Core Insights - The Phase 2 Istaroxime study demonstrated success across multiple endpoints, indicating potential for approval in targeted indications [1][3] - The primary endpoint of increasing systolic blood pressure was met, with additional benefits such as no increase in heart rate and preserved renal function [1][3] - Discussions are ongoing with multiple potential partners to fund the remaining clinical development, which could alleviate the company's cash burn in the cardiovascular pipeline [1][5] Company Developments - Windtree Therapeutics is nearing completion of the protocol design for a Phase 3 study in acute heart failure for a regional license partner, which will be fully funded by the licensee [2] - The early cardiogenic shock Phase 2 study, SEISMiC B, has been published, highlighting the safety and efficacy of intravenous Istaroxime for patients with pre-cardiogenic shock [2][4] - The cardiogenic shock market was valued at $1.25 billion in 2020, indicating significant market potential for Istaroxime [5] Clinical Study Results - Istaroxime significantly increased blood pressure within the first six hours of treatment, with effects persisting for 60 hours, and improved cardiac output without increasing heart rate or causing significant arrhythmias [3][7] - The drug has completed four positive Phase 2 studies, including two focused on early cardiogenic shock, showcasing a strong profile for potential innovation in treatment [4][5] - The upcoming SEISMiC C trial will assess more severe SCAI Stage C cardiogenic shock patients, aiming to complete the evaluation for the intended Phase 3 patient population [5]

Core Viewpoint - Windtree Therapeutics, Inc. has received a non-binding letter of intent for the sale of its preclinical oncology aPKCi inhibitor platform, which includes an upfront payment of $7.0 million and potential milestone payments totaling up to $130.0 million, along with high single-digit royalties that could reach up to $1.5 billion over the drug's lifecycle [1][2][3]. Group 1 - The agreement allows for additional options to acquire the Company's cardiovascular clinical and preclinical stage drug candidates and includes a manufacturing agreement for Evofem Biosciences' FDA-approved product [2]. - The Company has a 21-day window to finalize the oncology aPKCi portion of the transaction [2]. - The CEO of Windtree stated that the preclinical oncology aPKCi assets are not viewed as core to the Company's future vision, but the transaction may provide non-dilutive cash and a lucrative revenue stream through milestones and royalties [3]. Group 2 - Windtree Therapeutics aims to become a revenue-generating company across multiple growing industries to achieve overall profitability [4].

Core Viewpoint - Windtree Therapeutics is entering the $85 billion US environmental services market through the acquisition of Titan Environmental Services, aiming to generate $12 million in revenue over the next 12 months and pursue a roll-up strategy for growth [1][3]. Company Strategy - The acquisition of Titan Environmental Services will transform Titan into Windtree Environmental Services, a subsidiary focused on waste management, with the current management team retained to leverage their expertise [2][3]. - Windtree's refined corporate strategy includes diversifying its business model and pursuing opportunities in multiple growing industries to achieve overall profitability [4][5]. Market Context - The US waste collection market was valued at $85 billion in 2024, known for attractive EBITDA margins and free cash flow, presenting significant growth opportunities for Windtree through potential additional acquisitions [3]. Financial Considerations - Windtree will issue preferred shares and has secured debt financing to fund the acquisition and working capital for the new subsidiary [2]. - The transaction is expected to close in the third quarter, with an $8 million breakup fee if the agreement cannot be consummated [2].

Core Viewpoint - Windtree Therapeutics, Inc. plans to implement a cryptocurrency policy to accept cryptocurrency as a payment option and hold it as an asset, aligning with digital commerce trends [1][2][3] Company Strategy - The company is focused on becoming a revenue-generating entity while advancing innovative therapies for critical conditions and diseases [4] - Windtree is in discussions with groups specializing in Bitcoin and other cryptocurrencies to develop a treasury strategy [3] Cryptocurrency Policy - The cryptocurrency policy aims to allow the company to accept cryptocurrency payments and hold them long-term as a strategic asset [2][3] - The Board of Directors supports the development of this cryptocurrency policy, which is expected to be completed soon [3] Product Portfolio - Windtree's product candidates include istaroxime, a Phase 2 candidate for acute heart failure, and preclinical SERCA2a activators and precision aPKCi inhibitors for oncology applications [4]

Core Insights - Windtree Therapeutics is advancing its istaroxime cardiogenic shock program with the SEISMiC C Study, targeting interim analysis results for July 2025 [1][2][3] - Istaroxime is a first-in-class dual-mechanism therapy aimed at improving cardiac function in patients with cardiogenic shock [4] Company Overview - Windtree Therapeutics focuses on developing innovative therapies for critical conditions and aims to become a revenue-generating company [5] - The company's product portfolio includes istaroxime, which is in Phase 2 trials for acute heart failure and cardiogenic shock, as well as preclinical candidates for heart failure and oncology applications [5] Study Details - The SEISMiC C Study is a global, placebo-controlled, double-blinded trial assessing the efficacy of istaroxime in addition to standard care [2] - The primary endpoint is the systolic blood pressure profile over the first six hours, with additional measurements including cardiac function and treatment failure rates [2] Clinical Significance - Interim data from the SEISMiC C Study will provide insights into istaroxime's physiological impact and safety profile in more severely ill patients [3] - Previous Phase 2 studies have shown that istaroxime can significantly improve cardiac function and blood pressure without increasing heart rate or causing significant rhythm disturbances [4]

Company Overview - Windtree Therapeutics, Inc. is a biotechnology company focused on generating revenue and advancing innovative therapies for critical conditions and diseases [4] - The company's product portfolio includes istaroxime, a Phase 2 candidate for acute heart failure and associated cardiogenic shock, as well as preclinical SERCA2a activators and precision aPKCi inhibitors for oncology applications [4] Istaroxime Data Presentation - Istaroxime data from the SEISMiC Extension Phase 2b study will be presented at the European Society of Cardiology Heart Failure 2025 Conference [1] - The presentation will focus on the safety and efficacy of intravenous istaroxime for patients with pre-cardiogenic shock [2] Clinical Significance - The positive results from the SEISMiC Extension Study are seen as crucial for advancing istaroxime toward Phase 3 trials for cardiogenic shock [2] - Istaroxime is positioned as a potential new treatment for cardiogenic shock, which is associated with high mortality, morbidity, and healthcare costs [2] Mechanism of Action - Istaroxime is a first-in-class dual-mechanism therapy that improves both systolic and diastolic cardiac function [3] - It acts as a positive inotropic agent, enhancing myocardial contractility and facilitating myocardial relaxation without increasing heart rate or causing significant cardiac rhythm disturbances [3]

Financial Performance - The company reported a net loss of $1.8 million for the year ended December 31, 2024, a significant decrease from a net loss of $20.3 million in 2023, which included a $14.4 million non-cash gain on debt extinguishment[9]. - The company reported a net loss of $1,787,000 for 2024, a substantial improvement compared to a net loss of $20,291,000 in 2023[17]. - The net loss per share attributable to common stockholders improved from $(4,718.84) in 2023 to $(104.35) in 2024[17]. Research and Development - For the fiscal year ended December 31, 2024, research and development expenses increased to $16.3 million from $8.3 million in 2023, primarily due to a $7.5 million charge related to acquired in-process R&D from the Varian asset purchase[7]. - Research and development expenses increased significantly from $8,341,000 in 2023 to $16,276,000 in 2024, representing a 95.5% increase[17]. - The company announced positive results from its Phase 2 SEISMiC Extension Study of istaroxime in September 2024, and initiated enrollment in the global SEISMiC C trial for more severely ill patients[4]. Corporate Strategy and Licensing - A new corporate strategy was launched to become a revenue-generating biotech through acquisitions of small companies with FDA-approved products, aiming to provide near-term value to shareholders[4]. - The company entered into a licensing agreement with Evofem Biosciences for PHEXXI®, aiming to leverage manufacturing contacts to reduce costs[4]. - Licensing partner Lee's Pharmaceutical is preparing to initiate a Phase 3 program for acute heart failure in Greater China, with a deal worth up to $138 million in milestones plus royalties[6]. Financial Position - As of December 31, 2024, cash and cash equivalents were $1.8 million, with additional net proceeds of $1.5 million from the sale of common stock following mandatory redemption payments on Series C preferred stock[11]. - Total current assets decreased from $5,379,000 in 2023 to $2,574,000 in 2024, a decline of approximately 52.2%[16]. - Total liabilities decreased from $29,015,000 in 2023 to $14,698,000 in 2024, a reduction of approximately 49.3%[16]. - Stockholders' equity increased from $3,391,000 in 2023 to $9,996,000 in 2024, reflecting a growth of 194.5%[16]. Operational Metrics - Total operating expenses rose from $20,597,000 in 2023 to $26,139,000 in 2024, an increase of 27.1%[17]. - The company recorded a change in fair value of common stock warrant liability of $10,482,000 in 2024, with no prior year comparison available[17]. - The weighted average number of common shares outstanding increased from 4,300 in 2023 to 52,583 in 2024[17]. - The company regained Nasdaq compliance with the minimum bid price requirement, subject to a mandatory panel monitor until March 20, 2026[4]. - The company completed national phase filings for istaroxime patent applications in key global markets, strengthening its intellectual property portfolio[6]. - The company is actively evaluating revenue-generating opportunities across various sectors that align with its capabilities and strategic vision[4].

Core Insights - Windtree Therapeutics is focused on becoming a revenue-generating company by acquiring FDA-approved assets and advancing its cardiology and oncology pipeline [2] - The company reported a first-quarter operating loss of $4.1 million, an improvement from a loss of $4.4 million in the same period last year [4] - Windtree has entered into a strategic transaction to acquire a multifamily residential property, which is expected to generate revenue while the company develops its biotech pipeline [6] Financial Performance - For Q1 2025, research and development expenses remained stable at $2.3 million compared to Q1 2024 [5] - General and administrative expenses decreased to $1.8 million from $2.1 million in the previous year, primarily due to reduced professional fees [7] - The net loss attributable to common stockholders was $5.0 million ($4.63 per share) for Q1 2025, compared to a net income of $10.2 million ($1,099.37 per share) in Q1 2024 [8] Business Developments - The company is advancing its istaroxime program for cardiogenic shock, with ongoing enrollment in a clinical study and plans for an interim analysis in Q3 2025 [2] - Windtree has established a partnership with a biopharmaceutical company in China to reduce production costs by nearly 65%, with anticipated revenue generation by the end of 2026 [2] - The company has expanded its patent estate for istaroxime and received a notice of allowance in acute heart failure from the U.S. Patent and Trademark Office [6] Cash Position - As of March 31, 2025, Windtree reported cash and cash equivalents of $1.2 million and current liabilities of $6.5 million, indicating sufficient resources to fund operations through May 2025 [9]

[PART I - FINANCIAL INFORMATION](index=5&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) This section provides the unaudited condensed consolidated financial statements for Q1 2025 and Q1 2024, along with management's discussion and analysis of financial condition and results of operations [Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements for the three months ended March 31, 2025, compared to the same period in 2024, including balance sheets, statements of operations, changes in equity, and cash flows [Note 1 – The Company and Description of Business](index=10&type=page&id=Note%201%20%E2%80%93%20The%20Company%20and%20Description%20of%20Business) Windtree is a biotechnology company focused on therapies for critical conditions, with a pipeline including istaroxime and a new strategy to acquire revenue-generating FDA-approved products - The company's portfolio includes istaroxime, preclinical SERCA2a activators, rostafuroxin, and a preclinical aPKCi inhibitor for oncology[21](index=21&type=chunk) - A new corporate strategy was launched in January 2025 to acquire small companies with FDA-approved products to become a revenue-generating entity[22](index=22&type=chunk) - The lead product, istaroxime, is being evaluated in the SEISMiC C Study for severe cardiogenic shock, with enrollment completion anticipated in Q1 2026, dependent on securing additional funding[23](index=23&type=chunk) [Note 3 – Going Concern and Management's Plans](index=12&type=page&id=Note%203%20%E2%80%93%20Going%20Concern%20and%20Management%27s%20Plans) The company has a history of net losses and limited cash, raising substantial doubt about its ability to continue as a going concern, with management planning to secure additional capital - As of March 31, 2025, the company had an accumulated deficit of **$850.7 million**[32](index=32&type=chunk) - Cash and cash equivalents of **$1.2 million** as of March 31, 2025, are only sufficient to fund operations through May 2025[33](index=33&type=chunk) - These conditions raise substantial doubt about the company's ability to continue as a going concern, and management plans to seek additional capital, but there are no committed alternatives[33](index=33&type=chunk)[34](index=34&type=chunk) [Note 13 – Mezzanine Equity and Stockholders' Equity](index=23&type=page&id=Note%2013%20%E2%80%93%20Mezzanine%20Equity%20and%20Stockholders%27%20Equity) This note details significant and complex equity financing activities, including common stock sales, preferred stock conversions, and warrant exercises, with adjustments to conversion and exercise prices - During Q1 2025, the company sold **0.2 million shares** of common stock under its ELOC Purchase Agreement for gross proceeds of **$2.0 million**[122](index=122&type=chunk) - In Q1 2025, **8,521 shares** of Series C Preferred Stock were converted into **3,045,531 shares** of common stock[120](index=120&type=chunk) - In January 2025, the conversion price of Series C Preferred Stock and the exercise price of July 2024 Warrants were reduced to **$8.04 per share**[96](index=96&type=chunk)[97](index=97&type=chunk) [Note 15 – Licensing and Research Funding Agreements](index=28&type=page&id=Note%2015%20%E2%80%93%20Licensing%20and%20Research%20Funding%20Agreements) The company has several key licensing and research agreements, including a new supply agreement with Evofem Biosciences and ongoing agreements with Lee's Pharmaceutical for cardiovascular assets and the KL4 surfactant platform, with potential for significant milestone payments - Entered into a License and Supply Agreement with Evofem Biosciences in March 2025 to act as the supplier for its Phexxi® product outside the U.S[136](index=136&type=chunk) - An exclusive license agreement with Lee's (HK) for istaroxime, rostafuroxin, and SERCA2a activators in Greater China and other Asian territories could yield up to **$3.1 million** in upfront/development milestones and **$135.25 million** in sales milestones[161](index=161&type=chunk)[162](index=162&type=chunk) - An Amended & Restated License Agreement with Lee's (HK) and Zhaoke grants worldwide commercialization rights (with some exceptions) for the KL4 surfactant platform, with potential for up to **$78.9 million** in milestone payments[156](index=156&type=chunk)[157](index=157&type=chunk)[158](index=158&type=chunk) [Note 17 – Subsequent Events](index=33&type=page&id=Note%2017%20%E2%80%93%20Subsequent%20Events) After the quarter ended, the company engaged in significant financing activities, including a private placement of Series D Preferred Stock and the issuance and retirement of convertible senior secured notes, alongside a potential real estate acquisition - In April and May 2025, the company sold Series D Preferred Stock for aggregate gross proceeds of approximately **$2.65 million**[171](index=171&type=chunk)[172](index=172&type=chunk) - Issued **$0.3 million** in convertible senior secured notes in April 2025, which were fully retired in May 2025 for a payment of **$0.3 million**[181](index=181&type=chunk)[183](index=183&type=chunk) - On April 19, 2025, a wholly owned subsidiary, WINT Real Estate, LLC, entered into an assignment agreement to potentially purchase a real property in Houston, Texas for approximately **$43.0 million**[178](index=178&type=chunk)[180](index=180&type=chunk) Financial Position (in thousands) | Metric | March 31, 2025 (Unaudited) | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $1,173 | $1,779 | | Total assets | $26,766 | $27,875 | | Total current liabilities | $6,476 | $5,717 | | Total liabilities | $15,438 | $14,698 | | Total stockholders' equity | $10,290 | $9,996 | Statements of Operations (in thousands, except per share data) | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Operating loss | ($4,090) | ($4,405) | | Net (loss) income | ($4,045) | $10,219 | | Net (loss) income per share (Basic and diluted) | ($4.63) | $1,099.37 | Cash Flow Activity (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($2,407) | ($2,947) | | Net cash provided by financing activities | $1,801 | $1,034 | | Net decrease in cash, cash equivalents, and restricted cash | ($606) | ($1,913) | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=35&type=section&id=Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The MD&A details the company's financial performance, business strategy, and liquidity challenges, reiterating the new strategy to acquire revenue-generating assets and providing updates on the clinical pipeline [Results of Operations](index=40&type=page&id=Results%20of%20Operations) For Q1 2025, the company reported an operating loss of $4.1 million, a slight improvement from the prior year, with a net loss of $4.0 million primarily due to a non-cash gain in Q1 2024 Operating Results (in thousands) | Metric | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Research and development | $2,270 | $2,253 | $17 | | General and administrative | $1,820 | $2,152 | ($332) | | **Operating loss** | **($4,090)** | **($4,405)** | **$315** | | **Net (loss) income** | **($4,045)** | **$10,219** | **($14,264)** | - R&D expenses were comparable year-over-year, with costs for the istaroxime cardiogenic shock program (SEISMiC C study) being the primary driver in Q1 2025[221](index=221&type=chunk)[224](index=224&type=chunk) - The significant difference in net income between Q1 2025 and Q1 2024 is primarily due to a **$14.5 million** non-cash gain on debt extinguishment recognized in Q1 2024[219](index=219&type=chunk)[232](index=232&type=chunk) [Liquidity and Capital Resources](index=43&type=page&id=Liquidity%20and%20Capital%20Resources) The company's liquidity position is critical, with cash sufficient only through May 2025, raising substantial doubt about its ability to continue as a going concern, necessitating additional capital - The company has cash and cash equivalents of **$1.2 million** as of March 31, 2025, which is only sufficient to fund operations through May 2025[240](index=240&type=chunk) - Management has concluded that substantial doubt exists about the company's ability to continue as a going concern and plans to secure additional capital[241](index=241&type=chunk) Cash Flow Activity (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2025 | | :--- | :--- | | Net cash used in operating activities | ($2,407) | | Net cash provided by financing activities | $1,801 | | **Change in cash and cash equivalents** | **($606)** | [Quantitative and Qualitative Disclosures about Market Risk](index=45&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) This section is not applicable to the company for this reporting period - The company has indicated that this item is not applicable[259](index=259&type=chunk) [Controls and Procedures](index=46&type=section&id=Item%204.%20Controls%20and%20Procedures) The company's management concluded that its disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal control over financial reporting during the quarter - Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of the end of the period covered by the report[261](index=261&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that materially affected, or are reasonably likely to materially affect, internal controls[262](index=262&type=chunk) [PART II - OTHER INFORMATION](index=47&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) This section covers legal proceedings, critical risk factors, unregistered sales of equity securities, other information, and a list of exhibits [Legal Proceedings](index=47&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that it is not aware of any pending legal actions that would have a material adverse effect on its business and operations - The company is not aware of any pending legal actions that would have a material adverse effect on its business[264](index=264&type=chunk) [Risk Factors](index=47&type=page&id=Item%201A.%20Risk%20Factors) This section emphasizes the critical risks facing the company, primarily its ability to continue as a going concern due to limited cash, and the potential for delisting from Nasdaq - The company's ability to continue as a going concern is in substantial doubt, with resources sufficient only to fund business beyond May 2025[267](index=267&type=chunk) - Failure to raise sufficient capital could force the company to limit or cease development activities and operations[269](index=269&type=chunk) - Despite regaining compliance with Nasdaq's minimum bid price rule in March 2025, the company is under a 'Discretionary Panel Monitor' until March 2026, and there is no assurance it will maintain compliance with all listing requirements[271](index=271&type=chunk)[272](index=272&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=48&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - None[273](index=273&type=chunk) [Other Information](index=48&type=section&id=Item%205.%20Other%20Information) During the first quarter of 2025, none of the company's directors or officers adopted, terminated, or modified a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement - No directors or officers adopted, terminated, or modified a Rule 10b5-1 or non-Rule 10b5-1 trading arrangement during the three months ended March 31, 2025[276](index=276&type=chunk) [Exhibits](index=49&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Quarterly Report on Form 10-Q, including amendments to the Certificate of Incorporation, forms of various securities, and CEO/CFO certifications

Core Insights - Windtree Therapeutics, Inc. announced data on istaroxime and a selective SERCA2a activator demonstrating a reduction in arrhythmias in an animal study presented at the European Society of Cardiology Heart Failure Conference [1][2] - The study focused on the activation of SERCA2a to reduce calcium-dependent arrhythmias in a rat model induced by ischemia-reperfusion, identifying a potential mechanism for decreased arrhythmias [2] Company Overview - Windtree Therapeutics is a biotechnology company aiming to generate revenue and advance innovative therapies for critical conditions, with a focus on istaroxime, a Phase 2 candidate for acute heart failure and cardiogenic shock [6] - The company is also developing preclinical SERCA2a activators and precision aPKCi inhibitors for oncology applications, alongside a licensing business model with existing partnership out-licenses [6] Product Details - Istaroxime is a first-in-class dual-mechanism therapy that enhances both systolic and diastolic cardiac function, improving myocardial contractility and facilitating myocardial relaxation through SERCA2a activation [4] - Previous Phase 2 studies indicated that intravenous istaroxime significantly improves cardiac function and blood pressure without increasing heart rate or cardiac rhythm disturbances [4] Research and Development - The current research includes evaluating preclinical product candidates for heart failure, focusing on both oral and intravenous SERCA2a activators [5]