Equibles

10-Q

WINDTREE THERAPEUTICS INC /DE/ (WINT)

10-Q 2025-11-19 For: 2025-09-30
View Original
Added on April 06, 2026

Table of Contents

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2025

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: 001-39290

WINDTREE THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

Delaware<br> <br>(State or other jurisdiction of incorporation or organization) 94-3171943<br> <br>(I.R.S. Employer<br> Identification No.)
2600 Kelly Road, Suite 100<br> <br>Warrington, Pennsylvania<br> <br>(Address of principal executive offices) 18976-3622<br> <br>(Zip Code)

Registrant’s telephone number, including area code: (215) 488-9300

Securities registered pursuant to Section 12(b) of the Act:

Title of each class Trading symbol(s) Name of each exchange on which registered
Common Stock, $0.001 par value WINT 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.  Yes ☒  No ☐

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).  Yes ☒  No ☐

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      ☐
Non-accelerated filer      ☒ Smaller reporting company      ☒
Emerging growth company      ☐

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 ☐  No ☒

As of November 14, 2025, there were 33,708,784 shares of the registrant’s common stock outstanding, par value $0.001 per share.

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PART I - FINANCIAL INFORMATION

Page
Item 1. Financial Statements 4
CONDENSED CONSOLIDATED BALANCE SHEETS 4
As of September 30, 2025 (unaudited) and December 31, 2024
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) 5
For the Three and Nine Months Ended September 30, 2025 and 2024
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN MEZZANINE EQUITY AND STOCKHOLDERS’ EQUITY (unaudited)<br> <br>For the Three and Nine Months Ended September 30, 2025 and 2024 6
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited) 8
For the Nine Months Ended September 30, 2025 and 2024
Notes to Condensed Consolidated Financial Statements (unaudited) 9
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 38
Item 3. Quantitative and Qualitative Disclosures about Market Risk 51
Item 4. Controls and Procedures 51

PART II - OTHER INFORMATION

Item 1. Legal Proceedings 53
Item 1A. Risk Factors 53
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 55
Item 3. Defaults Upon Senior Securities 56
Item 4. Mine Safety Disclosures 56
Item 5. Other Information 56
Item 6. Exhibits 58
Signatures 60

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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:

● our estimates regarding future results of operations, financial position, research and development costs, capital requirements, and our needs for additional financing;
● how long we can continue to fund our operations with our existing cash and cash equivalents;
● the impact of the delisting of our Common Stock from the Nasdaq Stock Market ("Nasdaq");
● 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;
● the potential impairment of our intangible assets on our condensed consolidated balance sheet, which could lead to material impairment charges in the future;
● our ability to repay indebtedness;
● 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;
● 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;
● 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;
● the difficulties and expenses associated with obtaining and maintaining regulatory approval of our product candidates, and the indication and labeling under any such approval;
● risks related to manufacturing active pharmaceutical ingredients, drug product, and other materials we need;
● delays, interruptions or failures in the manufacture and supply of our product candidates;
● 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;
● 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;
● the success of competing therapies and products that are or may become available;
● our ability to limit our exposure under product liability lawsuits;
● our ability to obtain and maintain intellectual property protection for our product candidates;
● 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;
● our ability to recruit or retain key scientific, commercial or management personnel or to retain our executive officers;
● 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;
● economic uncertainty resulting from inflation and interest rate fluctuations, including concerns involving liquidity, defaults or other non-performance by financial institutions;
● our expectations regarding the use of proceeds from sales under our equity line of credit, if any;
● 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;
● the impact of macroeconomic conditions and geopolitical turmoil on our business and operations, including interest rates, inflationary pressures, capital market disruptions, changes in governmental agencies, international tariffs, trade protection measures, economic sanctions and economic slowdowns or recessions; and
● our ability to successfully implement our new business strategy to generate revenue through acquisitions of small companies and their FDA-approved products; and
● 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).

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ITEM 1.      Financial Statements

WINDTREE THERAPEUTICS, INC. AND SUBSIDIARIES

Condensed Consolidated Balance Sheets

(in thousands, except share and per share data)
December 31, 2024
--- --- --- --- --- ---
ASSETS **** ****
Current assets:
Cash and cash equivalents 204 $ 1,779
Prepaid expenses and other current assets 1,198 795
Note receivable, net 5,803 -
Total current assets 7,205 2,574
Property and equipment, net 61 111
Restricted cash 10 9
Operating lease right-of-use assets 707 1,051
Intangible assets 8,000 24,130
Total assets 15,983 $ 27,875
LIABILITIES, MEZZANINE EQUITY & STOCKHOLDERS’ EQUITY **** ****
Current liabilities:
Accounts payable 1,651 $ 1,879
Accrued expenses 2,007 1,706
Operating lease liabilities - current portion 544 508
Convertible notes payable 2,590 -
ELOC commitment note payable 9,443 328
Derivative liability - ELOC commitment note 5,089 299
Common stock warrant liability 2 305
Loans payable 111 333
Other current liabilities 464 359
Total current liabilities 21,901 5,717
Operating lease liabilities - non-current portion 240 653
Other liabilities 3,800 3,800
Deferred tax liabilities 1,643 4,528
Total liabilities 27,584 14,698
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 4 3,181
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 5 -
Total mezzanine equity 9 3,181
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 34 -
Additional paid-in capital 880,781 859,660
Accumulated deficit (889,371 ) (846,610 )
Treasury stock (at cost); 1 share (3,054 ) (3,054 )
Total stockholders’ equity (11,610 ) 9,996
Total liabilities, mezzanine equity & stockholders’ equity 15,983 $ 27,875

All values are in US Dollars.

See notes to condensed consolidated financial statements

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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 $ 1,897 $ 1,968 $ 6,349 $ 14,084
General and administrative 1,855 2,773 5,477 6,514
Impairment of intangible assets 16,130 - 16,130 -
Total operating expenses 19,882 4,741 27,956 20,598
Operating loss (19,882 ) (4,741 ) (27,956 ) (20,598 )
Other income (expense):
Loss on debt issuances (14,965 ) - (22,402 ) -
Gain on debt extinguishment, net - 71 52 14,591
Loss on deposit settlement (650 ) - (650 ) -
Change in fair value of convertible notes payable 2,684 - 3,473 -
Change in fair value of common stock warrant liability 50 2,166 292 2,166
Change in fair value of derivative liabilities 613 - 801 33
Interest income 758 12 963 62
Interest expense (328 ) (51 ) (427 ) (174 )
Other income (expense), net 204 (446 ) (338 ) (563 )
Total other (expense) income, net (11,634 ) 1,752 (18,236 ) 16,115
Loss before income taxes (31,516 ) (2,989 ) (46,192 ) (4,483 )
Income tax benefit (expense) 3,431 240 3,431 (71 )
Net loss $ (28,085 ) $ (2,749 ) $ (42,761 ) $ (4,554 )
Extinguishment of Series B preferred stock - 572 - 572
Dividends on Series C preferred stock (650 ) (1,573 ) (5,789 ) (1,573 )
Dividends on Series D preferred stock (203 ) - (340 ) -
Dividends on warrants - - (9 ) -
Net loss attributable to common stockholders $ (28,938 ) $ (3,750 ) $ (48,899 ) $ (5,555 )
Net loss per share attributable to common stockholders
Basic and diluted $ (1.08 ) $ (211.38 ) $ (4.46 ) $ (431.89 )
Weighted average number of common shares outstanding
Basic and diluted 26,675,559 17,740 10,974,186 12,862
See notes to condensed consolidated financial statements
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WINDTREE THERAPEUTICS, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Changes in Mezzanine Equity and Stockholders’ Equity

(Unaudited)

(in thousands)
Stockholders’ Equity
--- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- ---
Series C Preferred Stock Series D Preferred Stock **** Common Stock **** **** Treasury Stock ****
Amount Shares Amount Shares Amount Total Shares Amount Additional Paid-in Capital Accumulated Deficit Shares Amount Total
Balance - December 31, 2023 - $ - - $ - - $ - $ - 7 $ - $ 851,268 $ (844,823 ) - $ (3,054 ) $ 3,391
Net income - - - - - - - - - - 10,219 - - 10,219
Issuance of common stock, ATM Program, net of issuance costs of 44 - - - - - - - 3 1 1,366 - - - 1,367
Issuance of common stock, equity consideration in debt extinguishment - - - - - - - - 280 - - - 280
Stock-based compensation expense - - - - - - - - - 164 - - - 164
Balance - March 31, 2024 - $ - - $ - - $ - $ - 10 $ 1 $ 853,078 $ (834,604 ) - $ (3,054 ) $ 15,421
Net loss - - - - - - - - - - (12,024 ) - - (12,024 )
Issuance of preferred stock, net of issuance costs of 68 6 6,954 - - - - 6,954 - - - - - - -
Reverse split adjustments - fractional share round ups - - - - - - - 2 - - - - - -
Stock-based compensation expense - - - - - - - - - 97 - - - 97
Balance - June 30, 2024 6 $ 6,954 - $ - - $ - $ 6,954 12 $ 1 $ 853,175 $ (846,628 ) - $ (3,054 ) $ 3,494
Net loss - - - - - - - - - - (2,750 ) - - (2,750 )
ELOC sales, net of issuance costs of 156 - - - - - - - 29 - 4,371 - - - 4,371
Exchange of Series B preferred stock (6 ) (6,954 ) 9 992 - - (5,962 ) - - - 572 - - 572
Issuance of Series C preferred stock for cash proceeds, net of issuance costs of 172 - - 6 557 - - 557 - - - - - - -
Issuance of Series C preferred stock to extinguish debt - - 3 344 - - 344 - - - - - - -
Issuance of Series C preferred stock as consideration for services - - - 24 - - 24 - - - - - - -
Conversions of Series C preferred stock - - (1 ) (154 ) - - (154 ) 6 - 209 - - - 209
Redemptions of Series C preferred stock - - (1 ) (74 ) - - (74 ) - - (772 ) - - - (772 )
Deemed dividends on Series C preferred stock - - - 454 - - 454 - - (454 ) - - - (454 )
Deemed cash dividends on Series C preferred stock - - - - - - - - - (347 ) - - - (347 )
Stock-based compensation expense - - - - - - - - - 86 - - - 86
Balance - September 30, 2024 1 $ - 16 $ 2,142 - $ - $ 2,142 47 $ 1 $ 856,268 $ (848,806 ) - $ (3,054 ) $ 4,409

All values are in US Dollars.

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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 - $ - 12 $ 3,181 - $ - $ 3,181 256 $ - $ 859,660 $ (846,610 ) - $ (3,054 ) $ 9,996
Net loss - - - - - - - - - - (4,045 ) - - (4,045 )
Series C preferred stock conversions - - (9 ) (2,815 ) - - (2,815 ) 3,046 3 2,860 - - - 2,863
Series C preferred stock redemptions - - - (110 ) - - (110 ) - - (373 ) - - - (373 )
Deemed dividends on Series C preferred stock - - - 782 - - 782 - - (782 ) - - - (782 )
Cash dividends on Series C preferred stock - - - - - - - - - (216 ) - - - (216 )
Issuance of common stock, ELOC - - - - - - - 151 1 1,977 - - - 1,978
Issuance of common stock, equity consideration in debt extinguishment - - - - - - - 57 - 476 - - - 476
Exercise of common stock warrants - - - - - - - 46 - 312 - - - 312
Settlement of common stock warrant liability - - - - - - - - - 9 - - - 9
Stock-based compensation expense - - - - - - - - - 72 - - - 72
Balance - March 31, 2025 - $ - 3 $ 1,038 - $ - $ 1,038 3,556 $ 4 $ 863,995 $ (850,655 ) - $ (3,054 ) $ 10,290
Net loss - - - - - - - - - - (10,631 ) - - (10,631 )
Series C preferred stock conversions - - (2 ) (1,322 ) - - (1,322 ) 5,009 5 4,818 - - - 4,823
Deemed dividends on Series C preferred stock - - - 640 - - 640 - - (4,084 ) - - - (4,084 )
Deemed dividends on warrants - - - - - - - - - (9 ) - - - (9 )
Cash dividends on Series C preferred stock - - - - - - - - - (57 ) - - - (57 )
Issuance of Series D preferred stock, net of issuance costs - - - - 4 2,813 2,813 - - - - - - -
Issuance of June 2025 warrants - - - - - - - - - 2,930 - - - 2,930
Deemed dividends on Series D preferred stock - - - - - 74 74 - - (74 ) - - - (74 )
Cash dividends on Series D preferred stock - - - - - - - - - (63 ) - - - (63 )
Issuance of common stock, ELOC - - - - - - - 650 - 423 - - - 423
Exercise of common stock warrants - - - - - - - 33 - 15 - - - 15
Settlement of common stock warrant liability - - - - - - - - - 11 - - - 11
Stock-based compensation expense - - - - - - - - - 32 - - - 32
Balance - June 30, 2025 - $ - 1 $ 356 4 $ 2,887 $ 3,243 9,248 $ 9 $ 867,937 $ (861,286 ) - $ (3,054 ) $ 3,606
Net income - - - - - - - - - - (28,085 ) - - (28,085 )
Series C preferred stock conversions - - (1 ) (349 ) - - (349 ) 1,802 2 978 - - - 980
Series C preferred stock redemptions - - (0 ) (19 ) - - (19 ) - - (15 ) - - - (15 )
Series D preferred stock conversions - - - - (0 ) (202 ) (202 ) 689 1 297 - - - 298
Series D preferred stock redemptions - - - - (3 ) (2,761 ) (2,761 ) - - (1,410 ) - - - (1,410 )
Deemed dividends on Series C preferred stock - - - 16 - - 16 - - (647 ) - - - (647 )
Cash dividends on Series C preferred stock - - - - - - - - - (3 ) - - - (3 )
Deemed dividends on Series D preferred stock - - - - - 81 81 - - (171 ) - - - (171 )
Cash dividends on Series D preferred stock - - - - - - - - - (32 ) - - - (32 )
Issuance of Common stock, note conversions - - - - - - - 704 1 376 - - - 377
ELOC sales, net of issuance costs - - - - - - - 21,118 21 13,427 - - - 13,448
Exercise of common stock warrants - - - - - - - 73 0 25 - - - 26
Stock-based compensation expense - - - - - - - - - 17 - - - 17
Balance - September 30, 2025 - $ - 0 $ 4 0 $ 5 $ 9 33,634 $ 34 $ 880,781 $ (889,371 ) - $ (3,054 ) $ (11,610 )
See notes to condensed consolidated financial statements
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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 $ (42,761 ) $ (4,554 )
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 - 7,419
Depreciation and amortization 394 66
Stock-based compensation 121 434
Non-cash lease expense - 311
Accretion of discount on senior note receivable (952 ) -
Amortization of debt discount and debt issuance costs 179 86
Non-cash expense related to equity consideration for services - 189
Loss on ELOC commitment note and derivative liability 14,965 590
Loss on impairment of intangible assets 16,130 -
Loss on sale and disposal of property and equipment - -
Loss on settlement of deposit 650 -
Loss on debt issuances 7,437 -
Gain on debt extinguishment (52 ) (14,591 )
Deferred income tax benefit (3,226 ) -
Unrealized loss (gain) on foreign exchange rate changes 376 (180 )
Change in fair value of convertible notes (3,473 ) -
Change in fair value of derivative liabilities (801 ) (33 )
Change in fair value of senior secured notes - 150
Change in fair value of warrant liability (292 ) (2,166 )
Changes in assets and liabilities:
Prepaid expenses and other current assets 527 (11 )
Accounts payable (228 ) 1,245
Accrued expenses 122 48
Operating lease liabilities (377 ) (345 )
Other current liabilities (174 ) (375 )
Net cash used in operating activities (11,436 ) (11,717 )
Cash flows from investing activities:
Issuance of senior note (4,572 ) -
Deposit (1,400 ) -
Proceeds from sale of property and equipment - -
Purchase of property and equipment - (12 )
Net cash used in investing activities (5,972 ) (12 )
Cash flows from financing activities: **** ****
Proceeds from convertible notes 4,303 -
Proceeds from private placement of Series D preferred stock, net of issuance costs 2,813 -
Proceeds from ELOC Purchase Agreement, net of issuance costs 15,849 4,371
Proceeds from private placements, net of issuance costs - 3,925
Proceeds from senior secured notes payable 500 -
Proceeds from exercise of common stock warrants 353 -
Principal payments on senior secured notes payable (600 ) -
Principal payments on loans payable (407 ) (344 )
Redemptions of Series C preferred stock (517 ) (847 )
Cash dividend payments on Series C preferred stock (90 ) (347 )
Redemptions of Series D preferred stock (4,171 ) -
Proceeds from ATM Program, net of issuance costs - 1,367
Proceeds from senior convertible notes payable, net of issuance costs - 1,312
Principal payments on senior convertible notes payable (2,200 ) (150 )
Proceeds from senior secured and unsecured notes, net of issuance costs - 550
Issuance costs related to Series B Preferred Stock - (68 )
Payments on debt extinguishment - (200 )
Net cash provided by financing activities 15,833 9,569
Net decrease in cash, cash equivalents, and restricted cash (1,574 ) (2,160 )
Cash, cash equivalents, and restricted cash - beginning of period 1,788 4,469
Cash, cash equivalents, and restricted cash - end of period $ 214 $ 2,309
Supplementary disclosure of non-cash activity:
Private placement proceeds allocated to common stock warrant liability $ - $ 3,331
Non-cash issuance costs allocated to Series C preferred stock - 37
Conversions of Series C preferred stock 8,667 -
Deemed dividends on Series C preferred stock 5,513 -
Deemed dividends on Series D preferred stock 298 -
Deemed dividends on warrants 9 -
Cash dividends payable 141 -
Cash dividends converted into common stock 105 -
Issuance of common stock, note conversions 377 -
Fair value upon issuance of common stock warrant liability - 10,787
Fair value upon issuance of convertible notes 8,566 -
Fair value upon issuance of June 2025 warrants 2,930 -
Fair value of common stock consideration related to ELOC commitment note extinguishment 476 -
Fair value upon issuance of March 2025 senior secured notes 374 -
Settlement of common stock warrant liability 20 -
Fair value of Series B Preferred Stock issued in connection with the Varian asset acquisition - 7,022
Fair value upon issuance of derivative liability related to senior convertible notes payable - 458
Fair value upon issuance of derivative liability related to ELOC commitment note - 284
Fair value of common stock consideration related to debt extinguishment - 280
Prepayment of insurance through third-party financing - 555
See notes to condensed consolidated financial statements
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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.”

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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 $60 million securities purchase agreement led by Build and Build, Corp. with the potential for up $200 million of total subscriptions. However, management made the decision to not move forward with this strategy in August 2025.

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-18 reverse split of our common stock that was approved by our Board of Directors and stockholders and made effective on April 19, 2024 and the 1-for-50 reverse split of our common stock that was approved by our Board of Directors and stockholders and made effective on February 20, 2025. All share and per share information herein that relates to our common stock prior to the effective date has been retroactively restated to reflect the reverse stock splits.

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.

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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 $28.1 million and $42.8 million, respectively, for the three and nine months ended September 30, 2025. Our net loss was $2.7 million and $4.6 million, respectively, for the three and nine months ended September 30, 2024. We expect to continue to incur operating losses for at least the next several years. As of September 30, 2025, we had an accumulated deficit of $889.4 million. Our future success is dependent on our ability to fund and develop our product candidates, and ultimately upon our ability to attain profitable operations. We have devoted substantially all of our financial resources and efforts to research and development expense and general and administrative expense to support such research and development. Net losses and negative cash flows have had, and will continue to have, an adverse effect on our stockholders’ equity and working capital, and accordingly, our ability to execute our future operating plans.

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 23, 2025, we and Seven Knots entered into an amendment, or the ELOC Amendment, to the 2025 ELOC Purchase Agreement, pursuant to which the parties agreed to, among other things, expand the definition of “Eligible Market” to include over-the-counter markets, including The OTCID Basic Market. On October 24, 2025, pursuant to the 2025 ELOC 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”)  registering up to

555,555,556

shares of common stock under the 2025 ELOC Purchase Agreement and (ii) up to 166,687,215 shares of common stock, issuable upon the conversion of the outstanding unpaid principal balance, together with all accrued and unpaid interest, if any, of the convertible promissory note, issued to Seven Knots as consideration for it entering into the 2025 ELOC Purchase Agreement.

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 $35 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.  For the three months ended September 30, 2025, we sold 21.1 million shares of Common Stock under the 2024 ELOC Purchase Agreement for net proceeds of $13.4 million.

As of September 30, 2025, we had cash and cash equivalents of $0.2 million and current liabilities of $21.9 million. During July and August 2025, we sold 21.1 million shares of common stock for net proceeds of $13.4 million following mandatory redemption payments on our preferred stock (See the section titled, “Note 15 - Mezzanine Equity and Stockholders' Equity - Common Stock Purchase Agreement” for further details). We believe that we have sufficient resources available to fund our business operations through December 2025. We do not have sufficient cash and cash equivalents as of the date of this Quarterly Report on Form 10-Q to support our operations for at least the 12 months following the date that the financial statements are issued. These conditions raise substantial doubt about our ability to continue as a going concern.

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.

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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.

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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 $ 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.

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.

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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 $0.2 million and $0.1 million for the three-month periods ended September 30, 2025 and 2024, respectively. Foreign currency transactions resulted in a net loss of approximately $0.4 million and a net gain of $0.2 million for the nine-month periods ended September 30, 2025 and 2024, respectively.

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.

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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 23.8 million and 0.4 million shares, respectively. For the three and nine months ended September 30, 2025 and 2024, all potentially dilutive securities were anti-dilutive and therefore have been excluded from the computation of diluted weighted-average shares of common stock outstanding.

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.

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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 $ 57 $ 57 $ - $ -
Total Assets $ 57 $ 57 $ - $ -
Liabilities:
Convertible notes payable $ (2,590 ) $ - $ - $ (2,590 )
Derivative liability - ELOC commitment note (5,089 ) (5,089 )
Common stock warrant liability (2 ) - - (2 )
Total Liabilities $ (7,681 ) $ - $ - $ (7,681 )

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Fair Value Fair value measurement using
December 31, **** **** **** **** **** **** ****
(in thousands) 2024 Level 1 Level 2 Level 3
Assets:
Money market funds $ 598 $ 598 $ - $ -
Total Assets $ 598 $ 598 $ - $ -
Liabilities:
Derivative liability - ELOC commitment note $ (299 ) $ - $ - $ (299 )
Common stock warrant liability (305 ) - - (305 )
Total Liabilities $ (604 ) $ - $ - $ (604 )

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 8,566
Principal payments (2,200 )
Change in fair value (3,776 )
Balance at September 30, 2025 $ 2,590

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 $ 0.59 $ 0.07
Conversion price $ 0.59 $ 0.59
Volatility 198.8 % 244.4 %
Risk-free interest rate 4.1 % 3.8 %
Expected term (in years) 1.0 0.9
Discounting factor 0.842 0.899

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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 $ 305
Change in fair value (292 )
Settlement of common stock warrant liability (20 )
Deemed dividend 9
Balance at September 30, 2025 $ 2

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 $ 0.07 $ 0.35
Exercise price $ 0.30 $ 1.28
Volatility 161.6 % n/a
Risk-free interest rate 3.7 % 4.4 %
Expected term (in years) 4.3 5.1
Discounting factor n/a 0.81

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 $ 299
Change in fair value of June 2024 ELOC commitment note (188 )
Extinguishment of derivative of June 2024 ELOC commitment note (111 )
Initial recognition of derivative liability of July 2025 ELOC commitment note 5,702
Change in fair value of July 2025 ELOC commitment note (613 )
Balance at September 30, 2025 $ 5,089

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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 0.32-0.35
Volatility
Risk-free interest rate %
Conversion price discount %
Discounting period (in years)
Discount rate %
Discounting factor

All values are in US Dollars.

Fair Value on a Non-Recurring Basis

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 no indication of impairment as of September 30, 2025. (See the section titled, “Note 4 – Summary of Significant Accounting Policies – Intangible Assets”). The table below categorizes assets measured at fair value on a non-recurring basis for the periods presented:

Fair Value Fair value measurement using
December 31, **** **** **** **** **** ****
(in thousands) 2024 Level 1 Level 2 Level 3
Intangible assets:
Rostafuroxin drug candidate $ 1,790 $ - $ - $ 1,790

Significant factors considered in estimating the fair value of the IPR&D intangible asset related to our rostafuroxin drug candidate include the risks inherent in the development process, including the likelihood of achieving commercial success and the cost and related time to complete the remaining development. Future cash flows for the IPR&D intangible asset were estimated based on forecasted revenue and costs, taking into account the expected product life cycle, market penetration, and growth rates. Other significant estimates and assumptions inherent in this approach include (i) the amount and timing of the projected net cash flows associated with the IPR&D intangible asset; (ii) the discount rate, which seeks to reflect the various risks inherent in the projected cash flows; and (iii) the tax rate, which considers geographic diversity of the projected cash flows. Quantitative information about the significant unobservable inputs used in the fair value measurement of the IPR&D intangible asset included a discount rate of 20.0% and a tax rate of 30.0% for 2024. 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 candidate and market conditions which could result in future impairment charges related to the indefinite-lived intangible asset balance.

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 $6.6 million, or the Standard Waste Note, with an original issue discount, or OID, of $2.0 million. The Standard Waste Note matures on the earlier of (i) January 15, 2026 and (ii) the initial time of our consummation of the acquisition of all of the issued and outstanding equity of Titan Environmental Services, Inc., or Titan and does not accrue interest. The Standard Waste Note has been initially recorded at its fair value of $4.8 million representing the original principal less the OID.  The OID is being accreted to interest income using the interest method.  Accretion for the three and nine months ended September 30, 2025 was $0.8 and $1.0 million, respectively.

During the quarter ended September 30, 2025, the Company made the decision to not pursue the acquisition of Titan.

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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 $1.4 million, or the Advance, to TBB CPD to be held as part of the earnest money due under the Purchase Agreement. On  June 24, 2025, TBB CPD provided a notice of termination with respect to the Purchase Agreement to the Company. The notice of termination demanded the $3 million in earnest money held by the escrow agent for the transaction, of which $1.4 million was paid by the Company with the remainder by Way Maker, be released to TPP CPD. The Company had disputed TPP CPD’s entitlement to the $3 million in earnest money.

On September 30, 2025, WINT LLC and TBB CPD entered into a Settlement and Mutual Release Agreement which instructs the Escrow Holder to release $0.8 million of the Earnest Money to WINT LLC and to release the remaining earnest money to TBB CPD. In addition, the parties agree that the Purchase Agreement is validly terminated and WINT has no rights with regard to the Property along with a mutual release of claims as defined in the Agreement. The $0.8 million is included in prepaid and other current assets at September 30, 2025 and was disbursed by the Escrow Holder and received by the Company in October 2025.

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 $40,698 for a purchase price of $35,000 (collectively, the “July Promissory Notes”).

The Note Purchase Agreements accrue interest at 14% per annum and have a 12-month maturity date. The June and July Promissory Notes may be converted to shares of our common stock at a conversion price of $0.587 per share.

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 25% of the purchase price paid by each investor (the “Note Warrants” and each a “Note Warrant”). One June Purchaser received a Note Warrant for $20,833 worth of shares of our common stock, and the other June Purchasers received Note Warrants for $12,500 worth of shares of our common stock. Both July Purchasers received Note Warrants for $8,750 worth of shares of our common stock. All Note Warrants have an exercise price of $0.587 per share of our common stock. Because the Note Warrants entitle the holder to a number of shares based on a share value, the number of shares issuable upon exercise of a Note Warrant will change if the exercise price is adjusted.

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 $253,333 from the sale of the June and July Promissory Notes and Note Warrants, before deducting offering expenses. The proceeds of the June and July Promissory Notes were used to fund operational expenses of the Company, including the funding of a loan to Standard Waste.

On each of June 9, June 24, and June 27, 2025, we entered into several note purchase agreements, or the Additional June 2025 Note Purchase Agreements, pursuant to which we issued convertible promissory notes, or the Additional June 2025Convertible Notes, to investors, each an Additional  June 2025Purchaser and together the Additional June 2025 Purchasers, in the principal amount of $1.3 million and warrants to purchase common stock of the Company, or the Additional  June 2025Warrants. We received gross and net proceeds of $1.1 million from the sale of the Additional June 2025Convertible Notes and Additional June 2025 Warrants, or the Additional June 2025Note Financing. The Additional June 2025 Note Purchase Agreements provide that all proceeds from the Additional June 2025Notes were used for operational expenses and to provide additional funding to Standard Waste.

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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 2025Convertible 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 6 months after issuance, by increasing the outstanding principal in the aggregate principal amount of the interest accrued for the applicable interest period. Interest will accrue at a rate of 14% per annum, provided, however, that for the first 6 months following the Issue Date, interest on the principal will accrue immediately and be guaranteed. The rate of interest will increase immediately in connection with any Event of Default, as defined therein, up to an interest rate of 24% and will compound daily until the Event of Default is cured or the outstanding principal and accrued but unpaid interest is paid in full. Interest will be payable quarterly in arrears commencing September 15, 2025. The Convertible Notes may be prepaid in full or in part in accordance with the terms therein.

The holders may not exercise their conversion rights if the conversion would result in the holders (and their affiliates) beneficially owning in excess of 4.99% of the number of shares of Common Stock outstanding immediately after giving effect to the conversion, which percentage may be increased up to 9.99% at the holder’s election with 61 days prior written notice to the Company.

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 $0.587. The Convertible Notes will mature one year from their respective issuance dates, or such earlier date as the Convertible Notes are required or permitted to be repaid in accordance with their terms.

In connection with the Note Financings, we issued the June 2025 Purchasers the June 2025 Warrants to purchase an aggregate of $3.5 million worth of shares of the Company’s Common Stock. The June 2025 Warrants had an initial exercise price of $0.587 per share, subject to adjustment, were immediately exercisable and expires upon the earlier of (i) five years from the date of issuance or (ii) when the June 2025 Warrants are exercised in full. In July 2025, due to an inducement related to the Series C preferred stock, the conversion price of the Convertible Notes and the exercise price of the June 2025 Warrants was adjusted to $0.30. The Note Purchasers will not have the right to exercise any portion of the June 2025 Warrants if they (together with their affiliates) would beneficially own in excess of 4.99%, as such percentage ownership is determined in accordance with the terms of the June 2025 Warrants, of the number of shares of Common Stock outstanding immediately after giving effect to the exercise, which percentage be increased up to 9.99% at their election with 61 days prior written notice to the Company. The June 2025 Warrants were sold in reliance upon an exemption from the registration requirement of the Securities Act, pursuant to Section 4(a)(2) thereof and/or Rule 506(b) of Regulation D promulgated thereunder.

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 the fair value as of September 30, 2025 was $2.6 million. Accordingly, a 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 was in excess of the cash proceeds received, we incurred a loss on debt issuance of $7.3 million related to the June 2025 Notes and the June 2025 Warrants for the three and nine months ended September 30, 2025.

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 $3.6 million and a warrant to purchase common stock of the Company, or the First June 2025 Warrant. We received gross and net proceeds of $3.1 million from the sale of the First June 2025 Convertible Note and First June 2025 Warrant, or the First June 2025 Note Financing. On August 26, 2025, the Company made a principal payment of $2.2 million against the June 5, 2025 note.

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In July 2025, holders of the June 5and June 9 notes converted $0.4 million of the Convertible Notes into 0.7 million shares of common stock at a par value of $0.001.

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:

● 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.
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● June 9, 2025 senior unsecured convertible notes issued to C/M Capital Master Fund LP in the principal amount of $116,280.
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● June 9, 2025 senior unsecured convertible notes issued to WVP Emerging Manager Onshore Fund in the principal amount of $348,837.
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● June 24, 2025 senior unsecured convertible promissory note issued to certain purchasers for the aggregate purchase price of $100,000.
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● 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.
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● 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
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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 $10,000,000. The 2025 ELOC Commitment Note has a maturity date of April 26, 2026and bore interest at 5% per annum on a 365-day basis, due and payable on April 26, 2026. The Purchaser, in its sole discretion and upon written notice to us was able to convert all or a portion of the entire unpaid principal balance of the ELOC Commitment Note, together with all accrued and unpaid interest, if any, or the Conversion Amount, into a number of shares of our common stock equal to (x) the Conversion Amount divided by, as of the date of such conversion notice or other date of determination, the lesser of (i) a 20% discount to the lowest intraday sale price of our common stock as traded on the principal market on June 26, 2024 and (ii) a 20% discount to the lowest intraday sale price of our common stock as traded on the principal market during the 20 trading days immediately preceding the date of such conversion notice, subject to adjustment as provided in the terms of the ELOC Commitment Note.

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The ELOC Commitment Note in its entirety had an estimated fair value of $15.0 million at issuance, while the ELOC Commitment Note conversion option was required to be bifurcated as a separate derivative liability upon issuance. As a result, we recorded the fair value of the conversion option feature in the amount of $5.7 million as a derivative liability and $9.3 million as ELOC Commitment Note payable in our condensed consolidated balance sheet. Because there was no consideration paid by the Purchaser in exchange for the ELOC Commitment Note, the entire initial fair value of both instruments was recorded to other expense in the amount of $15.0 million.

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 *September 30, 2025,*we recorded a final fair value measurement of the derivative liability resulting in a $0.6 million change in fair value which was recorded as other income for the three months ended September 30, 2025.

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 $350,000. The ELOC Commitment Note had a maturity date of June 26, 2025 and bore interest at 5% per annum on a 365-day basis, due and payable on June 26, 2025. The Purchaser, in its sole discretion and upon written notice to us was able to convert all or a portion of the entire unpaid principal balance of the ELOC Commitment Note, together with all accrued and unpaid interest, if any, or the Conversion Amount, into a number of shares of our common stock equal to (x) the Conversion Amount divided by, as of the date of such conversion notice or other date of determination, the lesser of (i) a 20% discount to the lowest intraday sale price of our common stock as traded on the principal market on June 26, 2024 and (ii) a 20% discount to the lowest intraday sale price of our common stock as traded on the principal market during the 20 trading days immediately preceding the date of such conversion notice, subject to adjustment as provided in the terms of the ELOC Commitment Note.

The ELOC Commitment Note in its entirety had an estimated fair value of $0.6 million at issuance, while the ELOC Commitment Note conversion option was required to be bifurcated as a separate derivative liability upon issuance. As a result, we recorded the fair value of the conversion option feature in the amount of $0.3 million as a derivative liability and $0.3 million as ELOC Commitment Note payable in our condensed consolidated balance sheet. Because there was no consideration paid by the Purchaser in exchange for the ELOC Commitment Note, the entire initial fair value of both instruments was recorded to other expense in the amount of $0.6 million.

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 56,769 shares of our common stock with a fair value of $0.5 million. Immediately prior to the conversion, we recorded a final fair value measurement of the derivative liability resulting in a $0.2 million change in fair value which was recorded as other income for the three months ended March 31, 2025. Upon conversion, the remaining derivative liability and the ELOC Commitment Note were extinguished and we recognized a loss on debt extinguishment of approximately $22,000.

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Note 10 - Senior Secured Notes Payable

March 2025 Senior Secured Notes

On *March 18, 2025,*we issued senior secured notes, or the March 2025 Notes, with an aggregate principal amount of $312,500. The aggregate gross proceeds from the issuance of the March 2025 Notes was $250,000. The March 2025 Notes include a 20% OID. The March 2025 Notes bore interest at 10% per annum on a 360-day and twelve 30-day month basis, payable monthly in cash and in arrears on each Interest Date (as defined in the  March 2025 Notes) and such interest compounded each calendar month.

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 $312,500. The aggregate gross and net proceeds from the issuance of the April 2025 Notes was $250,000, representing a 20% OID. The April 2025 Notes bore interest at 10% per annum on a 360-day and twelve 30-day month basis, payable monthly in cash and in arrears on each Interest Date (as defined in the April 2025 Notes) and such interest compounded each calendar month. We may at any time redeem all, but not less than all, of the remaining amount under the March 2025 Notes and April 2025 Notes in cash at a price equal to 120% of the remaining amount being redeemed as of such optional redemption date.

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 $300,000 for the March 2025 Notes and $300,000 for the April 2025 Notes, or the Payoff Amount, to retire and fully satisfy the balance of each of the March 2025 Notes and the April 2025 Notes of $312,500 at a discount. The March 2025 Notes and the April 2025 Notes automatically terminated upon our payment of such Payoff Amount and will be of no further effect.

Certain conversion and redemption features of the  March 2025 Notes and April 2025 Notes would typically be considered derivatives that would require bifurcation. In lieu of bifurcating various features in the agreements, we elected the fair value option for the  March 2025 Notes and the April 2025 Notes and recorded the loss on debt issuance within the accompanying condensed consolidated statements of operations at the end of each reporting period. The excess of the initial fair value of $374,000 of the  March 2025 Notes over the proceeds received of $250,000 was recorded as loss on debt issuance in the amount of $124,000 during the nine months ended September 30, 2025. Upon the payment of the Payoff Amount, we recorded a gain on debt extinguishment of $74,000 during the three months ended September 30, 2025 related to the difference between the $374,000 fair value of the March 2025 Notes upon issuance and the Payoff Amount of $300,000 for the March 2025 Notes. For the April 2025 Notes, we recognized an initial fair value of $300,000 and recorded a $50,000 loss on debt issuance during the three and nine months ended September 30, 2025 related to the difference between the $250,000 in proceeds received and the $300,000 Payoff Amount for the April 2025 Notes.  Refer to Note 5, “Fair Value Measurements” for additional details regarding the fair value measurement.

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 $205.50 per share, subject to customary adjustments. The July 2024 Warrants are considered a freestanding financial instrument as they are separable and legally detachable from the Series C Preferred Stock. The July 2024 Warrants have been classified as a liability in the Company’s condensed consolidated balance sheet because they include a 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. If the Change of Control 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, and in accordance with U.S. GAAP, required the July 2024 Warrants to be treated as financial liabilities measured at fair value through profit or loss.

The July 2024 warrants had an initial fair value of $10.8 million upon issuance and were remeasured to a fair value of $0.3 million as of December 31, 2024. 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, and was recorded in the condensed consolidated statement of operations.

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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 $0.2 million of certain premiums at a 7.97% fixed annual interest rate. Payments of approximately $37,000

are due monthly from August 2025 through December 2025. As of September 30, 2025, the outstanding principal of the loan was $0.1 million. In August 2024, we entered into an insurance premium financing and security agreement with IPFS Corporation. Under the agreement, we financed $0.5

million of certain premiums at a 7.94% fixed annual interest rate. Payments of approximately $56,000 are due monthly from August 2024 through *May 2025.*As of December 31, 2024, the outstanding principal of the loan was $0.3 million. The balance of the loan was repaid during the second quarter of 2025.

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 $200,000 to PMUSA and $125,000 to PMPSA. Interest accrues at the rate of 36% per annum on such balance until the date of payment.  Accrued interest currently totals approximately $100,000.

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 $25.0 million and (ii) and certain warrants to purchase shares of our common stock held by Deerfield were cancelled in consideration for (x) a cash payment in the aggregate amount of $2.5 million, (y) a certain number of shares of common stock, representing 2% of fully-diluted shares outstanding (as defined in the Milestone Agreement) on the closing date, and (z) the right to receive certain milestone payments, or Milestone Payments, based on achievement of specified AEROSURF development and commercial milestones, which, if achieved, could potentially total up to $15.0 million. In addition, a related security agreement, pursuant to which Deerfield held a security interest in substantially all of our assets, was terminated. We established a $15.0 million long-term liability for the contingent milestone payments potentially due to Deerfield under the Milestone Agreement. The liability was recorded at the full value of the contingent milestones and was to be carried at full value until the milestones were achieved and paid or the milestones were not achieved and the liability was written off as a gain on debt extinguishment. As of December 31, 2023 the restructured debt liability balance was $15.0 million.

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 $0.2 million, $0.1 million of which was paid in January 2024 and $0.1 million of which was paid in September 2024, and (ii) an aggregate of 676 shares of our common stock, par value $0.001 per share. The shares of the common stock were issued to Deerfield in a transaction exempt from registration pursuant Section 4(a)(2) of the Securities Act of 1933.

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 676 shares of our common stock, which was amended on April 17, 2024. Such resale registration statement was declared effective by the SEC on April 19, 2024.

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 $14.6 million non-cash gain on debt extinguishment during the three months ended

March 31, 2024 consisting of the difference between the $15.0 million of the extinguished Milestone Payments and the consideration to Deerfield under the Exchange and Termination Agreement, which includes $0.2 million in cash and $0.3 million in fair value of common stock issued to Deerfield.

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Note 15 – Mezzanine Equity and Stockholders’ Equity

Securities Purchase Agreements

On July 16, 2025, we entered into a securities purchase agreement (the “Treasury Strategy Securities Purchase Agreement”) with the purchasers named therein (the “Treasury Strategy Purchasers,” and each, a “Treasury Strategy Purchaser”) pursuant to which we agreed to sell and issue to the Treasury Strategy Purchasers in a private placement offering (the “Treasury Strategy Offering”) an aggregate of (i) approximately 60,000 shares of our newly issued 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 “Treasury Strategy Conversion Shares”) at an offering price of $1,000 per share of Series E Preferred Stock (the “Stated Value”), and (ii) warrants (the “Treasury Strategy Warrants,” and such shares issuable upon exercise of the Treasury Strategy Warrants, the “Treasury Strategy Warrant Shares”) to purchase up to an aggregate of 66,000,000 shares of our common stock.

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 3,125 shares of our Series D Convertible Preferred Stock, par value $0.001 per share, or the Series D Preferred Stock for aggregate gross proceeds of approximately $2.5 million.

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 563 additional shares, or the Additional Shares, of Series D Preferred Stock in a private placement for aggregate gross proceeds of approximately $450,000. The Additional Buyers are purchasing the Additional Shares on the same terms as the Initial Buyers provided in the Purchase Agreement.

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 5,000 shares of Series D Preferred Stock with an initial conversion price of $1.368, or the Series D Preferred Conversion Price, which is subject to adjustment as provided in the Series D Certificate of Designation to no lower than $0.274. The Series D Preferred Stock has a stated value of $1,000 per share. Each share of Series D Preferred Stock is initially convertible into 731 shares of our common stock, subject to adjustment as provided in the Series D Certificate of Designation. No fractional shares will be issued upon conversion; rather any fractional share will be rounded up to the nearest whole share.

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 10.0% per annum and be payable by way of inclusion of the dividends in the Conversion Amount (as defined in the Series D Certificate of Designation) on each Conversion Date (as defined in the Series D Certificate of Designation) in accordance with the Series D Certificate of Designation or upon any redemption in accordance with the Series D Certificate of Designation or upon any required payment upon any Bankruptcy Triggering Event (as defined in the Series D Certificate of Designation). From and after the occurrence and during the continuance of any Triggering Event (as defined in the Series D Certificate of Designation), the accrual of the dividends will automatically be increased to 18.0% per annum.

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 $0.30.

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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 $0.001 per share (the “Series C Preferred Stock”), to redeem the Series C Preferred Stock with 40% of the aggregate gross proceeds from each Eligible Equity Line Transaction (as defined in the Series C COD) in accordance with the mechanics in such sections of the Series C COD and the Notes, mutatus mutandis (the “Mandatory Redemptions”), and (ii) such Mandatory Redemptions shall be paid in order first to the holders of Series C Preferred Stock and then to the holders of the Series D Preferred Stock.

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 $0.001 (the “Series C Preferred Stock”) (the “January 2025 Inducement”), and notified them that the Company had decided to offer to reduce the Conversion Price as defined in the Series C Certificate of Designation (as defined below) of each share of Series C Preferred Stock to $8.04 (the “Transaction”) pursuant to the Certificate of Designations of Rights and Preferences of Series C Convertible Preferred Stock of Windtree Therapeutics, Inc. filed with the Secretary of State of the State of Delaware on *July 19, 2024 (*the “Series C Certificate of Designation”). In exchange for signing the conversion notice (each a “Conversion Notice”) with the reduced Conversion Price offered by the Company, the holder of Series C Preferred Stock and the Company agreed to certain forbearance terms for claims arising up to and through April 30, 2025, under the Securities Purchase Agreements entered into on or about July 18, 2024 and on or about July 26, 2024, as applicable, the Registration Rights Agreements entered into on or about July 20, 2024 and on or about July 26, 2025, as applicable, the Warrants entered into on July 20, 2024, and all other transaction documents entered into with respect to the Series C Preferred Stock. The Conversion Notice stated that it must be signed by the holder and returned to the Company no later than 5:00 p.m. Eastern Time on January 31, 2025.

Pursuant to the Transaction, approximately 1,895 shares of Series C Preferred Stock were converted into 235,846 shares of the Company’s common stock at the reduced Conversion Price. In connection with the Transaction, and pursuant to the terms of the warrant agreement, the exercise price of the July 2024 Warrants originally issued in connection with the Series C Preferred Stock was reduced to $8.04 effective *January 24, 2025.*The Company calculated the excess of the value of common stock issued after the inducement over the value of common stock that was issuable pursuant to the original conversion terms. Accordingly, upon conversion the excess value of $1.7 million was recorded as a deemed dividend and a reduction to income available to common stockholders in the basic and diluted EPS calculation.

April 2025 Down Round

During April 2025, the Company issued the April 2025 Notes with a conversion price of $1.10 per share. The issuance of the April 2025 Notes triggered the down round provisions within the Series C Preferred Stock and July 2024 Warrants (the “April 2025 Down Round”), whereby the conversion price of the Series C Preferred Stock and the exercise price of the July 2024 Warrants were automatically reduced from $1.9714 to $1.10.

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 $0.4 million and a de minimis amount to the July 2024 Warrants. The value of the effect of $0.4 million is treated as a deemed dividend and a reduction to income available to common stockholders in the basic EPS calculation.

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 $1.10 per share down to an induced rate of $0.45 per share in exchange for the holder agreeing to convert at least 30% of its position within 45 days of offer acceptance. This inducement was accepted by two holders of the Series C Preferred Stock, resulting in the induced conversion of 710 shares of Series C Preferred Stock between May 29, 2025 and June 11, 2025 representing 65% of the holder’s Series C Preferred Stock and 1,262 shares of Series C Preferred Stock between June 4, 2025 and June 11, 2025 representing 100% of the holder’s Series C Preferred Stock.

In connection with the May 2025 Inducement, the converted Series C Preferred Stock was converted into 4,382,192 shares of common stock.  The Company calculated the excess of the value of common stock issued after the inducement over the value of common stock that was issuable pursuant to the original conversion terms. Accordingly, upon conversion the excess value of $1.7 million was recorded as a deemed dividend and a reduction to income available to common stockholders in the basic and diluted EPS calculation.

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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 540 shares of Series C Preferred Stock between July 14, 2025 and July 25, 2025.

In connection with the July 2025 Inducement, the converted Series C Preferred Stock was converted into 1,801,986 shares of common stock.  The Company calculated the excess of the value of common stock issued after the inducement over the value of common stock that was issuable pursuant to the original conversion terms. Accordingly, upon conversion the excess value of $0.3 million was recorded as a deemed dividend and a reduction to income available to common stockholders in the basic and diluted EPS calculation. The converted Series D Preferred Stock was converted into 689,442 shares of common stock.  The Company calculated the excess of the value of common stock issued after the inducement over the value of common stock that was issuable pursuant to the original conversion terms. Accordingly, upon conversion the excess value of $1.0 million was recorded as a deemed dividend and a reduction to income available to common stockholders in the basic and diluted EPS calculation.

July 2024 Warrant Exercises

During the three and nine months ended September 30, 2025, 72,618  July 2024 warrants and 151,266  July 2024 Warrants, respectively, were exercised for gross and net proceeds of $0.4 million.

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) 16,099 shares, or the Preferred Shares, of our Series C Convertible Preferred Stock, par value $0.001 per share, or the Series C Preferred Stock, and (ii) warrants, or the July 2024 Warrants, to acquire up to the aggregate number of 68,813 additional shares of our common stock for aggregate gross proceeds of approximately $12.9 million of which $9.5 million was paid through the cancellation and extinguishment of certain securities as further described below.

Additionally, we issued 161 Preferred Shares and 1,258 July 2024 Warrants as compensation for certain placement agent fees and expenses. We also reimbursed the lead buyer for certain fees and expenses of counsel in accordance with the terms of the First Purchase Agreement.

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 18,820 shares of Series C Preferred Stock with an initial conversion price of $187.00, or the Series C Preferred Conversion Price, which is subject to adjustment as provided in the Series C Certificate of Designation to no lower than $64.00. The Series C Preferred Stock has a stated value of $1,000 per share. Each share of Series C Preferred Stock is initially convertible into 5 shares of our common stock, subject to adjustment as provided in the Series C Certificate of Designation. No fractional shares will be issued upon conversion; rather any fractional share will be rounded up to the nearest whole share.

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).

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Dividends on the Series C Preferred Stock will accrue at 10.0% per annum and be payable by way of inclusion of the dividends in the Conversion Amount (as defined in the Series C Certificate of Designation) on each Conversion Date (as defined in the Series C Certificate of Designation) in accordance with the Series C Certificate of Designation or upon any redemption in accordance with the Series C Certificate of Designation or upon any required payment upon any Bankruptcy Triggering Event (as defined in the Series C Certificate of Designation). From and after the occurrence and during the continuance of any Triggering Event (as defined in the Series C Certificate of Designation), the accrual of the dividends will automatically be increased to 18.0% per annum.

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 $0.30.

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 $205.50 per share, subject to customary adjustments. In July 2025, due to an inducement related to the Series C preferred stock, the conversion price of the July 2024 Warrants was adjusted to $0.30.

Related Party Participation

Our former CEO and our CMO each participated in the First PIPE, with Mr. Fraser making a $15,000 purchase to receive 19 shares of Series C Preferred Stock and 80 July 2024 Warrants and Dr. Simonson making a $10,000 purchase to receive 13 shares of Series C Preferred Stock and 53 July 2024 Warrants.

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) 1,250 Preferred Shares, and (ii) July 2024 Warrants to acquire up to the aggregate number of 5,348 additional shares of our common stock for aggregate gross proceeds of approximately $1.0 million.

Additionally, we issued 30 Preferred Shares and 160 July 2024 Warrants as compensation for certain placement agent fees and expenses. We also reimbursed the lead buyer for certain fees and expenses of counsel in accordance with the terms of the Second Purchase Agreement.

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.

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Cash proceeds from the issuance of 4,255 Series C Convertible Preferred Stock and 18,182 July 2024 Warrants in the First Private Placement totaled $3.4 million. The proceeds were allocated first to the July 2024 Warrants based on their fair value which totaled $2.6 million, and the remaining $0.8 million was allocated to the Series C Preferred Stock using the residual method of allocation. Cash proceeds from the issuance of 1,250 Series C Convertible Preferred Stock and 5,348 July 2024 Warrants in the Second Private Placement totaled $1.0 million. The cash proceeds were allocated first to the July 2024 Warrants based on their fair value which totaled $0.7 million, and the remaining $0.3 million was allocated to the Series C Preferred Stock using the residual method of allocation. 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.

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 2,080 shares of Series C Preferred Stock and 8,891 July 2024 Warrants for the cancellation and extinguishment of certain holders’ outstanding principal amount, conversion/exchange premiums and all accrued interest thereon under our Senior Convertible Notes with a net carrying value of $1.2 million. In addition, the associated derivative liability which had a fair value of $0.3 million was also extinguished. The fair value of the instruments issued was determined based on the fair value of the July 2024 Warrants and the residual value determined for the Series C Preferred Stock as described above. The difference between the carrying value of the extinguished instruments and the fair value of the instruments issued totaling $1.6 million was $0.1 million and was recorded as a loss on debt extinguishment.

In addition, we issued 966 shares of Series C Preferred Stock and 4,125 July 2024 Warrants for the cancellation and extinguishment of certain holders’ outstanding principal amount, conversion/exchange premiums and all accrued interest thereon under our June 2024 Senior Secured Notes, July Secured Note, and July Unsecured Note, which are carried at fair value. The Company determined that the fair value of the instruments issued, which totaled $0.8 million represents the fair value of the instruments extinguished, and therefore there was no gain or loss recognized on the extinguishment. The fair value of the instruments issued were determined based on the fair value of the July 2024 Warrants and the residual value determined for the Series C Preferred Stock as described above.

Also in connection with the First PIPE, we issued 8,798 shares of Series C Preferred Stock and 437,614 July 2024 Warrants for the cancellation and extinguishment of 5,500 shares of the Series B Preferred Stock with a net carrying value of $6.9 million. The fair value of the instruments issued were determined based on the fair value of the July 2024 Warrants and the residual value determined for the Series C Preferred Stock as described above. The difference of $0.1 million between the carrying value of the extinguished instruments totaling $6.9 million and the fair value of the instruments issued totaling $7.0 million was debited to additional paid-in capital and adjusted to net loss per common share for the year ended December 31, 2024.

We incurred approximately $1.2 million of legal, placement and professional fees in connection with the First and Second PIPEs. In addition, we issued 191 Series C Preferred Shares and 1,418 July 2024 Warrants as compensation for certain placement agent fees and expenses. The fair value of the instruments issued for compensation were determined based on the fair value of the July 2024 Warrants and the residual value determined for the Series C Preferred Stock as described above, which amounted to $0.2 million and were accounted for as issuance costs. The issuance costs totaling $1.4 million were allocated to all of the Series C Preferred Stock and July 2024 Warrants issued in the First and Second PIPEs based on their fair values and residual value. Issuance costs allocated to the July 2024 Warrants totaling $1.1 million were expensed immediately and issuance costs allocated to the Series C Preferred Stock totaling $0.3 million were recorded as a reduction of the net carrying value of the Series C Preferred Stock at inception as additional discount, which will be accreted against additional paid-in capital as a deemed dividend using the interest method.

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Conversions of Series C Preferred Stock

During the three months ended September 30, 2025, 540 shares of Series C Convertible Preferred Stock and $1,000 of accrued and unpaid dividends were converted into 1,801,986 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 D Preferred Stock converted was reclassified to common stock $0.001 par value and additional paid-in capital in the aggregate amount of $0.3 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. 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.

Conversions of Series D Preferred Stock

During the three and nine months ended September 30, 2025, 256 shares of Series D Convertible Preferred Stock and $6,600 of accrued and unpaid dividends were converted into 689,442 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 $1.0 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.

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 $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 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

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 0.8 million shares of common stock under the ELOC Purchase Agreement for gross proceeds of $2.4 million. Pursuant to the Company’s Certificate of Designations of Rights and Preferences of Series C Convertible Preferred Stock, we are required to use 30% of the proceeds from sales pursuant to the ELOC Purchase Agreement to pay outstanding Series C Preferred Stock dividends and to redeem Series C Preferred Stock at a 20% premium to the $1,000 stated price per share.  For the nine months ended September 30, 2025, we paid an aggregate redemption price of $0.6 million with $0.1 million applied to accrued and unpaid dividends and $0.5 million to redeem 402 Series C Preferred Shares.

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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 5,500 shares of Series B Preferred Stock, or the Series B Preferred Stock, with an initial conversion price of $324.27, or the Series B Preferred Conversion Price, which is subject to adjustment as provided in the Series B Certificate of Designation to no lower than $64.89. The Series B Preferred Stock has a stated value of $1,000 per share. Each share of Series B Preferred Stock is initially convertible into 3 shares of our common stock, subject to adjustment as provided in the Series B Certificate of Designation. No fractional shares will be issued upon conversion; rather any fractional share will be rounded up to the nearest whole share.

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 $7.0 million, partially offset by issuance costs of $68,000. Because this initial carrying value is higher than the maturity redemption price (i.e., the stated value of $5.5 million with the 10% per annum dividend over the period from issuance until maturity on January 2, 2025), no accretion of Series B Preferred Stock dividends was recorded.

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 2,862 shares of our common stock under the 2023 ATM Program resulting in aggregate gross and net proceeds to us of approximately $1.4 million. No shares of common stock were sold under the 2023 ATM Program during the nine months ended September 30, 2025.

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 10-year term, are exercisable upon vesting, and vest with respect to one-twelfth of the total number of shares subject to the options on a quarterly basis (every three months) or vest with respect to one-third of the total number of shares subject to the options on an annual basis (every twelve months). Compensation expense related to restricted stock unit, or RSU, awards is also recognized ratably over the vesting period. While individual awards may vary, RSUs generally vest with respect to one-third of the total number of shares subject to the RSUs on an annual basis (every twelve months).

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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 290 $ 77,533
Forfeited or expired (123 ) 70,174
Outstanding at September 30, 2025 168 $ 82,920 4.9
Vested and exercisable at September 30, 2025 141 $ 98,377 4.4
Vested and expected to vest at September 30, 2025 168 $ 82,920 4.9

During the nine months ended September 30, 2025, there were no RSUs granted or forfeited. As of **** September 30, 2025, there were 154 RSU shares outstanding with a weighted-average grant date fair value of $1,895.03.

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 $ 9 $ 32 $ 44 $ 114
General and administrative 8 55 77 321
Total $ 17 $ 86 $ 121 $ 434

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. No options or RSUs were granted during the nine months ended September 30, 2025 and 2024.

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.

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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 $2.8 million through *October 2020.*In November 2020, Lee’s (HK) provided notice of termination of additional funding under the PF Agreement, and we and Lee’s (HK) revised our plans for the continued development of AEROSURF. Lee’s (HK) agreed to continue the development of AEROSURF in Asia at its own cost. Lee’s (HK) agreed to fund an additional $1.0 million to us in 2021 for certain transition and analytical services to be provided by us with respect to the development of AEROSURF, which will be considered “Project Expenses” under the terms of the PF Agreement. In 2021, we received payments totaling $1.0 million from Lee’s (HK) and no further amounts were due under the PF Agreement.

Since the 2018 acquisition of CVie Investments Limited and CVie Therapeutics, istaroxime has become our primary focus for investment and execution due to what we believe represents a greater potential value opportunity for us and our stockholders. Since completing our Phase 2 study of lucinactant (KL4 surfactant) for patients with severe COVID-19 associated ARDS and lung injury in January 2022, in order to preserve resources for the highest priority programs, we have begun to reduce costs not already being performed by our licensee, Lee’s (HK) and Zhaoke, under the terms of our Original License Agreement. These costs include certain reductions in headcount dedicated to KL4 surfactant and the decommissioning of both our analytical and technical support laboratory, which previously conducted release testing of APIs and supportive research for our lyophilized and aerosolized KL4 surfactant, and our medical device development laboratory, which was previously used to conduct development activities and testing for our ADS technologies. To support the future development of our KL4 surfactant platform in markets outside of Asia, including the U.S., we are pursuing one or more licensing transactions.

To repay the funds provided under the terms of the PF Agreement, until such time as we have repaid 125% of the amounts funded by Lee’s (HK) for the development of AEROSURF, we will pay to Lee’s (HK) 50% of all revenue amounts and payments received by us for any sale, divestiture, license or other development and/or commercialization of the KL4/AEROSURF patent portfolio, excluding (i) payments for bona fide research and development services; (ii) reimbursement of patent expenses and (iii) all amounts paid to us under the Original License Agreement, minus certain deductions and certain reductions for any payments made by us with respect to third party intellectual property not previously funded by Lee’s (HK).

As of September 30, 2025, the liability balance related to the payments under the PF Agreement was $3.8 million and is recorded in other liabilities.

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 $3.2 million recognized in the current quarter. The Company continues to evaluate the impact of the OBBBA on its overall tax position, including related elections and accounting method changes.

For the three months and nine months ended September 30, 2025, we realized an income tax benefit of $3.2 million from the reversal of deferred taxes due to the intangible asset impairment charge of $16.10 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”).

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Note 19 – Subsequent Events

Senior Convertible Promissory Notes

On October 9, 2025, the Company issued to certain institutional investors an aggregate principal amount of $1,600,000 in senior convertible promissory notes due 2026 (the “2026 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 2026 Commitment Notes mature on October 9, 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 on November 5, 2025.

The 2026 Commitment Notes 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 an institutional investor and the Company, with a mandatory prepayment premium of 120%.

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 Commitment Notes 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 120% of the Commitment Notes value on October 9, 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 Commitment Notes pursuant its terms.

The 2026 Commitment Notes provide 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 Commitment Notes held by the Holders (increasable to 9.99% upon 61 days’ notice by the Holders to the Company).

The 2026 Commitment Notes are 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 Commitment Notes for the related review and applicable deposit of the related shares. The 2026 Commitment Notes include customary Events of Default (as defined in the 2026 Commitment Notes), 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.

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%.

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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.

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.

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.

Pursuant to the Letter Agreement, the Outstanding Amount shall be converted into a number of shares of the equity of TESI or the of the surviving entity in any consolidation, merger or reorganization with TESI (the “Transaction”) to be agreed upon by the TESI and the Company prior to the closing of the Transaction (the “Equity Consideration”).

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.

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July 2025 Common Stock Purchase Agreement Amendment

The Company shall use at least 30% of the net proceeds from VWAP Purchases to repay any outstanding indebtedness of the Company. If there is any outstanding preferred stock of the Company, following the repayment of all indebtedness of the Company, such 30% net proceeds referred to above shall be applied to redeem any such outstanding preferred securities of the Company. Proceeds from the sale of the Shares by the Company to the Investor shall be used by the Company in the manner as will be set forth in the Prospectus included in any Registration Statement (and any post-effective amendment thereto) and any Prospectus Supplement thereto filed pursuant to the Registration Rights Agreement.

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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.

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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.

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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.

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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.

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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

On December 4, 2024, we received a deficiency letter from the Nasdaq Listing Qualifications Department, or the Nasdaq Staff, notifying that, for the last 30 consecutive business days, the closing bid price for 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. We 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.

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.”

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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.

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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.

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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.

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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.

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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.”

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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.

With the exception of certain non-recurring items such as gain on debt extinguishment, we have incurred net losses since inception. Our net loss was $28.1 million and $42.3 million, respectively, for the three and nine months ended September 30, 2025 . Our net loss was $2.7 million and $4.6 million, respectively, for the three and nine months ended September 30, 2024. We expect to continue to incur operating losses for at least the next several years. As of September 30, 2025 , we had an accumulated deficit of $889.4 million. Our future success is dependent on our ability to fund and develop our product candidates, and ultimately upon our ability to attain profitable operations. We have devoted substantially all of our financial resources and efforts to research and development expense and general and administrative expense to support such research and development. Net losses and negative cash flows have had, and will continue to have, an adverse effect on our stockholders’ equity and working capital, and accordingly, our ability to execute our future operating plans.

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 2025 ELOC Purchase Agreement, we filed a Form S-1 Registration Statement under the Securities Act of 1933 with the U.S. Securities and Exchange Commission registering up to 555,555,556 shares of common stock 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 2025 ELOC Purchase Agreement.

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As of  September 30, 2025 , we had cash and cash equivalents of  $0.2 million and current liabilities of  $21.9 million. During July 2025, we sold 21.1 million shares of common stock for proceeds of $13.4 million following mandatory redemption payments on our preferred stock (See the section titled, “Note 15 - Mezzanine Equity and Stockholders' Equity - Common Stock Purchase Agreement” for further details). We believe that we have sufficient resources available to fund our business operations through December 2025. We do not have sufficient cash and cash equivalents as of the date of this Quarterly Report on Form 10-Q to support our operations for at least the 12 months following the date that the financial statements are issued. These conditions raise substantial doubt about our ability to continue as a going concern.

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.

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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

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 21.9 million shares of common stock under the ELOC Purchase Agreement for gross proceeds of $15.8 million. Pursuant to the Company’s Certificate of Designations of Rights and Preferences of Series C Convertible Preferred Stock, we are required to use 30% of the proceeds from sales pursuant to the ELOC Purchase Agreement to pay outstanding Series C Preferred Stock dividends and to redeem Series C Preferred Stock at a 20% premium to the $1,000 stated price per share.  For the nine months ended September 30, 2025, we paid an aggregate redemption price of $0.6 million with $0.1 million applied to accrued and unpaid dividends and $0.5 million to redeem 402 Series C Preferred Shares.

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.

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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.

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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.

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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

however, none of these alternatives are committed at this time. There can be no assurance that we will be successful in obtaining sufficient funding, or that such funding will be available 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.

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.

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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 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 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.

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 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:

● a limited availability of market quotations for our securities;
● reduced liquidity with respect to our securities;
--- ---
● 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;
--- ---
● a limited amount of news and analyst coverage for our company; and
--- ---
● 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.

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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.

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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:

● 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.
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● June 9, 2025 senior unsecured convertible notes issued to WVP Emerging Manager Onshore Fund in the principal amount of $348,837.
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● June 24, 2025 senior unsecured convertible promissory note issued to certain purchasers for the aggregate purchase price of $100,000.
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● 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
--- ---
● 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.

Pursuant to the Letter Agreement, the Outstanding Amount shall be converted into a number of shares of the equity of TESI or the of the surviving entity in any consolidation, merger or reorganization with TESI (the “Transaction”) to be agreed upon by the TESI and the Company prior to the closing of the Transaction (the “Equity Consideration”).

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.

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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.

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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<br> <br>No. Description 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. Filed herewith.

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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. 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). Filed herewith.
101.SCH Inline XBRL Taxonomy Extension Schema Document (1). Filed herewith.
101.CAL Inline XBRL Taxonomy Extension Calculation Linkbase Document (1). Filed herewith.
101.DEF Inline XBRL Taxonomy Extension Definition Linkbase Document (1). Filed herewith.
101.LAB Inline XBRL Taxonomy Extension Label Linkbase Document (1). Filed herewith.
101.PRE Inline XBRL Taxonomy Extension Presentation Linkbase Document (1). 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.

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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.

Windtree Therapeutics, Inc.
(Registrant)
Date: November 14, 2025 By: /s/ Jed Latkin
Jed Latkin
President and Chief Executive Officer
(Principal Executive Officer, Principal Financial Officer and Principal Accounting Officer)

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ex_890835.htm

Exhibit 4.4

NEITHER THIS SECURITY NOR THE SECURITIES INTO WHICH THIS SECURITY IS CONVERTIBLE HAVE BEEN REGISTERED WITH THE SECURITIES AND EXCHANGE COMMISSION OR THE SECURITIES COMMISSION OF ANY STATE IN RELIANCE UPON AN EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), AND, ACCORDINGLY, MAY NOT BE OFFERED OR SOLD EXCEPT PURSUANT TO AN EFFECTIVE REGISTRATION STATEMENT UNDER THE SECURITIES ACT OR PURSUANT TO AN AVAILABLE EXEMPTION FROM, OR IN A TRANSACTION NOT SUBJECT TO, THE REGISTRATION REQUIREMENTS OF THE SECURITIES ACT AND IN ACCORDANCE WITH APPLICABLE STATE SECURITIES LAWS AS EVIDENCED BY A LEGAL OPINION OF COUNSEL TO THE TRANSFEROR TO SUCH EFFECT, THE SUBSTANCE OF WHICH SHALL BE REASONABLY ACCEPTABLE TO THE COMPANY. THIS SECURITY AND THE SECURITIES ISSUABLE UPON CONVERSION OF THIS SECURITY MAY BE PLEDGED IN CONNECTION WITH A BONA FIDE MARGIN ACCOUNT OR OTHER LOAN SECURED BY SUCH SECURITIES.

Dated as of: November 12, 2025 Original Principal Amount: $600,000
Maturity Date: November 11, 2026
Interest Rate: 10%

Windtree Therapeutics, inc.

SENIOR PROMISSORY NOTE

THIS SENIOR PROMISSORY NOTE is a duly authorized and validly issued Senior Promissory Note of COMMLOAN INC., a Delaware corporation (the “Company”), having its principal place of business at 9112 E Verde Grove View, Suite 105 Scottsdale, AZ 85255 (the “Note””).

FOR VALUE RECEIVED, the Company hereby promises to pay to the order of Windtree Therapeutics, Inc a Montana limited liability company or its registered assigns or successors-in-interest (the “Holder”), having a principal place of business located at 2600 Kelly Road, Suite 100 Warrington, PA or shall have paid pursuant to the terms hereunder, the principal amount set forth above on November 11, 2026 (the “Maturity Date”) or such earlier date as this Note is required or permitted to be repaid as provided hereunder, and to pay interest to the Holder on the aggregate unconverted and then outstanding principal amount of this Note in accordance with the provisions hereof.

This Note is subject to the following additional provisions:

1.            Definitions. For the purposes hereof, in addition to the terms defined elsewhere in this Note, (a) capitalized terms not otherwise defined herein shall have the meanings set forth in the Purchase Agreement and (b) the following terms shall have the following meanings:

“Alternate Consideration” shall have the meaning set forth in Section 5(e).

“Applicable Date” shall mean the earlier to occur of (x) the first date on which the resale by the Holder of all the Registrable Securities required to be filed on the initial Registration Statement pursuant to the Registration Rights Agreement is declared effective by the SEC (and each prospectus contained therein is available for use on such date) or (y) the first date on which all of the Registrable Securities are eligible to be resold by the Holder pursuant to Rule 144 (or, if a Current Public Information Failure has occurred and is continuing, such later date after which the Company has cured such Current Public Information Failure).

“Bankruptcy Event” means any of the following events: (a) the Company or any Significant Subsidiary (as such term is defined in Rule 1-02(w) of Regulation S-X) thereof commences a case or other proceeding under any bankruptcy, reorganization, arrangement, adjustment of debt, relief of debtors, dissolution, insolvency or liquidation or similar law of any jurisdiction relating to the Company or any Significant Subsidiary thereof, (b) there is commenced against the Company or any Significant Subsidiary thereof any such case or proceeding that is not dismissed within 60 days after commencement, (c) the Company or any Significant Subsidiary thereof is adjudicated insolvent or bankrupt or any order of relief or other order approving any such case or proceeding is entered, (d) the Company or any Significant Subsidiary thereof suffers any appointment of any custodian or the like for it or any substantial part of its property that is not discharged or stayed within 60 calendar days after such appointment, (e) the Company or any Significant Subsidiary thereof makes a general assignment for the benefit of creditors, (f) the Company or any Significant Subsidiary thereof calls a meeting of its creditors with a view to arranging a composition, adjustment or restructuring of its debts or (g) the Company or any Significant Subsidiary thereof, by any act or failure to act, expressly indicates its consent to, approval of or acquiescence in any of the foregoing or takes any corporate or other action for the purpose of effecting any of the foregoing.

“Beneficial Ownership Limitation” shall have the meaning set forth in Section 4(d).

“Change of Control Transaction” means the occurrence after the date hereof of any of (a) an acquisition after the date hereof by an individual or legal entity or “group” (as described in Rule 13d-5(b)(1) promulgated under the Exchange Act) of effective control (whether through legal or beneficial ownership of capital stock of the Company, by contract or otherwise) of in excess of 33% of the voting securities of the Company (other than by means of conversion or exercise of the Notes and the Securities issued together with the Notes), (b) the Company merges into or consolidates with any other Person, or any Person merges into or consolidates with the Company and, after giving effect to such transaction, the stockholders of the Company immediately prior to such transaction own less than 66% of the aggregate voting power of the Company or the successor entity of such transaction, (c) the Company sells or transfers all or substantially all of its assets to another Person and the stockholders of the Company immediately prior to such transaction own less than 66% of the aggregate voting power of the acquiring entity immediately after the transaction, (d) a replacement at one time or within a three-year period of more than one-half of the members of the Board of Directors which is not approved by a majority of those individuals who are members of the Board of Directors on the Original Issue Date (or by those individuals who are serving as members of the Board of Directors on any date whose nomination to the Board of Directors was approved by a majority of the members of the Board of Directors who are members on the date hereof), or (e) the execution by the Company of an agreement to which the Company is a party or by which it is bound, providing for any of the events set forth in clauses (a) through (d) above.

“Event of Default” shall have the meaning set forth in Section 6(a).

“Exchange Act” means the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder.

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“Fundamental Transaction” shall have the meaning set forth in Section 5(e).

“Late Fees” shall have the meaning set forth in Section 2(c).

“Mandatory Default Amount” means the payment of 105% of the outstanding principal amount of this Note and accrued and unpaid interest hereon, in addition to the payment of all other amounts, costs, expenses and liquidated damages due in respect of this Note.

“New York Courts” shall have the meaning set forth in Section 7(d).

“Note Register” shall have the meaning set forth in Section 2(b).

“Original Issue Date” means the date of the first issuance of this Note, regardless of any transfers of any Note and regardless of the number of instruments which may be issued to evidence such Notes.

“Registration Statement” shall have the meaning set forth in Section 4(c)(iii).

“Required Minimum” means, as of any date during the continuance of an Event of Default, 300% of the maximum aggregate number of shares of Common Stock issuable upon conversion in full of the Notes, ignoring any conversion limits set forth therein.

“Securities Act” means the Securities Act of 1933, as amended, and the rules and regulations promulgated thereunder.

“Successor Entity” shall have the meaning set forth in Section 5(e).

2.            Interest, Payments and Prepayments.

(a)         Payment of Interest in Cash. The Company shall pay interest to the Holder on the aggregate unconverted and then outstanding principal amount of this Note at the rate of ten percent (10%) per annum. All interest payments hereunder will be payable in cash. Accrued and unpaid interest shall be payable in arrears and shall be due on the 10^th^ calendar day of each month following the Original Issue Date, or as otherwise set forth herein.

(b)         Interest Calculations. Interest shall be calculated on the basis of a 360-day year, consisting of twelve 30 calendar day periods, commencing on the Original Issue Date until payment in full of the outstanding principal, together with all accrued and unpaid interest, liquidated damages and other amounts which may become due hereunder, has been made. Interest hereunder will be paid to the Person in whose name this Note is registered on the records of the Company regarding registration and transfers of this Note (the “Note Register”).

(c)         Late Fee. All overdue accrued and/or unpaid interest to be paid hereunder shall entail a late fee at an interest rate equal to the lesser of 5% per annum or the maximum rate permitted by applicable law (the “Late Fees”) which shall accrue daily from the date such interest is due hereunder through and including the date of actual payment in full.

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(d)         Mandatory Prepayment. This Note must be prepaid by the Company in an amount equal to 105% (the “Mandatory Prepayment Premium.”, in the event the note is satisfied prior to November 10, 2026..

(e)         Prepayment Upon Qualified Financing. If the Company completes a Qualified Financing (as defined below), the Company shall repay in full the then-outstanding principal amount of this Note, any accrued but unpaid interest and a pre-payment premium equal to 105% of the Note value on the Original Issue Date. Such repayment shall be due within one (5) Business Day of the closing of the Qualified Financing. The Company shall give written notice to Holder as soon as practicable, but in no event less than ten (10) days before the anticipated closing date of such Qualified Financing, during which period Holder shall have the opportunity to convert this Note pursuant to Section 4 hereof. The term “Qualified Financing” shall mean that the Company issues and sells shares of its equity securities to investors on or before the Maturity Date in an equity financing with total gross proceeds to the Company of not less than $1,000,000 (excluding the conversion of the notes or other convertible securities issued for capital raising purposes).

4.           Conversion.

By mutual written agreement of the Company and Holder, 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.

6.           Events of Default.

(a)         “Event of Default” means, wherever used herein, any of the following events (whatever the reason for such event and whether such event shall be voluntary or involuntary or effected by operation of law or pursuant to any judgment, decree or order of any court, or any order, rule or regulation of any administrative or governmental body):

i.         any default in the payment of (A) the principal amount of any Note or (B) interest, liquidated damages and other amounts owing to a Holder on any Note, as and when the same shall become due and payable (whether on a Conversion Date or the Maturity Date or by acceleration or otherwise) which default, solely in the case of an interest payment or other default under clause (B) above, is not cured within two (2) Trading Days;

iii.         the issuance by the Company of any indebtedness for money borrowed without the prior written consent of the Holder;

iv.         any representation or warranty made in this Note, any other Transaction Documents, any written statement pursuant hereto or thereto or any other report, financial statement or certificate made or delivered to the Holder shall be untrue or incorrect in any material respect as of the date when made or deemed made;

v.         the Company or any Significant Subsidiary (as such term is defined in Rule 1-02(w) of Regulation S-X) shall be subject to a Bankruptcy Event;

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viii.         the Company shall be a party to any Change of Control Transaction or Fundamental Transaction or shall agree to sell or dispose of all or in excess of 33% of its assets in one transaction or a series of related transactions (whether or not such sale would constitute a Change of Control Transaction);

xi.         if the Company or any Significant Subsidiary shall: (i) apply for or consent to the appointment of a receiver, trustee, custodian or liquidator of it or any of its properties, (ii) make a general assignment for the benefit of creditors, (iii) be adjudicated a bankrupt or insolvent or be the subject of an order for relief under Title 11 of the United States Code or any bankruptcy, reorganization, insolvency, readjustment of debt, dissolution or liquidation law or statute of any other jurisdiction or foreign country, or (iv) file a voluntary petition in bankruptcy, or a petition or an answer seeking reorganization or an arrangement with creditors or to take advantage or any bankruptcy, reorganization, insolvency, readjustment of debt, dissolution or liquidation law or statute, or an answer admitting the material allegations of a petition filed against it in any proceeding under any such law, or (v) take or permit to be taken any action in furtherance of or for the purpose of effecting any of the foregoing;

xii.         if any order, judgment or decree shall be entered, without the application, approval or consent of the Company or any Significant Subsidiary, by any court of competent jurisdiction, approving a petition seeking liquidation or reorganization of the Company or any Subsidiary, or appointing a receiver, trustee, custodian or liquidator of the Company or any Subsidiary, or of all or any substantial part of its assets, and such order, judgment or decree shall continue unstayed and in effect for any period of sixty (60) days;

xiii.         the occurrence of any levy upon or seizure or attachment of, or any uninsured loss of or damage to, any property of the Company or any Subsidiary having an aggregate fair value or repair cost (as the case may be) in excess of $100,000 individually or in the aggregate, and any such levy, seizure or attachment shall not be set aside, bonded or discharged within thirty (30) days after the date thereof;

xiv.         the Company or any subsidiary shall default on any of its obligations under any mortgage, credit agreement or other facility, indenture agreement, factoring agreement or other instrument under which there may be issued, or by which there may be secured or evidenced, any indebtedness for borrowed money or money due under any long term leasing or factoring arrangement that (a) involves an obligation greater than $100,000, whether such indebtedness now exists or shall hereafter be created, and (b) results in such indebtedness becoming or being declared due and payable prior to the date on which it would otherwise become due and payable;

xv.         any monetary judgement, writ or similar final process shall be entered or filed after the date hereof against the Company, any subsidiary or any of their respective property or assets for more than $100,000, and such judgement, writ or similar process shall remain unvacated, unbonded or unstayed for a period of 45 calendar days; or

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(b)         Remedies Upon Event of Default. Subject to the Beneficial Ownership Limitation as set forth in Section 4(d), if any Event of Default occurs, then the outstanding principal amount of this Note, plus accrued but unpaid interest, liquidated damages and other amounts owing in respect thereof through the date of acceleration, shall become, at the Holder’s election, immediately due and payable in cash at the Mandatory Default Amount.  After the occurrence of any Event of Default that results in the eventual acceleration of this Note, the interest rate on this Note shall accrue at an additional interest rate equal to the lesser of 2% per month (24% per annum) or the maximum rate permitted under applicable law.  Upon the payment in full of the Note, the Holder shall promptly surrender this Note to or as directed by the Company. In connection with such acceleration described herein, the Holder need not provide, and the Company hereby waives, any presentment, demand, protest or other notice of any kind, and the Holder may immediately and without expiration of any grace period enforce any and all of its rights and remedies hereunder and all other remedies available to it under applicable law. Such acceleration may be rescinded and annulled by Holder at any time prior to payment hereunder and the Holder shall have all rights as a holder of the Note until such time, if any, as the Holder receives full payment pursuant to this Section 6(b). No such rescission or annulment shall affect any subsequent Event of Default or impair any right consequent thereon.

7.        Assignment.         This note may be assigned at the sole option of the Holder without consent from the Company.

8.        Miscellaneous.

(a)         Notices. Any and all notices or other communications or deliveries to be provided by the Holder hereunder, including, without limitation, any Notice of Conversion, shall be in writing and delivered personally, by facsimile, by email, or sent by a nationally recognized overnight courier service, addressed to the Company, at the address set forth above, or such other facsimile number, email or other address as the Company may specify for such purposes by notice to the Holder delivered in accordance with this Section 7(a). Any and all notices or other communications or deliveries to be provided by the Company hereunder shall be in writing and delivered personally, by facsimile, by email or sent by a nationally recognized overnight courier service addressed to each Holder at the facsimile number, email or other address of the Holder appearing on the books of the Company, or if no such facsimile number, email or other address appears on the books of the Company, at the principal place of business of such Holder, as set forth in the Purchase Agreement. Any notice or other communication or deliveries hereunder shall be deemed given and effective on the earliest of (i) the date of transmission, if such notice or communication is delivered via facsimile or via email at the facsimile number or email set forth on the signature pages attached hereto prior to 12:00 p.m. (New York City time) on any date, (ii) the next Trading Day after the date of transmission, if such notice or communication is delivered via facsimile or via email at the facsimile number or email set forth on the signature pages attached hereto on a day that is not a Trading Day or later than 12:00 p.m. (New York City time) on any Trading Day, (iii) the second Trading Day following the date of mailing, if sent by U.S. nationally recognized overnight courier service or (iv) upon actual receipt by the party to whom such notice is required to be given.

(b)         Absolute Obligation. Except as expressly provided herein, no provision of this Note shall alter or impair the obligation of the Company, which is absolute and unconditional, to pay the principal of, liquidated damages and accrued interest, as applicable, on this Note at the time, place, and rate, and in the coin or currency, herein prescribed. This Note is a direct debt obligation of the Company.

(c)         Lost or Mutilated Note. If this Note shall be mutilated, lost, stolen or destroyed, the Company shall execute and deliver, in exchange and substitution for and upon cancellation of a mutilated Note, or in lieu of or in substitution for a lost, stolen or destroyed Note, a new Note for the principal amount of this Note so mutilated, lost, stolen or destroyed, but only upon receipt of evidence of such loss, theft or destruction of such Note, and of the ownership hereof, reasonably satisfactory to the Company.

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(d)         Governing Law. All questions concerning the construction, validity, enforcement and interpretation of this Note shall be governed by and construed and enforced in accordance with the internal laws of the State of New York, without regard to the principles of conflict of laws thereof. Each party agrees that all legal proceedings concerning the interpretation, enforcement and defense of the transactions contemplated by any of the Transaction Documents (whether brought against a party hereto or its respective Affiliates, directors, officers, shareholders, employees or agents) shall be commenced in the state and federal courts sitting in New York County, State of New York (the “New York Courts”). Each party hereto hereby irrevocably submits to the exclusive jurisdiction of the New York Courts for the adjudication of any dispute hereunder or in connection herewith or with any transaction contemplated hereby or discussed herein (including with respect to the enforcement of any of the Transaction Documents), and hereby irrevocably waives, and agrees not to assert in any suit, action or proceeding, any claim that it is not personally subject to the jurisdiction of such New York Courts, or such New York Courts are improper or inconvenient venue for such proceeding. Each party hereby irrevocably waives personal service of process and consents to process being served in any such suit, action or proceeding by mailing a copy thereof via registered or certified mail or overnight delivery (with evidence of delivery) to such party at the address in effect for notices to it under this Note and agrees that such service shall constitute good and sufficient service of process and notice thereof. Nothing contained herein shall be deemed to limit in any way any right to serve process in any other manner permitted by applicable law. Each party hereto hereby irrevocably waives, to the fullest extent permitted by applicable law, any and all right to trial by jury in any legal proceeding arising out of or relating to this Note or the transactions contemplated hereby. If any party shall commence an action or proceeding to enforce any provisions of this Note, then the prevailing party in such action or proceeding shall be reimbursed by the other party for its attorney’s fees and other costs and expenses incurred in the investigation, preparation and prosecution of such action or proceeding.

(e)         Waiver. Any waiver by the Company or the Holder of a breach of any provision of this Note shall not operate as or be construed to be a waiver of any other breach of such provision or of any breach of any other provision of this Note. The failure of the Company or the Holder to insist upon strict adherence to any term of this Note on one or more occasions shall not be considered a waiver or deprive that party of the right thereafter to insist upon strict adherence to that term or any other term of this Note on any other occasion. Any waiver by the Company or the Holder must be in writing.

(f)         Severability. If any provision of this Note is invalid, illegal or unenforceable, the balance of this Note shall remain in effect, and if any provision is inapplicable to any Person or circumstance, it shall nevertheless remain applicable to all other Persons and circumstances. If it shall be found that any interest or other amount deemed interest due hereunder violates the applicable law governing usury, the applicable rate of interest due hereunder shall automatically be lowered to equal the maximum rate of interest permitted under applicable law. The Company covenants (to the extent that it may lawfully do so) that it shall not at any time insist upon, plead, or in any manner whatsoever claim or take the benefit or advantage of, any stay, extension or usury law or other law which would prohibit or forgive the Company from paying all or any portion of the principal of or interest on this Note as contemplated herein, wherever enacted, now or at any time hereafter in force, or which may affect the covenants or the performance of this Note, and the Company (to the extent it may lawfully do so) hereby expressly waives all benefits or advantage of any such law, and covenants that it will not, by resort to any such law, hinder, delay or impede the execution of any power herein granted to the Holder, but will suffer and permit the execution of every such as though no such law has been enacted.

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(g)         Remedies, Characterizations, Other Obligations, Breaches and Injunctive Relief. The remedies provided in this Note shall be cumulative and in addition to all other remedies available under this Note and any of the other Transaction Documents at law or in equity (including a decree of specific performance and/or other injunctive relief), and nothing herein shall limit the Holder’s right to pursue actual and consequential damages for any failure by the Company to comply with the terms of this Note. The Company covenants to the Holder that there shall be no characterization concerning this instrument other than as expressly provided herein. Amounts set forth or provided for herein with respect to payments, conversion and the like (and the computation thereof) shall be the amounts to be received by the Holder and shall not, except as expressly provided herein, be subject to any other obligation of the Company (or the performance thereof). The Company acknowledges that a breach by it of its obligations hereunder will cause irreparable harm to the Holder and that the remedy at law for any such breach may be inadequate. The Company therefore agrees that, in the event of any such breach or threatened breach, the Holder shall be entitled, in addition to all other available remedies, to an injunction restraining any such breach or any such threatened breach, without the necessity of showing economic loss and without any bond or other security being required. The Company shall provide all information and documentation to the Holder that is requested by the Holder to enable the Holder to confirm the Company’s compliance with the terms and conditions of this Note.

(h)         Next Business Day. Whenever any payment or other obligation hereunder shall be due on a day other than a Business Day, such payment shall be made on the next succeeding Business Day.

(i)         Headings. The headings contained herein are for convenience only, do not constitute a part of this Note and shall not be deemed to limit or affect any of the provisions hereof.

*********************

(Signature Pages Follow)

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IN WITNESS WHEREOF, the Company has caused this Note to be duly executed by a duly authorized officer as of the date first above indicated.

CommLoan Inc.
By:
Name: Mitchell Ginsberg
Title: CEO

Email address for delivery of Notices:

mginsberg@commloan.com

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ex_890836.htm

Exhibit 4.5

NEITHER THIS SECURITY NOR THE SECURITIES INTO WHICH THIS SECURITY IS CONVERTIBLE HAVE BEEN REGISTERED WITH THE SECURITIES AND EXCHANGE COMMISSION OR THE SECURITIES COMMISSION OF ANY STATE IN RELIANCE UPON AN EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), AND, ACCORDINGLY, MAY NOT BE OFFERED OR SOLD EXCEPT PURSUANT TO AN EFFECTIVE REGISTRATION STATEMENT UNDER THE SECURITIES ACT OR PURSUANT TO AN AVAILABLE EXEMPTION FROM, OR IN A TRANSACTION NOT SUBJECT TO, THE REGISTRATION REQUIREMENTS OF THE SECURITIES ACT AND IN ACCORDANCE WITH APPLICABLE STATE SECURITIES LAWS AS EVIDENCED BY A LEGAL OPINION OF COUNSEL TO THE TRANSFEROR TO SUCH EFFECT, THE SUBSTANCE OF WHICH SHALL BE REASONABLY ACCEPTABLE TO THE COMPANY. THIS SECURITY AND THE SECURITIES ISSUABLE UPON CONVERSION OF THIS SECURITY MAY BE PLEDGED IN CONNECTION WITH A BONA FIDE MARGIN ACCOUNT OR OTHER LOAN SECURED BY SUCH SECURITIES.

Dated as of: November 14, 2025 Principal Amount: $750,000
Maturity Date: November 13, 2026
Interest Rate: 10%

Windtree Therapeutics, inc.

SENIOR CONVERTIBLE PROMISSORY NOTE

THIS SENIOR PROMISSORY NOTE is a duly authorized and validly issued Senior Promissory Note of Windtree Therapeutics., a Delaware corporation (the “Company”), having its principal place of business at 2600 Kelly Road, Warrington, PA (the “Note””).

FOR VALUE RECEIVED, the Company hereby promises to pay to the order of Seven Knots, LLC a Montana limited liability company or its registered assigns or successors-in-interest (the “Holder”), having a principal place of business located at 415 N Benton Avenue, Helena, MT 59601 or shall have paid pursuant to the terms hereunder, the principal amount set forth above on November 13, 2026 (the “Maturity Date”) or such earlier date as this Note is required or permitted to be repaid as provided hereunder, and to pay interest to the Holder on the aggregate unconverted and then outstanding principal amount of this Note in accordance with the provisions hereof.

This Note is subject to the following additional provisions:

1.            Definitions. For the purposes hereof, in addition to the terms defined elsewhere in this Note, (a) capitalized terms not otherwise defined herein shall have the meanings set forth in the Purchase Agreement and (b) the following terms shall have the following meanings:

“Alternate Consideration” shall have the meaning set forth in Section 5(e).

“Applicable Date” shall mean the earlier to occur of (x) the first date on which the resale by the Holder of all the Registrable Securities required to be filed on the initial Registration Statement pursuant to the Registration Rights Agreement is declared effective by the SEC (and each prospectus contained therein is available for use on such date) or (y) the first date on which all of the Registrable Securities are eligible to be resold by the Holder pursuant to Rule 144 (or, if a Current Public Information Failure has occurred and is continuing, such later date after which the Company has cured such Current Public Information Failure).

“Bankruptcy Event” means any of the following events: (a) the Company or any Significant Subsidiary (as such term is defined in Rule 1-02(w) of Regulation S-X) thereof commences a case or other proceeding under any bankruptcy, reorganization, arrangement, adjustment of debt, relief of debtors, dissolution, insolvency or liquidation or similar law of any jurisdiction relating to the Company or any Significant Subsidiary thereof, (b) there is commenced against the Company or any Significant Subsidiary thereof any such case or proceeding that is not dismissed within 60 days after commencement, (c) the Company or any Significant Subsidiary thereof is adjudicated insolvent or bankrupt or any order of relief or other order approving any such case or proceeding is entered, (d) the Company or any Significant Subsidiary thereof suffers any appointment of any custodian or the like for it or any substantial part of its property that is not discharged or stayed within 60 calendar days after such appointment, (e) the Company or any Significant Subsidiary thereof makes a general assignment for the benefit of creditors, (f) the Company or any Significant Subsidiary thereof calls a meeting of its creditors with a view to arranging a composition, adjustment or restructuring of its debts or (g) the Company or any Significant Subsidiary thereof, by any act or failure to act, expressly indicates its consent to, approval of or acquiescence in any of the foregoing or takes any corporate or other action for the purpose of effecting any of the foregoing.

“Base Conversion Price” shall have the meaning set forth in Section 5(b).

“Beneficial Ownership Limitation” shall have the meaning set forth in Section 4(d).

“Change of Control Transaction” means the occurrence after the date hereof of any of (a) an acquisition after the date hereof by an individual or legal entity or “group” (as described in Rule 13d-5(b)(1) promulgated under the Exchange Act) of effective control (whether through legal or beneficial ownership of capital stock of the Company, by contract or otherwise) of in excess of 33% of the voting securities of the Company (other than by means of conversion or exercise of the Notes and the Securities issued together with the Notes), (b) the Company merges into or consolidates with any other Person, or any Person merges into or consolidates with the Company and, after giving effect to such transaction, the stockholders of the Company immediately prior to such transaction own less than 66% of the aggregate voting power of the Company or the successor entity of such transaction, (c) the Company sells or transfers all or substantially all of its assets to another Person and the stockholders of the Company immediately prior to such transaction own less than 66% of the aggregate voting power of the acquiring entity immediately after the transaction, (d) a replacement at one time or within a three-year period of more than one-half of the members of the Board of Directors which is not approved by a majority of those individuals who are members of the Board of Directors on the Original Issue Date (or by those individuals who are serving as members of the Board of Directors on any date whose nomination to the Board of Directors was approved by a majority of the members of the Board of Directors who are members on the date hereof), or (e) the execution by the Company of an agreement to which the Company is a party or by which it is bound, providing for any of the events set forth in clauses (a) through (d) above.

“Common Stock” means the common stock, par value $0.001 per share, of the Company and any other class of securities into which such securities may hereafter be reclassified or changed.

“Common Stock Equivalents” means any securities of the Company or the Subsidiaries that would entitle the holder thereof to acquire at any time shares of Common Stock, including, without limitation, any debt, preferred stock, right, option, warrant or other instrument that is at any time convertible into or exercisable or exchangeable for, or otherwise entitles the holder thereof to receive, shares of Common Stock.

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“Conversion” shall have the meaning ascribed to such term in Section 4.

“Conversion Date” shall have the meaning set forth in Section 4(a).

“Conversion Price” shall have the meaning set forth in Section 4(b).

“Conversion Shares” means, collectively, the shares of Common Stock issuable upon conversion of this Note in accordance with the terms hereof.

“Dilutive Issuance” shall have the meaning set forth in Section 5(b).

“Dilutive Issuance Notice” shall have the meaning set forth in Section 5(b).

“Event of Default” shall have the meaning set forth in Section 6(a).

“Exchange Act” means the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder.

“Exempt Issuance” means the issuance of (a) shares of Common Stock or options to employees, officers, directors or consultants of the Company pursuant to the Company’s existing stock option and/or restricted stock plans or stock option and/or restricted stock plans which come into effect following the date hereof, (b) securities upon the exercise or exchange of or conversion of any Notes and/or other securities exercisable or exchangeable for or convertible into shares of Common Stock, issued and outstanding on the date of this Note, or pursuant to other agreements of the Company existing prior to the date hereof, provided that such securities and/or agreements have not been amended since the date of this Note to increase the number of such securities or to decrease the exercise price, exchange price or conversion price of such securities, and (c) securities issued pursuant to acquisitions or strategic transactions approved by a majority of the disinterested directors of the Company, but shall not include a transaction in which the Company is issuing securities primarily for the purpose of raising capital or to an entity whose primary business is investing in securities.

“Fundamental Transaction” shall have the meaning set forth in Section 5(e).

“Late Fees” shall have the meaning set forth in Section 2(c).

“Mandatory Default Amount” means the payment of 120% of the outstanding principal amount of this Note and accrued and unpaid interest hereon, in addition to the payment of all other amounts, costs, expenses and liquidated damages due in respect of this Note.

“Market Price” shall mean 90% of the lowest sale price for the twenty (20) consecutive Trading Days ending on the Trading Day that is immediately prior to the applicable Conversion Date (the resulting pricing being referred to herein as the “Adjustment Price”).

“New York Courts” shall have the meaning set forth in Section 7(d).

“Note Register” shall have the meaning set forth in Section 2(b).

“Notice of Conversion” shall have the meaning set forth in Section 4(a).

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“Original Issue Date” means the date of the first issuance of this Note, regardless of any transfers of any Note and regardless of the number of instruments which may be issued to evidence such Notes.

“Registration Statement” shall have the meaning set forth in Section 4(c)(iii).

“Required Minimum” means, as of any date during the continuance of an Event of Default, 300% of the maximum aggregate number of shares of Common Stock issuable upon conversion in full of the Notes, ignoring any conversion limits set forth therein.

“Review Fee” shall have the meaning set forth in Section 4(c)(ix)

“Securities Act” means the Securities Act of 1933, as amended, and the rules and regulations promulgated thereunder.

“Share Delivery Date” shall have the meaning set forth in Section 4(c)(ii).

“Successor Entity” shall have the meaning set forth in Section 5(e).

“Trading Market” means any of the following markets or exchanges on which the Common Stock (or any other common stock of any other Person that references the Trading Market for its common stock) is listed or quoted for trading on the date in question: The NASDAQ Global Market, The NASDAQ Global Select Market, The NASDAQ Capital Market, the New York Stock Exchange, NYSE Arca, the NYSE American, the OTCQX Marketplace, the OTCQB Marketplace, the OTC Pink Marketplace or any other tier operated by OTC Markets Group Inc. (or any successor to any of the foregoing).

2.         Interest, Payments and Prepayments.

(a)         Payment of Interest in Cash. The Company shall pay interest to the Holder on the aggregate unconverted and then outstanding principal amount of this Note at the rate of ten percent (10%) per annum. All interest payments hereunder will be payable in cash. Accrued and unpaid interest shall be payable in arrears and shall be due on the 5^th^ calendar day of each month following the Original Issue Date, or as otherwise set forth herein.

(b)         Interest Calculations. Interest shall be calculated on the basis of a 360-day year, consisting of twelve 30 calendar day periods, commencing on the Original Issue Date until payment in full of the outstanding principal, together with all accrued and unpaid interest, liquidated damages and other amounts which may become due hereunder, has been made. Interest hereunder will be paid to the Person in whose name this Note is registered on the records of the Company regarding registration and transfers of this Note (the “Note Register”).

(c)         Late Fee. All overdue accrued and/or unpaid interest to be paid hereunder shall entail a late fee at an interest rate equal to the lesser of 15% per annum or the maximum rate permitted by applicable law (the “Late Fees”) which shall accrue daily from the date such interest is due hereunder through and including the date of actual payment in full.

(d)         Mandatory Prepayment. This 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, 2025 by and between Seven Knots, LLC and the Company. The Parties hereby agree that the Mandatory Prepayment shall have a premium of 115% (the “Mandatory Prepayment Premium.”.

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(e)         Prepayment Upon Qualified Financing. If the Company completes a Qualified Financing (as defined below), the Company shall repay in full the then-outstanding principal amount of this Note, any accrued but unpaid interest and a pre-payment premium equal to 115% of the Note value on the Original Issue Date. Such repayment shall be due within one (1) Business Day of the closing of the Qualified Financing. The Company shall give written notice to Holder as soon as practicable, but in no event less than ten (10) days before the anticipated closing date of such Qualified Financing, during which period Holder shall have the opportunity to convert this Note pursuant to Section 4 hereof. The term “Qualified Financing” shall mean that the Company issues and sells shares of its equity securities to investors on or before the Maturity Date in an equity financing with total gross proceeds to the Company of not less than $1,000,000 (excluding the conversion of the notes or other convertible securities issued for capital raising purposes).

3.            Registration of Transfers and Exchanges.

(a)         Different Denominations. This Note is exchangeable for an equal aggregate principal amount of Notes of different authorized denominations, as requested by the Holder surrendering the same. No service charge will be payable for such registration of transfer or exchange.

(b)         Investment Representations. This Note may be transferred or exchanged only in compliance with applicable federal and state securities laws and regulations.

(c)         Reliance on Note Register. Prior to due presentment for transfer to the Company of this Note, the Company and any agent of the Company may treat the Person in whose name this Note is duly registered on the Note Register as the owner hereof for the purpose of receiving payment as herein provided and for all other purposes, whether or not this Note is overdue, and neither the Company nor any such agent shall be affected by notice to the contrary.

4.            Conversion.

(a)         Voluntary Conversion. This Note shall be convertible, in whole or in part, into shares of Common Stock at the option of the Holder, at any time and from time to time (subject to the conversion limitations set forth in Section 4(d) hereof). The Holder shall effect conversions by delivering to the Company a Notice of Conversion, the form of which is attached hereto as Annex A (each, a “Notice of Conversion”), specifying therein the principal amount of this Note to be converted, accrued and unpaid interest outstanding under this Note to be converted, and the date on which such conversion shall be effected (such date, the “Conversion Date”). If no Conversion Date is specified in a Notice of Conversion, the Conversion Date shall be the date that such Notice of Conversion is deemed delivered hereunder. No ink-original Notice of Conversion shall be required, nor shall any medallion guarantee (or other type of guarantee or notarization) of any Notice of Conversion form be required. To effect conversions hereunder, the Holder shall not be required to physically surrender this Note to the Company unless the entire principal amount of this Note, plus all accrued and unpaid interest thereon, has been so converted. Conversions hereunder shall have the effect of lowering the outstanding principal amount of this Note in an amount equal to the applicable conversion. The Holder and the Company shall maintain a Conversion Schedule showing the principal amount(s) converted and the date of such conversion(s). In the event of any dispute or discrepancy, the records of the Holder shall be controlling and determinative in the absence of manifest error. The Holder, and any assignee by acceptance of this Note, acknowledge and agree that, by reason of the provisions of this paragraph, following conversion of a portion of this Note, the unpaid and unconverted principal amount of this Note may be less than the amount stated on the face hereof.

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(b)         Conversion Price. The conversion price means, 90% of the lowest sale price for the twenty (20) consecutive Trading Days ending on the Trading Day that is immediately prior to the applicable Conversion Date subject to adjustment as provided herein.

All such determinations will be appropriately adjusted for any stock dividend, stock split, stock combination, reclassification or similar transaction that proportionately decreases or increases the Common Stock during such measuring period. Nothing herein shall limit a Holder’s right to pursue actual damages or declare an Event of Default pursuant to Section 6 hereof and the Holder shall have the right to pursue all remedies available to it hereunder, at law or in equity including, without limitation, a decree of specific performance and/or injunctive relief. The exercise of any such rights shall not prohibit the Holder from seeking to enforce damages pursuant to any other Section hereof or under applicable law.

(c)         Mechanics of Conversion.

i.         Conversion Shares Issuable Upon Conversion of Principal Amount, Interest and Mandatory Default Amount. The number of Conversion Shares issuable upon a conversion hereunder shall be determined by the quotient obtained by dividing (x) the outstanding principal amount of this Note to be converted and any accrued and unpaid interest to be converted, which amount may include the Mandatory Default Amount, by (y) the Conversion Price.

ii.         Delivery of Certificate Upon Conversion. Not later than one (1) Trading Day after each Conversion Date (the “Share Delivery Date”), the Company shall deliver, or cause to be delivered, to the Holder (A) a certificate or certificates representing the Conversion Shares which, on or after the date on which such Conversion Shares are eligible to be sold under Rule 144 without the need for current public information and the Company has received an opinion of counsel to such effect reasonably acceptable to the Company, shall be free of restrictive legends and trading restrictions (other than those which may then be required by the Purchase Agreement) representing the number of Conversion Shares being acquired upon the conversion of this Note, and (B) a bank check in the amount of accrued and unpaid interest (if the Company has elected or is required to pay accrued interest in cash). All certificate or certificates required to be delivered by the Company under this Section 4(c) shall be delivered electronically through the Depository Trust Company or another established clearing corporation performing similar functions, if available. If the Conversion Date is prior to the date on which such Conversion Shares are eligible to be sold under Rule 144 without the need for current public information the Conversion Shares shall bear a restrictive legend in the following form, as appropriate:

“NEITHER THE ISSUANCE AND SALE OF THE SECURITIES REPRESENTED BY THIS CERTIFICATE NOR THE SECURITIES INTO WHICH THESE SECURITIES ARE EXERCISABLE HAVE BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED, OR APPLICABLE STATE SECURITIES LAWS. THE SECURITIES MAY NOT BE OFFERED FOR SALE, SOLD, TRANSFERRED OR ASSIGNED (I) IN THE ABSENCE OF (A) AN EFFECTIVE REGISTRATION STATEMENT FOR THE SECURITIES UNDER THE SECURITIES ACT OF 1933, AS AMENDED, OR (B) AN OPINION OF COUNSEL (WHICH COUNSEL SHALL BE SELECTED BY THE HOLDER REASONABLY ACCEPTABLE TO COMPANY), IN A GENERALLY ACCEPTABLE FORM AND SUBSTANCE, THAT REGISTRATION IS NOT REQUIRED UNDER SAID ACT OR (II) UNLESS SOLD PURSUANT TO RULE 144 OR RULE 144A UNDER SAID ACT. NOTWITHSTANDING THE FOREGOING, THE SECURITIES MAY BE PLEDGED IN CONNECTION WITH A BONA FIDE MARGIN ACCOUNT OR OTHER LOAN OR FINANCING ARRANGEMENT SECURED BY THE SECURITIES.”

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iii.         Registration. Within 45 calendar days following the Original Issue Date, the Company shall file a registration statement on Form S-1 (the “Registration Statement”) for the resale of all registrable securities under the Note.

iv.         Failure to Deliver Certificates. If, in the case of any Notice of Conversion, such certificate or certificates are not delivered to or as directed by the applicable Holder by the Share Delivery Date, the Holder shall be entitled to elect by written notice to the Company at any time on or before its receipt of such certificate or certificates, to rescind such Conversion, in which event the Company shall promptly return to the Holder any original Note delivered to the Company and the Holder shall promptly return to the Company the Common Stock certificates issued to such Holder pursuant to the rescinded Conversion Notice. Notwithstanding the obligations of the Company contained in Section 4(c) to deliver share certificates, any requirement to deliver share certificates shall be remedied by recording share issuances in favor of the Holder in book entry form and delivery to the Holder of written evidence of such share issuances.

v.         Obligation Absolute; Partial Liquidated Damages. The Company’s obligations to issue and deliver the Conversion Shares upon conversion of this Note in accordance with the terms hereof are absolute and unconditional, irrespective of any action or inaction by the Holder to enforce the same, any waiver or consent with respect to any provision hereof, the recovery of any judgment against any Person or any action to enforce the same, or any setoff, counterclaim, recoupment, limitation or termination, or any breach or alleged breach by the Holder or any other Person of any obligation to the Company or any violation or alleged violation of law by the Holder or any other Person, and irrespective of any other circumstance which might otherwise limit such obligation of the Company to the Holder in connection with the issuance of such Conversion Shares; provided, however, that such delivery shall not operate as a waiver by the Company of any such action the Company may have against the Holder. Nothing herein shall limit a Holder’s right to pursue actual damages or declare an Event of Default pursuant to Section 6 hereof for the Company’s failure to deliver Conversion Shares within the period specified herein and the Holder shall have the right to pursue all remedies available to it hereunder, at law or in equity including, without limitation, a decree of specific performance and/or injunctive relief. The exercise of any such rights shall not prohibit the Holder from seeking to enforce damages pursuant to any other Section hereof or under applicable law.

vi.         Reservation of Shares Issuable Upon Conversion. The Company covenants that it will at all times reserve and keep available out of its authorized and unissued shares of Common Stock a number of shares of Common Stock at least equal to the Required Minimum for the sole purpose of issuance upon conversion of this Note and payment of interest on this Note, each as herein provided, free from preemptive rights or any other actual contingent purchase rights of Persons other than the Holder (and the other holders of the Notes), not less than such aggregate number of shares of the Common Stock as shall be issuable (taking into account the adjustments and restrictions of Section 5) upon the conversion of the then outstanding principal amount of this Note and payment of interest hereunder. The Company covenants that all shares of Common Stock that shall be so issuable shall, upon issue, be duly authorized, validly issued, fully paid and nonassessable.

vii.         Fractional Shares. No fractional shares or scrip representing fractional shares shall be issued upon the conversion of this Note. As to any fraction of a share which the Holder would otherwise be entitled to purchase upon such conversion, the Company shall at its election, either pay a cash adjustment in respect of such final fraction in an amount equal to such fraction multiplied by the Conversion Price or round up to the next whole share.

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viii.         Transfer Taxes and Expenses. The issuance of certificates for shares of the Common Stock on conversion of this Note shall be made without charge to the Holder hereof for any documentary stamp or similar taxes that may be payable in respect of the issue or delivery of such certificates, provided that, the Company shall not be required to pay any tax that may be payable in respect of any transfer involved in the issuance and delivery of any such certificate upon conversion in a name other than that of the Holder of this Note so converted and the Company shall not be required to issue or deliver such certificates unless or until the Person or Persons requesting the issuance thereof shall have paid to the Company the amount of such tax or shall have established to the satisfaction of the Company that such tax has been paid. The Company shall pay all Transfer Agent fees required for same-day processing of any Notice of Conversion.

ix.         Review Fee.         The Holder shall be entitled to an amount equal to $1500 for each conversion of the Note for the related review and applicable deposit of the related shares (the “Review Fee”).

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(d)         Holder’s Conversion Limitations. The Company shall not effect any conversion of principal and/or interest of this Note, and a Holder shall not have the right to convert any principal and/or interest of this Note, to the extent that after giving effect to the conversion set forth on the applicable Notice of Conversion, the Holder (together with the Holder’s Affiliates, and any Persons acting as a group together with the Holder or any of the Holder’s Affiliates) would beneficially own in excess of the Beneficial Ownership Limitation (as defined below). For purposes of the foregoing sentence, the number of shares of Common Stock beneficially owned by the Holder and its Affiliates shall include the number of shares of Common Stock issuable upon conversion of this Note with respect to which such determination is being made, but shall exclude the number of shares of Common Stock which are issuable upon (i) conversion of the remaining, unconverted principal amount of this Note beneficially owned by the Holder or any of its Affiliates and (ii) exercise or conversion of the unexercised or unconverted portion of any other securities of the Company subject to a limitation on conversion or exercise analogous to the limitation contained herein beneficially owned by the Holder or any of its Affiliates. Except as set forth in the preceding sentence, for purposes of this Section 4(d), beneficial ownership shall be calculated in accordance with Section 13(d) of the Exchange Act and the rules and regulations promulgated thereunder. To the extent that the limitation contained in this Section 4(d) applies, the determination of whether this Note is convertible (in relation to other securities owned by the Holder together with any Affiliates) and of which principal amount of this Note is convertible shall be in the sole discretion of the Holder, and the submission of a Notice of Conversion shall be deemed to be the Holder’s determination of whether this Note may be converted (in relation to other securities owned by the Holder together with any Affiliates) and which principal amount of this Note is convertible, in each case subject to the Beneficial Ownership Limitation. To ensure compliance with this restriction, the Holder will be deemed to represent to the Company each time it delivers a Notice of Conversion that such Notice of Conversion has not violated the restrictions set forth in this paragraph and the Company shall have no obligation to verify or confirm the accuracy of such determination. In addition, a determination as to any group status as contemplated above shall be determined in accordance with Section 13(d) of the Exchange Act and the rules and regulations promulgated thereunder. For purposes of this Section 4(d), in determining the number of outstanding shares of Common Stock, the Holder may rely on the number of outstanding shares of Common Stock as stated in the most recent of the following: (i) the Company’s most recent periodic or annual report filed with the Commission, as the case may be, (ii) a more recent public announcement by the Company, or (iii) a more recent written notice by the Company or the Company’s transfer agent setting forth the number of shares of Common Stock outstanding. Upon the written or oral request of a Holder, the Company shall within two (2) Trading Days confirm orally and in writing to the Holder the number of shares of Common Stock then outstanding. In any case, the number of outstanding shares of Common Stock shall be determined after giving effect to the conversion or exercise of securities of the Company, including this Note, by the Holder or its Affiliates since the date as of which such number of outstanding shares of Common Stock was reported. The “Beneficial Ownership Limitation” shall be 4.99% of the number of shares of the Common Stock outstanding immediately after giving effect to the issuance of shares of Common Stock issuable upon conversion of this Note held by the Holder. The Holder, upon not less than 61 days’ prior notice to the Company, may increase or decrease the Beneficial Ownership Limitation provisions of this Section 4(d), provided that the Beneficial Ownership Limitation in no event exceeds 9.99% of the number of shares of the Common Stock outstanding immediately after giving effect to the issuance of shares of Common Stock upon conversion of this Note held by the Holder and the Beneficial Ownership Limitation provisions of this Section 4(d) shall continue to apply. Any such increase or decrease will not be effective until the 61^st^ day after such notice is delivered to the Company. The Beneficial Ownership Limitation provisions of this paragraph shall be construed and implemented in a manner otherwise than in strict conformity with the terms of this Section 4(d) to correct this paragraph (or any portion hereof) which may be defective or inconsistent with the intended Beneficial Ownership Limitation contained herein or to make changes or supplements necessary or desirable to properly give effect to such limitation. The limitations contained in this paragraph shall apply to a successor holder of this Note.

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5.         Certain Adjustments.

(a)    Stock Dividends and Stock Splits. If the Company, at any time while this Note is outstanding: (i) pays a stock dividend or otherwise makes a distribution or distributions payable in shares of Common Stock on shares of Common Stock or any Common Stock Equivalents (which, for avoidance of doubt, shall not include any shares of Common Stock issued by the Company upon conversion of, or payment of interest on, the Notes), (ii) subdivides outstanding shares of Common Stock into a larger number of shares, (iii) combines (including by way of a reverse stock split) outstanding shares of Common Stock into a smaller number of shares or (iv) issues, in the event of a reclassification of shares of the Common Stock, any shares of capital stock of the Company, then the Conversion Price shall be multiplied by a fraction of which the numerator shall be the number of shares of Common Stock (excluding any treasury shares of the Company) outstanding immediately before such event, and of which the denominator shall be the number of shares of Common Stock outstanding immediately after such event. Any adjustment made pursuant to this Section shall become effective immediately after the record date for the determination of stockholders entitled to receive such dividend or distribution and shall become effective immediately after the effective date in the case of a subdivision, combination or re‑classification.

(b)     Subsequent Equity Sales. If, at any time while this Note is outstanding, the Company or any Subsidiary, as applicable, sells or grants any option to purchase or sells or grants any right to reprice, or otherwise disposes of or issues (or announces any sale, grant or any option to purchase or other disposition), any Common Stock or Common Stock Equivalents entitling any Person to acquire shares of Common Stock at an effective price per share that is lower than the then Conversion Price (such lower price, the “Base Conversion Price” and such issuances, collectively, a “Dilutive Issuance”) (if the holder of the Common Stock or Common Stock Equivalents so issued shall at any time, whether by operation of purchase price adjustments, reset provisions, floating conversion, exercise or exchange prices or otherwise, or due to warrants, options or rights per share which are issued in connection with such issuance, be entitled to receive shares of Common Stock at an effective price per share that is lower than the Conversion Price, such issuance shall be deemed to have occurred for less than the Conversion Price on such date of the Dilutive Issuance), then the Conversion Price shall be reduced to equal the Base Conversion Price. Such adjustment shall be made whenever such Common Stock or Common Stock Equivalents are issued. Notwithstanding the foregoing, no adjustment will be made under this Section 5(b) in respect of an Exempt Issuance and such Exempt Issuance shall not be deemed a Dilutive Issuance. The Company shall notify the Holder in writing, no later than the Trading Day following the issuance of any Common Stock or Common Stock Equivalents subject to this Section 5(b), indicating therein the applicable issuance price, or applicable reset price, exchange price, conversion price and other pricing terms (such notice, the “Dilutive Issuance Notice”). For purposes of clarification, whether or not the Company provides a Dilutive Issuance Notice pursuant to this Section 5(b), upon the occurrence of any Dilutive Issuance, the Holder is entitled to receive a number of Conversion Shares based upon the Base Conversion Price on or after the date of such Dilutive Issuance, regardless of whether the Holder accurately refers to the Base Conversion Price in the Notice of Conversion.

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(c)         Subsequent Rights Offerings. In addition to any adjustments pursuant to Section 5 above, if at any time the Company grants, issues or sells any Common Stock Equivalents or rights to purchase stock, warrants, securities or other property pro rata to the record holders of any class of shares of Common Stock (the “Purchase Rights”), then the Holder will be entitled to acquire, upon the terms applicable to such Purchase Rights, the aggregate Purchase Rights which the Holder could have acquired if the Holder had held the number of shares of Common Stock acquirable upon complete conversion of this Note (without regard to any limitations on exercise hereof, including without limitation, the Beneficial Ownership Limitation) immediately before the date on which a record is taken for the grant, issuance or sale of such Purchase Rights, or, if no such record is taken, the date as of which the record holders of shares of Common Stock are to be determined for the grant, issue or sale of such Purchase Rights (provided, however, to the extent that the Holder’s right to participate in any such Purchase Right would result in the Holder exceeding the Beneficial Ownership Limitation, then the Holder shall not be entitled to participate in such Purchase Right to such extent (or beneficial ownership of such shares of Common Stock as a result of such Purchase Right to such extent) and such Purchase Right to such extent shall be held in abeyance for the Holder until such time, if ever, as its right thereto would not result in the Holder exceeding the Beneficial Ownership Limitation).

(d)         Pro Rata Distributions. During such time as this Note is outstanding, if the Company shall declare or make any dividend or other distribution of its assets (or rights to acquire its assets) to holders of shares of Common Stock, by way of return of capital or otherwise (including, without limitation, any distribution of cash, stock or other securities, property or options by way of a dividend, spin off, reclassification, corporate rearrangement, scheme of arrangement or other similar transaction) (a “Distribution”), at any time after the issuance of this Note, then, in each such case, upon conversion of this Note, the Holder shall be entitled to participate in such Distribution to the same extent that the Holder would have participated therein if the Holder had held the number of shares of Common Stock acquirable upon complete conversion of this Note (without regard to any limitations on exercise hereof, including without limitation, the Beneficial Ownership Limitation) immediately before the date of which a record is taken for such Distribution, or, if no such record is taken, the date as of which the record holders of shares of Common Stock are to be determined for the participation in such Distribution (provided, however, to the extent that the Holder’s right to participate in any such Distribution would result in the Holder exceeding the Beneficial Ownership Limitation, then the Holder shall not be entitled to participate in such Distribution to such extent (or in the beneficial ownership of any shares of Common Stock as a result of such Distribution to such extent) and the portion of such Distribution shall be held in abeyance for the benefit of the Holder until such time, if ever, as its right thereto would not result in the Holder exceeding the Beneficial Ownership Limitation).

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(e)         Fundamental Transaction. If, at any time while this Note is outstanding, (i) the Company, directly or indirectly, in one or more related transactions effects any merger or consolidation of the Company with or into another Person, (ii) the Company, directly or indirectly, effects any sale, lease, license, assignment, transfer, conveyance or other disposition of all or substantially all of its assets in one or a series of related transactions, (iii) any, direct or indirect, purchase offer, tender offer or exchange offer (whether by the Company or another Person) is completed pursuant to which holders of Common Stock are permitted to sell, tender or exchange their shares for other securities, cash or property and has been accepted by the holders of 50% or more of the outstanding Common Stock, (iv) the Company, directly or indirectly, in one or more related transactions effects any reclassification, reorganization or recapitalization of the Common Stock or any compulsory share exchange pursuant to which the Common Stock is effectively converted into or exchanged for other securities, cash or property, (v) the Company, directly or indirectly, in one or more related transactions consummates a stock or share purchase agreement or other business combination (including, without limitation, a reorganization, recapitalization, spin-off or scheme of arrangement) with another Person whereby such other Person acquires more than 50% of the outstanding shares of Common Stock (not including any shares of Common Stock held by the other Person or other Persons making or party to, or associated or affiliated with the other Persons making or party to, such stock or share purchase agreement or other business combination) (each a “Fundamental Transaction”), then, upon any subsequent conversion of this Note, the Holder shall have the right to receive, for each Conversion Share that would have been issuable upon such conversion immediately prior to the occurrence of such Fundamental Transaction (without regard to any limitation in Section 4(d) on the conversion of this Note), the number of shares of Common Stock of the successor or acquiring corporation or of the Company, if it is the surviving corporation, and any additional consideration (the “Alternate Consideration”) receivable as a result of such Fundamental Transaction by a holder of the number of shares of Common Stock for which this Note is convertible immediately prior to such Fundamental Transaction (without regard to any limitation in Section 4(d) on the conversion of this Note). For purposes of any such conversion, the determination of the Conversion Price shall be appropriately adjusted to apply to such Alternate Consideration based on the amount of Alternate Consideration issuable in respect of one (1) share of Common Stock in such Fundamental Transaction, and the Company shall apportion the Conversion Price among the Alternate Consideration in a reasonable manner reflecting the relative value of any different components of the Alternate Consideration. If holders of Common Stock are given any choice as to the securities, cash or property to be received in a Fundamental Transaction, then the Holder shall be given the same choice as to the Alternate Consideration it receives upon any conversion of this Note following such Fundamental Transaction. Unless the Note is paid in full in connection with the Fundamental Transaction, the Company shall cause any successor entity in a Fundamental Transaction in which the Company is not the survivor (the “Successor Entity”) to assume in writing all of the obligations of the Company under this Note and the other Transaction Documents (as defined in the Purchase Agreement) in accordance with the provisions of this Section 5(e) pursuant to written agreements in form and substance reasonably satisfactory to the Holder and approved by the Holder (without unreasonable delay) prior to such Fundamental Transaction and shall, at the option of the holder of this Note, deliver to the Holder in exchange for this Note a security of the Successor Entity evidenced by a written instrument substantially similar in form and substance to this Note which is convertible for a corresponding number of shares of capital stock of such Successor Entity (or its parent entity) equivalent to the shares of Common Stock acquirable and receivable upon conversion of this Note (without regard to any limitations on the conversion of this Note) prior to such Fundamental Transaction, and with a conversion price which applies the conversion price hereunder to such shares of capital stock (but taking into account the relative value of the shares of Common Stock pursuant to such Fundamental Transaction and the value of such shares of capital stock, such number of shares of capital stock and such conversion price being for the purpose of protecting the economic value of this Note immediately prior to the consummation of such Fundamental Transaction), and which is reasonably satisfactory in form and substance to the Holder. Upon the occurrence of any such Fundamental Transaction, the Successor Entity shall succeed to, and be substituted for (so that from and after the date of such Fundamental Transaction, the provisions of this Note and the other Transaction Documents referring to the “Company” shall refer instead to the Successor Entity), and may exercise every right and power of the Company and shall assume all of the obligations of the Company under this Note and the other Transaction Documents with the same effect as if such Successor Entity had been named as the Company herein. Notwithstanding the foregoing, this Section 5(e) shall not apply in the event the Company pays the Note in full in connection with the Fundamental Transaction.

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(f)         Calculations. All calculations under this Section 5 shall be made to the nearest cent or the nearest 1/100th of a share, as the case may be. For purposes of this Section 5, the number of shares of Common Stock deemed to be issued and outstanding as of a given date shall be the sum of the number of shares of Common Stock (excluding any treasury shares of the Company) issued and outstanding.

(g)         Notice to the Holder.

i.         Adjustment to Conversion Price. Whenever the Conversion Price is adjusted pursuant to any provision of this Section 5, the Company shall promptly deliver to each Holder a notice setting forth the Conversion Price after such adjustment and setting forth a brief statement of the facts requiring such adjustment.

ii.         Notice to Allow Conversion by Holder. If (A) the Company shall declare a dividend (or any other distribution in whatever form) on the Common Stock, (B) the Company shall declare a special nonrecurring cash dividend on or a redemption of the Common Stock, (C) the Company shall authorize the granting to all holders of the Common Stock of rights or warrants to subscribe for or purchase any shares of capital stock of any class or of any rights, (D) the approval of any stockholders of the Company shall be required in connection with any reclassification of the Common Stock, any consolidation or merger to which the Company is a party, any sale or transfer of all or substantially all of the assets of the Company, or any compulsory share exchange whereby the Common Stock is converted into other securities, cash or property or (E) the Company shall authorize the voluntary or involuntary dissolution, liquidation or winding up of the affairs of the Company, then, in each case, the Company shall cause to be filed at each office or agency maintained for the purpose of conversion of this Note, and shall cause to be delivered to the Holder at its last address as it shall appear upon the Note Register, at least twenty (20) calendar days prior to the applicable record or effective date hereinafter specified, a notice stating (x) the date on which a record is to be taken for the purpose of such dividend, distribution, redemption, rights or warrants, or if a record is not to be taken, the date as of which the holders of the Common Stock of record to be entitled to such dividend, distributions, redemption, rights or warrants are to be determined or (y) the date on which such reclassification, consolidation, merger, sale, transfer or share exchange is expected to become effective or close, and the date as of which it is expected that holders of the Common Stock of record shall be entitled to exchange their shares of the Common Stock for securities, cash or other property deliverable upon such reclassification, consolidation, merger, sale, transfer or share exchange, provided that the failure to deliver such notice or any defect therein or in the delivery thereof shall not affect the validity of the corporate action required to be specified in such notice. To the extent that any notice provided hereunder constitutes, or contains, material, non-public information regarding the Company or any of the Subsidiaries, the Company shall simultaneously file such notice with the Commission pursuant to a Current Report on Form 8-K. The Holder shall remain entitled to convert this Note during the 20-day period commencing on the date of such notice through the effective date of the event triggering such notice except as may otherwise be expressly set forth herein.

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(h)         Rollover Rights. If at any time while this Note is outstanding, the Company completes any single public offering or private placement of its equity, equity-linked or debt securities (each, a “Future Transaction”), the Holder may, in its sole discretion, elect to apply all, or any portion, of the then outstanding principal amount of this Note and any accrued but unpaid interest, as purchase consideration for such Future Transaction (the “Rollover Rights”). The Company shall give written notice to Holder as soon as practicable, but in no event less than fifteen (15) days before the anticipated closing date of such Future Transaction. The Holder may exercise its Rollover Rights by providing the Company written notice of such exercise within five Business Days before the closing of the Future Transaction. In the event Holder exercises its Rollover Rights, then such elected portion of the outstanding principal amount of this Note and accrued but unpaid interest shall automatically convert into the corresponding securities issued in such Future Transaction under the terms of such Future Transaction (except as provided in the next sentence), such that the Holder will receive all securities (including, without limitation, any warrants) issuable under the Future Transaction. The conversion price applicable to such conversion shall equal eighty percent (80%) of the cash purchase price paid per share, unit or other security denomination for the Company securities issued in the Future Transaction to other investors in the Future Transaction. Notwithstanding the foregoing provisions of this Section 5(h), the Holder shall not be permitted to exercise the Rollover Rights in a public offering involving the offering of equity securities that will be listed on a national securities exchange unless the Holder executes and delivers to the Company at the closing of such public offering an industry-standard “lock up” letter with respect to such equity securities for a period not to exceed 90 days.

(i)    Adjustment for More Favorable Terms Contained in Future Financings. So long as this Note is outstanding, upon any issuance by the Company or any of its subsidiaries of any security, including any convertible debt security (whether such debt begins with a convertible feature or such feature is added at a later date), with any term more favorable to the holder of such security or with a term in favor of the holder of such security that was not similarly provided to the Holder in this Note, then the Company shall notify the Holder of such additional or more favorable term and such term, at the Holder’s option, shall become a part of this Note and its supporting documentation. The types of terms contained in the other security that may be more favorable to the holder of such security include, but are not limited to, terms addressing conversion discounts, conversion look back periods, interest rates, original issue discount percentages and warrant coverage.

6.         Events of Default.

(a)       “Event of Default” means, wherever used herein, any of the following events (whatever the reason for such event and whether such event shall be voluntary or involuntary or effected by operation of law or pursuant to any judgment, decree or order of any court, or any order, rule or regulation of any administrative or governmental body):

i.         any default in the payment of (A) the principal amount of any Note or (B) interest, liquidated damages and other amounts owing to a Holder on any Note, as and when the same shall become due and payable (whether on a Conversion Date or the Maturity Date or by acceleration or otherwise) which default, solely in the case of an interest payment or other default under clause (B) above, is not cured within two (2) Trading Days;

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ii.         the Company shall materially fail to observe or perform any other covenant or agreement contained in the Notes (other than a breach by the Company of its obligations to deliver shares of Common Stock to the Holder upon conversion, which breach is addressed in clause (ix) below) which failure is not cured, if possible to cure, within the earlier to occur of (A) ten (10) Trading Days after notice of such failure sent by the Holder or by any other Holder to the Company and (B) twenty (20) Trading Days after the Company has become or should have become aware of such failure;

iii.         the issuance by the Company of any indebtedness for money borrowed without the prior written consent of the Holder;

iv.         any representation or warranty made in this Note, any other Transaction Documents, any written statement pursuant hereto or thereto or any other report, financial statement or certificate made or delivered to the Holder shall be untrue or incorrect in any material respect as of the date when made or deemed made;

v.         the Company or any Significant Subsidiary (as such term is defined in Rule 1-02(w) of Regulation S-X) shall be subject to a Bankruptcy Event;

vi.         the Company shall be a party to any Change of Control Transaction or Fundamental Transaction or shall agree to sell or dispose of all or in excess of 33% of its assets in one transaction or a series of related transactions (whether or not such sale would constitute a Change of Control Transaction);

ix.         the Company shall fail for any reason to deliver certificates to a Holder prior to the first Trading Day after a Conversion Date pursuant to Section 4(c), including but not limited to a “chill” of the stock by DTC, or the Company shall provide at any time notice to the Holder, including by way of public announcement, of the Company’s intention to not honor requests for conversions of any Notes in accordance with the terms hereof;

x.         the Company fails to file with the Commission any required reports under Section 13 or 15(d) of the Exchange Act such that it is not in compliance with Rule 144(c)(1) (or Rule 144(i)(2), if applicable);

xi.         if the Company or any Significant Subsidiary shall: (i) apply for or consent to the appointment of a receiver, trustee, custodian or liquidator of it or any of its properties, (ii) make a general assignment for the benefit of creditors, (iii) be adjudicated a bankrupt or insolvent or be the subject of an order for relief under Title 11 of the United States Code or any bankruptcy, reorganization, insolvency, readjustment of debt, dissolution or liquidation law or statute of any other jurisdiction or foreign country, or (iv) file a voluntary petition in bankruptcy, or a petition or an answer seeking reorganization or an arrangement with creditors or to take advantage or any bankruptcy, reorganization, insolvency, readjustment of debt, dissolution or liquidation law or statute, or an answer admitting the material allegations of a petition filed against it in any proceeding under any such law, or (v) take or permit to be taken any action in furtherance of or for the purpose of effecting any of the foregoing;

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xii.         if any order, judgment or decree shall be entered, without the application, approval or consent of the Company or any Significant Subsidiary, by any court of competent jurisdiction, approving a petition seeking liquidation or reorganization of the Company or any Subsidiary, or appointing a receiver, trustee, custodian or liquidator of the Company or any Subsidiary, or of all or any substantial part of its assets, and such order, judgment or decree shall continue unstayed and in effect for any period of sixty (60) days;

xiii.         the occurrence of any levy upon or seizure or attachment of, or any uninsured loss of or damage to, any property of the Company or any Subsidiary having an aggregate fair value or repair cost (as the case may be) in excess of $100,000 individually or in the aggregate, and any such levy, seizure or attachment shall not be set aside, bonded or discharged within thirty (30) days after the date thereof;

xiv.         the Company or any subsidiary shall default on any of its obligations under any mortgage, credit agreement or other facility, indenture agreement, factoring agreement or other instrument under which there may be issued, or by which there may be secured or evidenced, any indebtedness for borrowed money or money due under any long term leasing or factoring arrangement that (a) involves an obligation greater than $100,000, whether such indebtedness now exists or shall hereafter be created, and (b) results in such indebtedness becoming or being declared due and payable prior to the date on which it would otherwise become due and payable;

xv.         any monetary judgement, writ or similar final process shall be entered or filed after the date hereof against the Company, any subsidiary or any of their respective property or assets for more than $100,000, and such judgement, writ or similar process shall remain unvacated, unbonded or unstayed for a period of 45 calendar days; or

(b)         Remedies Upon Event of Default. Subject to the Beneficial Ownership Limitation as set forth in Section 4(d), if any Event of Default occurs, then the outstanding principal amount of this Note, plus accrued but unpaid interest, liquidated damages and other amounts owing in respect thereof through the date of acceleration, shall become, at the Holder’s election, immediately due and payable in cash at the Mandatory Default Amount.  After the occurrence of any Event of Default that results in the eventual acceleration of this Note, the interest rate on this Note shall accrue at an additional interest rate equal to the lesser of 1.5% per month (18% per annum) or the maximum rate permitted under applicable law.  Upon the payment in full of the Note, the Holder shall promptly surrender this Note to or as directed by the Company. In connection with such acceleration described herein, the Holder need not provide, and the Company hereby waives, any presentment, demand, protest or other notice of any kind, and the Holder may immediately and without expiration of any grace period enforce any and all of its rights and remedies hereunder and all other remedies available to it under applicable law. Such acceleration may be rescinded and annulled by Holder at any time prior to payment hereunder and the Holder shall have all rights as a holder of the Note until such time, if any, as the Holder receives full payment pursuant to this Section 6(b). No such rescission or annulment shall affect any subsequent Event of Default or impair any right consequent thereon.

7.           Assignment.         This note may be assigned at the sole option of the Holder without consent from the Company.

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8.           Miscellaneous.

(a)         Notices. Any and all notices or other communications or deliveries to be provided by the Holder hereunder, including, without limitation, any Notice of Conversion, shall be in writing and delivered personally, by facsimile, by email, or sent by a nationally recognized overnight courier service, addressed to the Company, at the address set forth above, or such other facsimile number, email or other address as the Company may specify for such purposes by notice to the Holder delivered in accordance with this Section 7(a). Any and all notices or other communications or deliveries to be provided by the Company hereunder shall be in writing and delivered personally, by facsimile, by email or sent by a nationally recognized overnight courier service addressed to each Holder at the facsimile number, email or other address of the Holder appearing on the books of the Company, or if no such facsimile number, email or other address appears on the books of the Company, at the principal place of business of such Holder, as set forth in the Purchase Agreement. Any notice or other communication or deliveries hereunder shall be deemed given and effective on the earliest of (i) the date of transmission, if such notice or communication is delivered via facsimile or via email at the facsimile number or email set forth on the signature pages attached hereto prior to 12:00 p.m. (New York City time) on any date, (ii) the next Trading Day after the date of transmission, if such notice or communication is delivered via facsimile or via email at the facsimile number or email set forth on the signature pages attached hereto on a day that is not a Trading Day or later than 12:00 p.m. (New York City time) on any Trading Day, (iii) the second Trading Day following the date of mailing, if sent by U.S. nationally recognized overnight courier service or (iv) upon actual receipt by the party to whom such notice is required to be given.

(b)         Absolute Obligation. Except as expressly provided herein, no provision of this Note shall alter or impair the obligation of the Company, which is absolute and unconditional, to pay the principal of, liquidated damages and accrued interest, as applicable, on this Note at the time, place, and rate, and in the coin or currency, herein prescribed. This Note is a direct debt obligation of the Company.

(c)         Lost or Mutilated Note. If this Note shall be mutilated, lost, stolen or destroyed, the Company shall execute and deliver, in exchange and substitution for and upon cancellation of a mutilated Note, or in lieu of or in substitution for a lost, stolen or destroyed Note, a new Note for the principal amount of this Note so mutilated, lost, stolen or destroyed, but only upon receipt of evidence of such loss, theft or destruction of such Note, and of the ownership hereof, reasonably satisfactory to the Company.

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(d)         Governing Law. All questions concerning the construction, validity, enforcement and interpretation of this Note shall be governed by and construed and enforced in accordance with the internal laws of the State of New York, without regard to the principles of conflict of laws thereof. Each party agrees that all legal proceedings concerning the interpretation, enforcement and defense of the transactions contemplated by any of the Transaction Documents (whether brought against a party hereto or its respective Affiliates, directors, officers, shareholders, employees or agents) shall be commenced in the state and federal courts sitting in New York County, State of New York (the “New York Courts”). Each party hereto hereby irrevocably submits to the exclusive jurisdiction of the New York Courts for the adjudication of any dispute hereunder or in connection herewith or with any transaction contemplated hereby or discussed herein (including with respect to the enforcement of any of the Transaction Documents), and hereby irrevocably waives, and agrees not to assert in any suit, action or proceeding, any claim that it is not personally subject to the jurisdiction of such New York Courts, or such New York Courts are improper or inconvenient venue for such proceeding. Each party hereby irrevocably waives personal service of process and consents to process being served in any such suit, action or proceeding by mailing a copy thereof via registered or certified mail or overnight delivery (with evidence of delivery) to such party at the address in effect for notices to it under this Note and agrees that such service shall constitute good and sufficient service of process and notice thereof. Nothing contained herein shall be deemed to limit in any way any right to serve process in any other manner permitted by applicable law. Each party hereto hereby irrevocably waives, to the fullest extent permitted by applicable law, any and all right to trial by jury in any legal proceeding arising out of or relating to this Note or the transactions contemplated hereby. If any party shall commence an action or proceeding to enforce any provisions of this Note, then the prevailing party in such action or proceeding shall be reimbursed by the other party for its attorney’s fees and other costs and expenses incurred in the investigation, preparation and prosecution of such action or proceeding.

(e)         Waiver. Any waiver by the Company or the Holder of a breach of any provision of this Note shall not operate as or be construed to be a waiver of any other breach of such provision or of any breach of any other provision of this Note. The failure of the Company or the Holder to insist upon strict adherence to any term of this Note on one or more occasions shall not be considered a waiver or deprive that party of the right thereafter to insist upon strict adherence to that term or any other term of this Note on any other occasion. Any waiver by the Company or the Holder must be in writing.

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(f)         Severability. If any provision of this Note is invalid, illegal or unenforceable, the balance of this Note shall remain in effect, and if any provision is inapplicable to any Person or circumstance, it shall nevertheless remain applicable to all other Persons and circumstances. If it shall be found that any interest or other amount deemed interest due hereunder violates the applicable law governing usury, the applicable rate of interest due hereunder shall automatically be lowered to equal the maximum rate of interest permitted under applicable law. The Company covenants (to the extent that it may lawfully do so) that it shall not at any time insist upon, plead, or in any manner whatsoever claim or take the benefit or advantage of, any stay, extension or usury law or other law which would prohibit or forgive the Company from paying all or any portion of the principal of or interest on this Note as contemplated herein, wherever enacted, now or at any time hereafter in force, or which may affect the covenants or the performance of this Note, and the Company (to the extent it may lawfully do so) hereby expressly waives all benefits or advantage of any such law, and covenants that it will not, by resort to any such law, hinder, delay or impede the execution of any power herein granted to the Holder, but will suffer and permit the execution of every such as though no such law has been enacted.

(g)         Remedies, Characterizations, Other Obligations, Breaches and Injunctive Relief. The remedies provided in this Note shall be cumulative and in addition to all other remedies available under this Note and any of the other Transaction Documents at law or in equity (including a decree of specific performance and/or other injunctive relief), and nothing herein shall limit the Holder’s right to pursue actual and consequential damages for any failure by the Company to comply with the terms of this Note. The Company covenants to the Holder that there shall be no characterization concerning this instrument other than as expressly provided herein. Amounts set forth or provided for herein with respect to payments, conversion and the like (and the computation thereof) shall be the amounts to be received by the Holder and shall not, except as expressly provided herein, be subject to any other obligation of the Company (or the performance thereof). The Company acknowledges that a breach by it of its obligations hereunder will cause irreparable harm to the Holder and that the remedy at law for any such breach may be inadequate. The Company therefore agrees that, in the event of any such breach or threatened breach, the Holder shall be entitled, in addition to all other available remedies, to an injunction restraining any such breach or any such threatened breach, without the necessity of showing economic loss and without any bond or other security being required. The Company shall provide all information and documentation to the Holder that is requested by the Holder to enable the Holder to confirm the Company’s compliance with the terms and conditions of this Note.

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(h)         Next Business Day. Whenever any payment or other obligation hereunder shall be due on a day other than a Business Day, such payment shall be made on the next succeeding Business Day.

(i)         Headings. The headings contained herein are for convenience only, do not constitute a part of this Note and shall not be deemed to limit or affect any of the provisions hereof.

*********************

(Signature Pages Follow)

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IN WITNESS WHEREOF, the Company has caused this Note to be duly executed by a duly authorized officer as of the date first above indicated.

[__________________________________]

By:_____________________________

Name: Jed A Latkin

Title: CEO

Email address for delivery of Notices:

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ANNEX A

NOTICE OF CONVERSION

The undersigned hereby elects to convert principal and interest under the Senior Promissory Note of [____________________]. (the “Company”), into shares of its common stock (the “Common Stock”), according to the conditions hereof, as of the date written below. If shares of Common Stock are to be issued in the name of a person other than the undersigned, the undersigned will pay all transfer taxes payable with respect thereto and is delivering herewith such certificates and opinions as reasonably requested by the Company in accordance therewith. No fee will be charged to the holder for any conversion, except for such transfer taxes, if any.

By the delivery of this Notice of Conversion the undersigned represents and warrants to the Company that its ownership of the Common Stock does not exceed the amounts specified under Section 4 of this Note, as determined in accordance with Section 13(d) of the Exchange Act.

The undersigned agrees to comply with the prospectus delivery requirements under the applicable securities laws in connection with any transfer of the aforesaid shares of Common Stock.

Conversion calculations:

Date to Effect Conversion:______________________________________

Principal Amount of Note to be Converted:________________________

Conversion Price:

Number of shares of Common Stock to be issued:___________________

__________________________

Signature

__________________________

Name

Delivery Instructions:

__________________________

__________________________

__________________________

__________________________

__________________________

ex_857258.htm

Exhibit 31.1

CERTIFICATION

I, Jed Latkin, certify that:

1. I have reviewed this Quarterly Report on Form 10-Q of Windtree Therapeutics, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
--- ---
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
--- ---
4. The registrant’s other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
--- ---
(a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
--- ---
(b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
--- ---
(c) evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
--- ---
(d) disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
--- ---
5. The registrant’s other certifying officers and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent function):
--- ---
(a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
--- ---
(b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
--- ---

Date: November 14, 2025

/s/ Jed Latkin
Jed Latkin
President and Chief Executive Officer
(Principal Executive Officer, Principal Financial Officer and Principal Accounting Officer )

ex_857259.htm

Exhibit 32.1

Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

(Subsections (a) and (b) of Section 1350, Chapter 63 of Title 18, United States Code)

In connection with the Quarterly Report of Windtree Therapeutics, Inc. (the “Company”) on Form 10-Q for the quarter ended September 30, 2025, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), each of the undersigned officers of the Company certifies, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to such officer’s knowledge:

(1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
--- ---

Date: November 14, 2025

/s/ Jed Latkin
Jed Latkin
President and Chief Executive Officer
(Principal Executive Officer, Principal Financial Officer and Principal Accounting Officer)

A signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request. This certification “accompanies” the Form 10-Q to which it relates, is not deemed filed with the SEC and is not to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Form 10-Q), irrespective of any general incorporation language contained in such filing.

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