Windtree rapidly advancing lower cost PHEXXI manufacturing under March 2025 sourcing agreement Contract inked with outside U.S manufacturer to cut PHEXXI manufacturing costs by over 50% by end of 2026 Tech transfer underway with validation batch manufacturing expected to begin in 2026 Evofem and Windtree exploring other partnerships WARRINGTON, Pa., June 26, 2025 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or “the Company”) (Nasdaq: WINT) today announced that it has contracted with a pharma ...

-- BV Market Projected to Reach $1.0 Billion in the U.S. by 2033 -- -- BV Affects 21 Million U.S. Women; As many as 50% Experience Recurrent BV Within Six Months of Treatment -- SAN DIEGO, June 11, 2025 /PRNewswire/ -- Women's health innovator Evofem Biosciences, Inc. (OTCPK: EVFM) today announced that a study of SOLOSEC® (secnidazole) 2 g oral granules for recurrent bacterial vaginosis (BV) presented at the 2025 American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeti ...

Core Viewpoint - Evofem Biosciences and Pharma 1 have entered into a License and Supply Agreement for the commercialization of SOLOSEC in the Middle East, targeting regulatory submission in the UAE by mid-2025 [1][2][4] Group 1: Agreement Details - The agreement includes an upfront payment, milestone payments based on regulatory achievements, and sales-based milestone payments to Evofem for the exclusive rights to SOLOSEC in the region [2] - Pharma 1 will be responsible for obtaining regulatory approvals and managing all commercial functions related to SOLOSEC in the Middle East [7] Group 2: Market Opportunity - Bacterial vaginosis (BV) and trichomoniasis are prevalent in the Gulf Cooperation Council (GCC) region, with BV affecting 25% to 41% of women in the MENA region, translating to approximately 1.0 million to 1.7 million women in the UAE alone [4][6] - Trichomoniasis has an estimated prevalence of 4.7% among women in the MENA region, with higher rates in intermediate- and high-risk populations [6] Group 3: Product Information - SOLOSEC is an FDA-approved single-dose oral treatment for BV and trichomoniasis, providing a complete course of therapy in just one dose [11] - The product is manufactured in the United States, which enhances its appeal in markets where quality and regulatory trust are critical [3]

WARRINGTON, Pa., May 16, 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, today reported financial results for the first quarter ended March 31, 2025 and provided key business updates. “The first quarter of 2025 was marked with significant progress. We announced our new corporate strategy to become a reve ...

Core Insights - Evofem Biosciences reported a decrease in net sales for Q1 2025, totaling $0.8 million compared to $3.6 million in Q1 2024, attributed to order timing and magnitude shifts for PHEXXI [3][4] - The company achieved a net income of $1.0 million in Q1 2025, a significant improvement from a net loss of $4.9 million in the same quarter of the previous year [4] - Evofem's operating expenses decreased to $0.5 million in Q1 2025 from $6.4 million in Q1 2024, primarily due to reduced research and development costs [3][7] Financial Performance - Net sales for Q1 2025 were $0.8 million, down from $3.6 million in Q1 2024, reflecting a shift in order timing for PHEXXI [3] - Total operating expenses were $0.5 million in Q1 2025, significantly lower than $6.4 million in the prior year [3] - Income from operations was $0.3 million in Q1 2025, compared to a loss of $2.8 million in Q1 2024 [4] Income and Earnings - Net income attributable to common stockholders was $1.0 million in Q1 2025, equating to $0.01 per basic share, compared to a net loss of $4.9 million or $(0.16) per share in Q1 2024 [4][14] - The company recorded a significant reduction in research and development expenses, down by $5.6 million due to successful negotiations with vendors [7] Liquidity and Cash Position - As of March 31, 2025, the company had cash, cash equivalents, and restricted cash totaling $1.1 million, an increase from $0.7 million at the end of 2024 [5] - In April 2025, Evofem raised $1.5 million from the sale of senior subordinated notes and warrants [6][8] Strategic Developments - Evofem is partnering with Windtree Therapeutics to reduce PHEXXI manufacturing costs by 55% to 60% [6] - The company strengthened its intellectual property with the issuance of the 11th U.S. patent for SOLOSEC, extending coverage to 2040 [6] - Evofem is expanding into global markets, including a planned launch of PHEXXI in the UAE in early 2026 through a partnership with Pharma 1 Drug Store LLC [10]

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 ...