Windtree Therapeutics, Inc. (WINT) Stock Analysis

Why this analysis is different

• A 9-signal quantitative MoonshotScore built from filings, insider activity, and market data — computed from the numbers, not from opinion.
• An AI Council read across up to eight perspectives — value, macro, quantitative, and momentum lenses — that shows where they disagree instead of averaging the tension away.
• Figures come straight from FMP and Yahoo Finance filings data. The AI writes the narrative around the numbers — it never edits the numbers.

Windtree Therapeutics, Inc. (WINT) Healthcare & Pipeline Overview

Windtree Therapeutics, Inc. is a clinical-stage biopharmaceutical firm advancing a pipeline of therapies for acute cardiovascular and pulmonary conditions, including istaroxime for heart failure and AEROSURF for respiratory distress syndrome. The company leverages strategic collaborations to progress its drug candidates through various clinical trial phases.

What Is the Investment Thesis for WINT?

Windtree Therapeutics, Inc. presents a research-stage investment profile centered on its clinical pipeline targeting acute cardiovascular and pulmonary diseases, areas with significant unmet medical needs. The company's lead candidate, istaroxime, is progressing through Phase IIb trials for acute decompensated heart failure and Phase IIa for early cardiogenic shock, representing potential value drivers if successful. AEROSURF, an aerosolized KL4 surfactant, is also in Phase IIb for respiratory distress syndrome in preterm infants, offering a potentially differentiated delivery method. Strategic collaborations with entities like Universita degli Studi di Milano-Bicocca, Laboratorios del Dr. Esteve, S.A., and Battelle Memorial Institute enhance its development capabilities and potential commercialization pathways. However, as a clinical-stage biotechnology firm with a market capitalization of $0.00 billion and a profit margin of -44447.8%, the company's valuation is highly dependent on successful clinical trial outcomes, regulatory approvals, and future financing activities. The high beta of 1.60 indicates significant volatility, reflecting the inherent risks associated with drug development.

Based on FMP financials and quantitative analysis

WINT Key Highlights

The company maintains a negative profit margin of -44447.8%, indicative of its clinical-stage status and substantial R&D investments.

• Gross margin stands at 12.2%, reflecting the current operational structure which is not yet focused on large-scale product sales.
• Windtree Therapeutics, Inc. has a market capitalization of $0.00 billion, underscoring its early-stage valuation in the biotechnology sector.
• The stock exhibits a beta of 1.60, suggesting higher volatility compared to the broader market, typical for clinical-stage biopharmaceutical companies.
• The company's pipeline includes multiple therapeutic candidates in Phase II clinical trials, such as istaroxime and AEROSURF, signaling active drug development.

Who Are WINT's Competitors?

WINT is benchmarked below against 8 industry peers on price, market cap, and our AI MoonshotScore.

AI Score by Stock Expert AI · Price data: FMP / Yahoo Finance

What Are WINT's Key Strengths?

Diverse clinical pipeline addressing significant unmet medical needs in acute cardiovascular and pulmonary diseases.

• Lead candidates like istaroxime and AEROSURF are in mid-stage (Phase IIb) clinical development, indicating progress.
• Strategic collaborations with academic and industry partners enhance R&D capabilities and potential commercialization.
• Focus on novel mechanisms of action and delivery methods, such as aerosolized surfactant, offers differentiation.

What Are WINT's Weaknesses?

Clinical-stage company with no commercialized products, leading to negative profit margins and reliance on external financing.

• Small employee base of 14, which may limit the scope and speed of parallel development efforts.
• High beta of 1.60 indicates significant stock price volatility, reflecting inherent drug development risks.
• Operates as a subsidiary of Lee's Pharmaceutical Holdings Limited, which may influence strategic autonomy.

What Could Drive WINT Stock Higher?

WINT catalyst: Announcement of further clinical trial data or successful completion of Phase IIb trials for istaroxime in acute decompensated heart failure, which could validate its therapeutic potential.

• Positive interim or final results from the Phase IIb trial of AEROSURF for respiratory distress syndrome in preterm infants, potentially paving the way for late-stage development.
• Initiation or advancement of Phase III development for any of its lead drug candidates, signaling progress towards regulatory submission and commercialization.
• Formation of new strategic partnerships or expansion of existing collaborations for co-development, funding, or commercialization of its pipeline assets.
• Continued progress in the Phase IIa trial of istaroxime for early cardiogenic shock, which could expand its target patient population and market opportunity.

What Are the Key Risks for WINT?

Weak fundamentals — a Piotroski F-Score of 3/9 flags soft profitability, leverage or efficiency.

• Clinical trial failures for any of its drug candidates (istaroxime, AEROSURF, Lyophilized KL4 surfactant, Rostafuroxin) would significantly jeopardize the company's future prospects and valuation.
• Inability to secure adequate future financing to fund ongoing and future clinical trials, potentially leading to delays, scaling back of programs, or dilution of existing shareholders.
• Regulatory hurdles and lengthy approval processes by health authorities, which could delay or prevent the commercialization of its therapeutic candidates even with positive clinical data.
• Intense competition from larger pharmaceutical companies with greater financial resources and established market presence in cardiovascular and pulmonary therapeutic areas.
• The inherent risks associated with trading on the 'OTC Other' market, including limited liquidity, high volatility, and reduced transparency, which can impact investor confidence and stock performance.

What Are the Growth Opportunities for WINT?

• Successful advancement of istaroxime for acute decompensated heart failure and early cardiogenic shock represents a significant growth opportunity. The market for heart failure treatments is substantial, driven by an aging global population and increasing prevalence of cardiovascular diseases. Istaroxime's progression through Phase IIb and Phase IIa trials, respectively, positions it to potentially address a critical need for improved acute care options. Positive clinical outcomes and subsequent regulatory approvals could unlock access to a multi-billion dollar market, offering a novel mechanism of action to improve cardiac function in these severe conditions.
• The development of AEROSURF, an aerosolized KL4 surfactant for respiratory distress syndrome (RDS) in preterm infants, offers another substantial growth pathway. RDS remains a leading cause of morbidity and mortality in premature infants, and current surfactant delivery methods can be invasive. AEROSURF's aerosolized delivery system, currently in Phase IIb, aims to provide a less invasive and potentially more effective treatment. Successful clinical development and commercialization could capture a significant share of the global neonatal respiratory care market, which is continuously seeking safer and more patient-friendly interventions for vulnerable populations.
• Windtree's Lyophilized KL4 surfactant, in Phase IIa trials for lung injury stemming from COVID-19, addresses an ongoing global health challenge. While the acute phase of the pandemic may have subsided, the long-term sequelae of lung injury from viral infections, including COVID-19, represent a persistent medical need. Successful development and regulatory approval for this indication could position Windtree to provide a critical therapy for patients experiencing severe pulmonary complications, tapping into a market driven by both current and future respiratory viral outbreaks and associated lung damage.
• The advancement of Rostafuroxin in Phase IIb for genetically associated hypertension presents a targeted growth opportunity. Hypertension, particularly forms with a genetic component, can be challenging to manage with existing broad-spectrum treatments. A therapy specifically designed for genetically associated hypertension could offer a more personalized and effective approach for a subset of patients. Successful clinical development and market entry would allow Windtree to address a specific, underserved segment within the vast global hypertension market, potentially improving patient outcomes and establishing a niche for precision medicine in cardiovascular care.
• The collaboration with Universita degli Studi di Milano-Bicocca for novel SERCA2a compounds targeting chronic and acute human heart failure provides a long-term growth avenue. SERCA2a activation is a promising therapeutic strategy for improving cardiac contractility and relaxation. This early-stage discovery and advancement program could yield next-generation heart failure therapies beyond istaroxime. Successful identification and development of these compounds could diversify Windtree's pipeline, secure future intellectual property, and position the company at the forefront of innovative heart failure treatments, tapping into the sustained demand for advanced cardiovascular therapeutics.

What Are WINT's Competitive Advantages?

• Proprietary drug candidates like istaroxime, AEROSURF, and Rostafuroxin, which represent novel mechanisms of action or delivery methods.
• Extensive clinical trial data generated from ongoing Phase II studies, providing a foundation for regulatory submissions and market differentiation.
• Strategic collaborations with academic institutions and pharmaceutical partners, enhancing R&D capabilities and potential commercial reach.
• Intellectual property protection surrounding its therapeutic compounds and delivery technologies, offering a period of market exclusivity upon approval.

What Does WINT Do?

Windtree Therapeutics, Inc. is a clinical-stage biopharmaceutical company headquartered in Warrington, Pennsylvania, dedicated to the development of novel therapies for acute cardiovascular and, secondarily, acute pulmonary diseases. Established in 1992 as Discovery Laboratories, Inc., the company underwent a significant rebranding in April 2016 to become Windtree Therapeutics, Inc., reflecting its evolving strategic focus. Operating as a subsidiary of Lee's Pharmaceutical Holdings Limited, Windtree is distinguished by its diverse pipeline of therapeutic programs, each addressing areas of significant unmet medical need. Key among these is istaroxime, currently in Phase IIb clinical trials for acute decompensated heart failure and Phase IIa for early cardiogenic shock, targeting critical cardiac conditions. For acute pulmonary indications, the company is developing AEROSURF, an aerosolized KL4 surfactant, which is in Phase IIb for respiratory distress syndrome in preterm infants, aiming to provide a less invasive treatment option. Additionally, a Lyophilized KL4 surfactant is in Phase IIa trials for lung injury associated with COVID-19, addressing complications from viral infections. Another promising candidate is Rostafuroxin, undergoing Phase IIb for genetically associated hypertension. Windtree Therapeutics actively fosters strategic collaborations to accelerate its research and development efforts. These include a partnership with Universita degli Studi di Milano-Bicocca for the discovery and advancement of novel SERCA2a compounds for chronic and acute human heart failure, and a strategic alliance with Laboratorios del Dr. Esteve, S.A. for the development, marketing, and commercialization of its KL4 surfactant products. Furthermore, a collaboration with Battelle Memorial Institute supports the development of its ADS for its Phase III program, underscoring the company's commitment to advancing its pipeline through external expertise and resources.

What Products and Services Does WINT Offer?

• Develops therapies for acute cardiovascular ailments, including acute decompensated heart failure and early cardiogenic shock.
• Develops therapies for acute pulmonary diseases, such as respiratory distress syndrome in preterm infants and lung injury from COVID-19.
• Conducts Phase IIb clinical trials for istaroxime in acute decompensated heart failure.
• Conducts Phase IIa clinical trials for istaroxime in early cardiogenic shock.
• Conducts Phase IIb clinical trials for AEROSURF, an aerosolized KL4 surfactant, for respiratory distress syndrome.
• Conducts Phase IIa clinical trials for Lyophilized KL4 surfactant for lung injury stemming from COVID-19.
• Conducts Phase IIb clinical trials for Rostafuroxin for genetically associated hypertension.
• Engages in collaborations for drug discovery and development, including with Universita degli Studi di Milano-Bicocca and Laboratorios del Dr. Esteve, S.A.

How Does WINT Make Money?

• Primarily a clinical-stage biopharmaceutical company focused on research and development of drug candidates.
• Future revenue generation is contingent upon successful completion of clinical trials, regulatory approvals, and subsequent commercialization or out-licensing of its therapeutic products.
• Relies on strategic alliances and collaborations for co-development, marketing, and commercialization of its product portfolio.
• Funding for operations typically comes from equity financing, grants, and milestone payments from partnerships, rather than direct product sales at its current stage.

What Industry Does WINT Operate In?

Windtree Therapeutics, Inc. operates within the highly specialized and capital-intensive biotechnology industry, specifically focusing on acute cardiovascular and pulmonary diseases. This sector is characterized by lengthy and costly research and development cycles, stringent regulatory hurdles, and a high rate of clinical trial failures. The company's positioning is defined by its pursuit of novel therapies for conditions like acute decompensated heart failure, cardiogenic shock, and respiratory distress syndrome in preterm infants, which represent significant unmet medical needs. The competitive landscape includes both large pharmaceutical companies with established R&D budgets and numerous smaller biotech firms vying for breakthroughs in similar therapeutic areas. Windtree's strategy involves leveraging its proprietary drug candidates and strategic collaborations to carve out a niche, aiming to address critical conditions where current treatments may be insufficient or invasive. Success in this industry is heavily reliant on clinical data, intellectual property, and effective navigation of the regulatory approval process.

Who Are WINT's Key Customers?

• Future customers will include healthcare providers, such as hospitals and clinics, treating patients with acute cardiovascular diseases.
• Future customers will include neonatologists and pediatric intensivists caring for preterm infants with respiratory distress syndrome.
• Future customers will include pulmonologists and critical care specialists managing lung injury from viral infections.
• Potential licensing partners and pharmaceutical companies seeking to expand their portfolios in cardiovascular and pulmonary therapeutics.

Company Profile

Windtree Therapeutics, Inc. operates in the Biotechnology industry within the Healthcare sector. It is headquartered in Warrington, US. The company is led by CEO Jed A. Latkin. WINT has traded publicly since 1995.

Windtree Therapeutics, Inc. (WINT) Valuation Context

Relative to its peer group, WINT's quantitative score of 46/100 is below the peer average of 76/100.

Windtree Therapeutics, Inc.'s Piotroski F-Score is 3/9, a 9-point checklist of profitability, leverage and efficiency — flagging fundamental weakness worth scrutiny.

Wall Street analysts project Windtree Therapeutics, Inc. revenue of about $12.4M for fiscal 2026, with EPS near $-549.00.

WINT Financials

WINT Latest News

No recent news available for WINT.

WINT Analyst Consensus

WINT MoonshotScore

WINT Healthcare Stock FAQ

Disclaimer: This content is for informational purposes only and does not constitute investment advice. Always do your own research and consult a financial advisor.

Official Resources