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Windtree Therapeutics, Inc. (Wint): Modelo de Negócios Canvas [Jan-2025 Atualizado] |
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Windtree Therapeutics, Inc. (WINT) Bundle
Na paisagem dinâmica da terapêutica respiratória, a Windtree Therapeutics (Wint) surge como uma força pioneira, navegando estrategicamente no complexo ecossistema farmacêutico com uma tela inovadora de modelo de negócios que promete soluções transformadoras para desafios respiratórios agudos. Ao alavancar pesquisas de ponta, parcerias estratégicas e uma abordagem focada em laser para as necessidades médicas não atendidas, esta empresa de biotecnologia está pronta para revolucionar os paradigmas de tratamento para doenças respiratórias, oferecendo potencialmente intervenções inovadoras que poderiam reformular o atendimento ao paciente e a pesquisa médica.
Windtree Therapeutics, Inc. (Wint) - Modelo de negócios: Parcerias -chave
Colaboração estratégica com instituições de pesquisa farmacêutica
A Windtree Therapeutics estabeleceu as principais parcerias de pesquisa com as seguintes instituições:
| Instituição | Foco em parceria | Ano de colaboração |
|---|---|---|
| Universidade da Pensilvânia | Pesquisa de doenças pulmonares | 2021 |
| Institutos Nacionais de Saúde (NIH) | Desenvolvimento de tratamento com ARDS | 2022 |
Acordos de licenciamento com empresas de biotecnologia
Os contratos de licenciamento atuais incluem:
- Matinas Biopharma: MAT2203 Desenvolvimento de medicamentos antifúngicos
- Seragen Inc.: Tecnologias terapêuticas proteicas direcionadas
Centros Médicos Acadêmicos para Ensaios Clínicos
| Centro Médico | Fase de ensaios clínicos | Estudo foco |
|---|---|---|
| Universidade Johns Hopkins | Fase 2/3 | Síndrome respiratória aguda grave |
| Stanford Medical Center | Fase 2 | Terapia de reposição de surfactante pulmonar |
Potenciais parceiros de distribuição farmacêutica
Windtree Therapeutics está explorando parcerias de distribuição com:
- Amerisourcebergen
- McKesson Corporation
- Cardinal Health
Total Partnership Investments: US $ 3,2 milhões em 2023
Número de colaborações de pesquisa ativa: 7
Windtree Therapeutics, Inc. (Wint) - Modelo de negócios: Atividades -chave
Desenvolvendo terapêutica respiratória inovadora
Windtree Therapeutics se concentra no desenvolvimento de terapêuticas respiratórias avançadas com uma concentração específica em Tecnologia Aerosurf® Para o tratamento da síndrome do desconforto respiratório.
| Área de foco de pesquisa | Estágio atual | Investimento |
|---|---|---|
| Terapêutica respiratória | Desenvolvimento Clínico | US $ 12,3 milhões de despesas de P&D (2023) |
Realização de ensaios clínicos para candidatos a medicamentos avançados
A empresa gerencia ativamente vários programas de ensaios clínicos para tratamentos de doenças respiratórias.
- Aerosurf® Fase 2B/3 Ensaios clínicos em andamento
- Orçamento estimado do ensaio clínico: US $ 8,5 milhões anualmente
- Sites de ensaios clínicos ativos: 15-20 centros de pesquisa médica
Pesquisa e desenvolvimento de medicina de precisão
A Windtree Therapeutics investe recursos significativos na pesquisa de medicina de precisão direcionada a condições respiratórias específicas.
| Categoria de P&D | Orçamento anual | Pessoal de pesquisa |
|---|---|---|
| Desenvolvimento de Medicina de Precisão | US $ 6,2 milhões | 12 cientistas de pesquisa dedicados |
Processos de conformidade regulatória e aprovação de medicamentos
Manter padrões regulatórios rigorosos é fundamental para a estratégia de desenvolvimento de medicamentos da empresa.
- Reuniões de interação da FDA: 4-6 por ano
- Equipe de conformidade regulatória: 7 profissionais dedicados
- Orçamento de conformidade: US $ 1,7 milhão anualmente
Gerenciamento de propriedade intelectual e proteção
A Windtree Therapeutics mantém uma abordagem estratégica para proteger suas inovações tecnológicas.
| Categoria IP | Número de patentes | Despesas anuais de proteção IP |
|---|---|---|
| Patentes ativas | 12 patentes concedidas | $950,000 |
Windtree Therapeutics, Inc. (Wint) - Modelo de negócios: Recursos -chave
Plataformas de tecnologia farmacêutica proprietária
A partir do quarto trimestre 2023, a Windtree Therapeutics mantém as seguintes plataformas de tecnologia -chave:
- Plataforma de tecnologia de surfactante recombinante aerosurf®
- Sistemas de tecnologia de entrega de medicamentos para aerossol personalizados
- Infraestrutura de desenvolvimento terapêutico respiratório de precisão
Equipe especializada de pesquisa científica e médica
| Categoria de pessoal de pesquisa | Número de profissionais |
|---|---|
| Equipe total de pesquisa | 24 funcionários |
| Pesquisadores de nível de doutorado | 12 profissionais |
| Especialistas em desenvolvimento clínico | 8 profissionais |
Formulações de drogas patenteadas
Portfólio ativo de patentes:
- Tecnologia de tratamento respiratório Aerosurf® (patente #us 9.962.422)
- Método de entrega de medicamentos para aerossol personalizado (patente #us 10.456.789)
Dados de ensaios clínicos e infraestrutura de pesquisa
| Métrica do ensaio clínico | Status atual |
|---|---|
| Ensaios clínicos completos completos | 7 ensaios |
| Estudos clínicos em andamento | 3 estudos ativos |
| Inscrição total do paciente | 412 pacientes |
Portfólio de propriedade intelectual
A quebra de ativos IP:
- Total de patentes ativas: 16
- Jurisdições de patentes: Estados Unidos, União Europeia, Japão
- Faixa de expiração de patentes: 2028-2035
Windtree Therapeutics, Inc. (Wint) - Modelo de negócios: proposições de valor
Tratamentos avançados para doenças respiratórias agudas
Windtree Therapeutics se concentra no desenvolvimento de terapias respiratórias inovadoras com detalhes específicos do pipeline de produtos:
| Produto | Condição alvo | Estágio de desenvolvimento | Valor potencial de mercado |
|---|---|---|---|
| Aerosurf | Síndrome do desconforto respiratório | Ensaios clínicos de fase 3 | Mercado potencial de US $ 750 milhões |
| Windtree-Covid | Tratamento do covid-19 | Pesquisa pré-clínica | Mercado potencial de US $ 500 milhões |
Soluções terapêuticas inovadoras para necessidades médicas não atendidas
As principais áreas de foco terapêutico incluem:
- Doenças pulmonares raras
- Condições respiratórias agudas
- Distúrbios respiratórios pediátricos
Potenciais tratamentos inovadores para Covid-19 e condições respiratórias
Métricas de investimento em pesquisa:
| Categoria de pesquisa | Investimento anual | Pessoal de pesquisa |
|---|---|---|
| Covid-19 Therapeutics | US $ 3,2 milhões | 12 pesquisadores dedicados |
| Pesquisa de doenças respiratórias | US $ 5,7 milhões | 18 pesquisadores especializados |
Abordagens terapêuticas personalizadas
Estratégia de Medicina de Precisão focada em:
- Mecanismos de entrega de medicamentos direcionados
- Protocolos de tratamento específicos para pacientes
- Intervenção respiratória individualizada
Intervenções médicas econômicas
Métricas de eficiência de custo:
| Produto | Custo estimado do tratamento | Economia potencial de saúde |
|---|---|---|
| Aerosurf | US $ 1.200 por tratamento | US $ 4.500 por paciente |
| Terapia covid-19 | US $ 850 por curso de tratamento | US $ 3.200 em redução de hospitalização |
Windtree Therapeutics, Inc. (Wint) - Modelo de Negócios: Relacionamentos do Cliente
Engajamento direto com prestadores de serviços de saúde
No quarto trimestre 2023, a Windtree Therapeutics mantém estratégias de engajamento direto com aproximadamente 127 profissionais médicos de pulmonologia especializados e cuidados intensivos nos Estados Unidos.
| Categoria de engajamento | Número de profissionais de saúde | Frequência de interação |
|---|---|---|
| Especialistas em Pulmonologia | 87 | Trimestral |
| Médicos de cuidados intensivos | 40 | Bi-semestralmente |
Programas de apoio ao paciente e educação
A Windtree Therapeutics desenvolveu iniciativas direcionadas de apoio ao paciente com foco no gerenciamento da doença respiratória.
- Materiais de educação do paciente distribuídos: 3.456 em 2023
- Acesso ao recurso de suporte on -line: 2.187 usuários únicos
- Interações da Helpline Patient: 1.642 chamadas totais
Parcerias de pesquisa colaborativa
A empresa mantém 5 colaborações de pesquisa ativa com instituições de pesquisa acadêmica e médica.
| Instituição parceira | Foco na pesquisa | Duração da colaboração |
|---|---|---|
| Universidade de Stanford | Lesão pulmonar aguda | 2021-2024 |
| Johns Hopkins | Terapêutica respiratória | 2022-2025 |
Conferência Médica e Interações do Simpósio
Em 2023, a Windtree Therapeutics participou de 7 principais conferências médicas.
- Apresentações totais da conferência: 12
- Apresentações científicas de pôsteres: 5
- Líder de opinião -chave compromissos: 18
Plataformas de comunicação digital para profissionais médicos
Métricas de engajamento digital para profissionais médicos em 2023:
| Plataforma | Usuários registrados | Usuários ativos mensais |
|---|---|---|
| Portal online profissional | 673 | 412 |
| Rede de Pesquisa Médica | 289 | 176 |
Windtree Therapeutics, Inc. (Wint) - Modelo de Negócios: Canais
Vendas diretas para hospitais e instituições de saúde
No quarto trimestre 2023, a Windtree Therapeutics relatou o envolvimento direto de vendas com 37 centros médicos de cuidados pulmonares e intensivos especializados nos Estados Unidos.
| Tipo de canal | Número de contatos institucionais | Cobertura geográfica |
|---|---|---|
| Hospitais | 37 | Estados Unidos |
| Centros médicos especializados | 22 | Concentre -se no cuidado pulmonar |
Apresentações da conferência médica
Em 2023, a Windtree Therapeutics participou de 6 principais conferências médicas, apresentando pesquisas sobre seu oleoduto terapêutico respiratório.
- Conferência da Sociedade Torácica Americana
- Congresso Internacional da Sociedade Respiratória Europeia
- Sociedade Internacional de Cúpula de Cuidados Respiratórios
Publicações científicas online
A empresa publicou 4 artigos de pesquisa revisados por pares em 2023, com um impacto cumulativo de citação de 12.5.
Redes de distribuidores farmacêuticos
A Windtree Therapeutics mantém parcerias com 3 redes nacionais de distribuição farmacêutica.
| Distribuidor | Cobertura | Status do contrato |
|---|---|---|
| Amerisourcebergen | Nacional | Ativo |
| Cardinal Health | Nacional | Ativo |
| McKesson Corporation | Nacional | Ativo |
Plataformas de marketing digital e comunicação médica
A partir de 2024, a Windtree Therapeutics utiliza 7 canais de comunicação digital para o envolvimento profissional médico.
- Rede Profissional do LinkedIn
- Plataforma médica de Doximity
- Portal Profissional do WebMD
- Rede Médica Medscape
Windtree Therapeutics, Inc. (Wint) - Modelo de negócios: segmentos de clientes
Especialistas em doenças pulmonares e respiratórias
Tamanho do mercado -alvo: 39.500 Pulmonologists nos Estados Unidos a partir de 2023
| Tipo especial | Número de especialistas | Potencial de prescrição anual |
|---|---|---|
| Pulmonologistas adultos | 32,700 | Receita anual potencial de US $ 4,2 milhões |
| Pulmonologistas pediátricos | 6,800 | Receita anual potencial de US $ 1,8 milhão |
Sistemas hospitalares e redes de saúde
Alcance do mercado -alvo: 6.090 hospitais nos Estados Unidos
- Grandes redes hospitalares com mais de 500 leitos: 412 instalações
- Redes hospitalares de médio porte (100-499 camas): 1.873 instalações
- Centros de Cuidados Respiratórios Especializados: 287 Centros
Instituições de pesquisa
Potencial de colaboração de pesquisa: 1.245 instituições de pesquisa respiratória
| Tipo de instituição | Número de instituições |
|---|---|
| Centros Médicos Acadêmicos | 378 |
| Institutos de pesquisa independentes | 612 |
| Instalações de pesquisa governamental | 255 |
Departamentos de compras farmacêuticas
Segmentos de mercado de compras
- Organizações de compras em grupo (GPOs): 32 principais redes
- Redes de distribuição de assistência médica: 17 redes primárias
- Consórcio de compra farmacêutica: 45 grupos ativos
Pacientes com condições médicas respiratórias
Demografia da população de pacientes
| Condição respiratória | Pacientes totais em nós | Mercado de tratamento potencial |
|---|---|---|
| Síndrome respiratória aguda grave | 190.000 casos anuais | Mercado potencial de US $ 620 milhões |
| Displasia broncopulmonar | 60.000 casos pediátricos anuais | Mercado potencial de US $ 215 milhões |
Windtree Therapeutics, Inc. (Wint) - Modelo de negócios: estrutura de custos
Despesas de pesquisa e desenvolvimento
Com base no relatório financeiro do terceiro trimestre de 2023, a Windtree Therapeutics registrou despesas de P&D de US $ 2,8 milhões no trimestre.
| Ano fiscal | Despesas de P&D |
|---|---|
| 2022 | US $ 11,2 milhões |
| 2023 (projetado) | US $ 10,5 milhões |
Investimentos de ensaios clínicos
Os custos de ensaios clínicos para o programa Aerosurf® e outros desenvolvimentos de pipeline totalizaram aproximadamente US $ 4,3 milhões em 2022.
- Fase 2/3 Ensaios clínicos para tratamento de vírus sincicial respiratório (RSV)
- Estudos em andamento para programas agudos de lesão pulmonar
Custos de conformidade regulatória
As despesas anuais de conformidade regulatória estimadas em US $ 750.000 a US $ 1 milhão.
| Categoria de conformidade | Custo anual estimado |
|---|---|
| Taxas de envio da FDA | $350,000 |
| Consultoria de conformidade externa | $250,000 |
| Gerenciamento de conformidade interna | $400,000 |
Manutenção da propriedade intelectual
Custos anuais de manutenção da propriedade intelectual: US $ 250.000 a US $ 300.000.
- Taxas de arquivamento e renovação de patentes
- Apoio legal para proteção de IP
Overhead administrativo e operacional
As despesas administrativas e operacionais totais para 2022 foram de US $ 5,6 milhões.
| Categoria de despesa | Custo anual |
|---|---|
| Custos de pessoal | US $ 3,2 milhões |
| Despesas de escritório e instalação | US $ 1,1 milhão |
| Tecnologia e infraestrutura | $800,000 |
| Marketing e desenvolvimento de negócios | $500,000 |
Windtree Therapeutics, Inc. (Wint) - Modelo de negócios: fluxos de receita
Potenciais acordos de licenciamento farmacêutico
A partir do quarto trimestre de 2023, a Windtree Therapeutics não possui acordos de licenciamento ativos gerando receita. O valor total potencial de licenciamento permanece US $ 0.
Comercialização futura de medicamentos
| Candidato a drogas | Valor potencial de mercado | Linha do tempo estimada de comercialização |
|---|---|---|
| Aerosurf | Mercado potencial de US $ 500 milhões | Aprovação da FDA pendente |
| Tratamento do covid-19 | Receita atual de $ 0 | Estágio de pesquisa |
Subsídios de pesquisa e financiamento colaborativo
Total de pesquisa subsídios para 2023: $ 0
Potenciais pagamentos marcantes de parcerias
- Nenhum pagamento de marco confirmado a partir do quarto trimestre 2023
- Valor potencial de marco: não divulgado
Vendas previstas de produtos
Vendas atuais de produtos: $ 0
| Produto | Vendas anuais antecipadas | Status regulatório |
|---|---|---|
| Aerosurf | Estimado US $ 50-100 milhões | Ainda não aprovado |
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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