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]

Initial transaction provides the right to buy the target asset which may provide consistent revenue to Windtree while it continues to develop its biotech pipeline drug candidatesWARRINGTON, Pa., May 01, 2025 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on becoming a revenue generating company and advancing early and late-stage innovative therapies for critical conditions and diseases, is pleased to announce that it has entere ...

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 ...

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].

WARRINGTON, Pa., April 15, 2025 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. ("Windtree" or "the Company") (NasdaqCM: WINT), a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditions, today reported financial results for the fiscal year ended December 31, 2024 and provided key business updates. "The year 2024 saw Windtree make great progress in many key areas including clinical development of our lead drug candidate istaroxime in cardiogenic shock, bus ...

-- Evofem's Cost to Manufacture PHEXXI will Decrease by 55% - 60% -- SAN DIEGO, March 26, 2025 /PRNewswire/ -- Evofem Biosciences, Inc. (OTCQB: EVFM) (Evofem or the Company) today announced that it has entered into a License and Supply Agreement (L&S Agreement) with Windtree Therapeutics, Inc. (NasdaqCM: WINT), under which Windtree will be Evofem's sourcing partner for PHEXXI® (lactic acid, citric acid and potassium bitartrate). This FDA-approved hormone-free contraceptive vaginal gel is applied 0 to 60 min ...

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]

WARRINGTON, Pa., Feb. 27, 2025 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditions and diseases, announced today that the Company has filed a national phase patent application with the Indian patent office claiming priority to PCT/US2024/058923 entitled, “ISTAROXIME AND DERIVATIVES THEREOF FOR PREVENTING OR REDUCING THE RISK OF ACUTE MYOCARDIAL ARRHYTHMIA ...