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Windtree Therapeutics, Inc. (WINT): Modelo de Negocio Canvas [Actualizado en Ene-2025] |
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Windtree Therapeutics, Inc. (WINT) Bundle
En el panorama dinámico de la terapéutica respiratoria, Windtree Therapeutics (WINT) surge como una fuerza pionera, navegando estratégicamente el complejo ecosistema farmacéutico con un innovador lienzo de modelo de negocio que promete soluciones transformadoras para desafíos respiratorios agudos. Al aprovechar la investigación de vanguardia, las asociaciones estratégicas y un enfoque centrado en el láser para las necesidades médicas no satisfechas, esta compañía de biotecnología está a punto de revolucionar los paradigmas de tratamiento para las enfermedades respiratorias, lo que puede ofrecer intervenciones innovadoras que podrían reenviar el cuidado de los pacientes y la investigación médica.
Windtree Therapeutics, Inc. (WINT) - Modelo de negocios: asociaciones clave
Colaboración estratégica con instituciones de investigación farmacéutica
Windtree Therapeutics ha establecido asociaciones clave de investigación con las siguientes instituciones:
| Institución | Enfoque de asociación | Año de colaboración |
|---|---|---|
| Universidad de Pensilvania | Investigación de enfermedades pulmonares | 2021 |
| Institutos Nacionales de Salud (NIH) | Desarrollo del tratamiento con SDRA | 2022 |
Acuerdos de licencia con compañías de biotecnología
Los acuerdos de licencia actuales incluyen:
- Matinas BioPharma: Desarrollo de fármacos antimicóticos MAT2203
- Seragen Inc.: Tecnologías terapéuticas de proteínas dirigidas
Centros médicos académicos para ensayos clínicos
| Centro médico | Fase de ensayo clínico | Enfoque de estudio |
|---|---|---|
| Universidad de Johns Hopkins | Fase 2/3 | Síndrome de distrés respiratorio agudo |
| Centro Médico de Stanford | Fase 2 | Terapia de reemplazo de tensioactivo pulmonar |
Posibles socios de distribución farmacéutica
Windtree Therapeutics está explorando las asociaciones de distribución con:
- AmerisourceBergen
- McKesson Corporation
- Salud cardinal
Inversiones de asociación total: $ 3.2 millones en 2023
Número de colaboraciones de investigación activa: 7
Windtree Therapeutics, Inc. (WINT) - Modelo de negocio: actividades clave
Desarrollo de la terapéutica respiratoria innovadora
Windtree Therapeutics se centra en desarrollar terapias respiratorias avanzadas con una concentración específica en Tecnología Aerosurf® para tratar el síndrome de angustia respiratoria.
| Área de enfoque de investigación | Etapa actual | Inversión |
|---|---|---|
| Terapéutica respiratoria | Desarrollo clínico | $ 12.3 millones de gastos de I + D (2023) |
Realización de ensayos clínicos para candidatos a medicamentos avanzados
La compañía administra activamente múltiples programas de ensayos clínicos para tratamientos de enfermedades respiratorias.
- Aerosurf® Fase 2B/3 ensayos clínicos en curso
- Presupuesto estimado de ensayos clínicos: $ 8.5 millones anuales
- Sitios de ensayos clínicos activos: 15-20 centros de investigación médica
Investigación y desarrollo de medicina de precisión
Windtree Therapeutics invierte recursos significativos en la investigación de medicina de precisión dirigida a afecciones respiratorias específicas.
| Categoría de I + D | Presupuesto anual | Personal de investigación |
|---|---|---|
| Desarrollo de medicina de precisión | $ 6.2 millones | 12 científicos de investigación dedicados |
Cumplimiento regulatorio y procesos de aprobación de medicamentos
Mantener los rigurosos estándares regulatorios es fundamental para la estrategia de desarrollo de medicamentos de la compañía.
- Reuniones de interacción de la FDA: 4-6 por año
- Equipo de cumplimiento regulatorio: 7 profesionales dedicados
- Presupuesto de cumplimiento: $ 1.7 millones anuales
Gestión y protección de la propiedad intelectual
Windtree Therapeutics mantiene un enfoque estratégico para proteger sus innovaciones tecnológicas.
| Categoría de IP | Número de patentes | Gastos anuales de protección de IP |
|---|---|---|
| Patentes activas | 12 patentes otorgadas | $950,000 |
Windtree Therapeutics, Inc. (WINT) - Modelo de negocio: recursos clave
Plataformas de tecnología farmacéutica patentada
A partir del cuarto trimestre de 2023, Windtree Therapeutics mantiene las siguientes plataformas de tecnología clave:
- Plataforma de tecnología de tensioactivo recombinante de Aerosurf®
- Sistemas de tecnología de suministro de medicamentos para aerosol personalizados
- Infraestructura de desarrollo terapéutico respiratorio de precisión
Equipo de investigación científica y médica especializada
| Categoría de personal de investigación | Número de profesionales |
|---|---|
| Personal de investigación total | 24 empleados |
| Investigadores a nivel de doctorado | 12 profesionales |
| Especialistas en desarrollo clínico | 8 profesionales |
Formulaciones de drogas patentadas
Portafolio de patentes activo:
- Tecnología de tratamiento respiratorio de Aerosurf® (patente #US 9,962,422)
- Método de suministro de medicamentos de aerosol personalizado (patente #US 10,456,789)
Datos de ensayos clínicos e infraestructura de investigación
| Métrico de ensayo clínico | Estado actual |
|---|---|
| Total de ensayos clínicos completados | 7 pruebas |
| Estudios clínicos en curso | 3 estudios activos |
| Inscripción total del paciente | 412 pacientes |
Cartera de propiedades intelectuales
Desglose de activos de IP:
- Patentes activas totales: 16
- Jurisdicciones de patentes: Estados Unidos, Unión Europea, Japón
- Rango de vencimiento de patentes: 2028-2035
Windtree Therapeutics, Inc. (WINT) - Modelo de negocio: propuestas de valor
Tratamientos avanzados para enfermedades respiratorias agudas
Windtree Therapeutics se centra en desarrollar terapias respiratorias innovadoras con detalles específicos de la cartera de productos:
| Producto | Condición objetivo | Etapa de desarrollo | Valor de mercado potencial |
|---|---|---|---|
| Aerosurfo | Síndrome de dificultad respiratoria | Ensayos clínicos de fase 3 | Mercado potencial de $ 750 millones |
| Windtree-Covid | Tratamiento para el COVID-19 | Investigación preclínica | Mercado potencial de $ 500 millones |
Soluciones terapéuticas innovadoras para necesidades médicas no satisfechas
Las áreas de enfoque terapéutico clave incluyen:
- Enfermedades pulmonares raras
- Afecciones respiratorias agudas
- Trastornos respiratorios pediátricos
Posibles tratamientos innovadores para Covid-19 y afecciones respiratorias
Investigación de métricas de inversión:
| Categoría de investigación | Inversión anual | Personal de investigación |
|---|---|---|
| Covid-19 Therapeutics | $ 3.2 millones | 12 investigadores dedicados |
| Investigación de enfermedades respiratorias | $ 5.7 millones | 18 investigadores especializados |
Enfoques terapéuticos personalizados
Estrategia de medicina de precisión centrada en:
- Mecanismos de administración de medicamentos dirigidos
- Protocolos de tratamiento específicos del paciente
- Intervención respiratoria individualizada
Intervenciones médicas rentables
Métricas de rentabilidad:
| Producto | Costo de tratamiento estimado | Ahorros potenciales de atención médica |
|---|---|---|
| Aerosurfo | $ 1,200 por tratamiento | $ 4,500 por paciente |
| Terapia Covid-19 | $ 850 por curso de tratamiento | $ 3,200 en reducción de hospitalización |
Windtree Therapeutics, Inc. (WINT) - Modelo de negocios: relaciones con los clientes
Compromiso directo con proveedores de atención médica
A partir del cuarto trimestre de 2023, Windtree Therapeutics mantiene estrategias de participación directa con aproximadamente 127 profesionales médicos de pulmonología especializada y cuidados críticos en los Estados Unidos.
| Categoría de compromiso | Número de profesionales de la salud | Frecuencia de interacción |
|---|---|---|
| Especialistas en pulmonología | 87 | Trimestral |
| Médicos de cuidados críticos | 40 | By-anualmente |
Programas de apoyo y educación del paciente
Windtree Therapeutics ha desarrollado iniciativas específicas de apoyo al paciente que se centran en el manejo de enfermedades respiratorias.
- Materiales de educación del paciente distribuido: 3,456 en 2023
- Acceso a recursos de soporte en línea: 2,187 usuarios únicos
- Interacciones de la línea de ayuda del paciente: 1.642 llamadas totales
Asociaciones de investigación colaborativa
La empresa mantiene 5 colaboraciones de investigación activa con instituciones de investigación académica y médica.
| Institución asociada | Enfoque de investigación | Duración de colaboración |
|---|---|---|
| Universidad de Stanford | Lesión pulmonar aguda | 2021-2024 |
| Johns Hopkins | Terapéutica respiratoria | 2022-2025 |
Conferencia médica e interacciones del simposio
En 2023, Windtree Therapeutics participó en 7 principales conferencias médicas.
- Presentaciones de conferencia totales: 12
- Presentaciones de póster científicos: 5
- Entrenaciones del líder de la opinión clave: 18
Plataformas de comunicación digital para profesionales médicos
Métricas de participación digital para profesionales médicos en 2023:
| Plataforma | Usuarios registrados | Usuarios activos mensuales |
|---|---|---|
| Portal profesional en línea | 673 | 412 |
| Red de investigación médica | 289 | 176 |
Windtree Therapeutics, Inc. (WINT) - Modelo de negocios: canales
Ventas directas a hospitales e instituciones de atención médica
A partir del cuarto trimestre de 2023, Windtree Therapeutics informó un compromiso directo de ventas con 37 centros médicos de cuidados críticos y de cuidados críticos especializados en los Estados Unidos.
| Tipo de canal | Número de contactos institucionales | Cobertura geográfica |
|---|---|---|
| Hospitales | 37 | Estados Unidos |
| Centros médicos especializados | 22 | Centrarse en el cuidado pulmonar |
Presentaciones de conferencia médica
En 2023, Windtree Therapeutics participó en 6 conferencias médicas principales, presentando investigaciones sobre su tubería terapéutica respiratoria.
- Conferencia de la American Thoracic Society
- Congreso internacional de la Sociedad Respiratoria Europea
- Cumbre de la Sociedad Internacional para el Cuidado Respiratorio
Publicaciones científicas en línea
La compañía publicó 4 artículos de investigación revisados por pares en 2023, con un impacto de citas acumuladas de 12.5.
Redes de distribuidores farmacéuticos
Windtree Therapeutics mantiene asociaciones con 3 redes nacionales de distribución farmacéutica.
| Distribuidor | Cobertura | Estatus de contrato |
|---|---|---|
| AmerisourceBergen | Nacional | Activo |
| Salud cardinal | Nacional | Activo |
| McKesson Corporation | Nacional | Activo |
Plataformas de marketing digital y comunicación médica
A partir de 2024, Windtree Therapeutics utiliza 7 canales de comunicación digital para la participación profesional médico.
- Red profesional de LinkedIn
- Plataforma de médico de doximidad
- Portal profesional webmd
- Medscape Medical Network
Windtree Therapeutics, Inc. (WINT) - Modelo de negocios: segmentos de clientes
Especialistas en enfermedades pulmonares y respiratorias
Tamaño del mercado objetivo: 39,500 pulmonólogos en los Estados Unidos a partir de 2023
| Tipo especializado | Número de especialistas | Potencial de prescripción anual |
|---|---|---|
| Pulmonólogos adultos | 32,700 | $ 4.2 millones de ingresos anuales potenciales |
| Pulmonólogos pediátricos | 6,800 | $ 1.8 millones posibles ingresos anuales |
Sistemas hospitalarios y redes de atención médica
Mercado objetivo de alcance: 6.090 hospitales en los Estados Unidos
- Grandes redes hospitalarias con más de 500 camas: 412 instalaciones
- Redes hospitalarias de tamaño mediano (100-499 camas): 1,873 instalaciones
- Centros de atención respiratoria especializada: 287 centros
Instituciones de investigación
Potencial de colaboración de investigación: 1.245 instituciones de investigación respiratoria
| Tipo de institución | Número de instituciones |
|---|---|
| Centros médicos académicos | 378 |
| Institutos de investigación independientes | 612 |
| Instalaciones de investigación gubernamental | 255 |
Departamentos de adquisiciones farmacéuticas
Segmentos del mercado de adquisiciones
- Organizaciones de compras grupales (GPOS): 32 redes principales
- Redes de distribución de atención médica: 17 redes principales
- Consorciones de compra farmacéutica: 45 grupos activos
Pacientes con afecciones médicas respiratorias
Demografía de la población de pacientes
| Condición respiratoria | Total de pacientes en EE. UU. | Mercado potencial de tratamiento |
|---|---|---|
| Síndrome de distrés respiratorio agudo | 190,000 casos anuales | Mercado potencial de $ 620 millones |
| Displasia broncopulmonar | 60,000 casos pediátricos anuales | Mercado potencial de $ 215 millones |
Windtree Therapeutics, Inc. (WINT) - Modelo de negocio: Estructura de costos
Gastos de investigación y desarrollo
Basado en el informe financiero del tercer trimestre de 2023, Windtree Therapeutics reportó gastos de I + D de $ 2.8 millones para el trimestre.
| Año fiscal | Gastos de I + D |
|---|---|
| 2022 | $ 11.2 millones |
| 2023 (proyectado) | $ 10.5 millones |
Inversiones de ensayos clínicos
Los costos de ensayos clínicos para el programa AeroSurf® y otros desarrollos de tuberías totalizaron aproximadamente $ 4.3 millones en 2022.
- Ensayos clínicos de fase 2/3 para el tratamiento del virus sincitial respiratorio (RSV)
- Estudios en curso para programas de lesiones pulmonares agudas
Costos de cumplimiento regulatorio
Los gastos de cumplimiento regulatorio anual estimados en $ 750,000 a $ 1 millón.
| Categoría de cumplimiento | Costo anual estimado |
|---|---|
| Tarifas de presentación de la FDA | $350,000 |
| Consultoría de cumplimiento externo | $250,000 |
| Gestión de cumplimiento interno | $400,000 |
Mantenimiento de la propiedad intelectual
Costos anuales de mantenimiento de propiedad intelectual: $ 250,000 a $ 300,000.
- Tarifas de presentación y renovación de patentes
- Soporte legal para la protección de IP
Sobrecarga administrativa y operativa
Los gastos administrativos y operativos totales para 2022 fueron de $ 5.6 millones.
| Categoría de gastos | Costo anual |
|---|---|
| Costos de personal | $ 3.2 millones |
| Gastos de oficina e instalaciones | $ 1.1 millones |
| Tecnología e infraestructura | $800,000 |
| Marketing y desarrollo de negocios | $500,000 |
Windtree Therapeutics, Inc. (WINT) - Modelo de negocios: flujos de ingresos
Acuerdos potenciales de licencia farmacéutica
A partir del cuarto trimestre de 2023, Windtree Therapeutics no tiene acuerdos de licencia activos que generen ingresos. El valor de licencia potencial total sigue siendo $ 0.
Comercialización futura de drogas
| Candidato a la droga | Valor de mercado potencial | Línea de tiempo de comercialización estimada |
|---|---|---|
| Aerosurfo | Mercado potencial de $ 500 millones | Aprobación de la FDA pendiente |
| Tratamiento para el COVID-19 | $ 0 Ingresos actuales | Etapa de investigación |
Subvenciones de investigación y fondos colaborativos
Subvenciones totales de investigación para 2023: $ 0
Pagos potenciales de hitos de las asociaciones
- No hay pagos de hito confirmados a partir del cuarto trimestre de 2023
- Valor de hito potencial: no revelado
Venta anticipada de productos
Ventas de productos actuales: $ 0
| Producto | Ventas anuales anticipadas | Estado regulatorio |
|---|---|---|
| Aerosurfo | Estimado de $ 50-100 millones | Aún no aprobado |
Windtree Therapeutics, Inc. (WINT) - Canvas Business Model: Value Propositions
You're looking at the core reasons why a stakeholder would invest time or capital into Windtree Therapeutics, Inc. (WINT) right now, late in 2025. The value proposition hinges on a dual-track approach: advancing novel drug candidates while immediately pivoting to revenue generation through strategic deals.
Novel, Dual-Mechanism Therapy (Istaroxime) for Acute Heart Failure/Shock
The primary biotech value driver is istaroxime, an investigational therapy for acute decompensated heart failure (ADHF) and early cardiogenic shock. This compound offers a novel, first-in-class approach by targeting two mechanisms: increasing myocardial contractility via Na+/K+- ATPase inhibition and facilitating relaxation through SERCA2a calcium pump activation. Istaroxime has been studied across multiple positive Phase 2 trials.
Here's a quick look at where this asset stands as we approach the end of 2025:
| Metric | Value/Status |
|---|---|
| Current Clinical Phase (ADHF) | Phase II |
| Phase II to Phase III PTSR Benchmark (Indication) | 60% |
| SEISMiC C Trial Interim Analysis Subjects | First 20 subjects |
| Regulatory Interaction Target for Phase 3 | 2025 |
| Japanese Patent Expiration Year (Istaroxime) | 2039 |
Data from these Phase 2 studies show intravenous istaroxime significantly improves cardiac function and blood pressure without increasing heart rate or the incidence of clinically significant cardiac rhythm disturbances. The interim analysis of the first 20 subjects in the SCAI Stage C study identified no new safety concerns.
Non-Invasive Surfactant Delivery (AEROSURF) for Premature Infants
The second therapeutic pillar involves AEROSURF, a lucinactant for inhalation, aimed at treating respiratory distress syndrome (RDS) in premature infants. This program is currently operating under a global license agreement.
- Potential milestone payments under the license agreement could total up to $78.9 million.
- The agreement also includes low double-digit royalties on net sales.
Near-Term Revenue and Value Creation via Strategic Acquisitions
In January 2025, Windtree Therapeutics, Inc. launched a new corporate strategy to become a revenue-generating entity by acquiring small companies with FDA-approved products. This is designed to create near-term value while the pipeline progresses. The company recently signed a letter of intent to acquire CommLoan, Inc., a commercial mortgage lending marketplace.
The financial context surrounding this pivot is important:
| Financial Metric (As of March 31, 2025) | Amount |
| Net Loss Attributable to Common Stockholders (Q1 2025) | $5.0 million |
| Cash and Cash Equivalents (As of March 31, 2025) | $1.2 million |
| Current Liabilities (As of March 31, 2025) | $6.5 million |
| Negative EBITDA (Context of Acquisition Challenges) | $15.34 million |
| Current Ratio (Context of Acquisition Challenges) | 0.33 |
Also, leveraging a firm partnership in China, Windtree Therapeutics, Inc. is helping a biopharmaceutical company lower its production costs by almost 65%, with revenues anticipated to start by the end of 2026.
Potential to Reduce Intubation Risk in Neonatal Respiratory Distress Syndrome
The AEROSURF program directly addresses the need for better treatments for RDS in premature infants. While specific risk reduction statistics aren't in the latest filings, the value proposition is tied to the potential for a non-invasive delivery method for surfactant replacement therapy. This contrasts with standard treatments and aims to avoid the risks associated with mechanical ventilation and intubation.
- AEROSURF is a lucinactant for inhalation.
- It is covered under the license agreement with potential milestone payments up to $78.9 million.
Finance: draft 13-week cash view by Friday.
Windtree Therapeutics, Inc. (WINT) - Canvas Business Model: Customer Relationships
High-touch, collaborative relationships with key licensing partners.
Windtree Therapeutics, Inc. maintains an active licensing business model with partnership out-licenses currently in place, centered on advancing its proprietary therapies.
The primary relationship involves a global license agreement, amended and restated in August 2022, covering treatments including SURFAXIN, lyophilized lucinactant, and AEROSURF.
This collaboration is structured around performance incentives, which are a key component of the relationship management.
| Relationship Metric | Value/Detail |
| Potential Milestone Payments | Up to $78.9 million |
| Royalty Structure | Low double-digit royalties |
| Key Communication Event (Late 2025) | Announcement of potential license agreement payments (November 17, 2025) |
| Last Reported Financing Event (Investor Related) | Private placement gross proceeds of approximately $2.6 million (April/May 2025) |
The company's focus on advancing istaroxime in cardiogenic shock, following positive primary endpoint data, requires close alignment with the licensee on development pathways.
Transactional and platform-based service for commercial lending clients.
The strategic pivot announced in late 2025 introduced a new customer relationship dynamic through the signing of a letter of intent on December 3, 2025, to acquire CommLoan, Inc.
CommLoan operates a commercial mortgage lending marketplace through its proprietary platform, CUPID, which connects borrowers and originators with lenders nationwide, indicating a platform-based, transactional relationship model for its end-users.
Windtree Therapeutics, Inc. provided bridge financing to CommLoan during the transition period following the letter of intent.
The relationship with CommLoan is immediately operationalized by this bridge financing, which is a near-term obligation whose size and terms are undisclosed, but it signals an intent to integrate a revenue-generating fintech business.
Direct communication with investors on clinical and strategic pivots.
Communication with investors is critical, especially given the company's financial position, which included a net loss attributable to common stockholders of $5.0 million on 1,088,564 weighted-average common shares outstanding for the fiscal quarter ended March 31, 2025.
The CEO, Jed Latkin, directly communicates the strategic rationale for diversification, such as the CommLoan acquisition, to the investment community.
Investor engagement is characterized by capital-raising activities and updates on the core biotech pipeline.
- Financing Activity 1: Private placement gross proceeds of approximately $2.6 million closed in April 2025 and May 2025.
- Financing Activity 2: Issuance of senior convertible promissory notes on November 25, 2025, totaling an aggregate principal amount of $857,142.86.
- Note Terms: The 2026 Notes bear interest at 10% per annum.
- Q1 2025 Cash Position: Cash and cash equivalents reported as $1.2 million as of March 31, 2025.
- Strategic Update: Announcement of potential license agreement payments in November 2025.
The company's stock traded near its 52-week low of $0.04 with a market capitalization of approximately $1.55 million as of early December 2025.
Windtree Therapeutics, Inc. (WINT) - Canvas Business Model: Channels
You're looking at how Windtree Therapeutics, Inc. (WINT) plans to get its value proposition-both pipeline assets and newly acquired revenue streams-out to the world as of late 2025. The channels strategy has clearly shifted from purely biotech partnerships to a more diversified, revenue-focused approach following the Nasdaq delisting in August 2025.
Direct out-licensing agreements with global pharmaceutical companies
The traditional biotech channel remains active, focusing on non-dilutive cash generation from existing and renewed agreements. The amended and restated global license agreement, originally from August 2022, covers acute pulmonary treatments like SURFAXIN, lyophilized lucinactant, and AEROSURF. This deal is structured to potentially deliver up to $78.9 million in milestone payments, plus up to low double-digit royalties on sales. That's a significant upside if the licensee hits commercial targets.
Also, remember the regional partnership with Lee's Pharmaceutical for Greater China, which was valued at up to $138 million in milestones plus royalties, with a Phase 3 trial for istaroxime planned for the first half of 2025. Anyway, the focus now is on realizing these potential payments.
Here's a quick look at the potential financial upside tied to these licensing channels as of late 2025:
| Agreement/Asset | Potential Milestone Payments | Royalty Structure | Status/Note |
|---|---|---|---|
| Global Acute Pulmonary License (Amended) | Up to $78.9 million | Up to low double-digit percentage | Payments for renewed development work |
| Lee's Pharma (Greater China) | Up to $138 million | Royalties (structure not specified) | Phase 3 for istaroxime planned for 1H 2025 |
| Environmental Services Termination | $7.5 million (Cash and Securities) | N/A | Received from a recently executed termination agreement |
Still, the company is also realizing cash from other settlements; they announced receiving $7.5 million in cash and securities from a termination agreement with an environmental services company in November 2025.
Acquired digital marketplace for commercial real estate lending
This is the big strategic pivot for Windtree Therapeutics, Inc. On December 3, 2025, the company announced signing a letter of intent to acquire CommLoan, Inc. This move is designed to add a revenue-generating fintech division to the business, moving away from being solely dependent on R&D milestones. CommLoan operates a commercial mortgage lending marketplace using its proprietary platform, CUPID™. The financial terms of this acquisition weren't disclosed, but the intent is clear: use technology to streamline lending and generate immediate revenue.
CommLoan connects borrowers and originators with hundreds of active lenders nationwide across various property types, including multifamily, retail, office, industrial, healthcare, and SBA financing. They tout a massive proprietary database that management believes creates a significant competitive moat. Windtree provided bridge financing to CommLoan during the transition period following the LOI.
Global clinical trial network (U.S., Europe, Latin America) for data generation
The clinical development channel, historically the primary way to generate value for licensing, has seen significant restructuring. The focus was on istaroxime for cardiogenic shock. Windtree had been enrolling subjects in the SEISMiC C (SCAI Stage C) Phase 2 study, with an interim analysis planned for Q3 2025 on the first 20 subjects. However, reports indicate this specific trial was terminated, narrowing near-term clinical optionality.
This shift is reflected in the financials. The Istaroxime drug candidate was subject to a $16.1 million impairment of intangible assets in Q3 2025, reducing its recorded value to $6.2 million from $22.3 million at the end of 2024. Research and development expense for Q3 2025 was $1.9 million, down from prior periods due to focusing resources.
- SEISMiC C (SCAI Stage C) Phase 2 study enrollment ongoing as of Q1 2025.
- Interim analysis for the first 20 subjects planned for Q3 2025.
- The SEISMiC C trial was ultimately terminated.
- Istaroxime asset value dropped to $6.2 million post-impairment in Q3 2025.
- R&D expense for Q3 2025 was $1.9 million.
Finance: draft the pro-forma cash flow statement incorporating the CommLoan acquisition bridge financing by Friday.
Windtree Therapeutics, Inc. (WINT) - Canvas Business Model: Customer Segments
You're looking at a company in a significant pivot, moving from a pure R&D focus to a revenue-generating model through acquisitions and existing licensing structures. This means the customer segments are now split between traditional biotech partners, real estate/fintech users, and the ultimate patients for their drug pipeline.
Global pharmaceutical and biotech companies for licensing deals.
Windtree Therapeutics, Inc. has existing partnership structures that define this segment. The customer here is the licensee funding development and commercialization. One key relationship involves a regional license with Lee's Pharmaceutical for greater China, tied to a deal potentially worth up to $138 million in milestones plus royalties. Another is the amended global license agreement from August 2022 for the acute pulmonary franchise, which could yield up to $78.9 million in milestones plus low double digit royalties. Furthermore, through a partnership in China, Windtree Therapeutics, Inc. is helping a biopharmaceutical company lower its production costs by almost 65%.
Here's a quick look at the potential value tied to these licensing relationships:
| License/Asset Category | Potential Milestone Value (USD) | Royalty Structure | Geographic Focus/Product |
| Acute Pulmonary Franchise | Up to $78.9 million | Up to low double digit royalties | Global (SURFAXIN®, AEROSURF®) |
| Istaroxime/SERCA2a/Rostafuroxin | Up to $138 million | Royalties | Greater China (Lee's Pharmaceutical) |
The company anticipates this partnership structure should start generating revenues by the end of 2026.
Hospitals and Intensive Care Units (ICUs) treating cardiogenic shock.
This segment represents the end-user for their lead drug candidate, istaroxime, which is being developed for acute heart failure and associated cardiogenic shock. The immediate customer base is the clinical sites participating in the ongoing Phase 2 study. The company planned an interim analysis of the first 20 subjects enrolled in the SCAI Stage C study in Q3 2025. The goal of completing this study is to advance the program to Phase 3.
Commercial real estate borrowers and lenders using the acquired platform.
This segment emerged as part of the new corporate strategy to become revenue generating. The initial step involved gaining the rights to purchase a 436 unit, multifamily residential property in Houston, Texas, expected to contribute consistent rental revenue. More recently, as of December 3, 2025, Windtree Therapeutics, Inc. signed a letter of intent to acquire CommLoan, Inc., a commercial tech finance company. CommLoan's platform serves borrowers and originators by connecting them with hundreds of active lenders nationwide across various property types.
The customer base for the acquired fintech platform includes:
- Borrowers seeking commercial real estate financing.
- Lenders active in the middle market loan space.
- Users of the proprietary CUPID™ platform for comparing rates and terms.
Neonatologists and premature infants with respiratory distress syndrome.
This segment is tied to the licensed acute pulmonary franchise, which includes treatments like SURFAXIN®, lyophilized lucinactant, and AEROSURF® (a drug and device combination). The target patient population is premature infants suffering from respiratory distress syndrome (RDS). The direct customer is the licensee who is responsible for the development and commercialization of these treatments.
Finance: review the cash runway against the Q3 2025 current liabilities of $21.9 million by next Tuesday.
Windtree Therapeutics, Inc. (WINT) - Canvas Business Model: Cost Structure
You're looking at the cost side of Windtree Therapeutics, Inc. (WINT) and it's clear the burn rate is dominated by development activities, even with the pivot toward revenue generation. The core cost structure, as of late 2025, reflects a company still heavily invested in its pipeline while trying to manage overhead.
Research & Development (R&D) expenses were a significant, fixed-looking cost in the first part of the year. For the first quarter of 2025, R&D expenses totaled $2.3 million. This spending primarily covered the continued development of istaroxime, including costs associated with the SEISMiC C trial during that period. Honestly, for a clinical-stage biotech, this is where the bulk of the cash goes before any product revenue hits.
General and administrative (G&A) expenses showed some discipline early on. In Q1 2025, G&A costs were $1.8 million, which was actually a decrease from $2.1 million in the comparable quarter of 2024. That reduction came from lower professional fees, particularly legal costs, and a slight dip in non-cash stock-based compensation expense. Still, managing G&A is crucial when liquidity is tight.
The overall expense profile shifts dramatically when you factor in non-recurring, non-cash charges, which is a key feature of this cost structure. The third quarter of 2025 brought a massive write-down. Here's a look at how the operating expenses stacked up across the year's reported quarters:
| Expense Category | Q1 2025 Amount (Millions USD) | Q3 2025 Amount (Millions USD) |
| Research & Development (R&D) | 2.3 | 1.9 |
| General & Administrative (G&A) | 1.8 | 1.9 |
| Total Operating Expenses (Excl. Impairment) | 4.1 | 3.8 |
| Non-Cash Impairment of Intangible Assets | Not Reported | 16.1 |
| Total Reported Operating Expenses (Including Impairment) | Not Applicable | 19.9 |
Costs related to strategic acquisitions and corporate diversification represent a different kind of outlay. Windtree Therapeutics, Inc. initiated a new strategy to become a revenue-generating company by seeking to acquire FDA-approved assets. This involved entering into an initial strategic transaction for the right to buy a revenue-generating multifamily residential property, which is a departure from pure drug development costs.
The most significant single cost event in the latter half of 2025 was the significant non-cash impairment of intangible assets. In Q3 2025, the company recorded a $16.130 million impairment. This write-down heavily impacted the period's operating expenses and net loss, primarily stemming from the Istaroxime drug candidate's recorded value being marked down.
The major components driving the cost structure, especially in the third quarter, can be summarized like this:
- R&D Investment: Continued spending on the istaroxime program, though enrollment in the SEISMiC C trial was terminated.
- Strategic Transaction Costs: Capital allocated or committed for acquiring revenue-generating assets, like the multifamily property right.
- Asset Devaluation: The $16.130 million non-cash charge, reflecting a reassessment of the future economic benefit of intangible assets.
- Operational Overhead: Baseline G&A spending, which management managed to reduce in Q1 2025 to $1.8 million.
Finance: draft 13-week cash view by Friday.
Windtree Therapeutics, Inc. (WINT) - Canvas Business Model: Revenue Streams
You're looking at the current revenue streams for Windtree Therapeutics, Inc. as of late 2025. The business model is clearly pivoting, moving toward generating cash flow from non-biotech assets while retaining future upside from its core drug pipeline. Honestly, the near-term focus is on these non-dilutive cash events.
The potential revenue from Windtree Therapeutics, Inc.'s licensing agreements remains a significant, though contingent, part of the financial picture. These streams are structured to provide non-dilutive capital if development milestones are hit by the partners.
Here's a quick look at the key potential and realized financial figures driving the Revenue Streams block:
| Revenue Stream Component | Maximum Potential/Reported Amount (USD) | Status/Context |
| Istaroxime Licensee Milestones | $138,000,000 | Potential milestone payments |
| Acute Pulmonary Licensee Milestones | $78,900,000 | Potential milestone payments plus low double-digit royalties |
| Asset Monetization (Termination Agreement) | $7,500,000 | Cash and securities received November 2025 |
| Q3 2025 Financial Performance | ($28,085) | Reported Net Loss |
The shift toward operating revenue is evident in the recent strategic moves. Windtree Therapeutics, Inc. signed a letter of intent on December 3, 2025, to acquire CommLoan, Inc., which is explicitly described as a revenue-generating fintech firm focused on commercial real estate loan origination.
This acquisition signals a tangible, near-term revenue component, separate from the long-term drug development milestones. You should monitor the closing of this deal for the first reported revenue contribution from this segment.
The potential revenue from the pharmaceutical side is broken down into specific asset classes:
- Potential milestone and royalty payments from the istaroxime licensee, totaling up to $138 million.
- Milestone payments from the acute pulmonary licensee, which could reach up to $78.9 million, in addition to low double-digit royalties on products like SURFAXIN, lyophilized lucinactant, and AEROSURF.
To be fair, the near-term financial reality for Windtree Therapeutics, Inc. is reflected in its operating results. The company reported a net loss of $28,085 for the third quarter of 2025. This loss occurred while the company was actively executing its strategy to become a revenue-generating entity.
Also, a concrete, realized cash event occurred in November 2025. Windtree Therapeutics, Inc. executed a termination agreement with an environmental services company, resulting in the receipt of $7.5 million in cash and securities. This is a direct, non-dilutive cash inflow that supports current operations while the larger licensing deals mature.
The key revenue drivers you need to track are:
- The closing and subsequent revenue recognition from the CommLoan, Inc. acquisition.
- Any near-term milestone achievement from the acute pulmonary license agreement, potentially triggering payments up to $78.9 million.
- The status of the istaroxime development program, as milestones up to $138 million hinge on its progress with a partner.
Finance: draft 13-week cash view by Friday.
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