.
INDEX TO EXHIBITS
The following exhibits are included with this Quarterly Report on Form 10-Q.
| Exhibit No. |
Description |
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Method of Filing |
| 3.1 | Certificate of Amendment to Amended and Restated Certificate of Incorporation. | Incorporated by reference to Exhibit 3.3 to Windtree’s Registration Statement on Form S-1, as filed with the SEC on October 24, 2025. | |
| 4.1 | Form of Convertible Note issued on July 2, 2025. | Incorporated by reference to Exhibit 4.3 to Windtree’s Current Report on Form 8-K, as filed with the SEC on July 3, 2025. | |
| 4.2 | Form of Common Stock Purchase Warrant issued on July 2, 2025. | Incorporated by reference to Exhibit 4.4 to Windtree’s Current Report on Form 8-K, as filed with the SEC on July 3, 2025. | |
| 4.3 | Form of Convertible Promissory Note by and between the Company and the Purchaser, dated as of July 23, 2025. | Incorporated by reference to Exhibit 4.1 to Windtree’s Current Report on Form 8-K, as filed with the SEC on July 24, 2025. | |
| 4.4 | Form of Senior Promissory Note issued on November 12, 2025. | Filed herewith. | |
| 4.5 | Form of Senior Convertible Promissory Note issued on November 14, 2025. | Filed herewith. | |
| 10.1 | Form of Note Purchase Agreement dated July 2, 2025. | Incorporated by reference to Exhibit 10.2 to Windtree’s Current Report on Form 8-K, as filed with the SEC on July 3, 2025. | |
| 10.2 | Form of Securities Purchase Agreement, dated as of July 16, 2025. | Incorporated by reference to Exhibit 10.1 to Windtree’s Current Report on Form 8-K, as filed with the SEC on July 17, 2025. | |
| 10.3 | Form of Common Stock Purchase Agreement, dated as of July 23, 2025, by and between Windtree Therapeutics, Inc. and the Purchaser. | Incorporated by reference to Exhibit 10.1 to Windtree’s Current Report on Form 8-K, as filed with the SEC on July 24, 2025. | |
| 10.4 | Form of Registration Rights Agreement, dated as of July 23, 2025, by and between Windtree Therapeutics, Inc. and the Purchaser. | Incorporated by reference to Exhibit 10.2 to Windtree’s Current Report on Form 8-K, as filed with the SEC on July 24, 2025. | |
| 10.5 | Amendment, dated October 23, 2025, to the Common Stock Purchase Agreement, dated July 23, 2025, by and between Windtree and Seven Knots, LLC. | Incorporated by reference to Exhibit 10.90 to Windtree’s Registration Statement on Form S-1, as filed with the SEC on October 24, 2025. | |
| 31.1 |
Certification of Chief Executive Officer and Principal Financial Officer pursuant to Rule 13a-14(a) of the Exchange Act. |
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Filed herewith. |
| 32.1 |
Certification of Chief Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
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Furnished herewith. |
| 101.INS |
Inline XBRL Instance Document (the Instance Document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document) (1). |
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Filed herewith. |
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| 101.SCH |
Inline XBRL Taxonomy Extension Schema Document (1). |
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Filed herewith. |
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| 101.CAL |
Inline XBRL Taxonomy Extension Calculation Linkbase Document (1). |
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Filed herewith. |
| 101.DEF |
Inline XBRL Taxonomy Extension Definition Linkbase Document (1). |
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Filed herewith. |
| 101.LAB |
Inline XBRL Taxonomy Extension Label Linkbase Document (1). |
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Filed herewith. |
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| 101.PRE |
Inline XBRL Taxonomy Extension Presentation Linkbase Document (1). |
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Filed herewith. |
| 104 | Cover Page Interactive Data File (formatted as Inline XBRL and combined in Exhibit 101.1) | Filed herewith. |
(1) These Interactive Data Files shall not be deemed filed for purposes of Section 11 or 12 of the Securities Act of 1933, as amended, or Section 18 of the Securities Act of 1934, as amended, or otherwise subject to liability under those sections.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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Windtree Therapeutics, Inc. |
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(Registrant) |
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| Date: November 14, 2025 |
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By: /s/ Jed Latkin |
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Jed Latkin |
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President and Chief Executive Officer |
| (Principal Executive Officer, Principal Financial Officer and Principal Accounting Officer) | ||
FAQ
How did Windtree Therapeutics (WINT) perform financially in Q3 2025?
Windtree reported a net loss of $28,085 for the quarter and $42,761 for the nine months ended September 30, 2025. Total operating expenses were $19,882 in the quarter, up mainly due to an intangible asset impairment.
What was the major driver of Windtree Therapeutics’ increased loss in Q3 2025?
The primary driver was an impairment of intangible assets of $16,130, which significantly increased total operating expenses compared with the prior year period.
What is Windtree Therapeutics’ cash and debt position as of September 30, 2025?
As of September 30, 2025, Windtree had $204 in cash and cash equivalents and $15,983 in total assets, versus $27,584 in total liabilities and stockholders’ equity of $(11,610), indicating substantial leverage.
What strategic changes has Windtree Therapeutics announced in 2025?
In January 2025, Windtree launched a new strategy to become a revenue‑generating biotech by acquiring small companies and their FDA‑approved products, using equity and debt, while continuing to seek partnerships to advance its cardiovascular and oncology pipeline.
What is the status of Windtree’s cardiogenic shock program with istaroxime?
Windtree terminated the SEISMiC C study in more severe SCAI Stage C cardiogenic shock due to resourcing constraints, and plans to focus further development of istaroxime in acute decompensated heart failure with its partner Lee’s Pharmaceutical (HK) Ltd.
Why was Windtree Therapeutics delisted from Nasdaq and where does it trade now?
On August 19, 2025, Windtree was notified that, due to previously disclosed noncompliance with Nasdaq Listing Rule 5550(a)(2), its common stock would be delisted from the Nasdaq Capital Market. Trading moved to the over-the-counter market (OTCID) on August 22, 2025 under the symbol WINT.
Did Windtree pursue the announced crypto treasury strategy involving BNB?
On July 16, 2025, Windtree announced a planned crypto treasury strategy tied to BNB and a related securities purchase agreement, but management decided not to move forward with this strategy in August 2025.
