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].

-- 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 ...

WARRINGTON, Pa., March 24, 2025 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on becoming a revenue generating biotech and advancing early and late-stage innovative therapies for critical conditions and diseases, today announced that the Company received notice from The Nasdaq Stock Market LLC ("Nasdaq") that Windtree has regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2) for contin ...

Transaction is part of the Company's new corporate strategy to become a revenue generating biotech WARRINGTON, Pa., March 20, 2025 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. ("Windtree" or the "Company") (NasdaqCM: WINT), a biotechnology company focused on becoming a revenue generating biotech and advancing early and late-stage innovative therapies for critical conditions and diseases, is pleased to announce that it has entered into a License and Supply Agreement to become the sourcing partner for Evof ...

WARRINGTON, Pa., March 04, 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, is pleased to announce that the United States Patent and Trademark Office has issued a Notice of Allowance for U.S. application number 18/150,870 directed to “ISTAROXIME-CONTAINING INTRAVENOUS FORMULATION FOR THE TREATMENT OF ACUTE HEART FAILURE.” “Acute hear ...

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 ...

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]

WARRINGTON, Pa., Feb. 12, 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 that an istaroxime presentation featuring the positive Phase 2b SEISMiC study was given on February 11, 2025 at the Technology and Heart Failure Therapeutics Conference in Boston, MA. Matteo Pagnesi, MD, PhD a cardiologist from Spedali Civili di Bres ...

WARRINGTON, Pa., Jan. 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 and diseases, today announced the issuance of a patent in Japan for "Inhibitors of atypical protein kinase C (aPKCi) and their use in treating hedgehog pathway-dependent cancers." The patent number is 7603605 and expires in 2040. The aPKCi inhibitor platform is a novel, pot ...