Windtree Therapeutics(US:WINT)2025-11-19 22:01Financial Performance - The company reported a net loss of $28.1 million and $42.8 million for the three and nine months ended September 30, 2025, compared to a net loss of $2.7 million and $4.6 million for the same periods in 2024, resulting in an accumulated deficit of $889.4 million as of September 30, 2025[207]. - The net loss for the three months ended September 30, 2025, was $28,085,000, an increase of $25,336,000 (approximately 922.5%) compared to a net loss of $2,749,000 in 2024[237]. - For the three and nine months ended September 30, 2025, the net loss was $28.1 million and $42.3 million, respectively, compared to $2.7 million and $4.6 million for the same periods in 2024, indicating a significant increase in losses[261]. - As of September 30, 2025, the company had cash and cash equivalents of $0.2 million and current liabilities of $21.9 million, raising substantial doubt about its ability to continue as a going concern[263]. - The accumulated deficit as of September 30, 2025, was $889.4 million, reflecting ongoing financial challenges[261]. - Cash used in operating activities was $11.4 million, a slight decrease from $11.7 million in the same period of 2024[266]. - Net cash provided by financing activities for the nine months ended September 30, 2025, was $15.8 million, primarily from private placement notes and the ELOC Purchase Agreement[268]. - The company recognized an income tax benefit of $3.4 million for the three and nine months ended September 30, 2025, due to the reversal of deferred taxes related to an intangible asset impairment charge of $16.0 million[258]. - During the nine months ended September 30, 2025, the company sold 21.9 million shares of common stock under the ELOC Purchase Agreement for gross proceeds of $15.8 million[273]. - Cash used in investing activities for the nine months ended September 30, 2025, was $5.972 million, primarily due to senior note receivable issuance and a deposit on property[267]. Research and Development - Istaroxime, the lead product candidate, demonstrated significant improvement in systolic blood pressure (SBP) and cardiac function in Phase 2 clinical trials, leading to the initiation of a global Phase 2 study for early cardiogenic shock[201]. - The SEISMiC Extension study showed positive topline results, with significant improvements in SBP and cardiac function in patients with SCAI Stage B cardiogenic shock, supporting the dosing regimen optimization[213]. - The company plans to pursue further development of istaroxime in less severe acute decompensated heart failure, with a global Phase 3 study planned in collaboration with Lee's Pharmaceutical (HK) Ltd.[201]. - Istaroxime is being advanced as the lead indication for cardiogenic shock, with plans to potentially enter Phase 3 for acute decompensated heart failure in the normal to low SBP population[214]. - Research and development expenses for the three months ended September 30, 2025, were $1,897,000, a decrease of $71,000 (approximately 3.6%) compared to $1,968,000 in 2024[239]. - Research and development expenses related to the istaroxime – cardiogenic shock program are expected to continue increasing as the SEISMiC C study progresses[238]. - Total direct clinical and preclinical program expenses decreased by $0.2 million for the nine months ended September 30, 2025, compared to the same period in 2024[241]. - Product development and manufacturing expenses increased by $0.1 million for the nine months ended September 30, 2025, due to increased quality assurance costs[245]. - Clinical, medical, and regulatory operations expenses decreased by $0.1 million for the three and nine months ended September 30, 2025, compared to the same period in 2024[247]. Corporate Strategy and Partnerships - The company launched a new corporate strategy in January 2025 to become a revenue-generating biotech company through acquisitions of small companies with FDA-approved products[204]. - The company is actively seeking partnerships to support the advancement and commercialization of its biotechnology pipeline, which may lower or eliminate development costs[211]. - The company intends to secure additional capital through partnerships, public or private securities offerings, and strategic opportunities to advance its development programs[209]. - The company is seeking partnership opportunities to fund its clinical trial in acute decompensated heart failure due to insufficient capital[214]. - The company is actively exploring licensing transactions and strategic partnerships for its product candidates, including rostafuroxin[216]. - The cardiovascular portfolio includes next-generation SERCA2a activators and rostafuroxin, with plans to pursue licensing arrangements for further development[202]. - An Asset Purchase Agreement was entered into with Varian Biopharmaceuticals, Inc. in April 2024, acquiring assets related to a novel aPKCi inhibitor for potential oncology applications[206]. - The company became the manufacturing sourcing agent for Evofem's FDA-approved product Phexxi® in March 2025 and signed a manufacturing deal with Zhoake (Hong Kong) Ophthalmology Pharmaceutical Limited in June 2025[198]. Regulatory and Compliance - The company received a deficiency letter from Nasdaq for not meeting the minimum bid price requirement of $1.00 per share, leading to a delisting notification[222]. - The number of authorized shares was increased from 125 million to 1 billion, consisting of 995 million common shares and 5 million preferred shares[224]. - The European Patent Office granted Patent No. 3599243 for dual mechanism SERCA2a Activator candidates, providing protection until July 2038[215]. Operational Challenges - The company is monitoring global economic conditions and potential impacts on operations related to international trade policies and supply chain dynamics[236]. - The company recorded losses on impairment of long-lived intangible assets of $16.1 million during Q3 2025 due to declining share prices and strategic decisions[231]. - As of September 30, 2025, the identifiable intangible assets totaled $8 million, down from $24.13 million as of December 31, 2024[232]. - Total operating expenses for the three months ended September 30, 2025, were $19,882,000, an increase of $15,141,000 (approximately 318.5%) compared to $4,741,000 in 2024[237]. - The company incurred a loss on debt issuance of $14,965,000 related to the $10,000,000 July 2025 ELOC commitment note[250]. - The total other income (expense), net, for the three months ended September 30, 2025, was $(11,634,000), a decrease of $13,386,000 compared to $1,752,000 in 2024[250].