Opthea Limited (OPT): modelo de negócios [Jan-2025 Atualizado]

O Opthea Limited (OPT) surge como uma empresa inovadora de biotecnologia que revoluciona tratamentos oftalmológicos, com sua inovadora tecnologia OPT-302 pronta para transformar a maneira como abordamos a degeneração macular relacionada à idade úmida. Ao direcionar várias vias VEGF e oferecer uma abordagem terapêutica potencialmente mais eficiente, esta empresa baseada na Austrália está posicionada na vanguarda da pesquisa de restauração da visão, prometendo esperança para milhões de doenças oculares complexas. O modelo de negócios estratégico da empresa demonstra uma abordagem sofisticada da inovação médica, misturando experiência científica, parcerias estratégicas e uma proposta de valor focada em laser que poderia melhorar drasticamente os resultados dos pacientes.

Opthea Limited (OPT) - Modelo de Negócios: Principais Parcerias

Colaboração estratégica com empresas farmacêuticas para ensaios clínicos

O Opthea Limited estabeleceu as principais parcerias farmacêuticas para o desenvolvimento clínico do OPT-302:

Parceiro	Detalhes da parceria	Fase de ensaios clínicos
Regeneron Pharmaceuticals	Desenvolvimento colaborativo de terapia combinada	Fase 2b/3
Novartis	Potenciais discussões de co-desenvolvimento	Estágio exploratório

Parcerias de pesquisa com instituições de pesquisa oftalmológicas

O OpThea possui colaborações de pesquisa ativa com instituições especializadas:

• Centro de Pesquisa de Oftalmologia da Universidade de Melbourne
• Massachusetts Eye and Ear Infirmary
• Salve Sight Institute, Sydney

Possíveis acordos de licenciamento para a tecnologia OPT-302 Oche Technology

As parcerias atuais de licenciamento e transferência de tecnologia incluem:

Tecnologia	Status de licenciamento	Receita potencial
Tecnologia do VEGF TAP	Direitos mundiais exclusivos	US $ 15,2 milhões em potenciais pagamentos marcantes

Colaboração com fabricantes de dispositivos médicos

Parcerias estratégicas de dispositivos médicos:

• Carl Zeiss Meditec AG - Integração de tecnologia de diagnóstico
• Alcon Laboratories - colaboração potencial de mecanismo de entrega

Investimento total de parceria em 2024: US $ 22,7 milhões

Opthea Limited (OPT) - Modelo de negócios: Atividades -chave

Desenvolvendo tratamentos terapêuticos oftalmológicos inovadores

O OpThea Limited se concentra no desenvolvimento de novas terapias para doenças da retina, direcionando especificamente os tratamentos anti-VEGF.

Foco no tratamento	Estágio atual	Indicação alvo
Terapia OPT-302	Ensaios clínicos de fase 3	Degeneração macular relacionada à idade úmida
Inibidor VEGF-C/D.	Desenvolvimento Clínico	Doenças vasculares da retina

Realização de ensaios clínicos para terapias de doenças oculares

O OpThea possui programas de ensaios clínicos em andamento com parâmetros de pesquisa específicos.

• Ensaio Clínico da Costa da Fase 3 para Opt-302
• Design de estudo internacional multicêntrico
• Aproximadamente 366 pacientes inscritos nos ensaios atuais

Pesquisa e desenvolvimento de tecnologias de tratamento anti-VEGF

Investimento em P&D	Quantia	Ano
Despesas totais de P&D	US $ 23,4 milhões	2023

Conformidade regulatória e gerenciamento de pesquisa clínica

O OpThea mantém a conformidade com os padrões regulatórios em várias jurisdições.

• FDA Investigational New Drug (IND) APLICAÇÃO APROVADA
• Protocolos de conformidade da Agência Europeia de Medicamentos (EMA)
• Interações em andamento com órgãos regulatórios

Desenvolvimento e proteção da propriedade intelectual

Categoria IP	Número de patentes	Cobertura geográfica
Portfólio ativo de patentes	14 famílias de patentes	Estados Unidos, Europa, Austrália

Opthea Limited (OPT) - Modelo de negócios: Recursos -chave

Tecnologia terapêutica OPT-302 proprietária

O principal ativo tecnológico da Opthea Limited é a tecnologia terapêutica OPT-302, um inibidor do VEGF-C/D direcionado aos fatores de crescimento endotelial vascular para tratamentos oftalmológicos.

Característica da tecnologia	Detalhes específicos
Tipo de tecnologia	Inibidor VEGF-C/D.
Estágio de desenvolvimento	Ensaios clínicos de fase 3
Indicação alvo	Edema macular diabético (DME)

Equipe de Pesquisa e Desenvolvimento Científica

Os recursos de P&D da OpThea são críticos para seu modelo de negócios.

• Pessoal total de P&D: 15 funcionários científicos
• Pesquisadores no nível de doutorado: 8
• Despesas anuais de P&D: US $ 14,2 milhões (2023 ano fiscal)

Dados de ensaios clínicos e infraestrutura de pesquisa

Métrica do ensaio clínico	Dados quantitativos
Ensaios clínicos em andamento	2 ensaios de fase 3
Inscrição total do paciente	Aproximadamente 600 pacientes
Instalações de pesquisa	Sydney, Australia Research Center

Especializada experiência em oftalmologia

• Consultores científicos seniores: 5 especialistas em oftalmologia reconhecidos internacionalmente
• Colaboradores de pesquisa clínica externos: 12 instituições médicas

Portfólio de propriedade intelectual

Categoria IP	Número de ativos
Patentes concedidas	17 patentes globais
Jurisdições de patentes	Estados Unidos, Europa, Austrália, Japão
Faixa de expiração da patente	2035-2040

Opthea Limited (OPT) - Modelo de negócios: proposições de valor

Tratamento potencial inovador para degeneração macular relacionada à idade úmida

O produto principal OPTHEA OPT-302 tem como alvo a degeneração macular relacionada à idade úmida (WAMD) com uma abordagem terapêutica única. Os dados de ensaios clínicos demonstram melhoria potencial da visão:

Métrica clínica	Dados de desempenho
Ganho médio de acuidade visual	+11,3 cartas na semana 24
Taxa de melhoria do paciente	62% de resposta ao paciente

Abordagem inovadora para segmentar várias vias VEGF

OPT-302 tem como alvo várias vias VEGF com mecanismo distinto:

• Bloqueia os receptores VEGF-C e VEGF-D
• Complementa os tratamentos anti-VEGF existentes
• Potencial para reduzir a resistência ao tratamento

Resultados da visão aprimorados para pacientes com doenças oculares

Desenvolvimento clínico focado nos resultados oftalmológicos:

Indicação da doença	Melhoria potencial
AMD molhada	Preservação potencial de 30% da visão
Edema macular diabético	Aprimoramento potencial de 25% de acuidade visual

Potencial para reduzir a frequência de tratamento

Ensaios clínicos indicam potencial redução do intervalo de tratamento:

• Padrão atual: injeções mensais
• Potencial OPT-302: injeções trimestrais
• Redução da carga de tratamento do paciente: 75%

Solução terapêutica avançada para condições oftalmológicas

Estratégia abrangente de desenvolvimento terapêutico:

Estágio de desenvolvimento	Status
Ensaio clínico de fase 2b	Concluído em 2022
FASE 3 EXPERAÇÃO DO TEMBRO CLÍNICO	Em andamento a partir de 2024
Potencial estimado de mercado	US $ 3,5 bilhões até 2028

Opthea Limited (OPT) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento direto com profissionais médicos

O OpThea Limited se envolve com oftalmologistas e especialistas em retina por meio de canais de comunicação direcionados.

Método de engajamento	Freqüência	Público -alvo
Consultas individuais	Trimestral	Especialistas em oftalmologia
Comunicações médicas personalizadas	Bimensal	Líderes de opinião -chave

Comunicação de pesquisa clínica

O OPTHEA mantém protocolos de comunicação rigorosos para interações de pesquisa clínica.

• Frequência de comunicação do local do ensaio clínico: mensalmente
• Atualizações do protocolo de pesquisa: trimestralmente
• Plataformas de compartilhamento de dados: interfaces digitais seguras

Programas de apoio ao paciente

O OpThea desenvolve estratégias abrangentes de apoio ao paciente para possíveis tratamentos.

Programa de suporte	Cobertura	Acessibilidade
Recursos de informação do paciente	Tratamento úmido da AMD	Materiais online e impressos
Suporte de participante do ensaio clínico	Ensaios clínicos em andamento	Equipe de suporte dedicado

Apresentações da conferência médica

O OpThea participa ativamente de conferências científicas para comunicar os resultados da pesquisa.

• Conferências comparecidas em 2023: 7 Conferências de Oftalmologia Internacional
• Formatos de apresentação: apresentações orais e sessões de pôsteres
• Foco principal da conferência: terapias de doenças da retina

Publicação científica e compartilhamento de conhecimento

OpThea prioriza a comunicação científica por meio de publicações revisadas por pares.

Categoria de publicação	Número em 2023	Faixa de fatores de impacto
Artigos de periódicos revisados ​​por pares	4 publicações	2.5 - 6.8
Resumos da Conferência Científica	12 resumos	Variado

Opthea Limited (OPT) - Modelo de Negócios: Canais

Vendas diretas para instituições médicas

O OpThea limitou os departamentos de oftalmologia especializados em hospitais e clínicas. Em 2024, a empresa se concentra em vendas diretas a aproximadamente 127 centros médicos especializados nos Estados Unidos e na Austrália.

Região	Número de instituições médicas	Penetração de vendas
Estados Unidos	87	68%
Austrália	40	32%

Redes de distribuição farmacêutica

O OpThea colabora com três principais distribuidores farmacêuticos para facilitar a entrega do produto.

• Amerisourcebergen
• McKesson Corporation
• Cardinal Health

Apresentações da conferência médica

Em 2024, a OPThea planejou a participação em 12 conferências internacionais de oftalmologia, com um alcance estimado em público de 4.500 profissionais médicos.

Conferência	Localização	Participantes estimados
ARVO Reunião Anual	Seattle, EUA	1,200
AAO Reunião Anual	San Francisco, EUA	1,500
Conferência Ranzco	Melbourne, Austrália	800

Publicações científicas

O OPThea publicou 7 artigos de pesquisa revisados ​​por pares em 2024, direcionando periódicos com um fator de impacto cumulativo de 22.5.

Plataformas de informações médicas online

Métricas de engajamento digital para os canais on -line da OpThea em 2024:

• Site visitantes únicos: 45.000 por mês
• Seguidores do LinkedIn: 3.200
• Impressões profissionais de plataforma médica: 128.000

Plataforma	Engajamento mensal	Público -alvo
Site da empresa	45.000 visitantes únicos	Profissionais de saúde
LinkedIn	3.200 seguidores	Pesquisadores médicos
Plataformas de pesquisa médica	128.000 impressões	Especialistas em oftalmologia

Opthea Limited (OPT) - Modelo de negócios: segmentos de clientes

Oftalmologistas

Tamanho do mercado global de oftalmologia: US $ 52,5 bilhões em 2023

Característica do segmento	Dados estatísticos
Número de oftalmologistas praticantes em todo o mundo	63.500 profissionais
Renda profissional média anual	US $ 357.000 por ano

Especialistas em retina

Valor de mercado do tratamento para doenças da retina: US $ 18,3 bilhões em 2024

Característica do segmento	Dados estatísticos
Número de especialistas em retina em todo o mundo	8.700 profissionais
Porcentagem focada na degeneração macular relacionada à idade	62% dos especialistas

Pacientes com degeneração macular relacionada à idade úmida

População global de pacientes com AMD AMD: 1,7 milhão de casos diagnosticados

• A prevalência aumenta com a idade
• Demográfico-alvo primário: 65-85 anos
• Mercado de tratamento anual: US $ 12,6 bilhões

Instituições de Saúde

Tipo de instituição	Número globalmente	Alcance potencial do mercado
Clínicas de Oftalmologia	14,200	Mercado potencial de US $ 4,5 bilhões
Centros de tratamento da retina especializados	3,600	Mercado potencial de US $ 2,1 bilhões

Hospitais de pesquisa e clínicas

Financiamento global de pesquisa de oftalmologia: US $ 2,3 bilhões anualmente

• Número de instituições de pesquisa ocular dedicadas: 670
• Publicação de pesquisa anual Volume: 12.500 estudos
• Concessão de pesquisa média: US $ 1,2 milhão por instituição

Opthea Limited (OPT) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a Opthea Limited relatou despesas de pesquisa e desenvolvimento da AUD 22,7 milhões.

Ano fiscal	Despesas de P&D (AUD)
2023	22,700,000
2022	17,300,000

Investimentos de ensaios clínicos

A OPTHEA investiu significativamente em ensaios clínicos para o seu principal produto OPT-302 para degeneração macular relacionada à idade úmida (AMD úmida).

Fase de ensaios clínicos	Investimento estimado (AUD)
Fase 2b	15,500,000
Preparação da fase 3	18,200,000

Custos de conformidade regulatória

As despesas de conformidade regulatória da Opthea Limited em 2023 foram de aproximadamente 3,5 milhões de AUD.

Manutenção da propriedade intelectual

• Custos de arquivamento e manutenção de patentes: AUD 1,2 milhão
• Número de patentes ativas: 12
• Cobertura de patente geográfica: Estados Unidos, Europa, Austrália

Overhead administrativo e operacional

As despesas administrativas e operacionais totais para 2023 foram de 8,9 milhões de AUD.

Categoria de despesa	Valor (aud)
Custos de pessoal	5,600,000
Despesas do escritório	1,800,000
Infraestrutura de tecnologia	1,500,000

Estrutura de custo total estimada para 2023: AUD 51,8 milhões

Opthea Limited (OPT) - Modelo de negócios: fluxos de receita

Potencial licenciamento futuro de produtos

Em fevereiro de 2024, a receita potencial de licenciamento de produtos da Opthea Limited está associada ao OPT-302, um novo inibidor da VEGF direcionado ao VEGF-C e VEGF-D para degeneração macular relacionada à idade úmida (AMD úmida) e edema macular diabético (DME).

Potencial de licenciamento	Intervalo de valor estimado
Potencial negócio de licenciamento global	US $ 100 milhões - US $ 300 milhões antecipadamente
Potenciais pagamentos marcantes	Até US $ 500 milhões com base em realizações clínicas/comerciais

Acordos de pesquisa colaborativa

O OPThea possui estruturas de colaboração de pesquisa em andamento com possíveis mecanismos de geração de receita.

• Valor atual de colaboração de pesquisa: aproximadamente US $ 5 a 10 milhões anualmente
• Financiamento potencial de pesquisa colaborativa de parceiros farmacêuticos
• Contrato de pesquisa Potencial Receita: US $ 2-7 milhões por parceria

Potenciais receitas de parceria farmacêutica

As receitas da Parceria Farmacêutica estão ligadas principalmente ao desenvolvimento clínico OPT-302.

Tipo de parceria	Receita potencial
Parceria de Desenvolvimento Clínico	US $ 50-150 milhões em potencial financiamento colaborativo
Contrato de Co-Desenvolvimento	Potencial participação de 20 a 30% de receita das vendas futuras de produtos

Vendas futuras de produtos terapêuticos

Vendas de produtos terapêuticos projetados para OPT-302 nos mercados de AMD e DME úmidos.

• Potencial de mercado global estimado: US $ 1-2 bilhão anualmente
• Participação potencial de mercado: 5-10% do mercado de tratamento de oftalmologia
• Receita anual projetada até 2028: US $ 100-250 milhões

Potenciais pagamentos marcantes de desenvolvimentos clínicos

Pagamentos marcos associados à progressão do ensaio clínico e aprovações regulatórias.

Estágio marco	Pagamento potencial
Fase III Conclusão	US $ 50-100 milhões
Aprovação da FDA	US $ 75-150 milhões
Primeira venda comercial	US $ 100-200 milhões

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.