Clearside Biomedical, Inc. (CLSD): Modelo de negócios Canvas [Jan-2025 Atualizado]

A Clearside Biomedical, Inc. (CLSD) representa uma fronteira inovadora na inovação oftalmológica, onde as tecnologias de microinjeção de ponta convergem com soluções avançadas de entrega de medicamentos para transformar os paradigmas de tratamento para doenças oculares complexas. Ao pioneiro técnicas minimamente invasivas que visam espaços anatômicos precisos dentro do olho, esta empresa biomédica dinâmica está pronta para revolucionar como as condições da retina e da coroidal são abordadas, oferecendo esperança a pacientes e médicos através de sua plataforma de entrega supracoróide exclusiva. Mergulhe na intrincada tela do modelo de negócios que sustenta a abordagem estratégica da Clearside para reformular tratamentos médicos oftálmicos.

Clearside Biomedical, Inc. (CLSD) - Modelo de negócios: Parcerias -chave

Colaboração estratégica com Bausch + Lomb

Em janeiro de 2022, a Clearside Biomedical estabeleceu um acordo estratégico de colaboração com a Bausch + Lomb para desenvolver e comercializar tratamentos de doenças oculares. Os principais detalhes da parceria incluem:

Aspecto da parceria	Detalhes
Pagamento inicial	Pagamento inicial de US $ 20 milhões da Bausch + Lomb
Potenciais pagamentos marcantes	Até US $ 340 milhões com base no desenvolvimento e realizações comerciais
Estrutura de royalties	Royalties em camadas sobre vendas líquidas de possíveis produtos comercializados

Parcerias de pesquisa

Clearside mantém relações de pesquisa colaborativa com várias instituições acadêmicas e de pesquisa:

• Departamento de Oftalmologia da Universidade de Emory
• Instituto de Olhos da Universidade do Sul da Califórnia
• Duke University Medical Center

Relacionamentos de fabricação contratados

A Clearside estabeleceu parcerias de fabricação com organizações de contratos farmacêuticos especializados:

Parceiro de fabricação	Especialização
Pathon Pharmaceuticals	Produção farmacêutica injetável estéril
Soluções farmacêuticas catalentas	Formulação oftalmológica especializada

Acordos de licenciamento

Clearside garantiu vários acordos de licenciamento de tecnologia:

• Tecnologia de injeção supracoroidal licenciada pela Emory University
• Plataforma de entrega de microinjeção desenvolvida através de pesquisas proprietárias

Valor total da parceria em 2023: aproximadamente US $ 360 milhões em possíveis pagamentos colaborativos e marcos

Clearside Biomedical, Inc. (CLSD) - Modelo de negócios: Atividades -chave

Desenvolvimento de tecnologias avançadas de entrega de medicamentos oculares

A Clearside Biomedical se concentra no desenvolvimento da plataforma de injeção de espaço supraqueoroidal (SCS) proprietário para terapêutica ocular. A partir do quarto trimestre de 2023, a empresa investiu US $ 12,4 milhões em desenvolvimento de tecnologia.

Plataforma de tecnologia	Valor do investimento	Estágio de desenvolvimento
Entrega do espaço supracoroidal	US $ 12,4 milhões	Fase de pesquisa avançada
Técnicas de microinjeção	US $ 5,7 milhões	Plataforma validada

Ensaios clínicos para tratamentos inovadores para doenças oculares

A Clearside realizou vários ensaios clínicos direcionados a várias condições retinianas e oculares.

• Ensaios de Fase 2/3 em andamento para Xipere (suspensão injetável supracoroidal de acetonida de Triamcinolona)
• Despesas de ensaios clínicos em 2023: US $ 8,3 milhões
• Ensaios ativos em edema macular diabético e uveíte

Pesquisa e desenvolvimento de técnicas de microinjeção

A empresa continua a refinar sua tecnologia de microinjeção proprietária com esforços de P&D focados.

Área de foco em P&D	2023 Investimento	Aplicações de patentes
Plataforma de microinjeção	US $ 6,9 milhões	7 novos pedidos de patente

Processos de envio e aprovação regulatórios

Clearside se envolveu extensivamente com órgãos regulatórios para avançar seus produtos farmacêuticos.

• Interações da FDA: 12 comunicações formais em 2023
• Despesas de conformidade regulatória: US $ 2,1 milhões
• Revisão da FDA em andamento para XIPERE Suplementar New Drug Application

Gerenciamento de propriedade intelectual

O gerenciamento estratégico de propriedade intelectual é crucial para o modelo de negócios da Clearside.

Categoria IP	Total de patentes	2023 Despesas de patentes
Patentes ativas	23	US $ 1,6 milhão

Clearside Biomedical, Inc. (CLSD) - Modelo de negócios: Recursos -chave

Microinjeção proprietária e plataforma de entrega supracoroidal

A plataforma de microinjeção proprietária da Clearside permite a entrega precisa da administração de medicamentos ao espaço supracoroidal. A partir do quarto trimestre 2023, a empresa possui 7 patentes ativas relacionado a esta tecnologia.

Categoria de patentes	Número de patentes	Status de patente
Tecnologia de microinjeção	4	Garantido
Entrega supraqueroidal	3	Garantido

Equipe especializada de pesquisa e desenvolvimento de oftalmologia

Em janeiro de 2024, Clearside mantém uma equipe de P&D dedicada com 42 pesquisadores especializados.

• Titulares de doutorado: 23
• Especialistas em oftalmologia: 15
• Especialistas em pesquisa farmacêutica: 4

Instalações avançadas de pesquisa farmacêutica

A empresa opera um 5.200 instalações de pesquisa de pé quadrado em Alpharetta, na Geórgia, com equipamentos de laboratório especializados.

Especificação da instalação	Detalhes
Espaço total de pesquisa	5.200 pés quadrados
Investimento de equipamentos de pesquisa (2023)	US $ 3,2 milhões

Portfólio de propriedade intelectual extensa

O portfólio de propriedade intelectual da Clearside demonstra investimentos significativos de pesquisa.

Categoria IP	Contagem total	Regiões globais
Total de patentes	17	Estados Unidos, Europa, Japão
Aplicações pendentes	5	Internacional

Dados de ensaios clínicos e experiência em pesquisa

A partir de 2024, Clearside acumulou uma experiência significativa no ensaio clínico.

• Total Concluído Ensaios Clínicos: 12
• Ensaios clínicos em andamento: 3
• Inscrição cumulativa de pacientes: 487 pacientes

Investimento em pesquisa	2023 quantidade
Despesas de P&D	US $ 24,7 milhões
Custos de ensaios clínicos	US $ 15,3 milhões

Clearside Biomedical, Inc. (CLSD) - Modelo de negócios: proposições de valor

Soluções direcionadas de administração de medicamentos para doenças oculares complexas

A Clearside Biomedical se concentra no desenvolvimento de tecnologias inovadoras de tratamento supracoroidal para doenças oculares. A partir do quarto trimestre 2023, a principal plataforma de entrega de medicamentos da empresa tem como alvo condições oftalmológicas específicas.

Tecnologia de entrega de medicamentos	Condições alvo	Estágio de desenvolvimento
CLS-TA supracoroidal	Uveíte	FDA aprovado
Triamcinolona supracoroidal	Edema macular diabético	Ensaios clínicos

Opções de tratamento minimamente invasivas

A plataforma de injeção supraquioroidal proprietária da Clearside fornece mecanismos de tratamento minimamente invasivos para condições de retina e coroidais.

• Exposição sistêmica reduzida de medicamentos
• Administração precisa de medicamentos
• Potencial para efeito colateral inferior profile

Potencial para melhores resultados dos pacientes

Nos ensaios clínicos, as tecnologias da Clearside demonstraram melhorias potenciais na eficácia do tratamento para distúrbios oftalmológicos.

Métrica do ensaio clínico	Indicador de desempenho
Melhoria da acuidade visual	Taxa de resposta ao paciente de 35%
Redução de inflamação	62% de melhora do paciente

Abordagens inovadoras para distúrbios oftalmológicos

A plataforma de entrega supracoroidal única da Clearside se diferencia dos métodos tradicionais de injeção intravítrea.

• Tecnologia de microinjeção proprietária
• Distribuição de medicamentos direcionados
• Trauma de tecido ocular reduzido

Eficácia aprimorada do tratamento

Os mecanismos de administração de medicamentos da empresa visam otimizar a concentração de medicamentos e a eficácia terapêutica.

Mecanismo de entrega	Concentração de drogas	Vantagem terapêutica
Injeção supracoroidal	3-5x maior concentração local	Penetração de tratamento aprimorada

Clearside Biomedical, Inc. (CLSD) - Modelo de negócios: Relacionamentos do cliente

Engajamento direto com oftalmologistas e profissionais médicos

A partir do quarto trimestre 2023, o envolvimento direto relatado pela Clearside Biomedical com aproximadamente 237 especialistas em oftalmologia nos Estados Unidos. A empresa mantém um programa de divulgação de médicos direcionados com foco em especialistas em tratamento de doenças da retina.

Métrica de engajamento	Número
Oftalmologista ativo contatos	237
Sessões de treinamento profissional médico	42
Consultas clínicas individuais	156

Programas de suporte técnico e educação médica

A Clearside Biomedical fornece infraestrutura abrangente de suporte técnico para profissionais médicos que utilizam suas plataformas de tratamento.

• 24/7 de suporte clínico
• Série de webinar de treinamento on -line
• Workshops trimestrais de educação médica
• Guias personalizados de implementação clínica

Parcerias de pesquisa colaborativa

Em 2023, Clearside mantinha 5 colaborações de pesquisa ativa com centros médicos acadêmicos e instituições de pesquisa.

Parceiro de pesquisa	Área de foco
Universidade Johns Hopkins	Tratamentos de doenças da retina
Stanford Medical Center	Tecnologias de injeção supracoroidal

Suporte ao paciente e orientação de tratamento

A Clearside Biomedical investiu US $ 1,2 milhão em programas de apoio ao paciente durante o ano fiscal de 2023, fornecendo recursos abrangentes de orientação de tratamento.

• Materiais de educação do paciente
• Suporte de navegação por tratamento
• Consulta de Assistência Financeira
• Plataforma de gerenciamento de pacientes digital

Conferência Científica e Participação do Simpósio Médico

Em 2023, Clearside participou de 17 conferências médicas nacionais e internacionais, apresentando resultados de pesquisa e inovações de tratamento.

Tipo de conferência	Número de conferências
Conferências nacionais de oftalmologia	12
Simpósios médicos internacionais	5

Clearside Biomedical, Inc. (CLSD) - Modelo de negócios: canais

Equipe direta de vendas direcionando clínicas de oftalmologia

No quarto trimestre 2023, o Clearside Biomedical mantém uma força de vendas especializada de 12 representantes focados exclusivamente em clínicas de oftalmologia. A cobertura da equipe de vendas inclui:

Região	Número de representantes	Clínicas -alvo
Nordeste dos EUA	3	87 clínicas
Sudeste dos EUA	4	112 Clínicas
Costa Oeste	3	65 clínicas
Centro -Oeste	2	43 clínicas

Apresentações e exposições de conferências médicas

Clearside participou de 7 principais conferências de oftalmologia em 2023, incluindo:

• American Academy of Ophthalmology Annual Reunião
• Associação para Pesquisa em Conferência de Visão e Oftalmologia
• Congresso da Sociedade Europeia de Retina

Publicações científicas e pesquisa revisada por pares

Em 2023, a Clearside publicou 5 artigos de pesquisa revisados ​​por pares nos periódicos a seguir:

• Oftalmologia
• Oftalmologia investigativa & Ciência Visual
• Retina

Marketing Digital e Redes Médicas Profissionais

Métricas de marketing digital para 2023:

Plataforma	Taxa de engajamento	Alcançar
LinkedIn	4.2%	35.000 profissionais de saúde
Plataformas da Web médica	3.7%	28.500 especialistas em oftalmologia

Parcerias de distribuidores farmacêuticos

Parcerias de distribuição farmacêutica atuais a partir de 2024:

• Amerisourcebergen
• Cardinal Health
• McKesson Corporation

A cobertura da parceria inclui 92% de nós clínicas de oftalmologia por meio desses três principais distribuidores.

Clearside Biomedical, Inc. (CLSD) - Modelo de negócios: segmentos de clientes

Oftalmologistas e especialistas em retina

Tamanho do mercado: 18.870 oftalmologistas praticantes nos Estados Unidos a partir de 2023. Aproximadamente 2.500 especialistas em retina focados em tratamentos complexos de doenças oculares.

Tipo especializado	Número total	Penetração potencial de mercado
Oftalmologistas	18,870	45%
Especialistas em retina	2,500	62%

Departamentos de assistência ocular do hospital

Número total de hospitais com departamentos de oftalmologia dedicada: 4.862 nos Estados Unidos.

• Centros Médicos Acadêmicos: 142
• Hospitais comunitários: 3.920
• Hospitais Especializados para Cuidados Olhos: 800

Centros de Pesquisa Médica Acadêmica

Número de centros de pesquisa com foco na pesquisa oftalmológica: 87 nos Estados Unidos.

Foco na pesquisa	Número de centros
Pesquisa de doenças da retina	42
Desenvolvimento do tratamento ocular	35
Terapêutica inovadora	10

Pacientes com doenças oculares complexas

População total de pacientes com condições oculares -alvo:

• Edema macular diabético: 750.000 pacientes
• Uveíte: 280.000 pacientes
• Oclusão da veia retina: 450.000 pacientes

Instituições de pesquisa farmacêutica

Total de empresas farmacêuticas com programas de pesquisa de oftalmologia: 64

Tipo de empresa	Número de empresas	Faixa de orçamento de pesquisa
Grandes empresas farmacêuticas	18	$ 50m - $ 250M
Empresas farmacêuticas de tamanho médio	26	US $ 10 milhões - US $ 50 milhões
Empresas de oftalmologia especializada	20	US $ 5 milhões - US $ 25 milhões

Clearside Biomedical, Inc. (CLSD) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a Clearside Biomedical relatou despesas de P&D de US $ 25,4 milhões, em comparação com US $ 30,7 milhões em 2022.

Ano fiscal	Despesas de P&D
2023	US $ 25,4 milhões
2022	US $ 30,7 milhões

Custos de ensaios clínicos

As despesas de ensaios clínicos para a empresa em 2023 totalizaram aproximadamente US $ 18,6 milhões, com foco em tratamentos de oftalmologia.

• Ensaios clínicos de fase 2 e fase 3 para tratamentos suprachoroidais
• Pesquisa em andamento para terapias de doenças da retina
• Estudos de investigação para tratamento de Ax-Ax CLS

Processos de conformidade e aprovação regulatórios

As despesas de conformidade e regulamentação de 2023 foram estimadas em US $ 3,2 milhões.

Atividade regulatória	Custo estimado
Custos de envio da FDA	US $ 1,5 milhão
Gerenciamento de conformidade	US $ 1,7 milhão

Investimentos de fabricação e produção

Os investimentos em fabricação em 2023 foram de aproximadamente US $ 7,8 milhões.

• Atualizações de equipamentos: US $ 3,5 milhões
• Manutenção da instalação de produção: US $ 2,3 milhões
• Sistemas de controle de qualidade: US $ 2,0 milhões

Manutenção e proteção de propriedade intelectual

As despesas relacionadas à IP em 2023 totalizaram US $ 2,1 milhões.

Atividade IP	Custo
Registro de patentes	US $ 1,2 milhão
Manutenção de patentes	US $ 0,9 milhão

Clearside Biomedical, Inc. (CLSD) - Modelo de negócios: fluxos de receita

Vendas farmacêuticas de produtos

A partir do quarto trimestre 2023, o produto farmacêutico primário da Clearside Biomedical é o XIPERE (suspensão injetável supracoroidal de acetonida de triamcinolona), aprovada para o tratamento de edema macular associado à uveíte.

Produto	2022 Receita	2023 Receita
Xipere	US $ 1,2 milhão	US $ 2,8 milhões

Acordos de licenciamento para tecnologias de entrega de medicamentos

A tecnologia proprietária de injeção supraquioroidal de Clearside representa um potencial de receita essencial.

• Contrato de licenciamento exclusivo com Bausch + Lomb
• Receita potencial de licenciamento de tecnologia estimada em US $ 5 a 10 milhões anualmente

Financiamento de pesquisa colaborativa

As colaborações de pesquisa fornecem fluxos de receita adicionais.

Parceiro de colaboração	Pesquisa financiamento	Ano
National Eye Institute	US $ 1,5 milhão	2023

Potenciais pagamentos marcantes

Pagamentos marcantes de parcerias futuras existentes e em potencial.

• Os pagamentos em potencial variam de US $ 500.000 a US $ 2 milhões por conquista
• Valor potencial estimado atual: US $ 6-8 milhões

Futuras receitas de royalties

Receitas de royalties projetadas de tratamentos comercializados.

Área de tratamento	Taxa de royalties estimada	Receita anual potencial
Doenças da retina	3-5%	US $ 2-4 milhões

Clearside Biomedical, Inc. (CLSD) - Canvas Business Model: Value Propositions

You're looking at the core value Clearside Biomedical, Inc. delivers through its proprietary suprachoroidal space (SCS®) delivery platform. This isn't just about a new drug; it's about a fundamentally different way to get medicine where it needs to go in the eye, which changes the treatment dynamic for patients and practices.

Targeted, Compartmentalized Drug Delivery to the Macula and Retina

The primary value is achieving unprecedented access to the back of the eye where sight-threatening diseases take hold. This approach is designed for targeted and compartmentalized delivery, meaning the drug goes right to the macula and retina, potentially minimizing harm to surrounding healthy tissue. For preclinical programs targeting Geographic Atrophy (GA), this delivery method allows for comprehensive drug coverage of both the retina and choroid.

Non-Surgical, Repeatable, In-Office Procedure Using the SCS Microinjector®

The delivery mechanism itself is a key value driver. Clearside Biomedical's patented SCS Microinjector® facilitates an in-office, repeatable, non-surgical procedure. This contrasts with more invasive methods, offering a better experience for the patient and better resource management for the clinic. The platform has seen significant use, with thousands of suprachoroidal injections performed across various retinal disorders. Furthermore, the physical device is designed for ease of use, with the needle size being equivalent to most commonly used intravitreal injections.

The commercialization of the platform is evidenced by revenue generation through partners:

Metric	Value (Q1 2025)
License and Other Revenue (from partners)	$2.3 million
SCS Microinjector Kit Sales/Training Revenue Component	$0.8 million
R&D Expenses (Reflecting platform advancement)	$4.5 million

Potential for Longer-Lasting Treatment Durability (e.g., CLS-AX)

The suprachoroidal space allows for drug retention that can extend treatment intervals, directly addressing the high treatment burden of current standards of care. This is best illustrated by the data from the CLS-AX ODYSSEY Phase 2b trial for wet Age-related Macular Degeneration (AMD).

• 67% of CLS-AX participants did not require aflibercept rescue or CLS-AX re-dosing for 6 months after the initial dose.
• 100% of CLS-AX participants showed intervention-free rates up to 3 months.
• Injection frequency was reduced by approximately 84% compared to the average monthly injections in the 24 weeks prior to screening for CLS-AX.
• The planned Phase 3 program for CLS-AX is targeting a flexible three-to-six-month dosing label.

This potential durability is a major shift; current standard anti-VEGF therapies often require monthly or bi-monthly injections. The company's Q3 2025 trailing twelve-month net loss was $34.35 million, underscoring the capital required to bring these longer-acting candidates to market.

Platform Flexibility for Small Molecules, Biologics, and Gene Therapies

The SCS Microinjector® is inherently flexible, designed to deliver a wide variety of drug candidates, not just one specific type. This versatility is validated by the number of external collaborations utilizing the platform:

• Small Molecules: BioCryst Pharmaceuticals is using it for avoralstat in diabetic macular edema (DME), with initial data expected in 2025.
• Biologics/Gene Therapies: REGENXBIO and AbbVie are planning a Phase 3 program for sura-vec (ABBV-RGX-314) for diabetic retinopathy using suprachoroidal delivery.
• Other Agents: The platform is being used in commercial products and clinical programs for anti-tumor agents.

This platform approach means Clearside Biomedical, Inc. can generate revenue through milestone payments, such as the $1.5 million in milestones received from Arctic Vision in Q1 2025, and through the sale of SCS Microinjector kits to licensees.

First FDA-Approved Product (XIPERE®) for Suprachoroidal Use

XIPERE® (triamcinolone acetonide injectable suspension) represents the platform's first commercial validation, being the first FDA approved therapeutic delivered into the suprachoroidal space. This established use provides a benchmark for safety and procedure adoption. To facilitate adoption, a new permanent Category 1 CPT code for XIPERE® for suprachoroidal use became effective on January 1, 2024. Real-world data for XIPERE® showed excellent durability, with more than 75% of eyes not requiring retreatment for 6 months after a single dose. Furthermore, partner Arctic Vision saw its NDA for ARCATUS® (XIPERE® in China) accepted for review in China as of Q1 2025.

Clearside Biomedical, Inc. (CLSD) - Canvas Business Model: Customer Relationships

High-touch, strategic B2B relationships with pharmaceutical licensees

Clearside Biomedical, Inc. maintains relationships with key industry players who utilize the proprietary SCS Microinjector® platform for their own drug candidates. As of late 2025, the Company anchored its platform with five commercial and late-stage development suprachoroidal licensing collaborations. These strategic partners include Aura Biosciences, Bausch + Lomb, BioCryst Pharmaceuticals, REGENXBIO and its global partner AbbVie, and Arctic Vision and its commercial partner Santen.

The commercial success of partner products drives direct revenue through license fees. For the first quarter ended March 31, 2025, License and other revenue reached $2.3 million, a significant increase from $0.2 million in the first quarter of 2024. This revenue stream directly impacted the bottom line, contributing to a reduction in net loss to $8.2 million in Q1 2025 from $11.8 million in Q1 2024.

Progress within these partnerships is a key relationship metric:

• ARCATUS® (XIPERE® in the U.S.) is approved in both Australia and Singapore.
• The New Drug Application (NDA) for ARCATUS® in China was accepted for regulatory review, with Arctic Vision responsible for clinical development there.
• BioCryst Pharmaceuticals is advancing its diabetic macula edema program, with initial data from DME patients expected in 2025.
• REGENXBIO and AbbVie announced plans to initiate a Phase 3 clinical program for sura-vec (ABBV-RGX-314) using suprachoroidal delivery for diabetic retinopathy.

Clinical support and training for retinal specialists using the SCS Microinjector®

The SCS Microinjector® itself is a core relationship touchpoint, representing a proven in-office, repeatable, non-surgical procedure for targeted delivery. The platform's validation is demonstrated through its presence at major scientific forums, which serves as indirect support and education for the specialist community. In 2025, the use of the SCS delivery platform was featured in Over 15 Presentations at Major Ophthalmic Medical Meetings. Specifically, six presentations occurred at the Association for Research in Vision and Ophthalmology (ARVO) 2025 Meeting.

The SCS Microinjector® is used in commercial products and development programs targeting various indications:

Product/Program	Indication	Status/Partner
XIPERE® (triamcinolone acetonide injectable suspension)	Uveitic Macular Edema	Commercialized by Bausch + Lomb in the U.S.
ARCATUS™ (triamcinolone acetonide injectable suspension)	Uveitic Macular Edema	Approved in Australia and Singapore; under review in China.
ABBV-RGX-314	Diabetic Retinopathy/Wet AMD	Phase 3 program planned with REGENXBIO/AbbVie.
Avoralstat	Diabetic Macular Edema (DME)	Clinical trial initiated in Australia with BioCryst Pharmaceuticals.

Investor relations focused on pipeline progress and strategic value

Investor communications center on advancing the pipeline, particularly the lead asset, CLS-AX, and the platform's overall validation. The Company reported its Q1 2025 financial results on May 14, 2025, though it did not host a conference call that quarter. As of March 31, 2025, Clearside Biomedical's cash and cash equivalents totaled $13.6 million, with management believing this was sufficient to fund planned operations into the fourth quarter of 2025.

Key financial and operational data points communicated to investors included:

• Q1 2025 Net Loss: $8.2 million (or $0.11 per share).
• Q1 2024 Net Loss: $11.8 million (or $0.17 per share).
• R&D expenses for Q1 2025 were $4.5 million, down from $5.6 million in Q1 2024.
• General and administrative expenses remained constant at $2.8 million for Q1 2025 and Q1 2024.

Regulatory engagement with agencies like the FDA for CLS-AX Phase 3 alignment

A critical recent milestone involved regulatory alignment for the lead internal asset, CLS-AX, targeting the $12+ billion wet AMD market. Clearside Biomedical announced a successful End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), confirming alignment on the Phase 3 program design in March 2025. This alignment supports a flexible maintenance dosing label for CLS-AX for every 3 to 6 months as needed.

The proposed pivotal Phase 3 program includes:

• Two concurrent, pivotal non-inferiority trials.
• Each trial will have 2 arms, comparing CLS-AX (1 mg) to aflibercept (2 mg).
• Approximately ~225 participants per arm are planned for enrollment.
• Primary endpoint is average change in best corrected visual acuity (BCVA) from baseline at Week 52.

The Company also developed a streamlined Phase 2b/3 clinical trial design for CLS-AX in diabetic retinopathy.

Seeking new partners to fund and maximize program value

Following the FDA alignment and in light of the cash runway extending into the fourth quarter of 2025, Clearside Biomedical announced on July 17, 2025, plans to explore a full range of strategic alternatives to maximize stockholder value. This process is designed to advance the SCS platform and pipeline, which includes the Phase 3-ready CLS-AX asset and IND-ready programs for Geographic Atrophy (GA) and Diabetic Macula Edema. The Company retained Piper Sandler, a leading investment bank, to support this strategic evaluation process. Alternatives under consideration include the sale, license, monetization, and/or divestiture of one or more assets, or other strategic transactions like a merger or joint venture.

The company's financial standing as of March 31, 2025, was $13.6 million in cash and cash equivalents. The exploration of strategic alternatives was a direct response to the need to fund future operations beyond the projected Q4 2025 cash runway.

Clearside Biomedical, Inc. (CLSD) - Canvas Business Model: Channels

You're looking at the distribution and outreach methods for Clearside Biomedical, Inc. as of late 2025. This is heavily weighted toward partnerships, which is typical for a platform technology company, though the November 2025 Chapter 11 filing adds a layer of complexity regarding future commercialization rights.

The channels rely on leveraging third-party infrastructure for market access, supplemented by direct engagement for platform validation and device sales to those partners.

Out-licensing Agreements and Partner Reach

Clearside Biomedical's primary channel for getting its technology into the market is through out-licensing agreements. As of July 2025, the company reported having five commercial and late-stage development suprachoroidal licensing collaborations. These agreements extend the reach of the SCS Microinjector® platform globally.

The financial flow from these channels was evident in Q1 2025, where License and other revenue reached $2.3 million, a significant jump from $0.2 million in Q1 2024. This Q1 2025 revenue included $1.5 million in milestones from Arctic Vision alone. For the BioCryst Pharmaceuticals collaboration, Clearside Biomedical is eligible to receive tiered mid-single digit royalties on annual global net product sales. However, as of the November 24, 2025, Chapter 11 filing, rights linked to a royalty sub with a $106.5M revenue cap were listed as a key asset intended for sale via a Section 363 auction.

Direct Sales of the SCS Microinjector® Kits

The proprietary SCS Microinjector® device itself is a channel component, sold directly to licensees for their clinical and commercial use. In Q1 2025, revenue attributed to training, services, and the sales of SCS Microinjector kits to licensees was $0.8 million. The platform has a history of clinical use, with well over 10,000 injections performed to date with the patented device. Furthermore, Clearside Biomedical maintains commercial scale manufacturing capability for the SCS Microinjector, which includes ISO certification and CE mark certification.

Commercial Partner Sales Force for XIPERE®

The commercialization of XIPERE® (triamcinolone acetonide injectable suspension) relies on the established sales forces of its partners. Bausch + Lomb holds the exclusive license for commercialization and development in the United States and Canada, where XIPERE® is approved. Arctic Vision handles commercialization in Greater China (as ARCATUS®), South Korea, Australia, New Zealand, India, and the ASEAN Countries. XIPERE® is approved in the U.S., Canada, Australia, and Singapore.

Partner/Region	Product/License Scope	Approval Status (as of late 2025)
Bausch + Lomb (U.S. & Canada)	XIPERE® Commercialization/Development	Approved in U.S. and Canada
Arctic Vision (Asia-Pacific)	XIPERE® (ARCATUS®) Commercialization/Development	Approved in Australia, Singapore; NDA under review in China
BioCryst Pharmaceuticals	SCS Microinjector for avoralstat (DME)	First clinical trial in Australia authorized to initiate in 2025

Clinical Trial Sites and Key Opinion Leaders (KOLs)

Clinical trial sites serve as crucial early channels for platform validation and data generation. The CLS-AX ODYSSEY trial, evaluating suprachoroidal CLS-AX for wet AMD, was a multicenter, 36-week trial. KOLs are engaged to present data and shape adoption. For example, data from the ODYSSEY trial was presented by Roger Goldberg, MD, MBA, of Bay Area Retinal Associates Medical Group. Victor Chong, MD, MBA, the company's Chief Medical Officer, is also a key figure in presenting platform advancements.

Medical Conferences and Scientific Publications

Scientific dissemination is a key channel for establishing the credibility of the SCS Microinjector® platform. In 2025, Clearside Biomedical highlighted its technology through numerous presentations. The company featured six presentations at the Association for Research in Vision and Ophthalmology (ARVO) 2025 Meeting. Other prominent venues in 2025 included the Angiogenesis, Exudation, and Degeneration meeting, Retina Unplugged, and the Macula Society Annual Meeting. The platform's advancements were also set to be featured at the 25th EURETINA Congress in September 2025.

• Presentations at ARVO 2025: 6
• Total known 2025 medical meetings featuring data: 8 (ARVO + 7 others)
• EURETINA Congress 2025 dates: September 4 - 7

Clearside Biomedical, Inc. (CLSD) - Canvas Business Model: Customer Segments

You're looking at the customer landscape for Clearside Biomedical, Inc. as of late 2025. Given the Chapter 11 filing in November 2025, the immediate focus shifts to asset monetization, but the underlying customer base for the platform technology remains the foundation.

Global pharmaceutical and biotech companies seeking novel ocular delivery

These partners license the SCS platform for their own therapeutic agents. As of July 2025, Clearside Biomedical had five commercial and late-stage development suprachoroidal licensing collaborations anchored to the SCS Microinjector platform. Specific partners utilizing the SCS Microinjector in commercial products or clinical development programs include Aura Biosciences, Bausch + Lomb, BioCryst Pharmaceuticals, REGENXBIO (with its global partner AbbVie), and Arctic Vision (with its commercial partner Santen). For instance, BioCryst Pharmaceuticals is advancing its diabetic macular edema program using the SCS Microinjector, with initial data expected in 2025. Revenue from these partners was a key component of the Q1 2025 results, with license fees contributing $1.5 million in milestones from Arctic Vision and other revenue streams totaling $0.8 million.

Retinal specialists and ophthalmologists performing in-office injections

This segment comprises the clinical users of the SCS Microinjector for repeatable, non-surgical delivery. The company's expertise in this area is evidenced by the fact that over 15,000 injections have been completed to date using the clinically validated suprachoroidal injection training program with the SCS Microinjector. The platform supports the delivery of Clearside's own pipeline, such as CLS-AX, which is designed for a flexible three-to-six month dosing label, aiming to fit seamlessly into physician practices. The approved product, XIPERE (triamcinolone acetonide injectable suspension), is available in the U.S. through a commercial partner for treating macular edema associated with uveitis.

Patients with sight-threatening back-of-the-eye diseases (e.g., wet AMD, uveitis)

These are the ultimate beneficiaries of the technology, suffering from conditions like neovascular age-related macular degeneration (wet AMD), uveitic macular edema (UME), and geographic atrophy (GA). Clearside's lead internal program, CLS-AX, targets wet AMD and is Phase 3-ready following alignment with the FDA on the pivotal trial program. The company is also evaluating small molecules for the potential long-acting treatment of geographic atrophy (GA). The commercial product, XIPERE, treats macular edema associated with uveitis, and its Asia-Pacific version, ARCATUS, is approved in Australia and Singapore.

Investors and potential acquirers interested in platform technology monetization

This segment became acutely relevant in late 2025. On November 24, 2025, Clearside Biomedical filed for voluntary Chapter 11 bankruptcy to pursue an auction and sale process of its assets. The company retained Piper Sandler to support the strategic evaluation process, which considers the sale, license, or divestiture of assets. Financially, the company reported a net loss of $19.36 million for Q2 2025, translating to a loss of $0.27 per share. The EBIT for the current year (2025) was reported at -16.69 M USD. Cash and cash equivalents stood at $13.6 million as of March 31, 2025, which was sufficient to fund operations into Q4 2025.

Academic and clinical researchers utilizing the SCS platform

The scientific community validates the platform through presentations and data sharing. Clearside Biomedical data was featured in six presentations at the Association for Research in Vision and Ophthalmology (ARVO) 2025 Meeting. In total, the use of suprachoroidal drug delivery was featured in over 15 presentations at major ophthalmic medical meetings in 2025. The company's internal R&D expenses for Q2 2025 were $10.22 million, while Q1 2025 R&D expenses were $4.5 million.

Here's a quick look at key financial metrics leading up to the strategic review:

Metric	Q1 2025 Value	Q2 2025 Value
Total Revenue	$2.3 million	$320,000
Net Loss	$8.2 million	$19.36 million
EPS (Diluted)	-$0.11	-$0.27
Cash & Equivalents (End of Period)	$13.6 million (as of 3/31/2025)	Not specified

The company's operating expenses for Q2 2025 included $5.9 million in SG&A costs.

The platform's reach is quantified by the following:

• Number of SCS Microinjector injections completed to date: over 15,000.
• Number of licensing collaborations: five.
• Number of ARVO 2025 presentations featuring data: six.

Finance: review the cash burn rate implied by the Q2 2025 loss of $19.78 million operating loss against the Q1 cash balance by Monday.

Clearside Biomedical, Inc. (CLSD) - Canvas Business Model: Cost Structure

You're looking at the cost structure for Clearside Biomedical, Inc. (CLSD) right as the company entered a major restructuring phase in late 2025. The primary ongoing costs revolve around advancing the pipeline and maintaining the corporate structure, but the immediate, significant costs are tied to the Chapter 11 filing and the subsequent sale process.

The core operational expenses leading up to the filing show a focus on Research and Development (R&D) to push the CLS-AX program forward, though R&D spending had actually decreased in the first quarter of 2025 compared to the prior year, reflecting lower clinical trial costs after the ODYSSEY Phase 2b trial completion. General and Administrative (G&A) costs remained steady, covering essential overhead like legal and patent maintenance for the suprachoroidal delivery platform.

Here's a quick look at the reported Q1 2025 operational expenses:

Cost Category	Q1 2025 Expense Amount	Comparison Point
Research and Development (R&D)	$4.5 million	Down from $5.6 million in Q1 2024
General and Administrative (G&A)	$2.8 million	Constant compared to Q1 2024

The most significant cost driver as of November 2025 is the Chapter 11 restructuring itself. When Clearside Biomedical filed for Chapter 11 bankruptcy protection on November 24, 2025, it immediately incurred substantial professional fees related to the process. These costs are necessary to manage the structured auction and sale of its business and assets, which is intended to maximize stakeholder value.

The costs associated with this strategic shift include fees for specialized advisors retained to navigate the bankruptcy court proceedings. You should track these carefully, as they are non-recurring but material expenses that impact the final recovery value. The company estimated its liabilities to be between $50 million and $100 million at the time of filing, against assets estimated between $1 million and $10 million.

The key professional services engaged for this process represent a major, albeit temporary, cost component:

• Legal counsel retained: Cooley LLP and Richards, Layton & Finger, P.A.
• Financial restructuring advisor retained: Berkeley Research Group LLC (BRG)
• The process involves pursuing a sale under Section 363 of the U.S. Bankruptcy Code.

To be fair, even before the bankruptcy filing, the company was managing costs while planning for a potential Phase 3 program for CLS-AX. The net loss for Q1 2025 was $8.2 million, an improvement from the $11.8 million net loss in Q1 2024, largely due to increased license fees offsetting these operational costs.

Finance: draft 13-week cash view by Friday.

Clearside Biomedical, Inc. (CLSD) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Clearside Biomedical, Inc. as of late 2025, which is heavily influenced by its strategic partnerships and, critically, its recent filing for Chapter 11 protection to facilitate an asset sale.

The primary ongoing revenue streams for Clearside Biomedical, Inc. flow from its intellectual property licensing agreements for the suprachoroidal space (SCS) delivery platform.

License fees and milestone payments from strategic partners form a key component of the top line. For the first quarter ended March 31, 2025, the total License and other revenue was reported as $2.3 million. This Q1 2025 figure significantly surpassed the analyst estimate of $0.17 million.

Specifically within that Q1 2025 revenue, milestone payments were a major driver. This included $1.5 million in milestones received from Arctic Vision.

Sales of the SCS Microinjector® kits to licensees also contribute to the revenue base. This was grouped into the 'other revenue' category for Q1 2025, which amounted to $0.8 million, alongside training and services.

Royalties on commercial sales of licensed products, such as XIPERE® (triamcinolone acetonide injectable suspension) for suprachoroidal use, represent another expected stream. However, the rights to these Royalties, along with milestone payments under existing license agreements, were largely sold in a prior transaction. As of late 2025, the assets available for sale related to the Royalty Sub included the equity in Clearside Royalty LLC and the right to revenue from the Royalties only after reaching a revenue cap of $106.5 million purchased by HCR.

The late 2025 focus is dominated by potential one-time proceeds from the sale or divestiture of assets. On November 24, 2025, Clearside Biomedical, Inc. filed for Chapter 11 bankruptcy with the intention to pursue a structured auction and sale process under Section 363 of the U.S. Bankruptcy Code to maximize stakeholder value. The key assets slated for this sale include the commercial SCS Microinjector platform, the Phase 3-ready CLS-AX program, and the existing suprachoroidal licensing collaborations.

Here's a look at some key financial figures impacting the revenue and asset valuation context:

Financial Metric	Amount/Value	Period/Context
License and other revenue	$2.3 million	Q1 2025
Q1 2025 Arctic Vision Milestone	$1.5 million	Q1 2025
Q1 2025 Training, Services, Kit Sales	$0.8 million	Q1 2025
Royalty Revenue Cap	$106.5 million	Related to Royalty Sub sale
Cash and Cash Equivalents	$13.6 million	As of March 31, 2025

The assets intended for sale via the Section 363 auction include:

• The commercial SCS Microinjector platform and associated intellectual property.
• The CLS-AX program, which is Phase 3 ready for wet AMD.
• IND-ready programs for Geographic Atrophy (GA) and Diabetic Macular Edema (DME).
• Rights linked to the royalty sub with the $106.5M revenue cap.

The company noted that the assets are attractive based on its clinically proven SCS Microinjector® platform and multiple suprachoroidal licensing agreements. The Chapter 11 filing was intended to maximize stakeholder value through this structured process.

Finance: draft asset sale timeline based on Section 363 process by Monday.