Windtree is executing its corporate strategy to diversify its business with revenue and profit generating divisions CommLoan, Inc. is a tech company focused on transforming the way middle market loans are originated CommLoan has streamlined the process of obtaining commercial real estate financing WARRINGTON, Pa., Dec. 03, 2025 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or “the Company”) (OTCID: WINT), a diversified company with several divisions and focused on becoming a revenue generatin ...

Financial Performance - The company reported a net loss of $28.1 million and $42.8 million for the three and nine months ended September 30, 2025, compared to a net loss of $2.7 million and $4.6 million for the same periods in 2024, resulting in an accumulated deficit of $889.4 million as of September 30, 2025[207]. - The net loss for the three months ended September 30, 2025, was $28,085,000, an increase of $25,336,000 (approximately 922.5%) compared to a net loss of $2,749,000 in 2024[237]. - For the three and nine months ended September 30, 2025, the net loss was $28.1 million and $42.3 million, respectively, compared to $2.7 million and $4.6 million for the same periods in 2024, indicating a significant increase in losses[261]. - As of September 30, 2025, the company had cash and cash equivalents of $0.2 million and current liabilities of $21.9 million, raising substantial doubt about its ability to continue as a going concern[263]. - The accumulated deficit as of September 30, 2025, was $889.4 million, reflecting ongoing financial challenges[261]. - Cash used in operating activities was $11.4 million, a slight decrease from $11.7 million in the same period of 2024[266]. - Net cash provided by financing activities for the nine months ended September 30, 2025, was $15.8 million, primarily from private placement notes and the ELOC Purchase Agreement[268]. - The company recognized an income tax benefit of $3.4 million for the three and nine months ended September 30, 2025, due to the reversal of deferred taxes related to an intangible asset impairment charge of $16.0 million[258]. - During the nine months ended September 30, 2025, the company sold 21.9 million shares of common stock under the ELOC Purchase Agreement for gross proceeds of $15.8 million[273]. - Cash used in investing activities for the nine months ended September 30, 2025, was $5.972 million, primarily due to senior note receivable issuance and a deposit on property[267]. Research and Development - Istaroxime, the lead product candidate, demonstrated significant improvement in systolic blood pressure (SBP) and cardiac function in Phase 2 clinical trials, leading to the initiation of a global Phase 2 study for early cardiogenic shock[201]. - The SEISMiC Extension study showed positive topline results, with significant improvements in SBP and cardiac function in patients with SCAI Stage B cardiogenic shock, supporting the dosing regimen optimization[213]. - The company plans to pursue further development of istaroxime in less severe acute decompensated heart failure, with a global Phase 3 study planned in collaboration with Lee's Pharmaceutical (HK) Ltd.[201]. - Istaroxime is being advanced as the lead indication for cardiogenic shock, with plans to potentially enter Phase 3 for acute decompensated heart failure in the normal to low SBP population[214]. - Research and development expenses for the three months ended September 30, 2025, were $1,897,000, a decrease of $71,000 (approximately 3.6%) compared to $1,968,000 in 2024[239]. - Research and development expenses related to the istaroxime – cardiogenic shock program are expected to continue increasing as the SEISMiC C study progresses[238]. - Total direct clinical and preclinical program expenses decreased by $0.2 million for the nine months ended September 30, 2025, compared to the same period in 2024[241]. - Product development and manufacturing expenses increased by $0.1 million for the nine months ended September 30, 2025, due to increased quality assurance costs[245]. - Clinical, medical, and regulatory operations expenses decreased by $0.1 million for the three and nine months ended September 30, 2025, compared to the same period in 2024[247]. Corporate Strategy and Partnerships - The company launched a new corporate strategy in January 2025 to become a revenue-generating biotech company through acquisitions of small companies with FDA-approved products[204]. - The company is actively seeking partnerships to support the advancement and commercialization of its biotechnology pipeline, which may lower or eliminate development costs[211]. - The company intends to secure additional capital through partnerships, public or private securities offerings, and strategic opportunities to advance its development programs[209]. - The company is seeking partnership opportunities to fund its clinical trial in acute decompensated heart failure due to insufficient capital[214]. - The company is actively exploring licensing transactions and strategic partnerships for its product candidates, including rostafuroxin[216]. - The cardiovascular portfolio includes next-generation SERCA2a activators and rostafuroxin, with plans to pursue licensing arrangements for further development[202]. - An Asset Purchase Agreement was entered into with Varian Biopharmaceuticals, Inc. in April 2024, acquiring assets related to a novel aPKCi inhibitor for potential oncology applications[206]. - The company became the manufacturing sourcing agent for Evofem's FDA-approved product Phexxi® in March 2025 and signed a manufacturing deal with Zhoake (Hong Kong) Ophthalmology Pharmaceutical Limited in June 2025[198]. Regulatory and Compliance - The company received a deficiency letter from Nasdaq for not meeting the minimum bid price requirement of $1.00 per share, leading to a delisting notification[222]. - The number of authorized shares was increased from 125 million to 1 billion, consisting of 995 million common shares and 5 million preferred shares[224]. - The European Patent Office granted Patent No. 3599243 for dual mechanism SERCA2a Activator candidates, providing protection until July 2038[215]. Operational Challenges - The company is monitoring global economic conditions and potential impacts on operations related to international trade policies and supply chain dynamics[236]. - The company recorded losses on impairment of long-lived intangible assets of $16.1 million during Q3 2025 due to declining share prices and strategic decisions[231]. - As of September 30, 2025, the identifiable intangible assets totaled $8 million, down from $24.13 million as of December 31, 2024[232]. - Total operating expenses for the three months ended September 30, 2025, were $19,882,000, an increase of $15,141,000 (approximately 318.5%) compared to $4,741,000 in 2024[237]. - The company incurred a loss on debt issuance of $14,965,000 related to the $10,000,000 July 2025 ELOC commitment note[250]. - The total other income (expense), net, for the three months ended September 30, 2025, was $(11,634,000), a decrease of $13,386,000 compared to $1,752,000 in 2024[250].

Core Insights - Windtree Therapeutics has entered a global license agreement for acute pulmonary treatments that could yield up to $78.9 million in milestone payments and low double-digit royalties [1][3] - The licensed treatments include SURFAXIN, lyophilized lucinactant, and AEROSURF, aimed at treating respiratory distress syndrome (RDS) in premature infants [1][4] - The licensing partner is responsible for all development and commercialization costs, allowing Windtree to focus on its corporate strategy without dilution [3] Company Overview - Windtree Therapeutics is a diversified company with multiple divisions, focused on becoming a revenue-generating entity with future profitability [3] - The company is actively involved in the development of innovative treatments for RDS, a serious condition affecting premature infants [3][2] Treatment Details - Lyophilized lucinactant is an investigational synthetic peptide designed to manage RDS in premature infants who may lack fully developed natural lung surfactant [4] - AEROSURF is a drug/device combination that delivers aerosolized KL4 surfactant noninvasively, potentially reducing the need for invasive procedures [4] - SURFAXIN, a synthetic drug previously approved by the FDA, was designed to prevent RDS but is no longer available in the U.S. [5]

Core Insights - Windtree Therapeutics has strengthened its cardiovascular patent estate with recent notifications of allowed patents for Istaroxime in Canada and Mexico, and a granted patent for pure SERCA2a activators in Israel [1][2][5] Patent Developments - The company now holds a total of 59 issued or allowed patents and 17 pending patents related to Istaroxime and its SERCA2a activators [1][2] - The cardiovascular patent estate includes patents for Istaroxime, dual mechanism SERCA2a activators, and pure SERCA2a activators aimed at treating heart failure, preventing arrhythmias, and addressing cardiogenic shock [2] Market Context - Heart failure affects approximately 60 million people globally, with around 20 million annual hospital admissions due to acute heart failure, including 1.5 million in the US [3] - Current treatment options for acute heart failure are limited and can lead to side effects such as arrhythmias and renal function issues [4] Product Profile - Istaroxime is a first-in-class dual-mechanism therapy designed to enhance both systolic and diastolic cardiac function, showing significant improvement in cardiac function and blood pressure without increasing heart rate or causing significant cardiac rhythm disturbances [7] - The pure SERCA2a activators are being evaluated in preclinical studies, including both oral and intravenous formulations for heart failure [8]

Core Points - Windtree Therapeutics, Inc. has signed a letter of intent with Titan Environmental Services, Inc. (TESI) for a combination of cash and securities, amounting to $7.5 million [2][4] - The agreement allows both companies to part ways regarding the potential acquisition of Titan Environmental Services, which operates in the waste management sector in Michigan [3][4] - Windtree is shifting focus to other opportunities as part of its strategy to become a revenue-generating company, with several other letters of intent in progress [4][5] Company Overview - Windtree Therapeutics, Inc. is a diversified company with multiple divisions, aiming for future profitability and revenue generation [5]

Core Insights - Windtree Therapeutics, Inc. has signed a letter of intent with TESI for a combination of cash and securities, amounting to $7.5 million, to be paid to Windtree [1][3] - The companies were previously engaged in a potential acquisition of Titan Environmental Services, Inc., but have mutually decided to part ways [2] Company Strategy - Windtree is focusing on becoming a revenue-generating company and is exploring other opportunities, with several companies close to signing letters of intent [3][4]

Core Insights - Windtree Therapeutics, Inc. has received stockholder approval for all ten proposals aimed at enhancing revenue generation, particularly in environmental services [1][2] - The company will not pursue its cryptocurrency treasury strategy and will instead focus on environmental services and biotech asset partnerships [5][6] - Windtree plans to increase its authorized shares from 125 million to 1 billion to provide financial flexibility for future growth [3] Environmental Services Focus - The approved proposals include plans for a transaction related to environmental services, which is expected to generate revenue and allow for the acquisition of additional companies in this sector [2] - The corporate strategy aims for profitability in the Windtree Environmental Services division upon completion of future acquisitions [2] Biotech Asset Development - The company is seeking partnerships for its cardiovascular and oncology biotech assets to continue their development and potentially eliminate R&D expenses, which were $8.8 million in 2024 [4][6] - The focus on core business areas is believed to be beneficial for stockholders [5][6] Financial Strategy - The increase in authorized shares is intended to provide the company with greater flexibility in utilizing equity as a financial instrument [3] - The company is committed to a forward-looking plan to generate revenue and future profit from its assets [6]

[PART I - FINANCIAL INFORMATION](index=2&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) This section provides the unaudited condensed consolidated financial statements and management's analysis for the specified reporting periods [Item 1. Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements and related notes for the periods ended June 30, 2025, and December 31, 2024 [Condensed Consolidated Balance Sheets](index=6&type=section&id=CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) This section provides a snapshot of the company's financial position at specific dates, detailing assets, liabilities, and equity | (in thousands) | June 30, 2025 (Unaudited) | December 31, 2024 | | :--- | :--- | :--- | | **ASSETS** | | | | Cash and cash equivalents | $301 | $1,779 | | Total current assets | $6,785 | $2,574 | | Total assets | $31,826 | $27,875 | | **LIABILITIES, MEZZANINE EQUITY & STOCKHOLDERS' EQUITY** | | | | Total current liabilities | $15,721 | $5,717 | | Total liabilities | $24,977 | $14,698 | | Total mezzanine equity | $3,243 | $3,181 | | Total stockholders' equity | $3,606 | $9,996 | | Total liabilities, mezzanine equity & stockholders' equity | $31,826 | $27,875 | - Cash and cash equivalents decreased significantly from **$1,779 thousand** at December 31, 2024, to **$301 thousand** at June 30, 2025[19](index=19&type=chunk) - Total current liabilities increased substantially from **$5,717 thousand** at December 31, 2024, to **$15,721 thousand** at June 30, 2025, primarily due to convertible notes payable[19](index=19&type=chunk) [Condensed Consolidated Statements of Operations](index=7&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS) This section details the company's revenues, expenses, and net loss over specific reporting periods | (in thousands, except share and per share data) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $2,182 | $9,863 | $4,452 | $12,116 | | General and administrative | $1,802 | $1,589 | $3,622 | $3,741 | | Total operating expenses | $3,984 | $11,452 | $8,074 | $15,857 | | Operating loss | $(3,984) | $(11,452) | $(8,074) | $(15,857) | | Loss on debt issuances | $(7,313) | $- | $(7,437) | $- | | Gain on debt extinguishment, net | $74 | $- | $52 | $14,520 | | Net loss | $(10,631) | $(12,024) | $(14,676) | $(1,805) | | Net loss attributable to common stockholders | $(14,918) | $(12,024) | $(19,961) | $(1,805) | | Net loss per share attributable to common stockholders (Basic and diluted) | $(3.06) | $(1,045.84) | $(6.67) | $(173.62) | | Weighted average number of common shares outstanding (Basic and diluted) | 4,877,257 | 11,497 | 2,993,377 | 10,396 | - Net loss for the three months ended June 30, 2025, was **$(10,631) thousand**, an improvement from **$(12,024) thousand** in the same period of 2024[20](index=20&type=chunk) - For the six months ended June 30, 2025, net loss significantly increased to **$(14,676) thousand** from **$(1,805) thousand** in 2024, primarily due to a large loss on debt issuances in 2025 and a substantial gain on debt extinguishment in 2024[20](index=20&type=chunk) - Research and development expenses decreased significantly for both the three-month and six-month periods ended June 30, 2025, compared to 2024, largely due to non-cash charges related to acquired IPR&D in 2024[20](index=20&type=chunk) [Condensed Consolidated Statements of Changes in Mezzanine Equity and Stockholders' Equity](index=8&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20CHANGES%20IN%20MEZZANINE%20EQUITY%20AND%20STOCKHOLDERS%27%20EQUITY) This section outlines changes in the company's mezzanine equity and stockholders' equity over the reporting periods - Total stockholders' equity decreased from **$9,996 thousand** at December 31, 2024, to **$3,606 thousand** at June 30, 2025, primarily due to net losses and deemed dividends on preferred stock[19](index=19&type=chunk)[22](index=22&type=chunk) - Series C preferred stock conversions resulted in a decrease of **$2,815 thousand** in mezzanine equity for the six months ended June 30, 2025, and an increase of **$2,863 thousand** in stockholders' equity[22](index=22&type=chunk) - The company issued Series D preferred stock for **$2,813 thousand** (net of issuance costs) during the six months ended June 30, 2025[22](index=22&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=11&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20CASH%20FLOWS) This section reports the cash inflows and outflows from operating, investing, and financing activities | (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(5,064) | $(5,273) | | Net cash used in investing activities | $(5,183) | $(12) | | Net cash provided by financing activities | $8,770 | $2,628 | | Net decrease in cash, cash equivalents, and restricted cash | $(1,477) | $(2,657) | | Cash, cash equivalents, and restricted cash - end of period | $311 | $1,812 | - Net cash used in operating activities slightly decreased to **$5,064 thousand** for the six months ended June 30, 2025, from **$5,273 thousand** in the prior year[23](index=23&type=chunk) - Net cash used in investing activities significantly increased to **$5,183 thousand** in 2025, primarily due to the issuance of a senior note and a deposit, compared to **$12 thousand** in 2024[23](index=23&type=chunk) - Net cash provided by financing activities increased substantially to **$8,770 thousand** in 2025, driven by proceeds from convertible notes, preferred stock, and ELOC, compared to **$2,628 thousand** in 2024[23](index=23&type=chunk) [Notes to Condensed Consolidated Financial Statements (unaudited)](index=13&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements%20(unaudited)) This section provides detailed explanations of the accounting policies, financial instruments, and significant transactions underlying the financial statements [Note 1 – The Company and Description of Business](index=13&type=section&id=Note%201%20%E2%80%93%20The%20Company%20and%20Description%20of%20Business) This note describes the company's business, strategic initiatives, and key therapeutic programs - Windtree Therapeutics is a biotechnology company focused on innovative therapies for critical conditions, with a portfolio including istaroxime (Phase 2 for acute heart failure/cardiogenic shock), preclinical SERCA2a activators, rostafuroxin for hypertension, and a preclinical aPKCi inhibitor for oncology[25](index=25&type=chunk) - In January 2025, the company launched a new corporate strategy to become revenue-generating through acquisitions of small companies with FDA-approved products, while continuing its development pipeline[26](index=26&type=chunk) - On July 16, 2025, Windtree announced a crypto treasury strategy utilizing the BNB chain's native token, including a **$60 million** securities purchase agreement with potential for up to **$200 million** in total subscriptions[27](index=27&type=chunk) - The SEISMiC C clinical trial for istaroxime in severe cardiogenic shock (SCAI Stage C) was terminated due to resource limitations, with plans to pursue development in acute decompensated heart failure with licensing partner Lee's Pharmaceutical (HK) Ltd for a global Phase 3 study[28](index=28&type=chunk) [Note 2 – Basis of Presentation](index=14&type=section&id=Note%202%20%E2%80%93%20Basis%20of%20Presentation) This note explains the accounting principles and presentation methods used for the financial statements - The interim unaudited condensed consolidated financial statements are prepared in accordance with U.S. GAAP for interim financial information and include Windtree Therapeutics, Inc. and its wholly-owned subsidiaries[33](index=33&type=chunk)[41](index=41&type=chunk) - All share and per share information has been retroactively restated to reflect **1-for-18** reverse stock split effective April 19, 2024, and a **1-for-50** reverse stock split effective February 20, 2025[34](index=34&type=chunk) [Note 3 – Going Concern and Management's Plans](index=14&type=section&id=Note%203%20%E2%80%93%20Going%20Concern%20and%20Management%27s%20Plans) This note addresses the company's ability to continue operations and outlines management's plans to secure future funding - As of June 30, 2025, the company had cash and cash equivalents of **$0.3 million** and current liabilities of **$15.7 million**, with an accumulated deficit of **$861.3 million**[38](index=38&type=chunk) - The company believes it has sufficient resources to fund operations through December 2025 but lacks sufficient cash for the **12 months** following the financial statement issuance date, raising substantial doubt about its ability to continue as a going concern[38](index=38&type=chunk)[39](index=39&type=chunk) - Management plans to secure additional capital through public/private securities offerings, convertible debt financings, and/or strategic transactions, though none are committed[39](index=39&type=chunk) [Note 4 – Summary of Significant Accounting Policies](index=15&type=section&id=Note%204%20%E2%80%93%20Summary%20of%20Significant%20Accounting%20Policies) This note details the critical accounting policies, including those for intangible assets and new accounting pronouncements Identifiable Intangible Assets (in thousands) | (in thousands) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Istaroxime drug candidate | $22,340 | $22,340 | | Rostafuroxin drug candidate | $1,790 | $1,790 | | Intangible assets | $24,130 | $24,130 | - Acquired intangible assets, primarily IPR&D for istaroxime and rostafuroxin, are considered indefinite-lived and reviewed for impairment annually; no impairment was indicated as of June 30, 2025[42](index=42&type=chunk) - The company adopted ASU 2023-09 (Improvements to Income Tax Disclosures) on January 1, 2025, which will expand disclosures but is not expected to impact financial results[59](index=59&type=chunk) - ASU 2024-03 (Disaggregation of Income Statement Expenses) was issued in November 2024, effective for fiscal years beginning after December 15, 2026, and the company is evaluating its impact[60](index=60&type=chunk) [Note 5 – Fair Value Measurements](index=18&type=section&id=Note%205%20%E2%80%93%20Fair%20Value%20Measurements) This note provides information on the fair value of assets and liabilities, categorized by valuation input levels Fair Value of Assets and Liabilities (June 30, 2025) | (in thousands) | Fair Value June 30, 2025 | Level 1 | Level 2 | Level 3 | | :--- | :--- | :--- | :--- | :--- | | **Assets:** | | | | | | Money market funds | $57 | $57 | $- | $- | | **Liabilities:** | | | | | | Convertible notes payable | $(7,781) | $- | $- | $(7,781) | | Common stock warrant liability | $(52) | $- | $- | $(52) | | Total Liabilities | $(7,833) | $- | $- | $(7,833) | Change in Fair Value of Convertible Notes Payable (Six Months Ended June 30, 2025) | | Six Months Ended June 30, 2025 | | :--- | :--- | | Issuance of convertible notes payable | $8,566 | | Change in fair value | $(785) | | Balance at June 30, 2025 | $7,781 | Change in Fair Value of Common Stock Warrant Liability (Six Months Ended June 30, 2025) | | Six Months Ended June 30, 2025 | | :--- | :--- | | Balance at December 31, 2024 | $305 | | Change in fair value | $(242) | | Settlement of common stock warrant liability | $(20) | | Deemed dividend | $9 | | Balance at June 30, 2025 | $52 | [Note 6 - Note Receivable, Net](index=22&type=section&id=Note%206%20-%20Note%20Receivable%2C%20Net) This note details the senior note issued to Standard Waste Services, LLC, including its principal and fair value - On June 5, 2025, the company issued a senior note to Standard Waste Services, LLC, with a principal amount of **$6.6 million** and an original issue discount (OID) of **$2.0 million**, recorded at a fair value of **$4.6 million**[69](index=69&type=chunk)[70](index=70&type=chunk) - As of June 30, 2025, **$3.8 million** of the note had been funded, with the remaining **$0.8 million** funded in July and August 2025[70](index=70&type=chunk) [Note 7 - Deposit](index=22&type=section&id=Note%207%20-%20Deposit) This note describes the earnest money deposit for a property purchase and the ongoing dispute - WINT Real Estate, LLC advanced **$1.4 million** as earnest money for a property purchase, which is currently under dispute after the seller issued a notice of termination demanding the funds[73](index=73&type=chunk) [Note 8 - Convertible Notes Payable](index=23&type=section&id=Note%208%20-%20Convertible%20Notes%20Payable) This note details the issuance and terms of convertible promissory notes and warrants, including interest rates and conversion prices - In June 2025, the company issued convertible promissory notes and warrants, receiving net proceeds of **$3.1 million** from the First June 2025 Note Financing and **$1.1 million** from Additional June 2025 Note Financing[74](index=74&type=chunk)[75](index=75&type=chunk) - The convertible notes accrue interest at **14%** per annum (increasing to **24%** upon default) and have an initial conversion price of **$0.587**, adjusted to **$0.30** in July 2025 due to a Series C preferred stock inducement[78](index=78&type=chunk)[80](index=80&type=chunk)[81](index=81&type=chunk) - The fair value of the June 2025 Notes was **$8.6 million** at issuance and **$7.8 million** as of June 30, 2025, resulting in a **$0.8 million** fair value adjustment and a **$7.3 million** loss on debt issuance[82](index=82&type=chunk) [Note 9 – ELOC Commitment Note Payable](index=24&type=section&id=Note%209%20%E2%80%93%20ELOC%20Commitment%20Note%20Payable) This note describes the convertible promissory note issued for an equity line of credit and its fair value accounting - In June 2024, the company issued a **$350,000** convertible promissory note (ELOC Commitment Note) as consideration for an equity line of credit, with an estimated fair value of **$0.6 million** at issuance[83](index=83&type=chunk)[84](index=84&type=chunk) - The conversion option was bifurcated as a derivative liability (**$0.3 million**), and upon conversion in Q1 2025, a **$0.2 million** change in fair value was recorded as other income, and a **$22,000** loss on debt extinguishment was recognized[84](index=84&type=chunk)[85](index=85&type=chunk) [Note 10 - Senior Secured Notes Payable](index=25&type=section&id=Note%2010%20-%20Senior%20Secured%20Notes%20Payable) This note details the issuance and retirement of senior secured notes, including interest and original issue discount - In March and April 2025, the company issued senior secured notes with an aggregate principal of **$312,500** each, bearing **10%** interest and a **20%** OID[86](index=86&type=chunk)[87](index=87&type=chunk) - On May 2, 2025, these notes were retired at a discount with one-time payments of **$300,000** each, resulting in a **$74,000** gain on debt extinguishment for the March notes and a **$50,000** loss on debt issuance for the April notes[88](index=88&type=chunk)[89](index=89&type=chunk) [Note 11 – Common Stock Warrant Liability](index=25&type=section&id=Note%2011%20%E2%80%93%20Common%20Stock%20Warrant%20Liability) This note explains the classification and fair value measurement of common stock warrant liabilities - July 2024 Warrants are classified as a liability due to a contingent cash settlement feature (Change of Control Put) and are measured at fair value through profit or loss[90](index=90&type=chunk) - The warrants had an initial fair value of **$10.8 million**, remeasured to **$0.3 million** as of December 31, 2024[91](index=91&type=chunk) - For the three and six months ended June 30, 2025, the change in fair value was **$0.1 million** and **$0.2 million**, respectively[91](index=91&type=chunk) [Note 12 – Loans Payable](index=26&type=section&id=Note%2012%20%E2%80%93%20Loans%20Payable) This note describes the insurance premium financing agreement and its repayment - An insurance premium financing agreement for **$0.5 million** at **7.94%** interest, entered in August 2024, was fully repaid during the second quarter of 2025[92](index=92&type=chunk) [Note 13 - Other Current Liabilities](index=26&type=section&id=Note%2013%20-%20Other%20Current%20Liabilities) This note details other current liabilities, including amounts owed under license agreements and accrued interest - The company owes **$200,000** to PMUSA and **$125,000** to PMPSA under license agreements, with accrued interest totaling approximately **$100,000** at a **36%** per annum rate[93](index=93&type=chunk) [Note 14 – Restructured Debt Liability](index=26&type=section&id=Note%2014%20%E2%80%93%20Restructured%20Debt%20Liability) This note describes the termination of contingent milestone payments and the resulting gain on debt extinguishment - In January 2024, the company terminated Deerfield's rights to receive **$15.0 million** in contingent milestone payments in exchange for **$0.2 million** cash and **676** shares of common stock[95](index=95&type=chunk)[96](index=96&type=chunk) - This transaction resulted in a **$14.5 million** non-cash gain on debt extinguishment during the three months ended March 31, 2024[98](index=98&type=chunk) [Note 15 – Mezzanine Equity and Stockholders' Equity](index=27&type=section&id=Note%2015%20%E2%80%93%20Mezzanine%20Equity%20and%20Stockholders%27%20Equity) This note details transactions affecting mezzanine equity and stockholders' equity, including preferred stock issuances and conversions - In April and May 2025, the company completed a private placement of **3,688** shares of Series D Convertible Preferred Stock for aggregate gross proceeds of approximately **$2.95 million**[99](index=99&type=chunk)[100](index=100&type=chunk) - Series D Preferred Stock has a stated value of **$1,000** per share, accrues dividends at **10.0%** per annum (**18.0%** upon Triggering Event), and its conversion price was adjusted to **$0.30** in July 2025[102](index=102&type=chunk)[103](index=103&type=chunk)[104](index=104&type=chunk)[105](index=105&type=chunk) - Inducement offers in January and May 2025 reduced the Series C Preferred Stock conversion price, leading to conversions of **1,895** and **1,972** shares, respectively, and resulting in deemed dividends of **$1.7 million** each[107](index=107&type=chunk)[108](index=108&type=chunk)[111](index=111&type=chunk)[112](index=112&type=chunk) - Under the ELOC Purchase Agreement, the company sold **0.8 million** shares of common stock for **$2.4 million** gross proceeds during the six months ended June 30, 2025, and is required to use **30%** of proceeds for Series C Preferred Stock dividends and redemptions[136](index=136&type=chunk) [Note 16 – Stock-Based Compensation](index=33&type=section&id=Note%2016%20%E2%80%93%20Stock-Based%20Compensation) This note presents the stock-based compensation expense recognized across different functional areas Stock-Based Compensation Expense (in thousands) | (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $12 | $31 | $35 | $82 | | General and administrative | $20 | $66 | $69 | $266 | | Total | $31 | $97 | $104 | $348 | - Total stock-based compensation expense decreased for both the three-month and six-month periods ended June 30, 2025, compared to 2024[146](index=146&type=chunk) [Note 17 – Licensing and Research Funding Agreements](index=34&type=section&id=Note%2017%20%E2%80%93%20Licensing%20and%20Research%20Funding%20Agreements) This note describes key licensing and research funding agreements, including a supply agreement and development liabilities - The company entered a License and Supply Agreement with Evofem Biosciences, Inc. in March 2025, to act as a supplier for Evofem's Phexxi® product outside the U.S. for an initial **three-year** term[147](index=147&type=chunk) - The liability balance related to the Project Financing Agreement with Lee's (HK) for AEROSURF development was **$3.8 million** as of June 30, 2025[151](index=151&type=chunk) [Note 18 – Income Taxes](index=35&type=section&id=Note%2018%20%E2%80%93%20Income%20Taxes) This note explains the company's income tax expense and the impact of operating losses and valuation allowances - No income tax expense was recorded for the three and six months ended June 30, 2025, due to incurred losses and a full valuation allowance against deferred tax assets[152](index=152&type=chunk) - Income tax expense of **$0.2 million** and **$0.3 million** was recorded for the three and six months ended June 30, 2024, respectively, primarily due to the gain on debt extinguishment[152](index=152&type=chunk) [Note 19 – Subsequent Events](index=35&type=section&id=Note%2019%20%E2%80%93%20Subsequent%20Events) This note discloses significant events occurring after the reporting period, including new financing agreements and strategic initiatives - In July 2025, the company entered into additional note purchase agreements, issuing Convertible Promissory Notes with a **14%** annual interest rate and a **$0.587** conversion price, and Note Warrants[153](index=153&type=chunk)[154](index=154&type=chunk)[155](index=155&type=chunk) - On July 16, 2025, the company launched a crypto treasury strategy with a **$60 million** securities purchase agreement for Series E Convertible Preferred Stock and warrants, payable in cash, BNB, or OBNB, with potential for up to **$200 million**[157](index=157&type=chunk)[158](index=158&type=chunk) - On July 23, 2025, a new Equity Line of Credit (ELOC) Purchase Agreement was established with Seven Knots, LLC, allowing the company to sell up to **$500 million** of common stock[164](index=164&type=chunk)[165](index=165&type=chunk) - On August 8, 2025, the SEISMiC C study was terminated after **20** enrollments due to limited resources, to focus on advancing istaroxime in the broader acute heart failure market[168](index=168&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=38&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition, operational results, and liquidity, including key developments and future outlook [OVERVIEW](index=38&type=section&id=OVERVIEW) This section provides a general overview of the company's business, strategic direction, and financial performance - Windtree Therapeutics is a biotechnology company focused on advancing innovative therapies for critical conditions, including istaroxime for acute heart failure/cardiogenic shock, preclinical SERCA2a activators, rostafuroxin for hypertension, and an aPKCi inhibitor for oncology[174](index=174&type=chunk) - In January 2025, the company initiated a new corporate strategy to generate revenue through acquisitions of small companies with FDA-approved products, while continuing its existing development pipeline[175](index=175&type=chunk) - On July 16, 2025, Windtree announced a crypto treasury strategy involving the native token of the BNB chain, with a **$60 million** securities purchase agreement and potential for up to **$200 million** in total subscriptions[176](index=176&type=chunk) - The company has incurred net losses since inception, with a net loss of **$10.6 million** for Q2 2025 and an accumulated deficit of **$861.3 million** as of June 30, 2025[181](index=181&type=chunk) [Business and Program Updates](index=40&type=section&id=Business%20and%20Program%20Updates) This section details updates on the company's therapeutic programs, clinical trials, and intellectual property - The SEISMiC C study for istaroxime in severe cardiogenic shock was terminated after **20** enrollments due to resource constraints, with the company now pursuing further development in acute decompensated heart failure with its licensing partner, Lee's Pharmaceutical (HK) Ltd., for a global Phase 3 study[186](index=186&type=chunk)[187](index=187&type=chunk) - The company's heart failure cardiovascular portfolio includes preclinical oral and intravenous SERCA2a activators, with new patents granted in Europe and the U.S. extending protection until late 2039[188](index=188&type=chunk) - Development of rostafuroxin for hypertension is on hold without a licensing arrangement or strategic partnership, with a need for an additional Phase 2 clinical trial in African American patients[189](index=189&type=chunk) - The aPKCi inhibitor platform, acquired from Varian Biopharmaceuticals, includes topical and oral formulations with potential broad use in oncology, and IND-enabling activities are underway[190](index=190&type=chunk)[191](index=191&type=chunk) [Continued Listing on The Nasdaq Capital Market](index=42&type=section&id=Continued%20Listing%20on%20The%20Nasdaq%20Capital%20Market) This section addresses the company's compliance with Nasdaq listing requirements and related risks - The company received Nasdaq deficiency letters on December 4, 2024, and June 18, 2025, for failing to meet the minimum **$1.00** bid price requirement[192](index=192&type=chunk)[193](index=193&type=chunk) - Due to a Discretionary Panel Monitor until March 20, 2026, and two reverse stock splits within two years, the company is not eligible for the standard **180-day** compliance period[194](index=194&type=chunk) - A hearing was held on July 31, 2025, to address the non-compliance, with no assurance of an extension or regaining compliance[195](index=195&type=chunk)[196](index=196&type=chunk) [CRITICAL ACCOUNTING POLICIES](index=42&type=section&id=CRITICAL%20ACCOUNTING%20POLICIES) This section describes the company's critical accounting policies, particularly for intangible assets and derivative instruments Identifiable Intangible Assets (in thousands) | (in thousands) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Istaroxime drug candidate | $22,340 | $22,340 | | Rostafuroxin drug candidate | $1,790 | $1,790 | | Intangible assets | $24,130 | $24,130 | - Acquired IPR&D assets (istaroxime and rostafuroxin) are indefinite-lived intangible assets, not amortized but reviewed for impairment annually; no impairment was indicated as of June 30, 2025[199](index=199&type=chunk) - The company reviews convertible debt and equity instruments for embedded derivative instruments, which are bifurcated and accounted for separately at fair value, with changes recognized in other income (expense)[201](index=201&type=chunk)[202](index=202&type=chunk) [RESULTS OF OPERATIONS](index=43&type=section&id=RESULTS%20OF%20OPERATIONS) This section analyzes the company's financial performance, focusing on changes in revenues and expenses over the reporting periods Comparison of Three and Six Months Ended June 30, 2025 and 2024 (in thousands) | (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Change (3M) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change (6M) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Research and development | $2,182 | $9,863 | $(7,681) | $4,452 | $12,116 | $(7,664) | | General and administrative | $1,802 | $1,589 | $213 | $3,622 | $3,741 | $(119) | | Total operating expenses | $3,984 | $11,452 | $(7,468) | $8,074 | $15,857 | $(7,783) | | Operating loss | $(3,984) | $(11,452) | $7,468 | $(8,074) | $(15,857) | $7,783 | | Loss on debt issuance | $(7,313) | $- | $(7,313) | $(7,437) | $- | $(7,437) | | Gain on debt extinguishment | $74 | $- | $74 | $52 | $14,520 | $(14,468) | | Net loss | $(10,631) | $(12,024) | $1,393 | $(14,864) | $(1,805) | $(13,059) | [Research and Development Expenses](index=44&type=section&id=Research%20and%20Development%20Expenses) This section details the changes in research and development expenses, including acquired IPR&D and program-specific costs Research and Development Expenses (in thousands) | (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Increase (Decrease) (3M) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Increase (Decrease) (6M) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Acquired IPR&D from Varian asset purchase | $- | $7,495 | $(7,495) | $- | $7,495 | $(7,495) | | Istaroxime – cardiogenic shock program | $1,551 | $1,684 | $(133) | $2,959 | $3,159 | $(200) | | Product development and manufacturing | $201 | $215 | $(14) | $517 | $439 | $78 | | Clinical, medical, and regulatory operations | $434 | $469 | $(35) | $976 | $1,023 | $(47) | | Total research and development expenses | $2,182 | $9,863 | $(7,681) | $4,452 | $12,116 | $(7,664) | - Total R&D expenses decreased by **$7.681 million** for the three months and **$7.664 million** for the six months ended June 30, 2025, compared to 2024, primarily due to the absence of non-cash charges for acquired IPR&D in 2025[208](index=208&type=chunk) - Product development and manufacturing expenses increased by **$0.1 million** for the six months ended June 30, 2025, due to higher quality assurance costs related to GMP server validation[214](index=214&type=chunk) [General and Administrative Expenses](index=46&type=section&id=General%20and%20Administrative%20Expenses) This section analyzes the fluctuations in general and administrative expenses, including professional fees and stock-based compensation - General and administrative expenses increased by **$0.2 million** for the three months ended June 30, 2025, due to higher professional fees and insurance costs related to WINT Real Estate, LLC[218](index=218&type=chunk) - For the six months ended June 30, 2025, G&A expenses decreased by **$0.1 million**, driven by reduced legal fees and lower non-cash stock-based compensation, partially offset by the increase in WINT Real Estate, LLC related costs[218](index=218&type=chunk) [Other (Expense) Income, Net](index=46&type=section&id=Other%20(Expense)%20Income%2C%20Net) This section reports non-operating income and expenses, such as loss on debt issuance and gain on debt extinguishment - The company incurred a **$7.3 million** loss on debt issuance for the three months ended June 30, 2025, and **$7.4 million** for the six months, primarily from the June 2025 Notes and Warrants[219](index=219&type=chunk) - A **$14.5 million** non-cash gain on debt extinguishment was recognized in the six months ended June 30, 2024, related to the termination of milestone payments to Deerfield[220](index=220&type=chunk) - Net loss on foreign currency translation was **$0.4 million** and **$0.5 million** for the three and six months ended June 30, 2025, respectively[224](index=224&type=chunk) [Income Tax Expense](index=46&type=section&id=Income%20Tax%20Expense) This section explains the company's income tax position, including the impact of operating losses and valuation allowances - No income tax expense was recorded for the three and six months ended June 30, 2025, due to operating losses and a full valuation allowance[225](index=225&type=chunk) - Income tax expense of **$0.2 million** and **$0.3 million** was recorded for the three and six months ended June 30, 2024, respectively, primarily due to the gain on debt extinguishment[225](index=225&type=chunk) [LIQUIDITY AND CAPITAL RESOURCES](index=47&type=section&id=LIQUIDITY%20AND%20CAPITAL%20RESOURCES) This section discusses the company's cash position, funding needs, and strategies for securing capital - As of June 30, 2025, the company had **$0.3 million** in cash and cash equivalents and **$15.7 million** in current liabilities, with an accumulated deficit of **$861.3 million**[230](index=230&type=chunk)[228](index=228&type=chunk) - The company believes it has sufficient resources to fund operations through December 2025 but not for the subsequent **12 months**, raising substantial doubt about its ability to continue as a going concern[230](index=230&type=chunk)[231](index=231&type=chunk) - Management plans to secure additional capital through various financing activities, including public/private securities offerings, convertible debt, and strategic transactions, but none are committed[231](index=231&type=chunk) [Cash Flows](index=47&type=section&id=Cash%20Flows) This section summarizes the cash flows from operating, investing, and financing activities Summary of Cash Flows (in thousands) | (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash provided by (used in): | | | | Operating activities | $(5,064) | $(5,273) | | Investing activities | $(5,183) | $(12) | | Financing activities | $8,770 | $2,628 | | Change in cash and cash equivalents | $(1,477) | $(2,657) | [Operating Activities](index=48&type=section&id=Operating%20Activities) This section analyzes the net cash used in operating activities and its primary drivers - Net cash used in operating activities decreased by **$0.2 million** to **$5.1 million** for the six months ended June 30, 2025, compared to **$5.3 million** in 2024[233](index=233&type=chunk) - The decrease was primarily due to a **$0.2 million** change in operating assets and liabilities, partially offset by a **$12.9 million** increase in net loss and a **$14.5 million** change in gain on debt extinguishment[233](index=233&type=chunk) [Investing Activities](index=48&type=section&id=Investing%20Activities) This section details the cash used in investing activities, primarily for notes receivable and deposits - Cash used in investing activities was **$5.183 million** for the six months ended June 30, 2025, primarily due to a **$3.7 million** senior note receivable issuance and a **$1.4 million** deposit on the Aubrey property[234](index=234&type=chunk) [Financing Activities](index=48&type=section&id=Financing%20Activities) This section explains the cash provided by financing activities, including proceeds from notes, preferred stock, and ELOC - Net cash provided by financing activities was **$8.8 million** for the six months ended June 30, 2025, significantly higher than **$2.6 million** in 2024[235](index=235&type=chunk)[236](index=236&type=chunk) - This was driven by **$7.0 million** from private placement notes and Series D Preferred stock, **$2.4 million** from the ELOC Purchase Agreement, **$0.5 million** from senior secured notes, and **$0.3 million** from warrant exercises[235](index=235&type=chunk) - Offsetting these were **$0.6 million** in Series C Preferred Stock redemption and cash dividend payments, and **$0.9 million** in principal payments for notes and loans[235](index=235&type=chunk) [Common Stock Purchase Agreement](index=48&type=section&id=Common%20Stock%20Purchase%20Agreement) This section describes the ELOC Purchase Agreement, common stock sales, and dividend/redemption requirements - Under the ELOC Purchase Agreement, the company sold **0.8 million** shares of common stock for **$2.4 million** gross proceeds during the six months ended June 30, 2025[239](index=239&type=chunk) - **30%** of ELOC proceeds are required to pay Series C Preferred Stock dividends and redeem Series C Preferred Stock at a **20%** premium[239](index=239&type=chunk) - Subsequent to quarter-end (through August 19, 2025), the company sold **16.8 million** shares of common stock under the ELOC for net proceeds of **$10.1 million**[240](index=240&type=chunk) [Loans Payable](index=49&type=section&id=Loans%20Payable) This section reports on the repayment of the insurance premium financing loan - The **$0.5 million** insurance premium financing loan, entered in August 2024, was fully repaid by June 30, 2025[242](index=242&type=chunk) [Supplementary Disclosure of Non-Cash Activity](index=49&type=section&id=Supplementary%20Disclosure%20of%20Non-Cash%20Activity) This section discloses significant non-cash transactions, including preferred stock conversions and deemed dividends - During the six months ended June 30, 2025, **10,781** Series C Convertible Preferred Stock shares and **$105,000** in dividends were converted into **8,054,644** common shares, reclassifying **$3.3 million** to common stock and additional paid-in capital[243](index=243&type=chunk) - The company recognized **$4.9 million** in deemed dividends on Series C preferred stock and **$0.1 million** on Series D preferred stock during the six months ended June 30, 2025[244](index=244&type=chunk)[245](index=245&type=chunk) - Non-cash activities included the fair value upon issuance of June 2025 Notes (**$8.6 million**) and June 2025 Warrants (**$2.9 million**), and the fair value upon issuance of March 2025 Notes (**$0.4 million**)[246](index=246&type=chunk)[248](index=248&type=chunk) [Off-Balance Sheet Arrangements](index=49&type=section&id=Off-Balance%20Sheet%20Arrangements) This section confirms the absence of material off-balance sheet arrangements - The company did not have any material off-balance sheet arrangements as of June 30, 2025, or 2024[250](index=250&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=49&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) This section states that there are no applicable quantitative and qualitative disclosures about market risk for the company - The company has no applicable quantitative and qualitative disclosures about market risk[251](index=251&type=chunk) [Item 4. Controls and Procedures](index=50&type=section&id=Item%204.%20Controls%20and%20Procedures) This section details the evaluation of the company's disclosure controls and procedures, concluding their effectiveness as of June 30, 2025, and reporting no material changes in internal control over financial reporting during the quarter - Management concluded that disclosure controls and procedures were effective as of June 30, 2025, ensuring timely accumulation and communication of required information[253](index=253&type=chunk) - No changes in internal control over financial reporting materially affected, or are reasonably likely to materially affect, the company's internal control during the quarter ended June 30, 2025[254](index=254&type=chunk) [PART II - OTHER INFORMATION](index=51&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) This section provides other required information, including legal proceedings, risk factors, and exhibit listings [Item 1. Legal Proceedings](index=51&type=section&id=Item%201.%20Legal%20Proceedings) This section reports that the company is not aware of any pending legal actions that would have a material adverse effect on its business and operations, while acknowledging susceptibility to ordinary course disputes and securities litigation - The company is not aware of any pending legal actions that would have a material adverse effect on its business and operations[256](index=256&type=chunk) - The company is susceptible to disputes and proceedings arising in the ordinary course of business, including clinical trials, and potential securities litigation as a public company[257](index=257&type=chunk) [Item 1A. Risk Factors](index=51&type=section&id=Item%201A.%20Risk%20Factors) This section outlines significant risks, including substantial doubt about the company's ability to continue as a going concern due to insufficient funding, challenges in maintaining Nasdaq listing compliance, and the inherent volatility and specific risks associated with its new BNB crypto treasury strategy - The company's ability to continue as a going concern is in substantial doubt due to insufficient funding beyond December 2025, with no committed alternatives for securing additional capital[259](index=259&type=chunk)[261](index=261&type=chunk) - Restrictive covenants in purchase agreements may limit the company's ability to obtain future financing on favorable terms, adversely affecting its business and operations[260](index=260&type=chunk) - The company faces significant risk of delisting from The Nasdaq Capital Market due to repeated failure to meet the minimum **$1.00** bid price requirement and ineligibility for standard compliance periods[264](index=264&type=chunk)[265](index=265&type=chunk)[267](index=267&type=chunk) - The new BNB crypto treasury strategy exposes the company to extreme price fluctuations, dependence on Binance's success and centralized control, and unique liquidity challenges, which could materially devalue its reserve assets[268](index=268&type=chunk)[269](index=269&type=chunk)[270](index=270&type=chunk)[271](index=271&type=chunk)[272](index=272&type=chunk)[274](index=274&type=chunk)[275](index=275&type=chunk)[276](index=276&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=53&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section states that there were no unregistered sales of equity securities or use of proceeds to report - There were no unregistered sales of equity securities or use of proceeds to report[277](index=277&type=chunk) [Item 3. Defaults Upon Senior Securities](index=53&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section confirms that there were no defaults upon senior securities during the reporting period - There were no defaults upon senior securities[278](index=278&type=chunk) [Item 4. Mine Safety Disclosures](index=53&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section indicates that mine safety disclosures are not applicable to the company - Mine safety disclosures are not applicable[279](index=279&type=chunk) [Item 5. Other Information](index=53&type=section&id=Item%205.%20Other%20Information) This section reports that no directors or officers adopted, terminated, or modified Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the six months ended June 30, 2025 - No directors or officers adopted, terminated, or modified Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the six months ended June 30, 2025[280](index=280&type=chunk) [Item 6. Exhibits](index=54&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Quarterly Report on Form 10-Q, including corporate documents, forms of notes and warrants, and various agreements, along with their method of filing Selected Exhibits | Exhibit No. | Description | Method of Filing | | :--- | :--- | :--- | | 3.1 | Amended and Restated Certificate of Incorporation | Incorporated by reference | | 3.3 | Certificate of Designations of Series C Convertible Preferred Stock | Incorporated by reference | | 3.5 | Certificate of Designation for Series D Convertible Preferred Stock | Incorporated by reference | | 4.4 | Form of Convertible Note issued to DFU, LLC on June 5, 2025 | Incorporated by reference | | 4.8 | Form of Senior Note issued to Standard Waste Services, LLC on June 5, 2025 | Incorporated by reference | | 10.13 | Form of Securities Purchase Agreement, dated as of July 16, 2025 | Incorporated by reference | | 10.14 | Form of Common Stock Purchase Agreement, dated as of July 23, 2025 | Incorporated by reference | | 31.1 | Certification of Chief Executive Officer and Principal Financial Officer pursuant to Rule 13a-14(a) of the Exchange Act | Filed herewith | [Signatures](index=58&type=section&id=Signatures) This section contains the official signatures for the Quarterly Report on Form 10-Q, confirming its due authorization and filing - The report is duly signed by Jed Latkin, President and Chief Executive Officer (Principal Executive Officer, Principal Financial Officer and Principal Accounting Officer) on August 19, 2025[290](index=290&type=chunk)

Core Insights - Windtree Therapeutics is advancing istaroxime for treating SCAI Stage C cardiogenic shock, with interim data showing promising safety and efficacy [1][2][3] - Istaroxime has the potential to improve cardiac function and increase blood pressure without raising heart rate, addressing a significant unmet need in acute decompensated heart failure [2][3] Company Overview - Windtree Therapeutics is a diversified company with multiple divisions, including a cryptocurrency treasury strategy and two therapeutic pipelines [4] Product Details - Istaroxime is a first-in-class dual-mechanism therapy that enhances both systolic and diastolic cardiac function, showing significant improvements in cardiac function and blood pressure in previous studies [3]

Core Insights - Windtree Therapeutics is advancing istaroxime, a dual-mechanism therapy for cardiogenic shock, following positive interim analysis results from the SEISMiC C Phase 2 study [1][4][5] - The study demonstrated that istaroxime maintains a safety profile consistent with previous trials, showing no new safety signals and physiological improvements [1][3] Group 1: Study Overview - The SEISMiC C Study is a global, placebo-controlled, double-blinded trial assessing istaroxime in patients with severe cardiogenic shock (SCAI Stage C) [2] - Istaroxime was added to standard care, including inotropes and vasopressors, and showed potential advantages in efficacy and safety compared to existing therapies [2][4] - The interim analysis included the first 20 patients, revealing no new safety concerns or excess arrhythmias [3] Group 2: Istaroxime Profile - Istaroxime is a first-in-class therapy designed to enhance both systolic and diastolic cardiac function, improving myocardial contractility and facilitating relaxation [5] - Previous Phase 2 studies indicated that istaroxime significantly improves cardiac function and blood pressure without increasing heart rate or causing significant rhythm disturbances [5] Group 3: Company Background - Windtree Therapeutics operates with multiple divisions, including a cryptocurrency treasury strategy and therapeutic pipelines, actively seeking long-term development partners [6]