Windtree Therapeutics Inc Stock Price, News & Analysis

Windtree Therapeutics (NASDAQ: WINT) has announced potential U.S. exclusivity strategies for its drug candidate istaroxime in treating cardiogenic shock. If granted New Chemical Entity (NCE) designation by the FDA, istaroxime could receive 7.5 years of U.S. market exclusivity upon approval. The company also holds a U.S. method of use patent extending protection until 2039, with a pending patent that could provide coverage until 2043.

The company is currently conducting the SEISMiC C Phase 2 study, a global placebo-controlled trial evaluating istaroxime in SCAI Stage C cardiogenic shock patients. The study's primary endpoint focuses on systolic blood pressure profile over 6 hours of treatment, with an interim analysis planned for Q3 2025.

Windtree Therapeutics (WINT) has entered an Assignment and Conditional Assumption Agreement to acquire a 436-unit multifamily residential property in Houston, Texas. This strategic move marks a shift in the company's strategy to become revenue-generating while continuing its biotech pipeline development. The acquisition, planned for May 23, 2025, will be primarily funded through non-recourse secured mortgage financing and preferred stock issuance.

The company has the option to extend the closing date for two 30-day periods. The deal is contingent upon satisfactory due diligence and financing terms. Windtree's new corporate strategy includes acquiring revenue-generating assets, including small biotech companies with FDA-approved products, while maintaining its focus on cardiovascular and oncology drug development.

Windtree Therapeutics (WINT) reported its fiscal year 2024 results and key business updates. The company announced positive results from its Phase 2 SEISMiC Extension Study of istaroxime in early cardiogenic shock treatment and initiated the global SEISMiC C trial for more severe cases.

Financial highlights include R&D expenses of $16.3 million (up from $8.3 million in 2023) and reduced G&A expenses of $8.7 million (down from $9.2 million). The company reported a net loss of $1.8 million for 2024, significantly improved from a $20.3 million loss in 2023.

Key developments include a new corporate strategy to become revenue-generating through acquisitions of FDA-approved products, a licensing partnership with Lee's Pharmaceutical for Greater China, and patent developments for istaroxime. Cash position stands at $1.8 million as of December 31, 2024, with funding expected to last through April 2025.

Evofem Biosciences (OTCQB: EVFM) has entered into a License and Supply Agreement with Windtree Therapeutics (NasdaqCM: WINT) to reduce manufacturing costs of PHEXXI, their FDA-approved hormone-free contraceptive vaginal gel. The partnership is expected to decrease PHEXXI's manufacturing costs by 55% to 60% from current levels, with no tech transfer costs to Evofem.

PHEXXI, which prevents pregnancy by maintaining normal vaginal pH levels inhospitable to sperm, will benefit from Windtree's manufacturing contacts to achieve lower production costs. This cost reduction aims to facilitate PHEXXI's global expansion into price-sensitive markets where non-hormonal contraceptives are in demand.

Evofem maintains ownership and continues U.S. commercialization through its sales team, while pursuing international expansion through strategic partnerships, including a July 2024 license agreement with Pharma 1 Drug Store for UAE market entry.

Evofem Biosciences (OTCQB: EVFM) reported its financial results for Q4 and full-year 2024, marking its fourth consecutive year of net sales growth. The company achieved $19.4 million in net sales for 2024, a 6% increase from 2023, primarily driven by PHEXXI® sales and improved gross-to-net ratio.

Key operational highlights include:

• Total operating expense reduced by 27% to $26.4 million (excluding SOLOSEC amortization)
• Sales and marketing expense at 47% of net sales for 2024, the best ratio since PHEXXI's launch
• Loss from operations improved by 57% to $7.7 million
• Revenue stream diversified through SOLOSEC® acquisition in July 2024

The company entered a fifth amendment to the merger agreement with Aditxt (NASDAQ: ADTX), requiring $1.5 million funding by April 7, 2025, and merger consummation by September 30, 2025. Additionally, Evofem partnered with Windtree Therapeutics to reduce PHEXXI manufacturing costs.

Windtree Therapeutics (WINT) has successfully regained compliance with Nasdaq's minimum bid price requirement, following a notice of non-compliance received on December 4, 2024. The biotechnology company, which focuses on developing innovative therapies for critical conditions, had failed to maintain a closing bid price of $1.00 or more for 30 consecutive trading days.

To regain compliance, WINT needed to maintain a minimum closing bid price of $1.00 or more for at least 10 consecutive trading days. The company achieved this requirement, maintaining the required bid price since February 21, 2025. Windtree will remain under a mandatory panel monitor until March 20, 2026.

Windtree Therapeutics (WINT) has signed a License and Supply Agreement to become the sourcing partner for Evofem Biosciences' FDA-approved product PHEXXI®, a first-in-class hormone-free contraceptive vaginal gel. This partnership aligns with Windtree's new corporate strategy announced in January 2025 to become a revenue-generating biotech.

PHEXXI generated over $19 million in annual revenues with more than 96,000 boxes sold in 2024. Through its manufacturing contacts, Windtree aims to significantly reduce PHEXXI's production costs, while Evofem maintains asset ownership and continues commercialization efforts in the US and internationally.

The partnership focuses on making PHEXXI more accessible in price-sensitive global markets by decreasing per-box manufacturing costs. Windtree will work with a pharmaceutical manufacturer to handle tech transfer and produce initial and validation batches according to FDA requirements.

Windtree Therapeutics (WINT) has received a Notice of Allowance from the U.S. Patent and Trademark Office for its patent application number 18/150,870, focused on an istaroxime-containing intravenous formulation for treating acute heart failure (AHF).

The patent strengthens Windtree's intellectual property strategy for istaroxime in the U.S. market. According to CEO Jed Latkin, AHF affects millions of patients globally and poses significant healthcare system costs, highlighting the need for drug innovation in this space.

Windtree Therapeutics (NASDAQ: WINT) has filed a national phase patent application in India for istaroxime, targeting the prevention and reduction of acute myocardial arrhythmia risks. The patent application, claiming priority to PCT/US2024/058923, focuses on treating irregular heartbeats that can affect heart pumping function.

The filing is particularly significant as it covers India's population of over 1.4 billion people. The patent application is part of Windtree's strategic intellectual property plan as the company prepares for Phase 3 readiness in cardiogenic shock. The technology addresses arrhythmias in patients with heart failure and cardiomyopathy, which can be caused by underlying cardiac disease or heart failure treatments like catecholamines.