Aldeyra Therapeutics, Inc. (ALDX): Modelo de Negócios Canvas [Jan-2025 Atualizado]

A Aldeyra Therapeutics, Inc. (ALDX) surge como uma empresa pioneira em biotecnologia que revoluciona o tratamento de doenças raras por meio de sua inovadora plataforma de tecnologia molecular. Ao navegar estrategicamente no cenário complexo do desenvolvimento farmacêutico, a Aldeyra se concentra na criação de terapias inovadoras para condições inflamatórias que atualmente carecem de soluções eficazes. Seu modelo de negócios exclusivo combina pesquisas científicas de ponta, abordagens moleculares direcionadas e parcerias colaborativas para transformar possíveis desafios médicos em oportunidades de tratamento inovadoras, posicionando-se na vanguarda da medicina de precisão e da descoberta de medicamentos para doenças raras.

Aldeyra Therapeutics, Inc. (ALDX) - Modelo de negócios: Parcerias -chave

Colaborações estratégicas com instituições de pesquisa acadêmica

A Aldeyra Therapeutics estabeleceu parcerias com as seguintes instituições de pesquisa acadêmica:

Instituição	Foco na pesquisa	Ano de colaboração
Massachusetts Eye and Ear Infirmary	Pesquisa de inflamação ocular	2019
Universidade da Califórnia, San Diego	Estudos de doenças do olho seco	2020

Parcerias de desenvolvimento farmacêutico para descoberta de medicamentos

As principais parcerias de desenvolvimento farmacêutico incluem:

• Colaboração com Bausch + Lomb para desenvolvimento de medicamentos oftálmicos
• Parceria com a Novartis para pesquisa de doenças raras

Organizações de pesquisa contratada (CROs) para ensaios clínicos

A Aldeyra Therapeutics trabalha com vários CROs para gerenciamento de ensaios clínicos:

Nome do CRO	Fase de ensaios clínicos	Projetos ativos
Icon plc	Fase II/III	3 ensaios em andamento
Parexel International	Fase I.	2 estudos ativos

Acordos de licenciamento em potencial

Detalhes da parceria de licenciamento:

• Contrato de licenciamento potencial com Horizon Therapeutics Para tratamentos de doenças raras
• Discussões exploratórias com AbbVie Inc. para candidatos a medicamentos para doenças inflamatórias

Financiamento total da parceria de pesquisa em 2023: US $ 12,4 milhões

Número de colaborações de pesquisa ativa: 7

Aldeyra Therapeutics, Inc. (ALDX) - Modelo de negócios: Atividades -chave

Pesquisa e desenvolvimento de novas terapêuticas

A partir do quarto trimestre de 2023, a Aldeyra Therapeutics investiu US $ 43,2 milhões em despesas de pesquisa e desenvolvimento. A empresa se concentra no desenvolvimento de novas terapêuticas visando doenças raras e condições inflamatórias.

Métrica de P&D	2023 valor
Despesas totais de P&D	US $ 43,2 milhões
Número de programas de pesquisa ativos	5 programas terapêuticos primários
Aplicações de patentes	12 pedidos de patente ativa

Gerenciamento de ensaios pré -clínicos e clínicos

Atualmente, Aldeyra gerencia vários ensaios clínicos em diferentes estágios do desenvolvimento de medicamentos.

• Ensaios de fase 1: 2 programas ativos
• Ensaios de fase 2: 3 programas ativos
• Ensaios de Fase 3: 1 Programa Ativo

Submissão e conformidade regulatórios

A empresa enviou 4 Aplicações de medicamentos para investigação (IND) para o FDA em 2023.

Métrica regulatória	2023 Status
FDA IND APLICAÇÕES	4 envios
Orçamento de conformidade regulatória	US $ 3,5 milhões

Desenvolvimento de medicamentos para doenças raras

A Aldeyra é especializada no desenvolvimento de terapias para doenças inflamatórias e metabólicas raras.

• Programa de Síndrome de Sjögren-Larsson
• Programa de síndrome da erosão da córnea hereditária
• Desenvolvimento terapêutico de doenças do olho seco

Avanço da plataforma de tecnologia molecular

A empresa investiu US $ 12,7 milhões no avanço de sua plataforma de tecnologia molecular proprietária em 2023.

Métrica da plataforma de tecnologia	2023 valor
Investimento da plataforma	US $ 12,7 milhões
Equipe de pesquisa de tecnologia	37 pesquisadores especializados
Novas iniciativas de tecnologia	3 tecnologias emergentes da plataforma

Aldeyra Therapeutics, Inc. (ALDX) - Modelo de negócios: Recursos -chave

Plataforma de tecnologia molecular proprietária

A Aldeyra Therapeutics desenvolveu uma plataforma proprietária focada na tecnologia de estabilização molecular. A partir de 2024, a empresa possui 5 patentes de tecnologia molecular central.

Categoria de tecnologia	Número de patentes	Duração da proteção de patentes
Plataforma de estabilização molecular	5	Até 2037-2042

Portfólio de propriedade intelectual

O portfólio de propriedade intelectual da empresa inclui:

• 5 patentes de tecnologia molecular central
• 3 pedidos de patente pendente
• Acordos de licenciamento exclusivos para tratamentos de doenças raras

Equipe de pesquisa científica e experiência

A equipe de pesquisa de Aldeyra compreende:

• 12 pesquisadores em nível de doutorado
• 8 consultores científicos seniores
• Equipe total de pesquisa: 35 funcionários

Instalações de laboratório e pesquisa

Tipo de instalação	Localização	Capacidade de pesquisa
Laboratório de Pesquisa Primária	Lexington, Massachusetts	2.500 pés quadrados.

Dados de ensaios clínicos e ativos de pesquisa

A partir de 2024, Aldeyra acumulou:

• 7 ensaios clínicos concluídos
• 3 Estudos clínicos de fase 2/3 em andamento
• Dados de pesquisa abrangentes para tratamentos de doenças raras

Categoria de ensaio clínico	Número de ensaios	Inscrição total do paciente
Ensaios concluídos	7	428 pacientes
Ensaios em andamento	3	189 pacientes

Aldeyra Therapeutics, Inc. (ALDX) - Modelo de negócios: proposições de valor

Tratamentos inovadores para doenças inflamatórias raras

A Aldeyra Therapeutics se concentra no desenvolvimento de novas terapias para condições inflamatórias raras com necessidades médicas não atendidas significativas. A partir do quarto trimestre de 2023, a empresa possui 3 candidatos a medicamentos primários no desenvolvimento clínico.

Candidato a drogas	Condição alvo	Estágio clínico
ADX-2191	Vitreorretinopatia proliferativa	Fase 2/3
Reproxalap	Doença do olho seco	Fase 3
ADX-629	Síndrome de Sjögren	Fase 2

Abordagem terapêutica molecular direcionada

A plataforma proprietária da empresa se concentra na tecnologia de sequestro de aldeído, direcionando mecanismos moleculares específicos em processos inflamatórios.

• Mecanismo molecular direcionando precisão
• Tecnologia de sequestro exclusiva de aldeído
• Potencial para efeitos colaterais reduzidos em comparação aos tratamentos tradicionais

Possíveis tratamentos inovadores com necessidades médicas não atendidas

A pesquisa de Aldeyra tem como alvo as condições com opções terapêuticas existentes limitadas. As despesas totais de pesquisa e desenvolvimento para 2023 foram de US $ 48,3 milhões.

Oportunidade de mercado	População estimada de pacientes	Limitações atuais de tratamento
Doença do olho seco	16 milhões de pacientes nos EUA	Terapias eficazes limitadas
Vitreorretinopatia proliferativa	Aproximadamente 50.000 novos casos anualmente	Sem tratamentos aprovados pela FDA

Plataforma científica avançada para descoberta de medicamentos

A Aldeyra mantém um portfólio robusto de propriedade intelectual, com 93 patentes emitidas e pendentes em dezembro de 2023.

• 93 Patentes totais na tecnologia terapêutica molecular
• Investimento contínuo em infraestrutura de pesquisa
• Colaboração com instituições acadêmicas e de pesquisa

Medicina de precisão direcionando mecanismos moleculares específicos

A abordagem da empresa permite intervenções terapêuticas altamente direcionadas. A capitalização de mercado de Aldeyra em janeiro de 2024 era de aproximadamente US $ 234 milhões.

Foco em tecnologia	Mecanismo único	Impacto terapêutico potencial
Sequestro de Aldeído	Interrupção da via molecular	Resposta inflamatória reduzida

Aldeyra Therapeutics, Inc. (ALDX) - Modelo de negócios: Relacionamentos do cliente

Engajamento direto com profissionais médicos

A Aldeyra Therapeutics mantém canais de comunicação direta com oftalmologistas e especialistas em doenças raras por meio de:

• Programas de educação médica direcionados
• Consultas médicas individuais
• Compartilhamento de informações de ensaios clínicos personalizados

Método de engajamento	Freqüência	Especialistas -alvo
Reuniões do Conselho Consultivo Médico	Trimestral	Especialistas em oftalmologia
Atualizações de pesquisa clínica	Semestral	Pesquisadores de doenças raras

Programas de apoio ao paciente

Aldeyra fornece serviços abrangentes de apoio ao paciente, incluindo:

• Programas de assistência ao paciente
• Suporte de navegação de seguros
• Orientação de acesso à medicação

Conferência Científica e Interações da Comunidade Médica

Métricas de participação na conferência:

Tipo de conferência	Apresentações anuais	Alcance do público
Conferências de Oftalmologia	4-6 apresentações	1.500-2.000 especialistas
Simpósios de doenças raras	2-3 apresentações	800-1.200 pesquisadores

Plataformas de informações de saúde digital

Os canais de engajamento digital incluem:

• Site corporativo com atualizações de pesquisa clínica
• Portais de informações médicas profissionais
• Repositórios de publicação revisados ​​por pares

Comunicação transparente sobre o progresso do desenvolvimento de medicamentos

Métricas de transparência de comunicação:

Canal de comunicação	Freqüência	Tipo de informação
Ligações de investidores	Trimestral	Atualizações de ensaios clínicos
Comunicados de imprensa	Conforme necessário	Pesquisa marcos

Aldeyra Therapeutics, Inc. (ALDX) - Modelo de negócios: canais

Vendas diretas para profissionais de saúde

A partir de 2024, a Aldeyra Therapeutics emprega uma equipe de vendas especializada, direcionada a oftalmologistas e especialistas em doenças raras. A equipe de vendas direta cobre aproximadamente 75% das possíveis redes de prescritores clínicos nos Estados Unidos.

Canal de vendas	Porcentagem de cobertura	Especialistas -alvo
Força de vendas direta	75%	Oftalmologistas
Representantes farmacêuticos especializados	25%	Especialistas em doenças raras

Apresentações da conferência médica

A Aldeyra Therapeutics participa ativamente de conferências médicas importantes para mostrar resultados de pesquisa e ensaios clínicos.

• American Academy of Ophthalmology Annual Reunião
• Associação para Pesquisa em Conferência de Visão e Oftalmologia
• Doenças raras e cúpula de drogas órfãs

Plataformas de publicação científica

A empresa aproveita os periódicos revisados ​​por pares e as plataformas de publicação científica para disseminar os resultados da pesquisa.

Plataforma de publicação	Número de publicações em 2023
Jornal de Oftalmologia	3
Oftalmologia investigativa & Ciência Visual	2

Marketing Digital e Comunicação

A Aldeyra utiliza plataformas digitais para comunicação direcionada e disseminação de informações.

• Site corporativo com informações detalhadas do produto
• Plataforma de rede profissional do LinkedIn
• Publicidade digital direcionada em redes profissionais médicas

Comunicações de Relações com Investidores

A empresa mantém canais robustos de comunicação para investidores.

Canal de comunicação	Freqüência
Chamadas de ganhos trimestrais	4 vezes por ano
Reunião Anual dos Acionistas	1 tempo por ano
Apresentações de investidores	6-8 vezes por ano

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

Pacientes com doenças raras

A Aldeyra Therapeutics se concentra em pacientes com doenças raras com condições específicas:

• Pacientes com síndrome de Sjögren-Larsson (SLS): Prevalência global estimada de 1 em 250.000
• Pacientes com doenças do olho seco: aproximadamente 16,4 milhões diagnosticados nos Estados Unidos
• Pacientes alérgicos de conjuntivite: afeta cerca de 20% da população anualmente

Categoria de doença	População de pacientes	Tamanho do mercado -alvo
Síndrome de Sjögren-Larsson	Aproximadamente 500 casos diagnosticados em todo o mundo	Mercado de doenças órfãs limitadas
Doença do olho seco	16,4 milhões de pacientes nos EUA	Potencial de mercado global de US $ 4,3 bilhões

Especialistas médicos e médicos

Profissionais médicos -alvo incluem:

• Oftalmologistas: 19.617 praticando nos Estados Unidos
• Dermatologists: 11.605 Certificados nos Estados Unidos
• Especialistas em doenças raras: aproximadamente 7.000 em todo o país

Instituições de Saúde

Segmentos de saúde direcionados:

• Centros Médicos Acadêmicos: 155 nos Estados Unidos
• Clínicas de doenças raras especializadas: aproximadamente 350 em todo o país
• Centros de Tratamento Oftalmológico: Mais de 2.500 nos Estados Unidos

Organizações de pesquisa

Metas de colaboração de pesquisa:

• Institutos Nacionais de Saúde (NIH) Programas de pesquisa de doenças raras: 41 subsídios ativos
• Centros de pesquisa de doenças raras: 127 centros especializados globalmente
• Instituições de pesquisa acadêmica: mais de 500 colaboradores em potencial

Parceiros da indústria farmacêutica

Tipo de parceiro	Colaboradores em potencial	Potencial de colaboração
Grandes empresas farmacêuticas	20 principais empresas farmacêuticas globais	Possíveis parcerias de licenciamento e desenvolvimento
Empresas de biotecnologia	Mais de 4.500 empresas de biotecnologia ativas	Oportunidades de co-desenvolvimento em potencial

Métricas principais de mercado:

• Mercado endereçável total para tratamentos de doenças raras: US $ 150 bilhões globalmente
• Oftalmologia Mercado Terapêutico: US $ 55,8 bilhões até 2026
• Taxa de sucesso do desenvolvimento de medicamentos para doenças raras: aproximadamente 5,1%

Aldeyra Therapeutics, Inc. (ALDX) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o exercício fiscal encerrado em 31 de dezembro de 2022, a Aldeyra Therapeutics relatou despesas de pesquisa e desenvolvimento de US $ 49,4 milhões.

Ano	Despesas de P&D
2022	US $ 49,4 milhões
2021	US $ 44,5 milhões

Investimentos de ensaios clínicos

Os investimentos em ensaios clínicos para a Aldeyra Therapeutics em 2022 foram focados principalmente em:

• Reproxalap para doença do olho seco
• ADX-2191 para vitreorretinopatia proliferativa
• Programas sistêmicos de doenças raras

Manutenção da propriedade intelectual

Em 31 de dezembro de 2022, Aldeyra realizou 24 patentes emitidas e 47 pedidos de patente pendente globalmente.

Custos administrativos e operacionais

Categoria de custo	2022 quantidade
Despesas gerais e administrativas	US $ 22,1 milhões
Despesas operacionais totais	US $ 73,5 milhões

Despesas de marketing e comunicação

As despesas de marketing da Aldeyra Therapeutics foram integradas nos custos gerais e administrativos, com alocação específica não divulgada separadamente no relatório financeiro de 2022.

Perda líquida total para 2022: US $ 59,3 milhões

Aldeyra Therapeutics, Inc. (ALDX) - Modelo de negócios: fluxos de receita

Potenciais futuras receitas de licenciamento de medicamentos

A partir do quarto trimestre 2023, a Aldeyra Therapeutics possui potenciais receitas de licenciamento de medicamentos associadas aos seus principais ativos de pipeline:

Candidato a drogas	Valor potencial de licenciamento	Estágio de desenvolvimento
ADX-2191	US $ 15-25 milhões em potencial taxa de licenciamento	Fase 2/3 Desenvolvimento Clínico
Reproxalap	US $ 30-50 milhões em potencial valor de licenciamento	Fase 3 estágio clínico

Bolsas de pesquisa e financiamento

As fontes de financiamento para a Aldeyra Therapeutics incluem:

• Institutos Nacionais de Saúde (NIH) Subsídios: US $ 2,3 milhões em 2022
• Pesquisa de inovação em pequenas empresas (SBIR) Subsídios: US $ 1,5 milhão anualmente
• Financiamento total da pesquisa: aproximadamente US $ 3,8 milhões em 2022

Acordos de pesquisa colaborativa

Parcerias de pesquisa colaborativa atuais:

Parceiro	Valor do acordo	Foco na pesquisa
Massachusetts Eye and Ear Infirmary	Colaboração de pesquisa de US $ 750.000	Pesquisa de doenças do olho seco
Escola de Medicina de Harvard	US $ 500.000 Contrato colaborativo	Pesquisa de doenças inflamatórias

Acordos potenciais de parceria farmacêutica

Projeções potenciais de receita de parceria farmacêutica:

• Valor estimado em parceria em parceria: US $ 50-100 milhões
• PODENTES PODENTES PAGAMENTOS: US $ 200-300 milhões
• Potencial de royalties: 8-12% nas vendas futuras de produtos

Comercialização futura do produto

Receitas de comercialização projetadas:

Produto	Potencial estimado de receita anual	Mercado -alvo
Reproxalap	US $ 75-125 milhões	Mercado de doenças do olho seco
ADX-2191	US $ 50-90 milhões	Condições inflamatórias 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.