Core Viewpoint - Windtree Therapeutics, Inc. is set to become the first NASDAQ-listed company providing direct exposure to the Binance Smart Chain Ecosystem through a $60 million securities purchase agreement, with potential total subscriptions of up to $200 million [1][4] Group 1: Financial Strategy - The financing will primarily be used to launch a BNB crypto treasury strategy and purchase BNB, positioning Windtree as a leader in the BNB digital asset space [1][2] - The transaction is expected to establish a robust BNB Crypto Treasury Strategy, including custody, security, and yield generation [2] Group 2: Market Positioning - Windtree aims to fill a critical gap in the U.S. investment landscape by offering targeted exposure to Binance and BNB [3] - BNB is recognized as the largest and most liquid crypto exchange token globally, with average daily trading volumes exceeding $2 billion [3] Group 3: Company Background - Windtree Therapeutics operates with several divisions, including a cryptocurrency treasury strategy and therapeutic pipelines [5] - Build and Build Corp, involved in the transaction, has over 43 years of expertise in hedge funds and digital asset management, backed by prominent investors [6]

Core Insights - Windtree Therapeutics, Inc. has entered into a $60 million securities purchase agreement with Build and Build Corp, with potential future subscriptions totaling up to $200 million [1][4] - The financing will primarily be used to launch a BNB crypto treasury strategy and purchase BNB, positioning Windtree as a leader in the BNB digital asset space [1][2] - Windtree will become the first NASDAQ-listed company offering direct exposure to the BNB token, which has a market capitalization exceeding $95 billion [1][3] Company Strategy - The transaction aims to establish a robust BNB Crypto Treasury Strategy, focusing on custody, security, and yield generation [2] - The strategy addresses a critical gap in the U.S. investment landscape for regulated access to the Binance ecosystem [3] - Windtree's CEO highlighted the unique opportunity for shareholders to gain exposure to a BNB-focused crypto treasury strategy [4] Market Context - BNB is a leading cryptocurrency with average daily trading volumes exceeding $2 billion, making it the largest and most liquid crypto exchange token globally [3] - The Binance Smart Chain supports fast, low-cost transactions and a thriving decentralized finance ecosystem, indicating substantial growth potential in U.S. markets [3] - The involvement of Build and Build Corp reflects confidence in Windtree's vision to drive transformative opportunities within the digital asset landscape [2][3]

Core Insights - Istaroxime is a first-in-class dual-mechanism therapy aimed at treating acute heart failure (AHF) and has shown positive results in Phase 2 studies [3] - The United States Patent and Trademark Office has granted a patent for istaroxime, which will provide protection until 2039 if approved for AHF [1][2] - Windtree Therapeutics is focused on becoming a revenue-generating company across multiple growing industries [4] Company Overview - Windtree Therapeutics, Inc. is a diversified company with a focus on revenue generation and profitability in various industries [4] - The company is advancing istaroxime towards Phase 3 readiness for cardiogenic shock and AHF [2] Product Details - Istaroxime improves both systolic and diastolic cardiac function, increasing myocardial contractility and facilitating myocardial relaxation [3] - Clinical data indicates that istaroxime can significantly enhance cardiac function and blood pressure without raising heart rate or causing significant cardiac rhythm disturbances [3]

The SEISMiC C Study is the third study in the istaroxime cardiogenic shock development program - SEISMiC C is studying more severely ill SCAI Stage C cardiogenic shock patients Windtree has previously reported two positive early cardiogenic shock Phase 2 studies in SCAI Stage B patients The SEISMiC C interim analysis will provide a preliminary assessment of istaroxime safety in treating more severe cardiogenic shock patients who may be receiving standard of care with inotropes and vasopressors SCAI Stage C ...

Core Insights - Windtree Therapeutics has entered a contract with a Chinese pharmaceutical manufacturer to produce Evofem's PHEXXI, aiming to reduce manufacturing costs by over 50% by the end of 2026 [1][2][3] - The tech transfer process is currently underway, with validation batch manufacturing expected to begin in 2026, which is anticipated to generate revenue for Windtree [2][3] - Evofem has experienced four consecutive years of net sales growth for PHEXXI and is preparing to enter the UAE market in early 2026 [3] Company Developments - The manufacturing contract is part of a broader License and Supply Agreement established in March 2025 between Windtree and Evofem [4] - Windtree aims to become a revenue-generating company across various growing industries, focusing on overall profitability [5]

Company to receive $7.0 million up front for its preclinical oncology drug candidate Up to $130.0 million in milestone payments starting with initiation of Phase 1 High single digit royalties that could total up to $1.5 billion over the life of the drug WARRINGTON, Pa., June 11, 2025 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a diversified company focused on revenue generation in multiple growing industries, announced that it has received a non-binding l ...

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]

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].