[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]

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]