Aldeyra Therapeutics, Inc. (ALDX): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

Aldeyra Therapeutics, Inc. (ALDX) emerge como una compañía de biotecnología pionera que revoluciona el tratamiento de enfermedades raras a través de su innovadora plataforma de tecnología molecular. Al navegar estratégicamente por el complejo panorama del desarrollo farmacéutico, Aldeyra se enfoca en crear terapias innovadoras para afecciones inflamatorias que actualmente carecen de soluciones efectivas. Su modelo de negocio único combina investigación científica de vanguardia, enfoques moleculares específicos y asociaciones colaborativas para transformar posibles desafíos médicos en oportunidades de tratamiento innovadoras, posicionándose a la vanguardia de la medicina de precisión y el descubrimiento de drogas de enfermedades raras.

Aldeyra Therapeutics, Inc. (ALDX) - Modelo de negocios: asociaciones clave

Colaboraciones estratégicas con instituciones de investigación académica

Aldeyra Therapeutics ha establecido asociaciones con las siguientes instituciones de investigación académica:

Institución	Enfoque de investigación	Año de colaboración
Massachusetts ojo y enfermería en la oreja	Investigación de inflamación ocular	2019
Universidad de California, San Diego	Estudios de enfermedades secas	2020

Asociaciones de desarrollo farmacéutico para el descubrimiento de fármacos

Las asociaciones clave de desarrollo farmacéutico incluyen:

• Colaboración con Bausch + Lomb para el desarrollo de drogas oftálmicas
• Asociación con Novartis para la investigación de enfermedades raras

Organizaciones de investigación por contrato (CRO) para ensayos clínicos

Aldeyra Therapeutics trabaja con múltiples CRO para la gestión del ensayo clínico:

Nombre de Cro	Fase de ensayo clínico	Proyectos activos
Ícono plc	Fase II/III	3 pruebas en curso
Parexel International	Fase I	2 Estudios activos

Posibles acuerdos de licencia

Detalles de la asociación de licencias:

• Acuerdo potencial de licencia con Terapéutica de horizonte Para tratamientos de enfermedades raras
• Discusiones exploratorias con Abbvie Inc. para enfermedades inflamatorias candidatos a los medicamentos

Financiación total de la asociación de investigación en 2023: $ 12.4 millones

Número de colaboraciones de investigación activa: 7

Aldeyra Therapeutics, Inc. (ALDX) - Modelo de negocio: actividades clave

Investigación y desarrollo de nuevas terapias

A partir del cuarto trimestre de 2023, Aldeyra Therapeutics ha invertido $ 43.2 millones en gastos de investigación y desarrollo. La compañía se enfoca en desarrollar nuevas terapias dirigidas a enfermedades raras y afecciones inflamatorias.

I + D Métrica	Valor 2023
Gastos totales de I + D	$ 43.2 millones
Número de programas de investigación activos	5 programas terapéuticos primarios
Solicitudes de patentes	12 solicitudes de patentes activas

Gestión de ensayos preclínicos y clínicos

Aldeyra actualmente administra múltiples ensayos clínicos en diferentes etapas del desarrollo de medicamentos.

• Pruebas de fase 1: 2 programas activos
• Pruebas de fase 2: 3 programas activos
• Pruebas de fase 3: 1 programa activo

Presentación y cumplimiento regulatorio

La compañía ha presentado 4 Aplicaciones de New Drug (IND) de investigación en investigación a la FDA en 2023.

Métrico regulatorio	Estado 2023
Aplicaciones de la FDA IND	4 presentaciones
Presupuesto de cumplimiento regulatorio	$ 3.5 millones

Desarrollo de fármacos de enfermedades raras

Aldeyra se especializa en el desarrollo de terapias para enfermedades inflamatorias y metabólicas raras.

• Programa de síndrome de Sjögren-Larsson
• Programa de síndrome de erosión corneal recurrente hereditaria
• Desarrollo terapéutico de la enfermedad de ojo seco

Avance de la plataforma de tecnología molecular

La compañía ha invertido $ 12.7 millones en el avance de su plataforma de tecnología molecular patentada en 2023.

Métrica de plataforma tecnológica	Valor 2023
Inversión de plataforma	$ 12.7 millones
Personal de investigación de tecnología	37 investigadores especializados
Nuevas iniciativas tecnológicas	3 tecnologías de plataforma emergente

Aldeyra Therapeutics, Inc. (ALDX) - Modelo de negocio: recursos clave

Plataforma de tecnología molecular patentada

Aldeyra Therapeutics ha desarrollado una plataforma patentada centrada en la tecnología de estabilización molecular. A partir de 2024, la compañía posee 5 patentes de tecnología molecular de núcleo.

Categoría de tecnología	Número de patentes	Duración de protección de patentes
Plataforma de estabilización molecular	5	Hasta 2037-2042

Cartera de propiedades intelectuales

La cartera de propiedades intelectuales de la compañía incluye:

• 5 patentes de tecnología molecular de núcleo
• 3 solicitudes de patentes pendientes
• Acuerdos de licencia exclusivos para tratamientos de enfermedades raras

Equipo de investigación científica y experiencia

El equipo de investigación de Aldeyra comprende:

• 12 investigadores a nivel de doctorado
• 8 asesores científicos senior
• Personal de investigación total: 35 empleados

Laboratorio e instalaciones de investigación

Tipo de instalación	Ubicación	Capacidad de investigación
Laboratorio de investigación primaria	Lexington, Massachusetts	2.500 pies cuadrados.

Datos de ensayos clínicos y activos de investigación

A partir de 2024, Aldeyra ha acumulado:

• 7 ensayos clínicos completados
• 3 Fase en curso 2/3 Estudios clínicos
• Datos de investigación integrales para tratamientos de enfermedades raras

Categoría de ensayo clínico	Número de pruebas	Inscripción total del paciente
Pruebas completadas	7	428 pacientes
Pruebas en curso	3	189 pacientes

Aldeyra Therapeutics, Inc. (ALDX) - Modelo de negocio: propuestas de valor

Tratamientos innovadores para enfermedades inflamatorias raras

Aldeyra Therapeutics se centra en desarrollar nuevas terapias para afecciones inflamatorias raras con importantes necesidades médicas no satisfechas. A partir del cuarto trimestre de 2023, la compañía tiene 3 candidatos de medicamentos principales en el desarrollo clínico.

Candidato a la droga	Condición objetivo	Estadio clínico
ADX-2191	Vitreoretinopatía proliferativa	Fase 2/3
Reproxima	Enfermedad ocular seca	Fase 3
ADX-629	Síndrome de Sjögren	Fase 2

Enfoque terapéutico molecular dirigido

La plataforma patentada de la compañía se centra en la tecnología de secuestro de aldehído, dirigido a mecanismos moleculares específicos en procesos inflamatorios.

• Mecanismo molecular dirigido a la precisión
• Tecnología única de secuestro de aldehído
• Potencial para reducir los efectos secundarios en comparación con los tratamientos tradicionales

Posibles tratamientos innovadores con necesidades médicas no satisfechas

La investigación de Aldeyra se dirige a condiciones con opciones terapéuticas existentes limitadas. Los gastos totales de investigación y desarrollo para 2023 fueron de $ 48.3 millones.

Oportunidad de mercado	Población de pacientes estimada	Limitaciones de tratamiento actuales
Enfermedad ocular seca	16 millones de pacientes estadounidenses	Terapias efectivas limitadas
Vitreoretinopatía proliferativa	Aproximadamente 50,000 casos nuevos anualmente	Sin tratamientos aprobados por la FDA

Plataforma científica avanzada para el descubrimiento de fármacos

Aldeyra mantiene una sólida cartera de propiedades intelectuales con 93 patentes emitidas y pendientes a partir de diciembre de 2023.

• 93 Patentes totales en tecnología terapéutica molecular
• Inversión continua en infraestructura de investigación
• Colaboración con instituciones académicas e de investigación

Medicina de precisión dirigida a mecanismos moleculares específicos

El enfoque de la compañía permite intervenciones terapéuticas altamente específicas. La capitalización de mercado de Aldeyra a enero de 2024 era de aproximadamente $ 234 millones.

Enfoque tecnológico	Mecanismo único	Impacto terapéutico potencial
Secuestro de aldehído	Interrupción de la vía molecular	Respuesta inflamatoria reducida

Aldeyra Therapeutics, Inc. (ALDX) - Modelo de negocio: relaciones con los clientes

Compromiso directo con profesionales médicos

Aldeyra Therapeutics mantiene canales de comunicación directa con oftalmólogos y especialistas en enfermedades raras a través de:

• Programas de educación médica específicas
• Consultas médicas individuales
• Información de información sobre el ensayo clínico personalizado

Método de compromiso	Frecuencia	Especialistas en el objetivo
Reuniones de la Junta Asesora Médica	Trimestral	Especialistas en oftalmología
Actualizaciones de investigación clínica	Semestral	Investigadores de enfermedades raras

Programas de apoyo al paciente

Aldeyra ofrece servicios integrales de apoyo al paciente que incluyen:

• Programas de asistencia al paciente
• Soporte de navegación de seguros
• Guía de acceso a medicamentos

Conferencia científica e interacciones de la comunidad médica

Métricas de participación de la conferencia:

Tipo de conferencia	Presentaciones anuales	Alcance de la audiencia
Conferencias de oftalmología	4-6 Presentaciones	1,500-2,000 especialistas
Simposios de enfermedades raras	2-3 presentaciones	800-1,200 investigadores

Plataformas de información de salud digital

Los canales de participación digital incluyen:

• Sitio web corporativo con actualizaciones de investigación clínica
• Portales de información médica profesional
• Repositorios de publicación revisados ​​por pares

Comunicación transparente sobre el progreso del desarrollo de fármacos

Métricas de transparencia de comunicación:

Canal de comunicación	Frecuencia	Tipo de información
Llamadas de inversionista	Trimestral	Actualizaciones de ensayos clínicos
Comunicados de prensa	Como es necesario	Hitos de investigación

Aldeyra Therapeutics, Inc. (ALDX) - Modelo de negocios: canales

Ventas directas a proveedores de atención médica

A partir de 2024, Aldeyra Therapeutics emplea a un equipo de ventas especializado dirigido a oftalmólogos y especialistas en enfermedades raras. El equipo de ventas directas cubre aproximadamente el 75% de las posibles redes de prescriptores clínicos en los Estados Unidos.

Canal de ventas	Porcentaje de cobertura	Especialistas en el objetivo
Fuerza de ventas directa	75%	Oftalmólogos
Representantes farmacéuticos especializados	25%	Especialistas en enfermedades raras

Presentaciones de conferencia médica

Aldeyra Therapeutics participa activamente en conferencias médicas clave para mostrar los resultados de investigación y ensayos clínicos.

• Reunión anual de la Academia Americana de Oftalmología
• Asociación para la Investigación en Conferencia de Visión y Oftalmología
• Enfermedad rara y cumbre de drogas huérfanas

Plataformas de publicación científica

La compañía aprovecha las revistas revisadas por pares y las plataformas de publicación científica para difundir los hallazgos de la investigación.

Plataforma de publicación	Número de publicaciones en 2023
Revista de Oftalmología	3
Oftalmología de investigación & Ciencia visual	2

Marketing digital y comunicación

Aldeyra utiliza plataformas digitales para la comunicación dirigida y la difusión de información.

• Sitio web corporativo con información detallada del producto
• Plataforma de redes profesionales de LinkedIn
• Publicidad digital dirigida en redes médicas profesionales

Comunicaciones de relaciones con los inversores

La compañía mantiene canales de comunicación de inversores sólidos.

Canal de comunicación	Frecuencia
Llamadas de ganancias trimestrales	4 veces al año
Reunión anual de accionistas	1 vez por año
Presentaciones de inversores	6-8 veces al año

Aldeyra Therapeutics, Inc. (ALDX) - Modelo de negocio: segmentos de clientes

Pacientes con enfermedades raras

Aldeyra Therapeutics se centra en pacientes con enfermedades raras con afecciones específicas:

• Síndrome de Sjögren-Larsson (SLS): prevalencia global estimada de 1 en 250,000
• Pacientes de enfermedad de ojo seco: aproximadamente 16,4 millones diagnosticados en los Estados Unidos
• Pacientes de conjuntivitis alérgica: afecta a alrededor del 20% de la población anualmente

Categoría de enfermedades	Población de pacientes	Tamaño del mercado objetivo
Síndrome de Sjögren-Larsson	Aproximadamente 500 casos diagnosticados en todo el mundo	Mercado limitado de enfermedades huérfanas
Enfermedad ocular seca	16,4 millones de pacientes en EE. UU.	Potencial de mercado global de $ 4.3 mil millones

Especialistas médicos y médicos

Los profesionales médicos objetivo incluyen:

• Oftalmólogos: 19,617 practicando en los Estados Unidos
• Dermatólogos: 11,605 certificados por la junta en los Estados Unidos
• Especialistas en enfermedades raras: aproximadamente 7,000 en todo el país

Instituciones de atención médica

Segmentos de atención médica dirigidos:

• Centros médicos académicos: 155 en los Estados Unidos
• Clínicas especializadas de enfermedades raras: aproximadamente 350 en todo el país
• Centros de tratamiento de oftalmología: más de 2.500 en los Estados Unidos

Organizaciones de investigación

Objetivos de colaboración de investigación:

• Institutos Nacionales de Salud (NIH) Programas de investigación de enfermedades raras financiadas: 41 subvenciones activas
• Centros de investigación de enfermedades raras: 127 centros especializados a nivel mundial
• Instituciones de investigación académica: más de 500 colaboradores potenciales

Socios de la industria farmacéutica

Tipo de socio	Colaboradores potenciales	Potencial de colaboración
Grandes compañías farmacéuticas	Top 20 empresas farmacéuticas globales	Posibles asociaciones de licencias y desarrollo
Compañías de biotecnología	Más de 4.500 empresas de biotecnología activa	Oportunidades potenciales de desarrollo de co-desarrollo

Métricas clave del mercado:

• Mercado total direccionable para tratamientos de enfermedades raras: $ 150 mil millones a nivel mundial
• Mercado terapéutico de oftalmología: $ 55.8 mil millones para 2026
• Tasa de éxito del desarrollo de fármacos de enfermedades raras: aproximadamente 5.1%

Aldeyra Therapeutics, Inc. (ALDX) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal que finalizó el 31 de diciembre de 2022, Aldeyra Therapeutics informó gastos de investigación y desarrollo de $ 49.4 millones.

Año	Gastos de I + D
2022	$ 49.4 millones
2021	$ 44.5 millones

Inversiones de ensayos clínicos

Las inversiones de ensayos clínicos para Aldeyra Therapeutics en 2022 se centraron principalmente en:

• Reproxalap para la enfermedad del ojo seco
• ADX-2191 para vitreoretinopatía proliferativa
• Programas sistémicos de enfermedades raras

Mantenimiento de la propiedad intelectual

Al 31 de diciembre de 2022, Aldeyra sostuvo 24 patentes emitidas y 47 solicitudes de patentes pendientes a nivel mundial.

Costos administrativos y operativos

Categoría de costos	Cantidad de 2022
Gastos generales y administrativos	$ 22.1 millones
Gastos operativos totales	$ 73.5 millones

Gastos de marketing y comunicación

Los gastos de marketing para Aldeyra Therapeutics se integraron dentro de los costos generales y administrativos, con una asignación específica no divulgada por separado en el informe financiero de 2022.

Pérdida neta total para 2022: $ 59.3 millones

Aldeyra Therapeutics, Inc. (ALDX) - Modelo de negocios: flujos de ingresos

Ingresos potenciales de licencia de medicamentos futuros

A partir del cuarto trimestre de 2023, Aldeyra Therapeutics tiene ingresos potenciales de licencia de medicamentos asociados con sus activos clave de tuberías:

Candidato a la droga	Valor de licencia potencial	Etapa de desarrollo
ADX-2191	Tarifa potencial de licencia por adelantado de $ 15-25 millones	Fase 2/3 Desarrollo clínico
Reproxima	Valor de licencia potencial de $ 30-50 millones	Fase 3 Etapa clínica

Subvenciones de investigación y financiación

Las fuentes de financiación para Aldeyra Therapeutics incluyen:

• Subvenciones de los Institutos Nacionales de Salud (NIH): $ 2.3 millones en 2022
• Subvenciones de Investigación de Innovación de Pequeñas Empresas (SBIR): $ 1.5 millones anuales
• Financiación total de la investigación: aproximadamente $ 3.8 millones en 2022

Acuerdos de investigación colaborativos

Asociaciones actuales de investigación colaborativa:

Pareja	Valor de acuerdo	Enfoque de investigación
Massachusetts ojo y enfermería en la oreja	$ 750,000 de colaboración de investigación	Investigación de enfermedades secas
Escuela de Medicina de Harvard	Acuerdo de colaboración de $ 500,000	Investigación de enfermedades inflamatorias

Posibles acuerdos de asociación farmacéutica

Proyecciones potenciales de ingresos de asociación farmacéutica:

• Valor estimado de la oferta de asociación potencial: $ 50-100 millones
• Pagos potenciales de hitos: $ 200-300 millones
• Potencial de regalías: 8-12% en futuras ventas de productos

Comercialización futura de productos

Ingresos de comercialización proyectados:

Producto	Potencial de ingresos anual estimado	Mercado objetivo
Reproxima	$ 75-125 millones	Mercado de enfermedades secas
ADX-2191	$ 50-90 millones	Condiciones inflamatorias oftálmicas

Aldeyra Therapeutics, Inc. (ALDX) - Canvas Business Model: Value Propositions

You're looking at the core value Aldeyra Therapeutics, Inc. (ALDX) is trying to deliver across its product candidates. It's all about hitting specific, high-unmet-need areas with a novel mechanism.

Reproxalap: Rapid reduction of ocular discomfort and redness for dry eye disease

The value here centers on clinical proof points. In a Phase 3 dry eye chamber trial, reproxalap was statistically superior ($\text{P}=0.002$) to vehicle for the primary endpoint of ocular discomfort. Specifically, the $\text{LS mean difference}$ on the $\text{0-100}$ ocular discomfort symptom score from $\text{80}$ to $\text{100}$ minutes after chamber entry was $\text{-6.5}$ [$\text{-10.5, -2.5}$].

The market context is massive, with the Dry Eye Disease ($\text{DED}$) market projected to hit $\text{\$7.6}$ billion globally by $\text{2030}$. Aldeyra, Inc. estimates that only $\text{15\%}$ of $\text{DED}$ patients currently use prescription treatments. If approved, analysts estimate peak sales for reproxalap could reach $\text{\$500}$ million annually.

Here's a quick look at the numbers supporting the DED proposition as of late $\text{2025}$:

Metric	Value
Phase 3 Chamber Trial P-value (Ocular Discomfort)	0.002
Ocular Discomfort LS Mean Difference (Reproxalap vs. Vehicle)	-6.5
Total Patients Studied in Clinical Trials (to date)	>2,900
Projected Global DED Market by 2030	$7.6 billion
Estimated Peak Annual Sales (if approved)	$500 million
PDUFA Target Action Date (NDA Resubmission)	December 16, 2025

Also, the manufacturing facilities completed routine site inspections in $\text{2025}$ resulting in Voluntary Action Indicated ($\text{VAI}$) designations, with the $\text{FDA}$ notifying manufacturers that inspections are closed with no further action necessary.

First-in-class mechanism targeting RASP, a novel anti-inflammatory approach

The core value is the mechanism itself: targeting reactive aldehyde species ($\text{RASP}$). This approach aims to address both signs and symptoms of chronic inflammation. Across all clinical trials to date, reproxalap was studied in over $\text{2,900}$ patients, and the most commonly reported adverse event was mild and transient instillation site irritation; no serious safety signals were observed.

Potential treatment for rare retinal diseases with ADX-2191 (e.g., primary vitreoretinal lymphoma)

For Primary Vitreoretinal Lymphoma ($\text{PVRL}$), $\text{ADX-2191}$ offers a novel, sterile, non-compounded intravitreal formulation of methotrexate where currently no $\text{FDA}$-approved therapy exists. $\text{PVRL}$ affects approximately $\text{100}$ to $\text{200}$ people per year in the $\text{EU}$ and $\text{200}$ to $\text{600}$ in the $\text{US}$. The clinical trial proposed under the Special Protocol Assessment Agreement Letter is expected to begin in the second half of $\text{2025}$ and conclude in $\text{2026}$. For Retinitis Pigmentosa ($\text{RP}$), the $\text{FDA}$ granted Fast Track designation, and a planned Phase $\text{2/3}$ trial is expected to initiate in $\text{2025}$.

Pipeline of RASP modulators for systemic immune-mediated and metabolic diseases

Aldeyra, Inc. is focusing its $\text{RASP}$ platform on next-generation molecules following pipeline adjustments announced on $\text{October 28, 2025}$. This strategic shift extended the projected operational cash runway into the second half of $\text{2027}$. The company's market capitalization was approximately $\text{\$319}$ million with a share price of $\text{\$5.30}$ as of mid-November $\text{2025}$.

The reprioritization involved specific asset swaps:

• Stopping clinical development of $\text{ADX-629}$.
• Prioritizing $\text{ADX-248}$ over $\text{ADX-743}$ for metabolic inflammation, including obesity.
• Switching focus from $\text{ADX-631}$ to $\text{ADX-246}$ for dry Age-related Macular Degeneration ($\text{AMD}$).

The value proposition for these systemic candidates is supported by preclinical or Phase $\text{1}$ data suggesting broad applicability. For instance, $\text{ADX-248}$ showed high levels of exposure following once-daily oral dosing in Phase $\text{1}$ studies, and new preclinical data showed positive effects in Parkinson's disease and $\text{ALS}$ models, including improvements in grip strength and balance. Investigational New Drug ($\text{IND}$) application filings for both $\text{ADX-248}$ and $\text{ADX-246}$ are anticipated in $\text{2026}$.

Here's how the pipeline focus shifted:

Indication Area	Prioritized Asset	Replaced Asset	Next Step Timeline
Metabolic Inflammation (e.g., Obesity)	ADX-248	ADX-743	IND filing in 2026
Dry AMD	ADX-246	ADX-631	IND filing in 2026
Neuroinflammatory Diseases (Expansion)	ADX-248	N/A (Expansion)	Preclinical data supportive

Finance: review the $\text{Q3 2025}$ cash position of $\text{\$75.3}$ million against the extended runway forecast of $\text{H2 2027}$ runway by next week.

Aldeyra Therapeutics, Inc. (ALDX) - Canvas Business Model: Customer Relationships

You're looking at how Aldeyra Therapeutics, Inc. manages its relationships with the key groups that drive its success-from the doctors who will prescribe its drugs to the investors funding the pipeline. For a clinical-stage company, these relationships are everything, especially when you're navigating a major regulatory decision like the one for reproxalap.

High-touch engagement with key opinion leaders (KOLs) and specialists

Engagement with Key Opinion Leaders (KOLs) and specialists centers on the late-stage clinical data for reproxalap, a reactive aldehyde species (RASP) modulator for dry eye disease and allergic conjunctivitis. The relationship is built on presenting the clinical profile of this first-in-class therapy to the ophthalmology community, which has existing treatments like Xiidra and Restasis.

The focus here is on establishing credibility with prescribers ahead of potential commercialization. While specific counts of engaged specialists aren't public, the nature of the relationship is high-touch, driven by the need to educate on a novel mechanism of action-modulating protein systems to optimize multiple pathways while minimizing toxicity.

Investor relations and communication on clinical milestones

Investor relations for Aldeyra Therapeutics, Inc. is intensely focused on clinical and regulatory milestones, which directly impact valuation and partnership dynamics. The company maintains active communication channels, including a dedicated Investor Relations website at https://ir.aldeyra.com, managed by staff like Laura Nichols, Associate Director of Investor Relations & Business Operations.

Key communications in 2025 revolved around the reproxalap New Drug Application (NDA) resubmission, which received an FDA Prescription Drug User Fee Act (PDUFA) target action date of April 2, 2025. The company provided updates through webcasts and conference participation, such as the Research & Development Update Webcast on November 13, 2025, and the CEO's participation in the Jefferies Global Healthcare Conference on November 20, 2025 in London.

Financially, investor communication must address the burn rate and cash runway. For instance, the Q1 2025 financial results showed a net loss of approximately $9.93 million, with Research and development expenses at $7.4 million and General and administrative expenses at $3.0 million for that quarter. As of March 31, 2025, the company reported total cash, cash equivalents, and marketable securities of $90.1 million against total liabilities of $29.6 million.

Here are some key investor touchpoints from the period:

• PDUFA date set for reproxalap: April 2, 2025.
• R&D Update Webcast hosted: November 13, 2025.
• Jefferies Global Healthcare Conference participation: November 20, 2025.
• Q1 2025 Net Loss reported: $9.93 million.
• Cash position as of March 31, 2025: $90.1 million.

Indirect patient support and education via advocacy groups

Aldeyra Therapeutics, Inc. engages patients indirectly, primarily through collaboration with patient advocacy groups. While specific financial or engagement metrics for Aldeyra's direct support programs aren't detailed, the industry context for 2025 emphasizes a shift toward deeper partnership. Experts suggest that pharmaceutical companies must move beyond simple consultation to co-create products with patient advocacy groups and ensure transparency on how patient input shapes decisions.

This relationship is critical for building trust, which industry data suggests has been a challenge, with patient perceptions of the biopharmaceutical industry declining over the preceding two years. For Aldeyra, this means ensuring that advocacy groups are informed about the potential benefits of reproxalap and ADX-2191, especially given the focus on unmet needs in immune-mediated diseases.

Collaborative management with commercial partner AbbVie

The relationship with commercial partner AbbVie, Inc. is structured around the development, manufacture, and commercialization of reproxalap in the U.S. This partnership is defined by clear financial triggers and profit-sharing terms following the NDA acceptance and option agreement expansion.

The financial structure governing this collaboration is laid out below:

Financial Component	Aldeyra Therapeutics, Inc. Entitlement	AbbVie, Inc. Entitlement
Upfront Payment (Upon Option Exercise)	$100 million cash payment (less $6 million in prior option fees)	Option to co-exclusive license in the US
Regulatory/Commercial Milestones	Up to $300 million total, including $100 million upon FDA approval	Triggers for milestone payments
US Commercialization Profit/Loss Split	40% share	60% share
International Commercialization	Tiered royalties on net sales	Exclusive license for activities outside the US
Pre-commercial Activities Cost Split (If Option Exercised)	40% of costs	60% of costs

The option agreement was expanded in parallel with the NDA acceptance, allowing both Aldeyra Therapeutics, Inc. and AbbVie to initiate pre-commercial activities. AbbVie's option to exercise the license expires 10 business days following FDA approval, if granted.

Aldeyra Therapeutics, Inc. (ALDX) - Canvas Business Model: Channels

You're looking at how Aldeyra Therapeutics, Inc. plans to get reproxalap-if approved-into the hands of U.S. ophthalmologists and patients. This involves regulatory navigation, a major commercial partner, and scientific communication.

AbbVie's established U.S. ophthalmology and commercial sales force (post-approval)

The primary commercial channel hinges on the option agreement with AbbVie Inc. Should AbbVie exercise its option following FDA approval, the established U.S. ophthalmology and commercial sales force of AbbVie will drive market access.

The financial structure for this channel, post-option exercise, is clearly defined:

Commercial Aspect	AbbVie Share	Aldeyra Therapeutics Share
U.S. Commercialization Profits/Losses Split	60%	40%
U.S. Pre-commercial Activity Cost Split	60% (Implied by expanded agreement)	40% (Implied by expanded agreement)

This partnership also involves significant financial triggers that activate the channel. Aldeyra Therapeutics is eligible for up to $300 million in regulatory and commercial milestone payments, which includes a $100 million payment specifically upon FDA approval. AbbVie has also independently started certain pre-commercial planning activities.

Direct communication with the U.S. Food and Drug Administration (FDA) for NDA review

Direct engagement with the FDA is a critical channel for gaining market access. Aldeyra Therapeutics resubmitted the New Drug Application (NDA) for topical ocular reproxalap on June 17, 2025. The FDA officially accepted this resubmitted NDA for review on July 17, 2025. This acceptance established a Prescription Drug User Fee Act (PDUFA) target action date of December 16, 2025. This review period is the direct regulatory channel determining market entry.

Medical conferences and peer-reviewed publications for physician awareness

Building awareness among prescribing physicians relies on scientific dissemination. Aldeyra Therapeutics actively uses industry events to communicate data. For instance, the company was scheduled to participate in the 2025 Jefferies Global Healthcare Conference. Furthermore, the company presented data from its Phase 3 dry eye chamber trial, which met its primary endpoint of reducing ocular discomfort with a P-value of P=0.002 in May 2025.

Key communication milestones include:

• Data from Phase 3 dry eye chamber trial reported in August 2024.
• Fireside chat scheduled for June 5, 2025, at 4:20 p.m. ET.
• Research & Development Webcast event scheduled for November 13.

Specialty pharmacies and distributors for drug delivery (future)

The physical delivery channel for a specialty drug like reproxalap will likely involve a managed network. While Aldeyra Therapeutics has not disclosed its specific network structure as of late 2025, the broader U.S. specialty drug landscape provides context for this channel choice.

Industry data from early 2025 shows the following for manufacturer-defined specialty pharmacy networks:

Metric	Value
Total unique specialty drugs tracked with limited/exclusive networks (as of Jan 2025)	382
Percentage of tracked drugs with exclusive networks (only one pharmacy)	34%

The decision will likely fall into one of three models: Open distribution, Limited dispensing network, or Exclusive dispensing network. Given the partnership with AbbVie, a limited or exclusive network managed by AbbVie's existing infrastructure is the probable path.

Aldeyra Therapeutics, Inc. (ALDX) - Canvas Business Model: Customer Segments

You're looking at the core groups Aldeyra Therapeutics, Inc. targets with its development pipeline, especially around its late-stage assets. The focus is clearly on the ocular space, but the financial backing is just as critical for a clinical-stage firm.

Ophthalmologists and optometrists treating chronic dry eye disease (DED).

These are the prescribers you need to convince of the product's efficacy and tolerability. The market they operate in is substantial and growing, which signals a large potential pool for adoption if regulatory hurdles are cleared.

• The Dry Eye Disease treatment market was valued at $6.36 billion in 2025.
• This market is projected to reach $7.77 billion by 2030.
• Prescription drug growth in this sector is expanding at a 9.1% CAGR through 2030.
• In 2023, the United States represented the largest proportion of the 7MM DED market at 41% revenue share.
• Reproxalap has been studied in over 2,900 patients in clinical trials.

Patients with moderate-to-severe DED and allergic conjunctivitis (AC).

This segment represents the end-users who will ultimately use the product, assuming regulatory approval for reproxalap in DED and potential future indications like AC. The sheer scale of the diagnosed population is the opportunity here.

• The estimated total diagnosed prevalent cases of Dry Eye Disease in the 7MM reached nearly 54.7 million cases in 2023.
• The United States alone had an estimated 22.5 million diagnosed DED cases in 2023.
• In a Phase 3 chamber trial for DED, the ocular discomfort symptom score (0-100) showed an LS mean difference of -6.5 (P = 0.002) for reproxalap versus vehicle.
• The chamber trial involved 58 patients receiving reproxalap and 58 patients receiving vehicle.

Retinal specialists treating rare ocular inflammatory diseases.

While less data is immediately available on the specific patient numbers for rare inflammatory diseases like Primary Vitreoretinal Lymphoma (PVRL), this segment is targeted by the pipeline candidate ADX-2191. The focus here is on specialized, high-need areas.

Aldeyra Therapeutics had an NDA for ADX-2191 for PVRL under Priority Review with a PDUFA date of June 21, 2023, as reported in March 2023.

Institutional investors funding clinical-stage biotechnology companies.

This group provides the necessary capital to fund the late-stage trials and potential commercial launch activities. Their confidence, reflected in ownership stakes, is a key resource.

As of late 2025, the stock price was $4.96 per share on November 21, 2025. The company reported cash, cash equivalents, and marketable securities of $101 million as of December 31, 2024.

Institutional Shareholder (as of Q3 2025)	Shares Held	Total Value of Holdings (millions)
Knoll Capital Management, Llc.	5,475,516	Not explicitly stated for this holder
Perceptive Advisors Llc.	5,222,311	Not explicitly stated for this holder
Blackrock, Inc.	3,804,920	Not explicitly stated for this holder
Vanguard Group Inc.	3,591,869	Not explicitly stated for this holder
Total Institutional Owners/Shareholders Filing	42,499,995 (Total Shares Held)	$207 (Total Value of Holdings)

There are 255 institutional owners and shareholders filing 13D/G or 13F forms. The expected full-year 2025 costs for the ongoing DED clinical trials were approximately $6 million.

Aldeyra Therapeutics, Inc. (ALDX) - Canvas Business Model: Cost Structure

You're looking at where Aldeyra Therapeutics, Inc. is putting its capital to work, and it's heavily weighted toward getting reproxalap across the finish line. The cost structure is defined by significant, ongoing investment in clinical development, which is typical for a clinical-stage biopharma company like Aldeyra Therapeutics, Inc. The burn rate reflects the pursuit of regulatory approval for its lead candidate.

Here's a quick look at the core operating expenses for the third quarter and the nine months ending September 30, 2025, showing where the money is going:

Expense Category	Q3 2025 Amount (USD)	Nine Months Ended Sep 30, 2025 Amount (USD)
Research and Development (R&D) Expenses	$5.4 million	$21.4 million
General and Administrative (G&A) Expenses	$2.6 million	$7.2 million
Net Loss (Total)	$7.69 million	$27.4 million

The heavy investment in clinical trials is clearly visible in the R&D spend. Specifically, the full-year 2025 costs for the ongoing dry eye clinical trials are expected to be approximately $6 million. This figure represents a focused spend following the majority of costs incurred in 2024, as Aldeyra Therapeutics, Inc. works toward a potential New Drug Application (NDA) resubmission mid-year 2025.

General and administrative (G&A) costs, which cover things like legal fees and maintaining the company's intellectual property portfolio, also show a reduction compared to the prior year. For the third quarter of 2025, G&A expenses were $2.6 million, down from $3.7 million in Q3 2024. The nine-month total for G&A was $7.2 million, an improvement from $9.9 million in the same period of 2024. This reduction is primarily due to lower personnel and legal costs.

The bottom line reflects the development stage. For Q3 2025, Aldeyra Therapeutics, Inc. reported a basic loss per share from continuing operations of $0.13. This compares to an analyst estimate of $0.245 loss per share for the period, based on available data. The reported net loss for the quarter was $7.69 million.

To give you a sense of the financial runway supporting these costs, here are a few balance sheet highlights as of September 30, 2025:

• Cash, cash equivalents, and marketable securities totaled $75.3 million.
• Total assets were reported at $77.8 million.
• Total stockholders' equity amounted to approximately $49.2 million.

Finance: draft 13-week cash view by Friday.

Aldeyra Therapeutics, Inc. (ALDX) - Canvas Business Model: Revenue Streams

Aldeyra Therapeutics, Inc.'s revenue streams are heavily weighted toward potential future payments stemming from the exclusive option agreement with AbbVie Inc. concerning reproxalap, as of late 2025.

The core of the expected revenue generation is tied to the successful commercialization of reproxalap, contingent upon regulatory milestones. The agreement structure dictates specific financial triggers:

• Potential $100 million milestone payment from AbbVie upon U.S. Food and Drug Administration approval of reproxalap for dry eye disease.
• Potential future milestone payments totaling up to $300 million in regulatory and commercial achievements, which includes the $100 million approval payment. One analysis suggests this could total up to $400 million in milestone payments contingent on regulatory and commercial success.

Once commercialization begins in the United States, Aldeyra Therapeutics, Inc. is set to receive a significant share of the net profits from reproxalap sales. This profit-sharing arrangement is detailed as follows:

Geographic Market	Aldeyra Therapeutics, Inc. Share	Partner Share
United States	40% of profits and losses	60% for AbbVie Inc.
Outside the U.S.	Tiered royalties on net sales	N/A

For markets outside the U.S., the revenue stream shifts entirely to royalties. Aldeyra Therapeutics, Inc. would be eligible to receive tiered royalties on net sales of reproxalap. The specific royalty percentages are tiered and dependent on sales volume, which is a future-looking revenue component.

To put the company's current financial standing in context, Aldeyra Therapeutics, Inc. reported a net loss to common of -$7.68 million for the third quarter of 2025. For the nine months ending September 30, 2025, the company reflected a comprehensive loss of $27.4 million. The company's ability to realize these contingent revenues is paramount to its financial health.

The key financial components of the AbbVie collaboration are:

• Upfront Payment: $100 million, less prior option fees, upon option exercise.
• FDA Approval Milestone: $100 million payment.
• Total Potential Milestones: Up to $300 million.
• U.S. Profit Split: Aldeyra receives 40%.

Finance: draft 13-week cash view by Friday.