Windtree Therapeutics Inc Stock Price, News & Analysis

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.

Windtree Therapeutics (WINT) has announced a 1-for-50 reverse stock split of its common stock, effective February 20, 2025, at 5:00 p.m. Eastern Time. The company's stock will begin trading on a split-adjusted basis on February 21, 2025, maintaining its 'WINT' ticker symbol on the Nasdaq Capital Market.

The reverse split aims to increase the stock price to meet Nasdaq's $1.00 minimum bid price requirement for continued listing. Following the split, outstanding shares will be reduced to approximately 700,000. Proportional adjustments will be made to equity awards, convertible securities, and warrants. No fractional shares will be issued, with affected stockholders receiving proportional cash payments.

The split was approved by stockholders on February 3, 2025. Stockholders holding shares in book-entry form or through brokers will have their positions automatically adjusted.

Windtree Therapeutics (WINT) announced a presentation of their istaroxime Phase 2b SEISMiC study at the Technology and Heart Failure Therapeutics Conference in Boston. The presentation, given by Dr. Matteo Pagnesi on February 11, 2025, focused on the drug's hemodynamic effects in patients with SCAI Stage B cardiogenic shock.

Istaroxime, a first-in-class investigational therapy, aims to improve cardiac function and increase blood pressure in early cardiogenic shock patients. The drug has shown positive results in four Phase 2 trials, demonstrating favorable safety profile and no detrimental effects on renal function. The company has prioritized cardiogenic shock as an initial indication target due to substantial unmet medical needs, as current treatments often have unwanted side effects and poor outcomes.

Windtree Therapeutics (NASDAQ: WINT) has secured a new Japanese patent (No. 7603605) for its oncology pipeline, specifically for inhibitors of atypical protein kinase C (aPKCi) in treating hedgehog pathway-dependent cancers. The patent will expire in 2040.

The company's aPKCi inhibitor platform represents a novel, high-potency drug candidate targeting various cancers, including basal cell carcinoma, medulloblastoma, rhabdomyosarcoma, and small cell lung cancer. The platform features both topical and oral formulations, developed in collaboration with Cancer Research UK and academic research centers. The patent claims also cover combination therapies using hedgehog pathway inhibitors with HDAC inhibitors for enhanced anti-cancer efficacy.