Core Insights - Windtree Therapeutics is advancing istaroxime, a potential treatment for cardiogenic shock, which may receive New Chemical Entity designation from the FDA, providing 7.5 years of U.S. exclusivity if approved [1][3] - Istaroxime has existing patents protecting its method of use until 2039 and a pending patent extending protection until 2043 [2] - The company is focused on the development of istaroxime, with an interim analysis of its Phase 2 study planned for Q3 2025 [3] Company Overview - Windtree Therapeutics is a biotechnology company aiming to generate revenue through innovative therapies for critical conditions, with istaroxime being a key candidate in its portfolio [5] - Istaroxime is a first-in-class dual-mechanism therapy designed to enhance both systolic and diastolic cardiac function, showing significant improvements in cardiac function and blood pressure in Phase 2 studies [4]

Core Viewpoint - Windtree Therapeutics is pursuing a new corporate strategy focused on acquiring revenue-generating assets, including real estate and small biotech companies with FDA-approved products, while continuing to develop its therapeutic pipeline [1][2][3] Group 1: Acquisition and Revenue Generation - Windtree has entered into an agreement to acquire a 436-unit multifamily residential property in Houston, Texas, which is expected to provide consistent rental revenue [1] - The acquisition will be funded primarily through non-recourse secured mortgage financing, with additional funding from preferred stock issuance [1] - The company aims to diversify and stabilize its revenue streams through this acquisition, reducing reliance on capital that could dilute stock value [3] Group 2: Corporate Strategy and Pipeline Development - The new corporate strategy includes the acquisition of assets that contribute revenue while continuing the development of unique drug candidates in cardiovascular and oncology spaces [2][3] - Windtree's product candidates include istaroxime, a Phase 2 candidate for acute heart failure, and preclinical candidates for heart failure and oncology applications [4] - The company is actively seeking multiple acquisition candidates that could provide near-term revenue and profits [3]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____ to _____ WINDTREE THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware (State or other jurisdiction of incorporation or ...

Core Insights - Windtree Therapeutics, Inc. reported significant advancements in clinical development and business strategy for 2024, particularly focusing on its lead drug candidate, istaroxime, for treating cardiogenic shock [2][3] Business Development - The company announced positive results from the Phase 2 SEISMiC Extension Study of istaroxime in September 2024 and initiated the global SEISMiC C trial for more severely ill patients, with an interim assessment planned for Q3 2025 [3] - 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 [2][3] - Windtree entered a licensing partnership with Lee's Pharmaceutical for istaroxime and other drug candidates, enhancing its market reach in Greater China [2][3] Financial Performance - 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 [5] - General and administrative expenses decreased to $8.7 million from $9.2 million in 2023, attributed to reductions in stock-based compensation and personnel costs [6] - The company reported a net loss of $1.8 million for 2024, a significant improvement from a net loss of $20.3 million in 2023, influenced by non-cash gains on debt extinguishment and changes in fair value of common stock warrant liability [7][8] Intellectual Property and Regulatory Compliance - Windtree completed national phase filings for istaroxime patent applications in key markets, including the U.S., Germany, and China, strengthening its global intellectual property portfolio [9] - The company regained compliance with Nasdaq listing requirements, ensuring continued listing on the exchange [3] Cash Position - As of December 31, 2024, Windtree reported cash and cash equivalents of $1.8 million, with subsequent sales of common stock and warrant exercises providing additional liquidity [10]

Core Viewpoint - Evofem Biosciences has entered a License and Supply Agreement with Windtree Therapeutics to reduce the manufacturing cost of its contraceptive product PHEXXI by 55% to 60%, enabling global expansion into price-sensitive markets [1][2][3] Group 1: Cost Reduction and Manufacturing - The cost of goods sold (COGS) for PHEXXI is expected to decrease significantly due to Windtree leveraging its manufacturing contacts [2] - There will be no cost incurred by Evofem for the technology transfer to the new manufacturer [2] Group 2: Global Expansion Strategy - Evofem aims to expand PHEXXI into new international markets where there is a demand for non-hormonal contraceptives, addressing unmet needs in women's reproductive health [3] - The reduction in manufacturing costs is seen as a critical step to make PHEXXI commercially viable in markets outside the U.S. [3] Group 3: Product Overview and Recent Developments - PHEXXI is a hormone-free contraceptive vaginal gel that is applied before intercourse, designed to maintain a vaginal environment that is inhospitable to sperm [4] - In July 2024, Evofem expanded its product offerings by acquiring SOLOSEC, an FDA-approved oral antibiotic for treating bacterial vaginosis and trichomoniasis [5]

Core Points - Windtree Therapeutics, Inc. has regained compliance with Nasdaq's minimum bid price requirement, allowing it to continue listing on the exchange [1][2] - The company was previously notified of non-compliance on December 4, 2024, due to its stock closing below $1.00 for 30 consecutive trading days [2] - To regain compliance, Windtree needed to maintain a closing bid price of $1.00 or more for at least 10 consecutive trading days, which it achieved starting February 21, 2025 [2] Company Overview - Windtree Therapeutics is focused on becoming a revenue-generating biotechnology company, advancing innovative therapies for critical conditions and diseases [3] - The company's product portfolio includes istaroxime, a Phase 2 candidate for acute heart failure, and preclinical candidates for heart failure and oncology applications [3] - Windtree operates a licensing business model with existing partnership out-licenses [3]

Core Insights - Windtree Therapeutics, Inc. has entered into a License and Supply Agreement with Evofem Biosciences, Inc. to become the sourcing partner for PHEXXI, a hormone-free contraceptive vaginal gel, aiming to generate profitable revenue [1][2][3] - PHEXXI's annual revenues exceeded $19 million in 2024, with over 96,000 boxes sold, indicating strong market demand [1] - The partnership aims to reduce manufacturing costs for PHEXXI, enabling Evofem to expand into price-sensitive global markets [2][3] Company Strategy - Windtree's new corporate strategy, announced in January 2025, focuses on becoming a revenue-generating biotech by advancing innovative therapies and establishing partnerships [3][4] - The company plans to leverage its global manufacturing contacts to significantly lower the cost of goods for PHEXXI, enhancing profitability [2][3] Product and Market Potential - PHEXXI is positioned as a first-in-class product that empowers women by providing a non-hormonal contraceptive option [1][3] - The anticipated reduction in manufacturing costs is expected to facilitate Evofem's entry into new international markets, addressing the need for affordable contraceptive options [3]

Core Insights - Windtree Therapeutics, Inc. has received a Notice of Allowance from the United States Patent and Trademark Office for its patent application related to an intravenous formulation of istaroxime for treating acute heart failure [1] - The CEO of Windtree emphasizes the significant impact of acute heart failure on patients and healthcare systems, highlighting the need for innovative drug treatments [1] Company Overview - Windtree Therapeutics is a biotechnology company focused on developing innovative therapies for critical conditions, with a portfolio that includes istaroxime, which is in Phase 2 trials for acute heart failure and cardiogenic shock [3] - Istaroxime is a first-in-class dual-mechanism therapy that aims to enhance both systolic and diastolic cardiac function, showing promising results in improving cardiac function and blood pressure without adverse effects on heart rate [2][3]

Core Insights - Windtree Therapeutics, Inc. has filed a national phase patent application in India for istaroxime, aimed at preventing or reducing the risk of acute myocardial arrhythmia [1][2] - Istaroxime is a first-in-class dual-mechanism therapy designed to enhance both systolic and diastolic cardiac function, showing significant improvements in cardiac function and blood pressure in Phase 2 studies [2][3] Company Overview - Windtree Therapeutics focuses on developing innovative therapies for critical conditions, with a portfolio that includes istaroxime for acute heart failure and cardiogenic shock, as well as preclinical candidates for oncology applications [3] - The company employs a licensing business model and has established partnership out-licenses [3] Product Details - Istaroxime functions as a positive inotropic agent, increasing myocardial contractility and facilitating myocardial relaxation, which is crucial for patients with heart failure [2] - Clinical data indicates that intravenous infusion of istaroxime significantly improves cardiac function without increasing heart rate or the incidence of cardiac rhythm disturbances [2] Strategic Focus - The CEO of Windtree emphasizes the importance of India, with its population exceeding 1.4 billion, in the company's strategic intellectual property plan for istaroxime [2] - The company is preparing for Phase 3 readiness in cardiogenic shock, highlighting its commitment to securing intellectual property protection in key markets [2]

Core Points - Windtree Therapeutics, Inc. has announced a 1-for-50 reverse stock split approved by its board of directors and stockholders to comply with Nasdaq's minimum bid price requirement [1][2] - The reverse stock split will take effect on February 20, 2025, and trading on a reverse-adjusted basis will begin on February 21, 2025 [2] - Post-split, the number of outstanding shares will be reduced to approximately 700,000, with no fractional shares issued [4] Company Overview - Windtree Therapeutics is a biotechnology company focused on developing innovative therapies for critical conditions and diseases, including a Phase 2 candidate for acute heart failure [7] - The company has a licensing business model with existing partnership out-licenses [7]