Core Insights - Windtree Therapeutics, Inc. announced a positive presentation on istaroxime at the Technology and Heart Failure Therapeutics Conference, highlighting its potential in treating early cardiogenic shock [1][2] Company Overview - Windtree Therapeutics is a biotechnology company focused on innovative therapies for critical conditions, with a portfolio that includes istaroxime, which is in Phase 2 trials for acute heart failure and cardiogenic shock [5] Istaroxime Details - Istaroxime is a first-in-class dual-mechanism therapy designed to improve both systolic and diastolic cardiac function, enhancing myocardial contractility and facilitating myocardial relaxation [4] - The therapy has shown significant improvements in cardiac function and blood pressure in multiple Phase 2 studies without increasing heart rate or causing cardiac rhythm disturbances [4] Clinical Development - The company is prioritizing cardiogenic shock as an initial indication for istaroxime due to its unique profile and the positive outcomes from Phase 2 studies [3] - There is a substantial unmet need in treating early cardiogenic shock, as existing treatments often have undesirable side effects and poor outcomes [3]

Core Insights - Windtree Therapeutics, Inc. has announced the issuance of a patent in Japan for aPKCi inhibitors aimed at treating hedgehog pathway-dependent cancers, with the patent number 7603605 expiring in 2040 [1][2][3] Company Overview - Windtree Therapeutics is a biotechnology company focused on developing innovative therapies for critical conditions and diseases, with a portfolio that includes istaroxime for acute heart failure and preclinical aPKCi inhibitors for oncology applications [4] Product Development - The aPKCi inhibitor platform is a high-potency drug candidate with applications in treating various cancers, including basal cell carcinoma and small cell lung cancer, and includes both topical and oral formulations developed in collaboration with Cancer Research UK [2][3] - The company is also pursuing additional patent applications for crystalline forms of aPKCi inhibitors for cancer treatment [3] Strategic Direction - The issuance of the new patent is a significant part of the company's development strategy, with plans to expand its intellectual property portfolio in key global markets [3]

Core Insights - Windtree Therapeutics, Inc. has announced the issuance of a patent in Japan for its oncology aPKCi inhibitor, a novel drug candidate aimed at treating hedgehog pathway-dependent cancers, with the patent expiring in 2040 [1][3] Company Overview - Windtree Therapeutics is a biotechnology company focused on developing innovative therapies for critical conditions and diseases, with a portfolio that includes istaroxime for acute heart failure and preclinical aPKCi inhibitors for oncology applications [4] Product Development - The aPKCi inhibitor platform is a high-potency, specific drug candidate with applications in treating various cancers, including basal cell carcinoma and small cell lung cancer, and includes both topical and oral formulations developed in collaboration with Cancer Research UK [2][3] - The company is also pursuing additional intellectual property to expand its patent portfolio globally [3]

Core Insights - WINT Water Intelligence has formed a strategic partnership with Ferguson to enhance leak mitigation and water management solutions across the U.S. [1][2] - The collaboration aims to elevate industry standards in water management and leak detection, providing advanced technologies to Ferguson's distribution network [3][4] Company Overview - WINT Water Intelligence specializes in AI-based water management and leak-prevention solutions, focusing on reducing environmental impact and water waste [7][8] - Ferguson is the largest value-added distributor in the North American construction market, with sales of $29.6 billion in FY'24 and approximately 35,000 associates [9] Partnership Details - Ferguson will distribute WINT's advanced water management solutions, enhancing capabilities for construction companies [2][3] - The partnership is expected to improve water consumption monitoring, damage prevention, and sustainability efforts [3][4] Technological Impact - WINT's systems can reduce water consumption and associated carbon emissions by 20%-25% [4] - Construction sites using WINT technology report 73% fewer insurance claims and 90% less payout compared to sites without the technology [4] Clientele and Applications - WINT's solutions are utilized by major clients including Suffolk Construction, HP, and PepsiCo, among others [5] - The WINT platform offers comprehensive water monitoring, real-time leak detection, and advanced analytics powered by AI [6] Environmental Contributions - In 2023, WINT prevented over 900 water damage incidents, saving customers tens of millions of dollars and conserving 652 million gallons of water [7] - The company also prevented 22,000 metric tons of carbon emissions, contributing to sustainability goals [7]

Core Insights - Windtree Therapeutics, Inc. has appointed Leanne Kelly as an independent director and chair of the audit committee, enhancing the board's expertise [1][3] - Ms. Kelly brings over 20 years of experience in finance and management within the life sciences and technology sectors, having held various executive roles [2] - The company aims to become a revenue-generating biotech by acquiring small biotech firms with FDA-approved products, leveraging its equity for these acquisitions [3] Company Overview - Windtree Therapeutics focuses on developing innovative therapies for critical conditions, with a portfolio that includes istaroxime, a Phase II candidate for acute heart failure [3] - The company also has preclinical candidates targeting heart failure and oncology applications, alongside a licensing business model with existing partnerships [3]

Corporate Strategy - Windtree Therapeutics has launched a new corporate strategy aimed at becoming a revenue-generating biotech company through acquisitions of small companies with FDA-approved products while continuing to develop its cardiovascular and oncology pipeline [1][4] - The company sees an opportunity in acquiring small biotech firms that struggle with commercialization, intending to become a parent company that can optimize commercial performance across future subsidiaries [2][4] Acquisition Approach - Windtree plans to use equity to acquire subsidiaries, with the number of deals depending on the valuation and growth potential of the target companies [3] - The management team possesses commercialization expertise from both large pharmaceutical and small biotech sectors, which may help leverage synergies in future acquisitions [2][4] Product Pipeline - Windtree's product candidates include istaroxime, a Phase 2 candidate for acute heart failure, and preclinical candidates for heart failure and oncology applications [5]

Core Insights - Windtree Therapeutics, Inc. announced a presentation by Dr. Alexandre Mebazaa on istaroxime, highlighting data from the Phase 2b SEISMiC B study for early cardiogenic shock due to heart failure [1][4] - Istaroxime is a first-in-class investigational therapy aimed at improving cardiac function and increasing blood pressure, showing a favorable safety profile [3][5] Company Overview - Windtree Therapeutics focuses on innovative therapies for critical conditions, with a portfolio that includes istaroxime, which is currently in Phase 2 trials for acute heart failure and cardiogenic shock [6] - The company also develops preclinical SERCA2a activators for heart failure and aPKCi inhibitors for oncology applications, alongside a licensing business model [6] Clinical Data and Efficacy - Istaroxime has demonstrated significant improvements in systolic blood pressure and cardiac output without increasing heart rate or causing clinically significant arrhythmias [4][5] - The therapy has been studied in four positive Phase 2 trials, indicating its potential effectiveness in treating early cardiogenic shock [3][5]

WARRINGTON, Pa., Dec. 04, 2024 (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 that it has engaged New Growth Advisors (“NGA”), a leading life sciences consulting firm chosen by companies seeking discreet, conflict-free, and knowledgeable advice on complex M&A, asset sale, research, capital markets, and licensing transact ...

Core Viewpoint - Windtree Therapeutics, Inc. reported significant progress in its clinical studies and financial results for Q3 2024, highlighting advancements in its istaroxime therapy for cardiogenic shock and ongoing efforts to secure funding for future developments [2][3]. Financial Results - For Q3 2024, the company reported an operating loss of $4.7 million, consistent with the same period in 2023 [9]. - Research and development expenses were $2.0 million, slightly down from $2.1 million in Q3 2023, primarily related to the SEISMiC Extension trial [10]. - General and administrative expenses increased to $2.8 million from $2.6 million in Q3 2023 [11]. - The net loss attributable to common stockholders was $3.8 million ($4.23 per basic share), an improvement from a net loss of $4.4 million ($15.47 per basic share) in Q3 2023 [12]. Clinical Developments - The SEISMiC B study demonstrated significant improvements in cardiac function and blood pressure in heart failure patients with early cardiogenic shock, meeting its primary endpoint [3][6]. - The company initiated the SEISMiC C study to further evaluate istaroxime in SCAI Stage C cardiogenic shock, aiming to transition to Phase 3 trials [6]. Capital and Funding - Windtree completed two private placements in July 2024, raising approximately $13.9 million, which included $4.4 million in new funding [4]. - An equity line of credit was established, allowing the company to sell up to $35 million of newly issued shares [5]. Patent Developments - The company expanded its patent estate with new patents for istaroxime in cardiogenic shock and acute heart failure, including filings in major markets such as the U.S., Japan, and China [7][8].

Financial Performance and Losses - Net loss for the three and nine months ended September 30, 2024 was $2.7 million and $4.6 million, respectively, with a $7.5 million non-cash R&D expense related to the Varian asset acquisition and a $14.6 million gain on debt extinguishment[236] - The company reported a net loss of $4.55 million for the nine months ended September 30, 2024, compared to a net loss of $15.14 million in the same period in 2023[268] - A gain on debt extinguishment of $14.59 million was recorded for the nine months ended September 30, 2024[268] - The company recognized a $14.5 million non-cash gain on debt extinguishment related to the Exchange and Termination Agreement with Deerfield Management Company L.P.[284] - The company recognized a $14.5 million non-cash gain on debt extinguishment during the three months ended September 30, 2024, related to the Exchange and Termination Agreement with Deerfield[320] Accumulated Deficit and Financing - Accumulated deficit as of September 30, 2024 was $848.8 million, with financing primarily through private placements, public offerings, and borrowings[236] - The company expects to continue to incur operating losses for at least the next several years and had an accumulated deficit of $848.8 million as of September 30, 2024[293] - Management has concluded substantial doubt exists about the company's ability to continue as a going concern for at least 12 months, with plans to secure additional capital through public or private securities offerings, convertible debt financings, and strategic transactions[296] Research and Development Expenses - Research and development expenses for the nine months ended September 30, 2024, increased by $8.8 million compared to the same period in 2023[268] - Research and development expenses for the nine months ended September 30, 2024 increased by $8.8 million to $14.1 million, primarily due to a $7.5 million non-cash charge related to the acquired IPR&D from the Varian asset purchase[270] - The istaroxime – cardiogenic shock program costs increased by $2.1 million for the nine months ended September 30, 2024 compared to the same period in 2023, driven by trial execution costs for the SEISMiC Extension study and start-up procedures for the SEISMiC C study[273] - Total direct clinical and preclinical programs expenses increased by $2.2 million for the nine months ended September 30, 2024 compared to the same period in 2023, primarily due to the istaroxime – cardiogenic shock program[272] Clinical Trials and Studies - Istaroxime demonstrated significant improvement in systolic blood pressure and cardiac function in the SEISMiC Extension study, with enrollment for the SEISMiC C study expected to complete by late 2025[230][241][242] - The SEISMiC C study is expected to enroll up to 100 subjects with SCAI Stage C cardiogenic shock, with an unblinded review of data from the first 20 subjects planned for early Q2 2025[230][242] - Rostafuroxin demonstrated efficacy in Caucasian patients in a Phase 2b trial for treatment-naïve hypertension, but an additional Phase 2 trial is needed for African American patients with treatment-resistant hypertension[246] Strategic Partnerships and Licensing - The company is pursuing licensing arrangements and strategic partnerships for rostafuroxin, a novel product candidate for hypertension treatment in patients with a specific genetic profile[232] - The company has regional licensed partnerships with Lee's Pharmaceutical (HK) Ltd. for the development and commercialization of istaroxime and other cardiovascular assets in Greater China[233] - The company is actively exploring licensing transactions, research partnerships, or other strategic opportunities to advance SERCA2a activator candidates[245] Intellectual Property and Patents - The company holds patents for dual mechanism and pure SERCA2a activators, with protection extending until 2038 and 2039, respectively[245] - Intangible assets as of September 30, 2024, included $22.34 million for istaroxime and $2.91 million for rostafuroxin[259] Preclinical and Oncology Research - The topical formulation of aPKCi inhibitor (VAR-101) showed dose-dependent anti-tumor activity in murine and human basal cell carcinoma (BCC) cell lines, supported by preclinical data from Cancer Research UK[247] - The oral formulation of aPKCi inhibitor (VAR-102) demonstrated dose-dependent anti-tumor activity in a mouse model of non-small cell lung cancer (NSCLC)[248] - The company plans to advance investigational new drug enabling activities for the aPKCi inhibitor platform acquired from Varian, with potential applications in oncology and rare malignant diseases[235] Stock and Financing Activities - The company implemented a 1-for-18 reverse stock split on April 19, 2024, to regain compliance with Nasdaq's minimum bid price requirement[249][252] - The company regained compliance with Nasdaq's Rule 5550(a)(2) on May 6, 2024, following the reverse stock split[252] - The company sold 1.4 million shares of Common Stock under the ELOC Purchase Agreement for net proceeds of $3.1 million during the three months ended September 30, 2024[294] - The company completed two private placement transactions in July 2024 for aggregate gross proceeds of approximately $13.9 million, with net proceeds of $2.3 million[294] - The company entered into the ELOC Purchase Agreement in June 2024, allowing it to sell up to $35 million of newly issued shares of common stock over a 36-month period[306] - For the three months ended September 30, 2024, the company sold 1.4 million shares of common stock under the ELOC Purchase Agreement for gross proceeds of $4.4 million[307] - The company's April 2023 public offering resulted in gross proceeds of approximately $12.4 million, with net proceeds of $10.8 million after deducting underwriting discounts and commissions[311][312] - During the nine months ended September 30, 2024, the company sold 143,120 shares of common stock under the 2023 ATM Program, resulting in aggregate gross and net proceeds of approximately $1.4 million[317] Cash Flow and Liabilities - Net cash used in operating activities for the nine months ended September 30, 2024 was $11.7 million, primarily driven by a net loss of $4.6 million and a $14.6 million gain on debt extinguishment[299] - Net cash provided by financing activities for the nine months ended September 30, 2024 was $9.6 million, including $4.4 million from the ELOC Purchase Agreement and $3.9 million from private placements[302] - As of September 30, 2024, the company had cash and cash equivalents of $2.3 million and current liabilities of $14.4 million, including an $8.6 million warrant liability[295] - The company financed $0.5 million of insurance premiums in August 2024 at a 7.94% fixed annual interest rate, with monthly payments of approximately $56,000 due through May 2025[318] Goodwill and Intangible Assets - Goodwill impairment losses totaled $3.1 million for the nine months ended September 30, 2023, with goodwill written down to zero as of June 30, 2023[258] - Intangible assets as of September 30, 2024, included $22.34 million for istaroxime and $2.91 million for rostafuroxin[259] General and Administrative Expenses - Clinical, medical, and regulatory operations expenses decreased by $0.8 million for the nine months ended September 30, 2024 compared to the same period in 2023, due to a $0.7 million decrease in personnel costs and a $0.1 million decrease in non-cash stock-based compensation[280] - General and administrative expenses decreased by $0.8 million for the nine months ended September 30, 2024 compared to the same period in 2023, driven by reductions in personnel costs, severance costs, non-cash stock-based compensation, and insurance costs[283] Off-Balance Sheet Arrangements - The company did not have any material off-balance sheet arrangements as of September 30, 2024 or 2023[322]