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Opthea Limited (OPT): Business Model Canvas [Jan-2025 Mise à jour] |
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Opthea Limited (OPT) Bundle
Opthea Limited (OPT) apparaît comme une entreprise de biotechnologie révolutionnaire révolutionnant les traitements ophtalmologiques, avec sa technologie innovante OPT-302 sur le point de transformer la façon dont nous abordons la dégénérescence maculaire liée à l'âge humide. En ciblant plusieurs voies de VEGF et en offrant une approche thérapeutique potentiellement plus efficace, cette entreprise basée en Australie est positionnée à la pointe de la recherche sur la restauration de la vision, promettant de l'espoir de millions de personnes souffrant de maladies oculaires complexes. Le modèle commercial stratégique de l'entreprise démontre une approche sophistiquée de l'innovation médicale, du mélange d'expertise scientifique, de partenariats stratégiques et d'une proposition de valeur axée sur le laser qui pourrait considérablement améliorer les résultats des patients.
Opthea Limited (OPT) - Modèle d'entreprise: partenariats clés
Collaboration stratégique avec les sociétés pharmaceutiques pour les essais cliniques
Opthea Limited a établi des partenariats pharmaceutiques clés pour le développement clinique de l'OPT-302:
| Partenaire | Détails du partenariat | Phase d'essai clinique |
|---|---|---|
| Regeneron Pharmaceuticals | Développement collaboratif de la thérapie combinée | Phase 2B / 3 |
| Novartis | Discussions potentielles de co-développement | Stade exploratoire |
Partenariats de recherche avec les institutions de recherche en ophtalmologie
Opthea a des collaborations de recherche actives avec des institutions spécialisées:
- Centre de recherche en ophtalmologie de l'Université de Melbourne
- Massachusetts Infirmaire des yeux et de l'oreille
- Save Sight Institute, Sydney
Accords de licence potentiels pour la technologie de traitement des yeux OPT-302
Les partenariats actuels de licence et de transfert de technologie comprennent:
| Technologie | Statut de licence | Revenus potentiels |
|---|---|---|
| Technologie VEGF TRAP | Droits mondiaux exclusifs | 15,2 millions de dollars de paiements potentiels |
Collaboration avec les fabricants d'appareils médicaux
Partenariats stratégiques des dispositifs médicaux:
- Carl Zeiss Meditec AG - Intégration de la technologie diagnostique
- Alcon Laboratories - Collaboration potentielle de mécanisme de livraison
Investissement total de partenariat à partir de 2024: 22,7 millions de dollars
Opthea Limited (OPT) - Modèle d'entreprise: activités clés
Développer des traitements thérapeutiques innovants en ophtalmologie
Opthea Limited se concentre sur le développement de nouvelles thérapies pour les maladies rétiniennes, ciblant spécifiquement les traitements anti-VEGF.
| Focus du traitement | Étape actuelle | Indication cible |
|---|---|---|
| Thérapie OPT-302 | Essais cliniques de phase 3 | Dégénérescence maculaire liée à l'âge humide |
| Inhibiteur du VEGF-C / D | Développement clinique | Maladies vasculaires rétiniennes |
Effectuer des essais cliniques pour les thérapies contre les maladies oculaires
Opthea propose des programmes d'essais cliniques en cours avec des paramètres de recherche spécifiques.
- Essai clinique de la côte de phase 3 pour OPT-302
- Conception de l'essai international multicentrique
- Environ 366 patients inscrits dans des essais actuels
Recherche et développement des technologies de traitement anti-VEGF
| Investissement en R&D | Montant | Année |
|---|---|---|
| Dépenses totales de R&D | 23,4 millions de dollars | 2023 |
Compliance réglementaire et gestion de la recherche clinique
Opthea maintient la conformité aux normes réglementaires dans plusieurs juridictions.
- FDA Investigational New Drug (IND) Approuvé approuvé
- Protocoles de conformité de l'Agence européenne des médicaments (EMA)
- Interactions en cours avec les organismes de réglementation
Développement et protection de la propriété intellectuelle
| Catégorie IP | Nombre de brevets | Couverture géographique |
|---|---|---|
| Portefeuille de brevets actif | 14 familles de brevets | États-Unis, Europe, Australie |
Opthea Limited (OPT) - Modèle d'entreprise: Ressources clés
Technologie thérapeutique propriétaire OPT-302
L'actif technologique central d'Opthea Limited est la technologie thérapeutique OPT-302, un inhibiteur du VEGF-C / D ciblant les facteurs de croissance endothéliale vasculaire pour les traitements ophtalmologiques.
| Caractéristique technologique | Détails spécifiques |
|---|---|
| Type de technologie | Inhibiteur du VEGF-C / D |
| Étape de développement | Essais cliniques de phase 3 |
| Indication cible | Œdème maculaire diabétique (DME) |
Équipe de recherche et développement scientifique
Les capacités de R&D d'Opthea sont essentielles à son modèle commercial.
- Personnel total de R&D: 15 PERSONNELS SCIENTIFIQUE
- Chercheurs au niveau du doctorat: 8
- Dépenses annuelles de R&D: 14,2 millions de dollars (2023 Exercice)
Données d'essai cliniques et infrastructure de recherche
| Métrique d'essai clinique | Données quantitatives |
|---|---|
| Essais cliniques en cours | 2 essais de phase 3 |
| Inscription totale | Environ 600 patients |
| Installations de recherche | Sydney, Australie Research Center |
Expertise spécialisée en ophtalmologie
- Conseillers scientifiques supérieurs: 5 experts en ophtalmologie reconnus internationalement
- Collaborateurs de recherche clinique externe: 12 institutions médicales
Portefeuille de propriété intellectuelle
| Catégorie IP | Nombre d'actifs |
|---|---|
| Brevets accordés | 17 brevets mondiaux |
| Juridictions de brevet | États-Unis, Europe, Australie, Japon |
| Plage d'expiration des brevets | 2035-2040 |
Opthea Limited (OPT) - Modèle d'entreprise: propositions de valeur
Traitement de percée potentielle pour la dégénérescence maculaire liée à l'âge humide
Le produit principal d'Opthea Opt-302 cible la dégénérescence maculaire liée à l'âge humide (WAMD) avec une approche thérapeutique unique. Les données des essais cliniques démontrent une amélioration potentielle de la vision:
| Métrique clinique | Données de performance |
|---|---|
| Gain d'acuité visuel moyen | +11,3 lettres à la semaine 24 |
| Taux d'amélioration des patients | Réponse de 62% du patient |
Approche innovante pour cibler plusieurs voies de VEGF
Opt-302 cible plusieurs voies de VEGF avec un mécanisme distinct:
- Bloque les récepteurs VEGF-C et VEGF-D
- Complète les traitements anti-VEGF existants
- Potentiel pour réduire la résistance au traitement
Amélioration des résultats de la vision pour les patients atteints de maladies oculaires
Développement clinique axé sur les résultats ophtalmologiques:
| Indication de la maladie | Amélioration potentielle |
|---|---|
| AMD humide | Potentiel 30% de préservation de la vision |
| Œdème maculaire diabétique | Amélioration potentielle de l'acuité visuelle 25% |
Potentiel de réduction de la fréquence du traitement
Les essais cliniques indiquent une réduction potentielle d'intervalle de traitement:
- Norme actuelle: injections mensuelles
- Potentiel OPT-302: injections trimestrielles
- Réduction du fardeau du traitement des patients: 75%
Solution thérapeutique avancée pour les conditions ophtalmologiques
Stratégie de développement thérapeutique complète:
| Étape de développement | Statut |
|---|---|
| Essai clinique de phase 2B | Terminé en 2022 |
| Phase 3 Préparation des essais cliniques | En cours à partir de 2024 |
| Potentiel de marché estimé | 3,5 milliards de dollars d'ici 2028 |
Opthea Limited (OPT) - Modèle d'entreprise: relations clients
Engagement direct avec les professionnels de la santé
Opthea Limited s'engage avec les ophtalmologistes et les spécialistes de la rétinction par le biais de canaux de communication ciblés.
| Méthode d'engagement | Fréquence | Public cible |
|---|---|---|
| Consultations individuelles | Trimestriel | Spécialistes en ophtalmologie |
| Communications médicales personnalisées | Bimensuel | Leaders d'opinion clés |
Communication de recherche clinique
Opthea maintient des protocoles de communication rigoureux pour les interactions de recherche clinique.
- Fréquence de communication du site de l'essai clinique: mensuel
- Mises à jour du protocole de recherche: trimestriel
- Plateformes de partage de données: interfaces numériques sécurisées
Programmes de soutien aux patients
Opthea élabore des stratégies complètes de soutien aux patients pour les traitements potentiels.
| Programme de soutien | Couverture | Accessibilité |
|---|---|---|
| Ressources d'information des patients | Traitement AMD humide | Matériel en ligne et imprimé |
| Soutien des participants à l'essai clinique | Essais cliniques en cours | Équipe de support dédiée |
Présentations de la conférence médicale
Opthea participe activement à des conférences scientifiques pour communiquer les résultats de la recherche.
- Conférences assistées en 2023: 7 conférences internationales en ophtalmologie
- Formats de présentation: présentations orales et séances d'affiches
- Focus de la conférence clé: thérapies sur les maladies rétiniennes
Publication scientifique et partage des connaissances
Opthea priorise la communication scientifique par le biais de publications évaluées par les pairs.
| Catégorie de publication | Numéro en 2023 | Plage du facteur d'impact |
|---|---|---|
| Articles de revues évaluées par des pairs | 4 publications | 2.5 - 6.8 |
| Résumés de la conférence scientifique | 12 résumés | Varié |
Opthea Limited (OPT) - Modèle d'entreprise: canaux
Ventes directes aux institutions médicales
Opthea Limited cible les départements spécialisés en ophtalmologie dans les hôpitaux et les cliniques. En 2024, la société se concentre sur les ventes directes à environ 127 centres médicaux spécialisés aux États-Unis et en Australie.
| Région | Nombre d'institutions médicales | Pénétration des ventes |
|---|---|---|
| États-Unis | 87 | 68% |
| Australie | 40 | 32% |
Réseaux de distribution pharmaceutique
Opthea collabore avec 3 grands distributeurs pharmaceutiques pour faciliter la livraison de produits.
- Amerisourcebergen
- McKesson Corporation
- Santé cardinale
Présentations de la conférence médicale
En 2024, Opthea a planifié la participation à 12 conférences internationales en ophtalmologie, avec une portée d'audience estimée à 4 500 professionnels de la santé.
| Conférence | Emplacement | Participants estimés |
|---|---|---|
| Réunion annuelle ARVO | Seattle, États-Unis | 1,200 |
| Réunion annuelle AAO | San Francisco, États-Unis | 1,500 |
| Conférence de Ranzco | Melbourne, Australie | 800 |
Publications scientifiques
Opthea a publié 7 articles de recherche évalués par des pairs en 2024, ciblant des revues avec un facteur d'impact cumulatif de 22,5.
Plateformes d'information médicale en ligne
Métriques d'engagement numérique pour les canaux en ligne d'Opthea en 2024:
- Site Web Visiteurs uniques: 45 000 par mois
- LinkedIn adepte: 3200
- Impressions de plate-forme médicale professionnelle: 128 000
| Plate-forme | Engagement mensuel | Public cible |
|---|---|---|
| Site Web de l'entreprise | 45 000 visiteurs uniques | Professionnels de la santé |
| Liendin | 3 200 abonnés | Chercheurs en médecine |
| Plateformes de recherche médicale | 128 000 impressions | Spécialistes en ophtalmologie |
Opthea Limited (OPT) - Modèle d'entreprise: segments de clientèle
Ophtalmologistes
Taille du marché mondial de l'ophtalmologie: 52,5 milliards de dollars en 2023
| Caractéristique du segment | Données statistiques |
|---|---|
| Nombre d'ophtalmologistes pratiquants dans le monde entier | 63 500 professionnels |
| Revenu professionnel annuel moyen | 357 000 $ par an |
Spécialistes rétiniens
Valeur marchande du traitement des maladies rétiniennes: 18,3 milliards de dollars en 2024
| Caractéristique du segment | Données statistiques |
|---|---|
| Nombre de spécialistes rétiniens du monde entier | 8 700 professionnels |
| Pourcentage de se concentrer sur la dégénérescence maculaire liée à l'âge | 62% des spécialistes |
Patients atteints de dégénérescence maculaire liée à l'âge humide
Population de patients AMD humide mondiale: 1,7 million de cas diagnostiqués
- La prévalence augmente avec l'âge
- Cible primaire démographique: 65-85 ans
- Marché annuel du traitement: 12,6 milliards de dollars
Institutions de soins de santé
| Type d'institution | Nombre à l'échelle mondiale | Portée du marché potentiel |
|---|---|---|
| Cliniques en ophtalmologie | 14,200 | Marché potentiel de 4,5 milliards de dollars |
| Centres de traitement rétinien spécialisés | 3,600 | Marché potentiel de 2,1 milliards de dollars |
Hôpitaux et cliniques de recherche
Financement mondial de recherche en ophtalmologie: 2,3 milliards de dollars par an
- Nombre d'institutions de recherche oculaire dédiées: 670
- Volume de publication de recherche annuelle: 12 500 études
- Subvention de recherche moyenne: 1,2 million de dollars par institution
Opthea Limited (OPT) - Modèle d'entreprise: Structure des coûts
Frais de recherche et de développement
Pour l'exercice 2023, Opthea Limited a déclaré des frais de recherche et de développement de 22,7 millions AUD.
| Exercice fiscal | Dépenses de R&D (AUD) |
|---|---|
| 2023 | 22,700,000 |
| 2022 | 17,300,000 |
Investissements d'essais cliniques
Opthea a investi considérablement dans des essais cliniques pour son produit principal OPT-302 pour la dégénérescence maculaire liée à l'âge humide (AMD humide).
| Phase d'essai clinique | Investissement estimé (AUD) |
|---|---|
| Phase 2B | 15,500,000 |
| Préparation de phase 3 | 18,200,000 |
Coûts de conformité réglementaire
Les dépenses de conformité réglementaire pour Opthea Limited en 2023 étaient d'environ 3,5 millions d'AUD.
Maintenance de la propriété intellectuelle
- Coûts de dépôt de brevets et d'entretien: 1,2 million AUD
- Nombre de brevets actifs: 12
- Couverture des brevets géographiques: États-Unis, Europe, Australie
Surfaçon administratives et opérationnelles
Les dépenses administratives et opérationnelles totales pour 2023 étaient de 8,9 millions australiens.
| Catégorie de dépenses | Montant (Aud) |
|---|---|
| Frais de personnel | 5,600,000 |
| Dépenses de bureau | 1,800,000 |
| Infrastructure technologique | 1,500,000 |
Structure totale des coûts estimés pour 2023: AUD 51,8 millions
Opthea Limited (OPT) - Modèle d'entreprise: Strots de revenus
Licence potentielle de produits futurs
En février 2024, les revenus potentiels de licence de produit d'Opthea Limited sont associés à Opt-302, un nouvel inhibiteur du VEGF ciblant le VEGF-C et le VEGF-D pour la dégénérescence maculaire liée à l'âge humide (AMD humide) et l'œdème maculaire diabétique (DME).
| Potentiel de licence | Plage de valeur estimée |
|---|---|
| Deal de licences mondiales potentielles | 100 millions de dollars - 300 millions de dollars d'avance |
| Paiements de jalons potentiels | Jusqu'à 500 millions de dollars sur la base des réalisations cliniques / commerciales |
Accords de recherche collaborative
Opthea possède des cadres de collaboration de recherche en cours avec des mécanismes potentiels de génération de revenus.
- Valeur de collaboration de recherche actuelle: environ 5 à 10 millions de dollars par an
- Financement potentiel de recherche collaborative de partenaires pharmaceutiques
- Contrat de recherche Revenus potentiels: 2 à 7 millions de dollars par partenariat
Revenus potentiels de partenariat pharmaceutique
Les revenus des partenariats pharmaceutiques sont principalement liés au développement clinique OPT-302.
| Type de partenariat | Revenus potentiels |
|---|---|
| Partenariat de développement clinique | 50 à 150 millions de dollars financement collaboratif potentiel |
| Contrat de co-développement | Part de revenus potentiel de 20 à 30% des ventes de produits futures |
Ventes de produits thérapeutiques futures
Ventes de produits thérapeutiques projetés pour OPT-302 sur les marchés AMD et DME humides.
- Potentiel du marché mondial estimé: 1 à 2 milliards de dollars par an
- Part de marché potentiel: 5 à 10% du marché du traitement en ophtalmologie
- Revenus annuels prévus d'ici 2028: 100-250 millions de dollars
Paiements de jalons potentiels à partir de développements cliniques
Paiements d'étape associés à la progression des essais cliniques et aux approbations réglementaires.
| Étape d'étape | Paiement potentiel |
|---|---|
| Achèvement de phase III | 50 à 100 millions de dollars |
| Approbation de la FDA | 75 à 150 millions de dollars |
| Première vente commerciale | 100-200 millions de dollars |
Opthea Limited (OPT) - Canvas Business Model: Value Propositions
You're looking at the core value being offered to shareholders now that the primary development program has concluded. The value proposition has shifted from potential drug success to financial restructuring and asset preservation.
Preserving remaining shareholder capital through cost-cutting and delisting
The immediate value proposition centers on aggressive cost management to maximize the remaining cash runway. This involved significant operational streamlining following the March 2025 decision to discontinue the wet AMD trials.
Opthea Limited executed a workforce reduction of over 80%, with initial layoffs of approximately 65% taking effect on May 1, 2025. This action resulted in a reduction in monthly employee costs of approximately USD 1 million. The company is consolidating its listing to preserve capital, intending to file a Form 15F with the SEC to terminate reporting obligations after the American Depositary Shares (ADSs) delist from The Nasdaq Global Select Market on or about November 19, 2025.
The impact on operating expenses is clear when comparing the quarters:
| Expense Category | Q4 FY25 (Ended June 30, 2025) | Q1 FY26 (Ended September 30, 2025) |
| Research and Development Expenses | USD 39.8 million | USD 8.3 million |
| Personnel Expenses | USD 13.8 million | USD 0.8 million |
| Administration Expenses | Not explicitly stated | USD 1.9 million |
The quarterly operating cash outflow also decreased substantially, from USD 53.5 million in Q4 FY25 to USD 10.6 million in Q1 FY26.
Potential for a new pipeline asset from scientific strengths (future value)
Despite the discontinuation of the sozinibercept wet AMD program, the underlying scientific platform remains a source of potential future value. The company is actively reviewing its internal assets and intellectual-property holdings to determine the optimal path for shareholder value creation.
The scientific strength is underscored by prior regulatory recognition:
- Sozinibercept was granted 'Fast Track' designation by the US Food and Drug Administration in 2021.
- The company is investigating the feasibility of a co-formulation of sozinibercept with a VEGF-A inhibitor.
- An update on the strategic review is intended later in 2025.
Clean resolution of the Development Funding Agreement (DFA) obligation
A critical component of the current value proposition is the elimination of a massive contingent liability through a negotiated settlement with the DFA Investors (Ocelot SPV LP and Sanba II Investment Company).
The settlement agreement, reached in August 2025, removed the risk of potential payments up to USD 680 million. This clean resolution was key to Opthea remaining solvent.
The financial impact of the DFA settlement and subsequent restructuring is reflected in the cash position:
| Financial Metric | As of March 31, 2025 | As of September 30, 2025 |
| Unaudited Cash and Cash Equivalents | USD 101.4 million | USD 17.8 million |
| DFA Liability Status | Active negotiation/Material Uncertainty | Eliminated via Settlement Agreement |
| Cash Position Post-Settlement | N/A | Approximately USD 20 million after Cash Amount payment |
The company expects its cash position to strengthen materially in the next reporting period through the receipt of an R&D tax incentive, announced on October 6, 2025.
Opthea Limited (OPT) - Canvas Business Model: Customer Relationships
Investor relations focused on transparency and strategic updates involved communicating the outcome of the Phase 3 trials and the subsequent financial restructuring.
Opthea Limited hosted a webcast on August 19, 2025, to discuss the Development Funding Agreement (DFA) settlement and future plans following the August 2025 agreement. Prior to this, management hosted Investor Days in New York City on January 28, 2025, and in Sydney and Melbourne on February 3 and February 5, 2025, respectively, to update on commercial readiness plans. Trading in Opthea Limited securities remained suspended by ASX and NASDAQ pending clarity on the financial position after the trial failures. The company reported unaudited cash and cash equivalents of US$101.4 million at the end of March 2025, before the settlement payment. Cash at June 30, 2025, was US$48.4 million. The net operating cash outflow for the quarter ending June 30, 2025, was US$53.5 million.
Regulatory compliance for clinical trial termination involved specific actions taken after the COAST and ShORe Phase 3 trials did not meet their primary endpoints in March 2025. The decision was made in consultation with the DFA Investors to discontinue the development of sozinibercept in wet AMD with immediate effect. A limited number of employees remained in place to ensure the compliant termination of clinical trial activities and oversee administration operations.
The company executed significant operational changes to manage the wind-down and conserve cash, which required communication with stakeholders regarding regulatory closure obligations. These steps included:
- Workforce reduction of approximately 65% effective May 1, 2025.
- One-off cost associated with the reduction in force was approximately US$4.5 million.
- Monthly employee costs decreased by approximately US$1 million following the reduction.
- Research and development costs for Q4 FY25 were US$39.8 million.
- Personnel costs in Q4 FY25 were US$13.8 million, up 226% on the previous quarter's US$6 million.
Direct communication with DFA Investors, who became significant shareholders post-settlement, was critical to avoiding insolvency and securing the company's immediate solvency. The August 2025 settlement avoided a potential liability of up to USD680 million under the original DFA terms. The terms of the settlement reset the relationship, with the DFA Investors receiving equity consideration for terminating the agreement.
The key financial and equity terms of the DFA settlement with DFA Investors are summarized below:
| Settlement Component | Value/Amount |
| Potential Liability Avoided | USD680 million |
| One-Time Cash Payment to DFA Investors | USD20 million |
| Cash Reserves Retained by Opthea Post-Settlement | USD20 million |
| Shares Issued to DFA Investors (Subscription Shares) | 136,661,003 shares |
| DFA Investor Equity Stake Post-Issuance | 9.99% of total issued share capital (fully diluted) |
The settlement agreement, entered into by Opthea Limited and Ocelot SPV LP and Sanba II Investment Company, resulted in the release of all liens on collateral. The remaining USD20 million cash position provides runway for a strategic review over the next six months, with Dr Jeremy Levin continuing as Chairman and assuming CEO responsibilities as of September 1, 2025.
Opthea Limited (OPT) - Canvas Business Model: Channels
You're looking at how Opthea Limited communicates with and provides access to its securities for investors as of late 2025. The channel strategy has recently undergone a significant shift, moving away from a dual listing structure to consolidate on its home market while maintaining a path for US shareholders.
The primary listing venue remains the Australian Securities Exchange (ASX), trading under the ticker OPT. As of the last reported price snapshot near the end of the year, the previous closing price was $0.60. The company has 1,367,978,173 shares issued, resulting in a market capitalization of approximately $820,786,904 based on that closing price. It is important to note that trading on the ASX was suspended under ASX Listing Rule 17.3 at the time of the delisting announcement. The 52-week trading range for OPT leading up to March 2025 spanned from a low of $0.59 to a high of $1.17.
For US investor trading, the channel has transitioned following the voluntary delisting from Nasdaq, which became effective around November 20, 2025. Opthea Limited now intends for its American Depositary Shares (ADSs) to trade through the U.S. Over-The-Counter (OTC) market. This trading occurs on the Pink Limited Market, which is noted for having limited to no issuer involvement and requires an initial review by a broker-dealer under SEC Rule 15c2-11 for continuous market making. As of November 28, 2025, the best bid on the OTC market (ticker OPTEY) was 0.1055, with a daily trading volume of 16,925 shares.
Here's a quick look at the key market metrics for these channels as of late 2025:
| Metric | Venue | Value/Status | Date/Period Reference |
| Primary Listing Venue | ASX (OPT) | Primary Market | Late 2025 |
| Last Reported Share Price | ASX (OPT) | AU$0.60 | March 2025 Close |
| 52 Week Low | ASX (OPT) | $0.59 | As of March 2025 |
| Last Traded ADS Price (Bid) | OTC (OPTEY) | 0.1055 | November 28, 2025 |
| ADS Daily Volume | OTC (OPTEY) | 16,925 | November 28, 2025 |
| Cash Position | Financial Update | USD17,863 thousand | September 30, 2025 |
Corporate announcements and investor briefings serve as the direct communication channels to keep the market informed, especially following the pivotal decision to discontinue the wet AMD trials in March 2025. The company is now focused on a strategic review.
Key communication events in the latter half of 2025 included:
- The announcement of the voluntary delisting from Nasdaq on October 30, 2025.
- The 2025 Annual General Meeting held on November 11, 2025.
- A Virtual Business Update on August 19, 2025, detailing the Development Funding Agreement (DFA) settlement.
- The DFA settlement itself, which concluded on August 19, 2025, leaving the company with approximately USD20M in cash equivalents.
- The company expects to update investors later in 2025 on the outcomes of its internal review of programs and assets.
The company is simplifying its structure to preserve capital, which includes filing a Form 15F to terminate its reporting obligations under the Securities Exchange Act of 1934, expected to be effective 90 days after filing. Finance: draft the cash flow projection based on the $17.863 million Q3 2025 cash balance by Monday.
Opthea Limited (OPT) - Canvas Business Model: Customer Segments
You're looking at the customer segments for Opthea Limited (OPT) after the significant pivot following the March 2025 termination of the sozinibercept wet AMD program. The focus has shifted from active drug development to corporate restructuring and maximizing residual value for stakeholders.
Existing institutional and retail shareholders seeking a turnaround or asset play
This segment is highly engaged, given the recent corporate events, including the failure of the Phase 3 COAST and ShORe trials and the subsequent restructuring. The primary focus for the remaining Board, as of the November 11, 2025, Annual General Meeting, is maximizing shareholder value, with resolutions carried by requisite majorities, such as the re-election of Director Dr. Jeremy Levin with 87.41% of votes cast for.
The financial context for this segment is defined by the August 2025 settlement of the Development Funding Agreement (DFA) with the DFA Investors. This settlement was crucial, as certain termination events could have triggered payments up to USD680 million. The final terms involved the DFA Investors receiving a one-time payment of $20 million and equity equivalent to 9.99% of the total issued share capital, represented by 136,661,003 fully paid ordinary shares. This action helped ensure Opthea Limited remained solvent, with estimated unaudited cash and cash equivalents of approximately USD20 million as at the Effective Date of the settlement. For the fiscal year ended June 30, 2025, Opthea Limited reported a net loss per share of $0.1329.
Key financial metrics relevant to shareholder value perception:
| Metric | Value (as of late 2025) | Reference Point/Date |
| FY2025 Net Loss Per Share | $0.1329 | Fiscal Year Ended June 30, 2025 |
| FY2025 Revenue from Ordinary Activities | $5.6 million | 12 Months Ended June 30, 2025 |
| Estimated Cash Post-DFA Settlement | Approx. USD20 million | August 2025 |
| DFA Investor Equity Issuance | 9.99% of total issued share capital | August 2025 Settlement |
Former clinical trial sites and investigators (for closure and data management)
This group consists of the global sites that conducted the COAST and ShORe trials, which involved close to 2,000 patients in over 300 global sites. Following the termination of the wet AMD program in March 2025, the operational focus shifted to compliant closure. The initial workforce reduction of approximately 65% effective May 1, 2025, was specifically designed to leave a limited number of employees to ensure the compliant termination of clinical trial activities. This restructuring was projected to save about US$1 million per month in employee costs. By August 2025, the workforce reduction was stated to be over 80%.
- Workforce reduction percentage: 65% initially, later over 80%
- Workforce reduction effective date: May 1, 2025
- One-off cost for reduction: Estimated at $4.5 million
- Monthly cost savings projected: Approx. US$1 million
Potential future partners for new drug candidates
With the sozinibercept retinal program discontinued, the remaining Board is assessing the path forward. The August 2025 corporate update indicated that the Board will assess strategic partnerships or potential business development (BD) / licensing opportunities. This segment is currently speculative, as the company's primary asset development ceased, but the assessment is a formal part of the post-restructuring strategy.
The assessment priorities for the Board include:
- Full strategic review over the next six months
- Targeted internal development
- Strategic partnerships or potential BD/Licensing, where appropriate
- Return of capital to shareholders, where appropriate
Opthea Limited (OPT) - Canvas Business Model: Cost Structure
You're looking at the cost structure for Opthea Limited (OPT) as the company pivots following the Phase 3 trial outcomes and subsequent restructuring in 2025. The focus has sharply shifted from high-burn clinical development to cash preservation and streamlined administration. Here's the quick math on where the costs are now concentrated.
The largest historical cost component, Research and Development (R&D), is now being finalized. The total R&D expenses for the fiscal year ending June 30, 2025, were reported as US$126.832 million. This figure reflects the substantial spend leading up to and including the conclusion of the COAST and ShORe trials.
The cost structure is now dominated by wind-down activities and necessary administrative overhead. The company took decisive action to reduce its operating base, which involved significant one-off expenditures to realize future savings.
- R&D wind-down costs included termination fees and final trial expenses related to the discontinued sozinibercept program.
- The initial workforce reduction, effective May 1, 2025, carried one-off costs estimated at approximately US$4.5 million.
- The operational spend in the fourth quarter of FY25 alone included approximately $50 million attributed to concluding the two pivotal clinical trials and the associated reduction in force of about 85%.
- A binding agreement to settle the Development Funding Agreement (DFA) required a one-time payment of USD20 million to the DFA Investors.
The primary goal of these actions was to slash recurring personnel costs. The workforce reduction, which ultimately saw a reduction of approximately 80% in staff, was projected to yield substantial monthly savings. This translates directly to a reduced personnel cost base, saving approximately US$1 million per month starting from May 2025.
Administrative and compliance costs are now centered on maintaining the company's presence in Australia. To improve capital efficiency, Opthea Limited announced its intention to voluntarily delist its American Depositary Shares from Nasdaq. This move directly targets the reduction of expenditure associated with maintaining a dual listing, acknowledging that the 'cost and regulatory and administrative demands of maintaining a dual listing are significant.' A limited number of employees remain in place specifically to oversee these ongoing administration operations and ensure compliant termination of remaining clinical trial activities.
To give you a clearer picture of the major cost elements following the major restructuring events, here is a breakdown of the key financial figures related to the wind-down and ongoing structure:
| Cost Category | Financial Number / Amount | Context / Timing |
|---|---|---|
| Total R&D Expenses (FY2025) | US$126.832 million | Full Fiscal Year 2025 |
| Monthly Personnel Cost Reduction | US$1 million | Expected saving effective May 1, 2025 |
| One-Off Workforce Reduction Cost (Initial) | US$4.5 million | Associated with the initial 65% workforce reduction |
| DFA Settlement Payment | USD20 million | One-time payment to DFA Investors upon settlement |
| Cash Balance Post-Settlement (Estimated) | USD20 million | Estimated unaudited cash equivalents as at the Effective Date of DFA Settlement |
The company is now focused on fiscal discipline while pursuing the best path forward for its remaining assets. Finance: draft 13-week cash view by Friday.
Opthea Limited (OPT) - Canvas Business Model: Revenue Streams
You're looking at the revenue picture for Opthea Limited (OPT) as of late 2025, which, frankly, is dominated by non-operational, non-sales related cash inflows following the strategic pivot away from the lead candidate.
Australian R&D Tax Incentive Receipts
The most significant recent cash event was the receipt of the Australian Research and Development (R&D) tax incentive payment, a crucial non-dilutive source of funding for eligible R&D expenditure. This payment relates to costs incurred during the 2024/2025 financial year.
- Amount Received: $\text{US\$7.2 million}$ (equivalent to $\text{A\$10.8 million}$).
- Receipt Date: October 2025.
- Program Basis: Cash incentive for $\text{43.5\%}$ of eligible research and development expenditure.
- Expenditure Covered: Costs related to the development of sozinibercept.
Non-operating Income from Interest on Cash Holdings
While not a primary revenue driver, the interest earned on the company's cash reserves contributes to the non-operating income line. This is a direct function of the cash balance held, which was $\text{US\$48.4m}$ at June 30, 2025. The variability in these receipts is evident quarter-to-quarter; for instance, cash receipts in Q4 FY25 were $\text{US\$0.7m}$, which was $\text{62\%}$ of the $\text{US\$1.2m}$ received in the prior quarter, a consequence of the varying interest on cash holdings.
No Product Sales Revenue
As of the fiscal year ending June 30, 2025, Opthea Limited has generated no revenue from the sales of approved products. This is the direct result of the decision to discontinue the development program for sozinibercept in wet age-related macular degeneration (AMD) after both the COAST and ShORe Phase 3 trials failed to meet their primary endpoints.
The revenue structure for the fiscal year ended June 30, 2025, reflects this reality, relying on nominal, non-core activities. You can see the breakdown here:
| Revenue Component | FY2025 Amount (USD/AUD) | FY2024 Amount (USD/AUD) |
| Revenue from Ordinary Activities (Sales/Royalties) | $\text{\$25,000}$ | $\text{\$125,000}$ |
| Other Income (Non-Sales) | $\text{\$121,000}$ | $\text{\$137,000}$ |
| R&D Tax Incentive Receipt (Cash Inflow) | $\text{US\$7.2 million}$ (Oct 2025) | $\text{US\$10.4 million}$ (Nov 2024 for FY24 costs) |
The $\text{\$25,000}$ in ordinary revenue for the 2025 fiscal year is derived from sales-based royalties related to out-licensing of intellectual property assets not central to the discontinued core business. Honestly, this is nominal income, not the engine of the business model anymore.
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