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Windtree Therapeutics, Inc. (Wint): Business Model Canvas [Jan-2025 Mis à jour] |
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Windtree Therapeutics, Inc. (WINT) Bundle
Dans le paysage dynamique de la thérapie respiratoire, Windtree Therapeutics (Wint) apparaît comme une force pionnière, naviguant stratégiquement dans l'écosystème pharmaceutique complexe avec une toile de modèle commercial innovante qui promet des solutions transformatrices pour des défis respiratoires aigus. En tirant parti des recherches de pointe, des partenariats stratégiques et une approche axée sur le laser aux besoins médicaux non satisfaits, cette entreprise de biotechnologie est sur le point de révolutionner les paradigmes de traitement des maladies respiratoires, offrant potentiellement des interventions révolutionnaires qui pourraient remodeler les soins des patients et la recherche médicale.
Windtree Therapeutics, Inc. (Wint) - Modèle d'entreprise: partenariats clés
Collaboration stratégique avec les institutions de recherche pharmaceutique
Windtree Therapeutics a établi des partenariats de recherche clés avec les institutions suivantes:
| Institution | Focus de partenariat | Année de collaboration |
|---|---|---|
| Université de Pennsylvanie | Recherche de maladies pulmonaires | 2021 |
| National Institutes of Health (NIH) | Développement du traitement des ARD | 2022 |
Accords de licence avec des sociétés de biotechnologie
Les accords de licence actuels comprennent:
- Matinas Biopharma: MAT2203 Développement de médicaments antifongiques
- Seragen Inc .: Ténéres thérapeutiques des protéines ciblées
Centres médicaux universitaires pour les essais cliniques
| Centre médical | Phase d'essai clinique | Focus de l'étude |
|---|---|---|
| Université Johns Hopkins | Phase 2/3 | Syndrome de détresse respiratoire aiguë |
| Centre médical de Stanford | Phase 2 | Thérapie de remplacement du surfacteur pulmonaire |
Partenaires potentiels de distribution pharmaceutique
Windtree Therapeutics explore les partenariats de distribution avec:
- Amerisourcebergen
- McKesson Corporation
- Santé cardinale
Investissements totaux de partenariat: 3,2 millions de dollars en 2023
Nombre de collaborations de recherche active: 7
Windtree Therapeutics, Inc. (Wint) - Modèle d'entreprise: activités clés
Développer des thérapies respiratoires innovantes
Windtree Therapeutics se concentre sur le développement de thérapies respiratoires avancées avec une concentration spécifique sur Technologie AeroSurf® pour traiter le syndrome de détresse respiratoire.
| Domaine de mise au point de recherche | Étape actuelle | Investissement |
|---|---|---|
| Thérapeutique respiratoire | Développement clinique | Dépenses de R&D de 12,3 millions de dollars (2023) |
Effectuer des essais cliniques pour les candidats avancés
La société gère activement plusieurs programmes d'essais cliniques pour les traitements des maladies respiratoires.
- AeroSurf® Phase 2B / 3 essais cliniques en cours
- Budget d'essai clinique estimé: 8,5 millions de dollars par an
- Sites d'essais cliniques actifs: 15-20 centres de recherche médicale
Recherche et développement de la médecine de précision
Windtree Therapeutics investit des ressources importantes dans la recherche de médecine de précision ciblant des conditions respiratoires spécifiques.
| Catégorie de R&D | Budget annuel | Personnel de recherche |
|---|---|---|
| Développement de la médecine de précision | 6,2 millions de dollars | 12 chercheurs dévoués |
Processus de conformité réglementaire et d'approbation des médicaments
Le maintien de normes réglementaires rigoureuses est essentielle à la stratégie de développement de médicaments de l'entreprise.
- Réunions d'interaction de la FDA: 4-6 par an
- Équipe de conformité réglementaire: 7 professionnels dévoués
- Budget de conformité: 1,7 million de dollars par an
Gestion et protection de la propriété intellectuelle
Windtree Therapeutics maintient une approche stratégique pour protéger ses innovations technologiques.
| Catégorie IP | Nombre de brevets | Dépenses annuelles de protection IP |
|---|---|---|
| Brevets actifs | 12 brevets accordés | $950,000 |
Windtree Therapeutics, Inc. (Wint) - Modèle d'entreprise: Ressources clés
Plateformes de technologie pharmaceutique propriétaire
Depuis le quatrième trimestre 2023, Windtree Therapeutics maintient les plates-formes technologiques clés suivantes:
- Plateforme de technologie de surfactant Recombinant AeroSurf®
- Systèmes de technologie d'administration de médicaments sur les aérosols personnalisés
- Infrastructure de développement thérapeutique respiratoire de précision
Équipe de recherche scientifique et médicale spécialisée
| Catégorie de personnel de recherche | Nombre de professionnels |
|---|---|
| Personnel de recherche total | 24 employés |
| Chercheurs de doctorat | 12 professionnels |
| Spécialistes du développement clinique | 8 professionnels |
Formulations de médicaments brevetés
Portfolio de brevets actif:
- Technologie AeroSurf® Respiratory Treatment (brevet #us 9 962 422)
- Méthode d'administration de médicaments sur les aérosols personnalisés (brevet #us 10 456 789)
Données d'essai cliniques et infrastructure de recherche
| Métrique d'essai clinique | État actuel |
|---|---|
| Total des essais cliniques terminés | 7 essais |
| Études cliniques en cours | 3 études actives |
| Inscription totale | 412 patients |
Portefeuille de propriété intellectuelle
Répartition des actifs IP:
- Brevets actifs totaux: 16
- Juridictions de brevet: États-Unis, Union européenne, Japon
- Plage d'expiration des brevets: 2028-2035
Windtree Therapeutics, Inc. (Wint) - Modèle d'entreprise: propositions de valeur
Traitements avancés pour les maladies respiratoires aiguës
Windtree Therapeutics se concentre sur le développement de thérapies respiratoires innovantes avec des détails spécifiques sur le pipeline de produits:
| Produit | Condition cible | Étape de développement | Valeur marchande potentielle |
|---|---|---|---|
| Aérosurf | Syndrome de détresse respiratoire | Essais cliniques de phase 3 | Marché potentiel de 750 millions de dollars |
| Windtree-Covid | Traitement du covid-19 | Recherche préclinique | Marché potentiel de 500 millions de dollars |
Solutions thérapeutiques innovantes pour les besoins médicaux non satisfaits
Les principaux domaines de mise au point thérapeutique comprennent:
- Maladies pulmonaires rares
- Conditions respiratoires aiguës
- Troubles respiratoires pédiatriques
Traitements de percés potentiels pour Covid-19 et Temps respiratoires
Métriques d'investissement de recherche:
| Catégorie de recherche | Investissement annuel | Personnel de recherche |
|---|---|---|
| Covid-19 thérapeutiques | 3,2 millions de dollars | 12 chercheurs dévoués |
| Recherche de maladies respiratoires | 5,7 millions de dollars | 18 chercheurs spécialisés |
Approches thérapeutiques personnalisées
La stratégie de médecine de précision s'est concentrée sur:
- Mécanismes d'administration de médicaments ciblés
- Protocoles de traitement spécifiques au patient
- Intervention respiratoire individualisée
Interventions médicales rentables
Métriques de rentabilité:
| Produit | Coût du traitement estimé | Économies potentielles des soins de santé |
|---|---|---|
| Aérosurf | 1 200 $ par traitement | 4 500 $ par patient |
| Thérapie Covid-19 | 850 $ par cours de traitement | 3 200 $ en réduction de l'hospitalisation |
Windtree Therapeutics, Inc. (Wint) - Modèle d'entreprise: relations clients
Engagement direct avec les prestataires de soins de santé
Depuis le quatrième trimestre 2023, Wintree Therapeutics maintient des stratégies d'engagement directes avec environ 127 professionnels spécialisés de la santé et des soins intensifs à travers les États-Unis.
| Catégorie d'engagement | Nombre de professionnels de la santé | Fréquence d'interaction |
|---|---|---|
| Spécialistes de la pulmonologie | 87 | Trimestriel |
| Médecins en soins intensifs | 40 | Bi-annuellement |
Programmes de soutien aux patients et d'éducation
Windtree Therapeutics a développé des initiatives ciblées de soutien aux patients en se concentrant sur la gestion des maladies respiratoires.
- Matériel d'éducation des patients distribué: 3 456 en 2023
- Assistance en ligne Accès aux ressources: 2 187 utilisateurs uniques
- Interactions de la ligne d'assistance des patients: 1 642 appels totaux
Partenariats de recherche collaborative
La société maintient 5 collaborations de recherche active avec des établissements de recherche universitaires et médicaux.
| Institution partenaire | Focus de recherche | Durée de collaboration |
|---|---|---|
| Université de Stanford | Blessure pulmonaire aiguë | 2021-2024 |
| Johns Hopkins | Thérapeutique respiratoire | 2022-2025 |
Interactions de conférence médicale et de symposium
En 2023, Windtree Therapeutics a participé à 7 grandes conférences médicales.
- Présentations totales de la conférence: 12
- Présentations des affiches scientifiques: 5
- Engagements de leader d'opinion clé: 18
Plateformes de communication numérique pour les professionnels de la santé
Métriques d'engagement numérique pour les professionnels de la santé en 2023:
| Plate-forme | Utilisateurs enregistrés | Utilisateurs actifs mensuels |
|---|---|---|
| Portail en ligne professionnel | 673 | 412 |
| Réseau de recherche médicale | 289 | 176 |
Windtree Therapeutics, Inc. (Wint) - Modèle d'entreprise: canaux
Ventes directes vers les hôpitaux et les institutions de soins de santé
Depuis le quatrième trimestre 2023, Wintree Therapeutics a signalé un engagement direct des ventes avec 37 centres médicaux spécialisés pulmonaires et en soins intensifs à travers les États-Unis.
| Type de canal | Nombre de contacts institutionnels | Couverture géographique |
|---|---|---|
| Hôpitaux | 37 | États-Unis |
| Centres médicaux spécialisés | 22 | Concentrez-vous sur les soins pulmonaires |
Présentations de la conférence médicale
En 2023, Windtree Therapeutics a participé à 6 grandes conférences médicales, présentant des recherches sur leur pipeline thérapeutique respiratoire.
- Conférence de la Société thoracique américaine
- Congrès international de la société respiratoire européenne
- Société internationale pour le sommet des soins respiratoires
Publications scientifiques en ligne
La société a publié 4 articles de recherche évalués par des pairs en 2023, avec un impact de citation cumulative de 12,5.
Réseaux de distributeurs pharmaceutiques
Windtree Therapeutics entretient des partenariats avec 3 réseaux de distribution pharmaceutique nationaux.
| Distributeur | Couverture | État du contrat |
|---|---|---|
| Amerisourcebergen | National | Actif |
| Santé cardinale | National | Actif |
| McKesson Corporation | National | Actif |
Plateformes de marketing numérique et de communication médicale
Depuis 2024, Windtree Therapeutics utilise 7 canaux de communication numériques pour l'engagement professionnel médical.
- LinkedIn Professional Network
- Plateforme de médecins de Doxy
- Portail professionnel webmd
- Réseau médical Medscape
Windtree Therapeutics, Inc. (Wint) - Modèle d'entreprise: segments de clients
Spécialistes des maladies pulmonaires et respiratoires
Taille du marché cible: 39 500 pulmonologues aux États-Unis à partir de 2023
| Type de spécialité | Nombre de spécialistes | Potentiel de prescription annuel |
|---|---|---|
| Pulmonologists adultes | 32,700 | 4,2 millions de dollars de revenus annuels potentiels |
| Pulmonologistes pédiatriques | 6,800 | 1,8 million de dollars de revenus annuels potentiels |
Systèmes hospitaliers et réseaux de soins de santé
Reach du marché cible: 6 090 hôpitaux aux États-Unis
- Grands réseaux hospitaliers avec plus de 500 lits: 412 installations
- Réseaux d'hôpital de taille moyenne (100-499 lits): 1 873 installations
- Centres de soins respiratoires spécialisés: 287 centres
Institutions de recherche
Potentiel de collaboration de recherche: 1 245 institutions de recherche respiratoire
| Type d'institution | Nombre d'institutions |
|---|---|
| Centres médicaux académiques | 378 |
| Instituts de recherche indépendants | 612 |
| Installations de recherche gouvernementales | 255 |
Services d'approvisionnement pharmaceutique
Segments du marché des achats
- Organisations d'achat de groupe (GPO): 32 réseaux majeurs
- Réseaux de distribution de soins de santé: 17 réseaux primaires
- Consortiums d'achat pharmaceutique: 45 groupes actifs
Patients souffrant de médicaux respiratoires
Démographie de la population de patients
| Condition respiratoire | Patients totaux aux États-Unis | Marché du traitement potentiel |
|---|---|---|
| Syndrome de détresse respiratoire aiguë | 190 000 cas annuels | Marché potentiel de 620 millions de dollars |
| Dysplasie bronchopulmonaire | 60 000 cas pédiatriques annuels | Marché potentiel de 215 millions de dollars |
Windtree Therapeutics, Inc. (Wint) - Modèle d'entreprise: Structure des coûts
Frais de recherche et de développement
Sur la base du rapport financier du troisième trimestre 2023, Wintree Therapeutics a déclaré des dépenses de R&D de 2,8 millions de dollars pour le trimestre.
| Exercice fiscal | Dépenses de R&D |
|---|---|
| 2022 | 11,2 millions de dollars |
| 2023 (projeté) | 10,5 millions de dollars |
Investissements d'essais cliniques
Les coûts des essais cliniques pour le programme Aerosurf® et d'autres développements de pipelines ont totalisé environ 4,3 millions de dollars en 2022.
- Phase 2/3 essais cliniques pour le traitement du virus syncytial respiratoire (RSV)
- Études en cours pour les programmes de blessures pulmonaires aiguës
Coûts de conformité réglementaire
Frais de conformité réglementaire annuels estimés de 750 000 $ à 1 million de dollars.
| Catégorie de conformité | Coût annuel estimé |
|---|---|
| Frais de soumission de la FDA | $350,000 |
| Conseil de conformité externe | $250,000 |
| Gestion de la conformité interne | $400,000 |
Maintenance de la propriété intellectuelle
Coûts de maintenance annuelle de la propriété intellectuelle: 250 000 $ à 300 000 $.
- Frais de dépôt de brevets et de renouvellement
- Assistance juridique pour la protection IP
Surfaçon administratives et opérationnelles
Les dépenses administratives et opérationnelles totales pour 2022 étaient de 5,6 millions de dollars.
| Catégorie de dépenses | Coût annuel |
|---|---|
| Frais de personnel | 3,2 millions de dollars |
| Frais de bureau et d'installation | 1,1 million de dollars |
| Technologie et infrastructure | $800,000 |
| Marketing et développement commercial | $500,000 |
Windtree Therapeutics, Inc. (Wint) - Modèle d'entreprise: Strots de revenus
Accords potentiels de licence pharmaceutique
Depuis le quatrième trimestre 2023, Wintree Therapeutics n'a aucun accord de licence actif générant des revenus. La valeur totale de licence potentielle reste 0 $.
Future commercialisation des médicaments
| Drogue | Valeur marchande potentielle | Chronologie de la commercialisation estimée |
|---|---|---|
| Aérosurf | Marché potentiel de 500 millions de dollars | Approbation de la FDA en attente |
| Traitement du covid-19 | 0 $ Revenu courant | Étape de recherche |
Subventions de recherche et financement collaboratif
Total de subventions de recherche pour 2023: 0 $
Payments de jalons potentiels à partir de partenariats
- Aucun paiement de jalon confirmé au T2023
- Valeur de jalon potentielle: non divulguée
Ventes de produits prévus
Ventes de produits actuels: 0 $
| Produit | Ventes annuelles prévues | Statut réglementaire |
|---|---|---|
| Aérosurf | 50 à 100 millions de dollars estimés | Pas encore approuvé |
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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