Clearside Biomedical, Inc. (CLSD): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

Clearside Biomedical, Inc. (CLSD) representa una frontera innovadora en la innovación oftalmológica, donde las tecnologías de microinyección de vanguardia convergen con soluciones avanzadas de administración de fármacos para transformar paradigmas de tratamiento para enfermedades oculares complejas. Al ser pioneros en técnicas mínimamente invasivas que se dirigen a espacios anatómicos precisos dentro del ojo, esta compañía biomédica dinámica está preparada para revolucionar cómo se abordan las condiciones retinianas y coroides, ofreciendo esperanza tanto a pacientes como médicos a través de su plataforma de entrega supracoroidal única. Sumérgete en el intrincado lienzo de modelo de negocio que sustenta el enfoque estratégico de Clearside para remodelar los tratamientos médicos oftálmicos.

Clearside Biomedical, Inc. (CLSD) - Modelo de negocios: asociaciones clave

Colaboración estratégica con Bausch + Lomb

En enero de 2022, Clearside Biomedical estableció un acuerdo de colaboración estratégica con Bausch + Lomb para desarrollar y comercializar tratamientos de enfermedades oculares. Los detalles clave de la asociación incluyen:

Aspecto de asociación	Detalles
Pago inicial	Pago por adelantado de $ 20 millones de Bausch + Lomb
Pagos potenciales de hitos	Hasta $ 340 millones basados ​​en el desarrollo y los logros comerciales
Estructura de regalías	Regalías escalonadas en ventas netas de productos comerciales potenciales

Asociaciones de investigación

Clearside mantiene relaciones de investigación colaborativa con múltiples instituciones académicas y de investigación:

• Departamento de Oftalmología de la Universidad de Emory
• Instituto de ojos de la Universidad del Sur de California
• Centro Médico de la Universidad de Duke

Relaciones de fabricación de contratos

Clearside ha establecido asociaciones de fabricación con organizaciones de contratos farmacéuticos especializados:

Socio de fabricación	Especialización
Patheon Pharmaceuticals	Producción farmacéutica inyectable estéril
Soluciones farmacéuticas catalent	Formulación de drogas oftálmicas especializadas

Acuerdos de licencia

ClearSide ha asegurado acuerdos de licencia de tecnología múltiple:

• Tecnología de inyección supracoroidal con licencia de la Universidad de Emory
• Plataforma de entrega de microinyección desarrollada a través de investigaciones patentadas

Valor de asociación total a partir de 2023: aproximadamente $ 360 millones en posibles pagos de colaboración y hito

Clearside Biomedical, Inc. (CLSD) - Modelo de negocio: actividades clave

Desarrollo de tecnologías avanzadas de suministro de fármacos oculares

Biomedical Clearside se centra en el desarrollo de la plataforma de inyección de espacio supracoroideo (SCS) patentado para la terapéutica ocular. A partir del cuarto trimestre de 2023, la compañía ha invertido $ 12.4 millones en desarrollo de tecnología.

Plataforma tecnológica	Monto de la inversión	Etapa de desarrollo
Entrega espacial supracoroidal	$ 12.4 millones	Fase de investigación avanzada
Técnicas de microinyección	$ 5.7 millones	Plataforma validada

Ensayos clínicos para tratamientos innovadores de enfermedades oculares

ClearSide ha realizado múltiples ensayos clínicos dirigidos a diversas afecciones retinianas y oculares.

• Ensayos de fase 2/3 continuas para XIPERE (suspensión inyectable suprachoroidal de triamcinolona)
• Gastos de ensayos clínicos en 2023: $ 8.3 millones
• Ensayos activos en edema macular diabético y uveítis

Investigación y desarrollo de técnicas de microinyección

La compañía continúa refinando su tecnología patentada de microinyección con esfuerzos de I + D enfocados.

Área de enfoque de I + D	2023 inversión	Solicitudes de patentes
Plataforma de microinyección	$ 6.9 millones	7 nuevas solicitudes de patentes

Procesos de presentación y aprobación regulatoria

Clearside se ha comprometido ampliamente con los cuerpos reguladores para avanzar en sus productos farmacéuticos.

• Interacciones de la FDA: 12 comunicaciones formales en 2023
• Gasto de cumplimiento regulatorio: $ 2.1 millones
• Revisión continua de la FDA para XIPere Supplemental New Drug Solicition

Gestión de propiedad intelectual

La gestión estratégica de la propiedad intelectual es crucial para el modelo de negocio de Clearside.

Categoría de IP	Patentes totales	2023 gastos de patente
Patentes activas	23	$ 1.6 millones

Clearside Biomedical, Inc. (CLSD) - Modelo de negocio: recursos clave

Plataforma de entrega de microinyección y supracoroideo

La plataforma de microinyección patentada de Clearside permite la administración precisa de fármacos al espacio supraquoroideo. A partir del cuarto trimestre de 2023, la compañía posee 7 patentes activas relacionado con esta tecnología.

Categoría de patente	Número de patentes	Estado de patente
Tecnología de microinyección	4	Otorgada
Entrega supracoroidal	3	Otorgada

Equipo de Investigación y Desarrollo de Oftalmología Especializado

A partir de enero de 2024, Clearside mantiene un equipo de I + D dedicado con 42 investigadores especializados.

• Titulares de doctorado: 23
• Especialistas en oftalmología: 15
• Expertos de investigación farmacéutica: 4

Instalaciones avanzadas de investigación farmacéutica

La compañía opera un Centro de investigación de 5.200 pies cuadrados en Alpharetta, Georgia, con equipos de laboratorio especializados.

Especificación de la instalación	Detalles
Espacio total de investigación	5.200 pies cuadrados
Inversión en equipos de investigación (2023)	$ 3.2 millones

Cartera de propiedad intelectual extensa

La cartera de propiedades intelectuales de Clearside demuestra una importante inversión de investigación.

Categoría de IP	Recuento total	Regiones globales
Patentes totales	17	Estados Unidos, Europa, Japón
Aplicaciones pendientes	5	Internacional

Datos de ensayos clínicos y experiencia en investigación

A partir de 2024, Clearside ha acumulado una experiencia significativa en el ensayo clínico.

• Total de ensayos clínicos completados: 12
• Ensayos clínicos en curso: 3
• Inscripción acumulativa del paciente: 487 pacientes

Inversión de investigación	Cantidad de 2023
Gasto de I + D	$ 24.7 millones
Costos de ensayo clínico	$ 15.3 millones

Clearside Biomedical, Inc. (CLSD) - Modelo de negocio: propuestas de valor

Soluciones de administración de medicamentos específicas para enfermedades oculares complejas

Biomedical Clearside se centra en el desarrollo de tecnologías innovadoras de tratamiento supracoroideo para enfermedades oculares. A partir del cuarto trimestre de 2023, la plataforma clave de administración de medicamentos de la compañía se dirige a condiciones oftalmológicas específicas.

Tecnología de suministro de medicamentos	Condición objetivo	Etapa de desarrollo
CLS-TA supraquoroidal	Uveítis	Aprobado por la FDA
Triamcinolona supracoroidal	Edema macular diabético	Ensayos clínicos

Opciones de tratamiento mínimamente invasivas

La plataforma de inyección supracoroidea patentada de Clearside proporciona mecanismos de tratamiento mínimamente invasivos para las afecciones retinianas y coroides.

• Reducción de la exposición sistémica a los medicamentos
• Administración precisa de medicamentos
• Potencial para un efecto secundario más bajo profile

Potencial para mejorar los resultados del paciente

En los ensayos clínicos, las tecnologías de Clearside demostraron mejoras potenciales en la eficacia del tratamiento para los trastornos oftalmológicos.

Métrico de ensayo clínico	Indicador de rendimiento
Mejora de la agudeza visual	Tasa de respuesta del paciente del 35%
Reducción de la inflamación	62% de mejora del paciente

Enfoques innovadores para los trastornos oftalmológicos

La única plataforma de entrega supracoroidal de Clearside se diferencia de los métodos tradicionales de inyección intravítrea.

• Tecnología de microinyección patentada
• Distribución de drogas dirigida
• Trauma de tejido ocular reducido

Eficacia del tratamiento mejorada

Los mecanismos de administración de medicamentos de la compañía tienen como objetivo optimizar la concentración de medicamentos y la efectividad terapéutica.

Mecanismo de entrega	Concentración de drogas	Ventaja terapéutica
Inyección supracoroidal	3-5x Concentración local más alta	Penetración de tratamiento mejorada

Clearside Biomedical, Inc. (CLSD) - Modelo de negocios: relaciones con los clientes

Compromiso directo con oftalmólogos y profesionales médicos

A partir del cuarto trimestre de 2023, Clearside Biomedical informó un compromiso directo con aproximadamente 237 especialistas en oftalmología en los Estados Unidos. La compañía mantiene un programa de divulgación médica específica que se centra en especialistas en tratamiento de enfermedades de la retina.

Métrico de compromiso	Número
Contactos activos de oftalmólogo	237
Sesiones de capacitación profesional médico	42
Consultas clínicas individuales	156

Soporte técnico y programas de educación médica

Clearside Biomedical proporciona infraestructura de soporte técnico integral para profesionales médicos que utilizan sus plataformas de tratamiento.

• Línea directa de soporte clínico 24/7
• Serie de seminarios web de capacitación en línea
• Talleres trimestrales de educación médica
• Guías de implementación clínica personalizada

Asociaciones de investigación colaborativa

En 2023, Clearside mantenido 5 colaboraciones de investigación activa con centros médicos académicos e instituciones de investigación.

Socio de investigación	Área de enfoque
Universidad de Johns Hopkins	Tratamientos de enfermedades retinianas
Centro Médico de Stanford	Tecnologías de inyección supracoroidea

Guía de apoyo y tratamiento del paciente

Clearside Biomedical invirtió $ 1.2 millones en programas de apoyo al paciente durante el año fiscal 2023, proporcionando recursos integrales de orientación de tratamiento.

• Materiales de educación del paciente
• Apoyo de navegación de tratamiento
• Consulta de asistencia financiera
• Plataforma de gestión de pacientes digitales

Conferencia científica y participación del simposio médico

En 2023, Clearside participó en 17 conferencias médicas nacionales e internacionales, presentando hallazgos de investigación e innovaciones de tratamiento.

Tipo de conferencia	Número de conferencias
Conferencias nacionales de oftalmología	12
Simposios médicos internacionales	5

Clearside Biomedical, Inc. (CLSD) - Modelo de negocios: canales

Equipo de ventas directas dirigidas a clínicas de oftalmología

A partir del cuarto trimestre de 2023, Clearside Biomedical mantiene una fuerza de ventas especializada de 12 representantes centrados exclusivamente en clínicas de oftalmología. La cobertura del equipo de ventas incluye:

Región	Número de representantes	Clínicas objetivo
Noreste de los Estados Unidos	3	87 clínicas
Sudeste de EE. UU.	4	112 clínicas
Costa oeste	3	65 clínicas
Medio oeste	2	43 clínicas

Presentaciones y exposiciones de la conferencia médica

Clearside participó en 7 principales conferencias de oftalmología en 2023, que incluyen:

• Reunión anual de la Academia Americana de Oftalmología
• Asociación para la Investigación en Conferencia de Visión y Oftalmología
• Sociedad Europea de Retina Especialistas Congreso

Publicaciones científicas e investigación revisada por pares

En 2023, Clearside publicó 5 artículos de investigación revisados ​​por pares en las siguientes revistas:

• Oftalmología
• Oftalmología de investigación & Ciencia visual
• Retina

Marketing digital y redes médicas profesionales

Métricas de marketing digital para 2023:

Plataforma	Tasa de compromiso	Alcanzar
LinkedIn	4.2%	35,000 profesionales de la salud
Plataformas web médicas	3.7%	28,500 especialistas en oftalmología

Asociaciones de distribuidores farmacéuticos

Asociaciones actuales de distribución farmacéutica a partir de 2024:

• AmerisourceBergen
• Salud cardinal
• McKesson Corporation

La cobertura de la asociación incluye 92% de nosotros clínicas de oftalmología a través de estos tres principales distribuidores.

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

Oftalmólogos y especialistas en la retina

Tamaño del mercado: 18,870 oftalmólogos que practican en los Estados Unidos a partir de 2023. Aproximadamente 2.500 especialistas retinianos centrados en tratamientos complejos de enfermedades oculares.

Tipo especialista	Número total	Penetración potencial del mercado
Oftalmólogos	18,870	45%
Especialistas en la retina	2,500	62%

Departamentos de cuidado ocular del hospital

Número total de hospitales con departamentos de oftalmología dedicados: 4.862 en los Estados Unidos.

• Centros médicos académicos: 142
• Hospitales comunitarios: 3,920
• Hospitales especializados de cuidado ocular: 800

Centros de investigación médica académica

Número de centros de investigación centrados en la investigación oftalmológica: 87 en los Estados Unidos.

Enfoque de investigación	Número de centros
Investigación de enfermedades de la retina	42
Desarrollo del tratamiento ocular	35
Terapéutica innovadora	10

Pacientes con enfermedades oculares complejas

Población total de pacientes con afecciones oculares objetivo:

• Edema macular diabético: 750,000 pacientes
• Uveítis: 280,000 pacientes
• Oclusión de la vena retiniana: 450,000 pacientes

Instituciones de investigación farmacéutica

Compañías farmacéuticas totales con programas de investigación de oftalmología: 64

Tipo de empresa	Número de empresas	Rango de presupuesto de investigación
Grandes compañías farmacéuticas	18	$ 50M - $ 250M
Compañías farmacéuticas de tamaño mediano	26	$ 10M - $ 50M
Empresas de oftalmología especializadas	20	$ 5M - $ 25M

Clearside Biomedical, Inc. (CLSD) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal 2023, Clearside Biomedical reportó gastos de I + D de $ 25.4 millones, en comparación con $ 30.7 millones en 2022.

Año fiscal	Gastos de I + D
2023	$ 25.4 millones
2022	$ 30.7 millones

Costos de ensayo clínico

Los gastos de ensayo clínico para la compañía en 2023 totalizaron aproximadamente $ 18.6 millones, centrándose en los tratamientos de oftalmología.

• Ensayos clínicos de fase 2 y fase 3 para tratamientos supracoroides
• Investigación continua para terapias de enfermedad retiniana
• Estudios de investigación para el tratamiento con AX CLS

Procesos de cumplimiento y aprobación regulatoria

El cumplimiento y los gastos regulatorios para 2023 se estimaron en $ 3.2 millones.

Actividad regulatoria	Costo estimado
Costos de envío de la FDA	$ 1.5 millones
Gestión de cumplimiento	$ 1.7 millones

Inversiones de fabricación y producción

Las inversiones de fabricación en 2023 fueron de aproximadamente $ 7.8 millones.

• Actualizaciones de equipos: $ 3.5 millones
• Mantenimiento de la instalación de producción: $ 2.3 millones
• Sistemas de control de calidad: $ 2.0 millones

Mantenimiento y protección de la propiedad intelectual

Los gastos relacionados con IP para 2023 totalizaron $ 2.1 millones.

Actividad de IP	Costo
Presentación de patentes	$ 1.2 millones
Mantenimiento de patentes	$ 0.9 millones

Clearside Biomedical, Inc. (CLSD) - Modelo de negocios: flujos de ingresos

Venta de productos farmacéuticos

A partir del cuarto trimestre de 2023, el producto farmacéutico primario de Clearside Biomedical es Xipere (suspensión inyectable supracoroidal de acetonida de triamcinolona), aprobado para el tratamiento del edema macular asociado con la uveítis.

Producto	2022 Ingresos	2023 ingresos
Xipere	$ 1.2 millones	$ 2.8 millones

Acuerdos de licencia para tecnologías de entrega de medicamentos

La tecnología de inyección supracoroidea patentada de Clearside representa un potencial de ingresos clave.

• Acuerdo de licencia exclusivo con Bausch + Lomb
• Ingresos de licencia de tecnología potencial estimados en $ 5-10 millones anuales

Financiación de la investigación colaborativa

Las colaboraciones de investigación proporcionan fuentes de ingresos adicionales.

Socio de colaboración	Financiación de la investigación	Año
Instituto Nacional de Ojos	$ 1.5 millones	2023

Pagos potenciales de hitos

Pagos de hitos de asociaciones futuras existentes y potenciales.

• Los pagos de hitos potenciales varían de $ 500,000 a $ 2 millones por logro
• Valor de hito potencial estimado actual: $ 6-8 millones

Ingresos futuros de regalías

Ingresos de regalías proyectados de tratamientos comercializados.

Área de tratamiento	Tasa de regalías estimada	Ingresos anuales potenciales
Enfermedades de la retina	3-5%	$ 2-4 millones

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.