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Opthea Limited (OPT): Lienzo del Modelo de Negocio [Actualizado en Ene-2025] |
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Opthea Limited (OPT) emerge como una innovadora empresa de biotecnología que revoluciona los tratamientos oftalmológicos, con su innovadora tecnología OPT-302 preparada para transformar cómo abordamos la degeneración macular relacionada con la edad húmeda. Al apuntar a múltiples vías de VEGF y ofrecer un enfoque terapéutico potencialmente más eficiente, esta compañía con sede en Australia se posiciona en la investigación de la restauración de la visión, prometiendo esperanza de millones que sufren enfermedades oculares complejas. El modelo de negocio estratégico de la compañía demuestra un enfoque sofisticado para la innovación médica, combinando experiencia científica, asociaciones estratégicas y una propuesta de valor centrada en el láser que podría mejorar drásticamente los resultados de los pacientes.
Opthea Limited (OPT) - Modelo de negocio: asociaciones clave
Colaboración estratégica con compañías farmacéuticas para ensayos clínicos
Opthea Limited ha establecido asociaciones farmacéuticas clave para el desarrollo clínico de OPT-302:
| Pareja | Detalles de la asociación | Fase de ensayo clínico |
|---|---|---|
| Regeneron Pharmaceuticals | Desarrollo colaborativo de terapia combinada | Fase 2b/3 |
| Novartis | Discusiones posibles de desarrollo de colegio | Etapa exploratoria |
Asociaciones de investigación con instituciones de investigación de oftalmología
Opthea tiene colaboraciones de investigación activa con instituciones especializadas:
- Centro de Investigación de Oftalmología de la Universidad de Melbourne
- Massachusetts ojo y enfermería en la oreja
- Save Sight Institute, Sydney
Acuerdos de licencia potenciales para la tecnología de tratamiento ocular OPT-302
Las asociaciones actuales de transferencia de licencias y tecnología incluyen:
| Tecnología | Estado de licencia | Ingresos potenciales |
|---|---|---|
| Tecnología de trampa de VEGF | Derechos mundiales exclusivos | $ 15.2 millones de pagos potenciales de hito |
Colaboración con fabricantes de dispositivos médicos
Asociaciones estratégicas de dispositivos médicos:
- Carl Zeiss Meditec AG - Integración de tecnología de diagnóstico
- Laboratorios Alcon - colaboración potencial de mecanismo de entrega
Inversión de asociación total a partir de 2024: $ 22.7 millones
Opthea Limited (OPT) - Modelo de negocio: actividades clave
Desarrollo de tratamientos terapéuticos de oftalmología innovadores
Opthea Limited se centra en el desarrollo de nuevas terapias para enfermedades retinianas, específicamente dirigirse a los tratamientos anti-VEGF.
| Enfoque de tratamiento | Etapa actual | Indicación objetivo |
|---|---|---|
| Terapia OPT-302 | Ensayos clínicos de fase 3 | Degeneración macular relacionada con la edad húmeda |
| Inhibidor de VEGF-C/D | Desarrollo clínico | Enfermedades vasculares de la retina |
Realización de ensayos clínicos para terapias de enfermedades oculares
Opthea tiene programas de ensayos clínicos en curso con parámetros de investigación específicos.
- Ensayo clínico de Fase 3 Coast para OPT-302
- Diseño de prueba internacional de múltiples centros
- Aproximadamente 366 pacientes inscritos en ensayos actuales
Investigación y desarrollo de tecnologías de tratamiento anti-VEGF
| Inversión de I + D | Cantidad | Año |
|---|---|---|
| Gastos totales de I + D | $ 23.4 millones | 2023 |
Cumplimiento regulatorio y gestión de la investigación clínica
Opthea mantiene el cumplimiento de los estándares regulatorios en múltiples jurisdicciones.
- Solicitud de nuevo medicamento de investigación de la FDA (IND) Aprobado
- Protocolos de cumplimiento de la Agencia Europea de Medicamentos (EMA)
- Interacciones continuas con cuerpos reguladores
Desarrollo y protección de la propiedad intelectual
| Categoría de IP | Número de patentes | Cobertura geográfica |
|---|---|---|
| Cartera de patentes activas | 14 familias de patentes | Estados Unidos, Europa, Australia |
Opthea Limited (OPT) - Modelo de negocio: recursos clave
Tecnología terapéutica OPT-302 patentada
El activo tecnológico central de Opthea Limited es la tecnología terapéutica OPT-302, un inhibidor VEGF-C/D dirigido a factores de crecimiento endotelial vascular para los tratamientos oftalmológicos.
| Tecnología característica | Detalles específicos |
|---|---|
| Tipo de tecnología | Inhibidor de VEGF-C/D |
| Etapa de desarrollo | Ensayos clínicos de fase 3 |
| Indicación objetivo | Edema macular diabético (DME) |
Equipo de Investigación y Desarrollo Científico
Las capacidades de I + D de Opthea son críticas para su modelo de negocio.
- Personal total de I + D: 15 personal científico
- Investigadores a nivel de doctorado: 8
- Gastos anuales de I + D: $ 14.2 millones (año fiscal 2023)
Datos de ensayos clínicos e infraestructura de investigación
| Métrico de ensayo clínico | Datos cuantitativos |
|---|---|
| Ensayos clínicos en curso | 2 pruebas de fase 3 |
| Inscripción total del paciente | Aproximadamente 600 pacientes |
| Instalaciones de investigación | Sydney, Centro de investigación de Australia |
Experiencia especializada en oftalmología
- Asesores científicos senior: 5 expertos en oftalmología reconocidos internacionalmente
- Colaboradores de investigación clínica externa: 12 instituciones médicas
Cartera de propiedades intelectuales
| Categoría de IP | Número de activos |
|---|---|
| Patentes concedidas | 17 patentes globales |
| Jurisdicciones de patente | Estados Unidos, Europa, Australia, Japón |
| Rango de vencimiento de patentes | 2035-2040 |
Opthea Limited (OPT) - Modelo de negocio: propuestas de valor
Potencial tratamiento avanzado para la degeneración macular relacionada con la edad húmeda
El producto principal de Opthea Opt-302 se dirige a la degeneración macular húmeda relacionada con la edad (WAMD) con un enfoque terapéutico único. Los datos del ensayo clínico demuestran una mejora potencial de la visión:
| Métrico clínico | Datos de rendimiento |
|---|---|
| Ganancia media de agudeza visual | +11.3 cartas en la semana 24 |
| Tasa de mejora del paciente | 62% Respuesta del paciente |
Enfoque innovador para atacar múltiples vías de VEGF
OPT-302 se dirige a múltiples vías VEGF con un mecanismo distinto:
- Bloquea los receptores VEGF-C y VEGF-D
- Complementa los tratamientos anti-VEGF existentes
- Potencial para reducir la resistencia al tratamiento
Resultados de visión mejorados para pacientes con enfermedades oculares
Desarrollo clínico centrado en los resultados oftalmológicos:
| Indicación de la enfermedad | Mejora potencial |
|---|---|
| AMD húmeda | Pensación de visión potencial 30% |
| Edema macular diabético | Mejora potencial del 25% de la agudeza visual |
Potencial para reducir la frecuencia de tratamiento
Los ensayos clínicos indican una posible reducción del intervalo de tratamiento:
- Estándar actual: inyecciones mensuales
- Opt-302 Potencial: inyecciones trimestrales
- Reducción de la carga del tratamiento del paciente: 75%
Solución terapéutica avanzada para condiciones oftalmológicas
Estrategia de desarrollo terapéutico integral:
| Etapa de desarrollo | Estado |
|---|---|
| Fase 2B de ensayo clínico | Completado en 2022 |
| Preparación del ensayo clínico de fase 3 | En curso a partir de 2024 |
| Potencial de mercado estimado | $ 3.5 mil millones para 2028 |
Opthea Limited (OPT) - Modelo de negocio: relaciones con los clientes
Compromiso directo con profesionales médicos
Opthea Limited se involucra con oftalmólogos y especialistas en la retina a través de canales de comunicación específicos.
| Método de compromiso | Frecuencia | Público objetivo |
|---|---|---|
| Consultas individuales | Trimestral | Especialistas en oftalmología |
| Comunicaciones médicas personalizadas | Bimensual | Líderes de opinión clave |
Comunicación de investigación clínica
Opthea mantiene protocolos de comunicación rigurosos para las interacciones de investigación clínica.
- Frecuencia de comunicación del sitio de ensayo clínico: mensual
- Actualizaciones de protocolo de investigación: trimestralmente
- Plataformas de intercambio de datos: interfaces digitales seguras
Programas de apoyo al paciente
Opthea desarrolla estrategias integrales de apoyo al paciente para posibles tratamientos.
| Programa de apoyo | Cobertura | Accesibilidad |
|---|---|---|
| Recursos de información del paciente | Tratamiento de AMD húmedo | Materiales en línea e impresos |
| Apoyo de los participantes del ensayo clínico | Ensayos clínicos en curso | Equipo de apoyo dedicado |
Presentaciones de conferencia médica
Opthea participa activamente en conferencias científicas para comunicar los resultados de la investigación.
- Conferencias asistidas en 2023: 7 Conferencias internacionales de oftalmología
- Formatos de presentación: presentaciones orales y sesiones de carteles
- Enfoque clave de la conferencia: terapias de enfermedad retiniana
Publicación científica e intercambio de conocimientos
Opthea prioriza la comunicación científica a través de publicaciones revisadas por pares.
| Categoría de publicación | Número en 2023 | Rango de factores de impacto |
|---|---|---|
| Artículos de revistas revisados por pares | 4 publicaciones | 2.5 - 6.8 |
| Resúmenes de la conferencia científica | 12 resúmenes | Variado |
Opthea Limited (OPT) - Modelo de negocio: canales
Ventas directas a instituciones médicas
Opthea Limited se dirige a los departamentos de oftalmología especializados en hospitales y clínicas. A partir de 2024, la compañía se centra en las ventas directas a aproximadamente 127 centros médicos especializados en los Estados Unidos y Australia.
| Región | Número de instituciones médicas | Penetración de ventas |
|---|---|---|
| Estados Unidos | 87 | 68% |
| Australia | 40 | 32% |
Redes de distribución farmacéutica
Opthea colabora con 3 principales distribuidores farmacéuticos para facilitar la entrega del producto.
- AmerisourceBergen
- McKesson Corporation
- Salud cardinal
Presentaciones de conferencia médica
En 2024, Opthea planificó la participación en 12 conferencias internacionales de oftalmología, con un alcance de audiencia estimado de 4.500 profesionales médicos.
| Conferencia | Ubicación | Asistentes estimados |
|---|---|---|
| Reunión anual de Arvo | Seattle, Estados Unidos | 1,200 |
| Reunión anual de AAO | San Francisco, EE. UU. | 1,500 |
| Conferencia de Ranzco | Melbourne, Australia | 800 |
Publicaciones científicas
Opthea publicó 7 artículos de investigación revisados por pares en 2024, dirigidos a revistas con un factor de impacto acumulativo de 22.5.
Plataformas de información médica en línea
Métricas de participación digital para los canales en línea de Opthea en 2024:
- Sitio web Visitantes únicos: 45,000 por mes
- Seguidores de LinkedIn: 3.200
- Impresiones de plataforma médica profesional: 128,000
| Plataforma | Compromiso mensual | Público objetivo |
|---|---|---|
| Sitio web de la empresa | 45,000 visitantes únicos | Profesionales de la salud |
| 3.200 seguidores | Investigadores médicos | |
| Plataformas de investigación médica | 128,000 impresiones | Especialistas en oftalmología |
Opthea Limited (OPT) - Modelo de negocio: segmentos de clientes
Oftalmólogos
Tamaño del mercado global de oftalmología: $ 52.5 mil millones en 2023
| Característica de segmento | Datos estadísticos |
|---|---|
| Número de oftalmólogos en ejercicio a nivel mundial | 63,500 profesionales |
| Ingresos profesionales anuales promedio | $ 357,000 por año |
Especialistas en la retina
Valor de mercado del tratamiento de la enfermedad de la retina: $ 18.3 mil millones en 2024
| Característica de segmento | Datos estadísticos |
|---|---|
| Número de especialistas en la retina en todo el mundo | 8.700 profesionales |
| Porcentaje centrado en la degeneración macular relacionada con la edad | 62% de especialistas |
Pacientes con degeneración macular relacionada con la edad húmeda
Población global de pacientes con AMD húmedo: 1,7 millones de casos diagnosticados
- La prevalencia aumenta con la edad
- Demográfico objetivo principal: 65-85 años
- Mercado de tratamiento anual: $ 12.6 mil millones
Instituciones de atención médica
| Tipo de institución | Número a nivel mundial | Alcance del mercado potencial |
|---|---|---|
| Clínicas de oftalmología | 14,200 | Mercado potencial de $ 4.5 mil millones |
| Centros de tratamiento de retina especializados | 3,600 | Mercado potencial de $ 2.1 mil millones |
Investigue hospitales y clínicas
Financiación global de investigación de oftalmología: $ 2.3 mil millones anuales
- Número de instituciones de investigación ocular dedicadas: 670
- Volumen de publicación de investigación anual: 12,500 estudios
- Subvención de investigación promedio: $ 1.2 millones por institución
Opthea Limited (OPT) - Modelo de negocio: Estructura de costos
Gastos de investigación y desarrollo
Para el año fiscal 2023, Opthea Limited informó gastos de investigación y desarrollo de AUD 22.7 millones.
| Año fiscal | Gastos de I + D (AUD) |
|---|---|
| 2023 | 22,700,000 |
| 2022 | 17,300,000 |
Inversiones de ensayos clínicos
Opthea ha invertido significativamente en los ensayos clínicos para su producto principal Opt-302 para la degeneración macular húmeda relacionada con la edad (AMD húmeda).
| Fase de ensayo clínico | Inversión estimada (AUD) |
|---|---|
| Fase 2B | 15,500,000 |
| Preparación de fase 3 | 18,200,000 |
Costos de cumplimiento regulatorio
Los gastos de cumplimiento regulatorio para Opthea Limited en 2023 fueron aproximadamente AUD 3.5 millones.
Mantenimiento de la propiedad intelectual
- Costos de presentación y mantenimiento de patentes: AUD 1.2 millones
- Número de patentes activas: 12
- Cobertura de patentes geográficas: Estados Unidos, Europa, Australia
Sobrecarga administrativa y operativa
Los gastos administrativos y operativos totales para 2023 fueron AUD 8.9 millones.
| Categoría de gastos | Cantidad (AUD) |
|---|---|
| Costos de personal | 5,600,000 |
| Gastos de oficina | 1,800,000 |
| Infraestructura tecnológica | 1,500,000 |
Estructura de costos estimada total para 2023: AUD 51.8 millones
OPTHEA LIMITED (OPT) - Modelo de negocio: flujos de ingresos
Licencias potenciales de productos futuros
A partir de febrero de 2024, los ingresos potenciales de licencias de productos de Opthea Limited se asocian con OPT-302, un nuevo inhibidor de VEGF dirigido a VEGF-C y VEGF-D para la degeneración macular húmeda relacionada con la edad (AMD húmeda) y edema macular diabético (DME).
| Potencial de licencia | Rango de valor estimado |
|---|---|
| Acuerdo potencial de licencia global | $ 100 millones - $ 300 millones por adelantado |
| Pagos potenciales de hitos | Hasta $ 500 millones basado en logros clínicos/comerciales |
Acuerdos de investigación colaborativos
Opthea tiene marcos de colaboración de investigación en curso con posibles mecanismos de generación de ingresos.
- Valor de colaboración de investigación actual: aproximadamente $ 5-10 millones anuales
- Financiación de investigación colaborativa potencial de socios farmacéuticos
- Acuerdo de investigación Ingresos potenciales: $ 2-7 millones por asociación
Ingresos potenciales de asociación farmacéutica
Los ingresos de la asociación farmacéutica están vinculados principalmente al desarrollo clínico OPT-302.
| Tipo de asociación | Ingresos potenciales |
|---|---|
| Asociación de desarrollo clínico | $ 50-150 millones de fondos colaborativos potenciales |
| Acuerdo de desarrollo | Potencial del 20-30% participación de ingresos de futuras ventas de productos |
Venta de productos terapéuticos futuros
Ventas de productos terapéuticos proyectados para OPT-302 en los mercados de AMD y DME húmedos.
- Potencial de mercado global estimado: $ 1-2 mil millones anualmente
- Cuota de mercado potencial: 5-10% del mercado de tratamiento de oftalmología
- Ingresos anuales proyectados para 2028: $ 100-250 millones
Pagos potenciales de hitos de desarrollos clínicos
Pagos de hitos asociados con la progresión del ensayo clínico y las aprobaciones regulatorias.
| Etapa hito | Pago potencial |
|---|---|
| Finalización de fase III | $ 50-100 millones |
| Aprobación de la FDA | $ 75-150 millones |
| Primera venta comercial | $ 100-200 millones |
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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