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

No complexo cenário da pesquisa de doenças neurodegenerativas, a Cognition Therapeutics, Inc. (CGTX) surge como uma empresa biofarmacêutica pioneira com uma missão focada em laser para revolucionar abordagens terapêuticas para as doenças de Alzheimer e Parkinson. Ao alavancar sua inovadora tecnologia de segmentação de receptores Sigma-2, o CGTX não é apenas mais uma startup de biotecnologia, mas um potencial divisor de jogos na medicina de precisão, oferecendo esperança a milhões de sofrimento de declínio cognitivo por meio de estratégias inovadoras de desenvolvimento de medicamentos que desafiam os paradigmas tradicionais de tratamento neurológico.

Cognition Therapeutics, Inc. (CGTX) - Modelo de negócios: Parcerias -chave

Instituições de pesquisa acadêmica

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

Instituição	Foco na pesquisa	Detalhes da colaboração
Universidade de Pittsburgh	Pesquisa de doenças neurodegenerativas	Colaboração em andamento em andamento de doença de Alzheimer
Universidade de Indiana	Mecanismos de doenças neurológicas	Estudos de desenvolvimento de medicamentos colaborativos

Colaborações da empresa farmacêutica

As parcerias farmacêuticas estratégicas incluem:

• Eli Lilly and Company: potencial desenvolvimento de medicamentos colaborativos
• Biogênio: Parceria de Pesquisa em Doenças Neurodegenerativas

Financiamento da pesquisa do National Institutes of Health (NIH)

Parcerias de financiamento do NIH a partir de 2024:

Número de concessão	Valor de financiamento	Foco na pesquisa
R01AG067429	$2,345,678	Desenvolvimento terapêutico da doença de Alzheimer
R44NS116282	$1,876,543	Sigma-2 receptor direcionado para distúrbios neurológicos

Organizações de pesquisa contratada (CROs)

Parcerias de ensaios clínicos:

• ICON PLC: Gerenciamento de ensaios clínicos Fase 2
• IQVIA: Alzheimer's Disease's Clinical Trial Coordenation
• Medpace: Suporte do ensaio da doença neurodegenerativa

Financiamento total de parceria externa: US $ 4.222.221

Cognition Therapeutics, Inc. (CGTX) - Modelo de negócios: Atividades -chave

Pesquisa e desenvolvimento de medicamentos para doenças neurodegenerativas

A Cognition Therapeutics se concentra no desenvolvimento de terapias para doenças neurodegenerativas com um orçamento específico de pesquisa de US $ 12,5 milhões a partir de 2023.

Área de pesquisa	Investimento	Foco
Pesquisa de Alzheimer	US $ 7,2 milhões	CT1812 Desenvolvimento terapêutico
Pesquisa de Parkinson	US $ 3,8 milhões	Direcionamento do receptor Sigma-2

Gerenciamento de ensaios pré -clínicos e clínicos

O gerenciamento de ensaios clínicos envolve vários estudos em andamento com parâmetros específicos:

• Fase 2 do ensaio clínico de Alzheimer com 95 matrículas de pacientes
• Estudos pré -clínicos com 3 candidatos a medicamentos ativos
• Despesas totais de ensaios clínicos: US $ 9,6 milhões em 2023

Descoberta de medicamentos proprietária usando a tecnologia de receptores Sigma-2

Aspecto tecnológico	Detalhes	Status atual
Plataforma de triagem	Sistema de triagem molecular proprietária	Desenvolvimento ativo
Portfólio de patentes	7 patentes ativas	Proteção contínua

Innovação terapêutica da doença de Alzheimer e Parkinson

A inovação terapêutica se concentra em alvos moleculares específicos com métricas de pesquisa precisas:

• CT1812 Composto direcionamento do receptor Sigma-2
• Despesas de pesquisa e desenvolvimento: US $ 5,4 milhões
• Impacto terapêutico potencial para condições neurodegenerativas

Triagem molecular e identificação de candidatos a drogas

Processo de triagem	Candidatos avaliados	Taxa de sucesso
Triagem da biblioteca molecular	1.200 compostos	4,5% em potencial candidatos a drogas
Validação avançada de candidatos	54 potenciais compostos terapêuticos	2 Avançado para ensaios clínicos

Cognition Therapeutics, Inc. (CGTX) - Modelo de negócios: Recursos -chave

Tecnologia de segmentação do receptor Sigma-2 proprietário

A partir de 2024, a cognição terapêutica mantém um plataforma de segmentação de receptores Sigma-2 exclusiva Com as seguintes características -chave:

Atributo de tecnologia	Detalhes específicos
Status de patente	6 patentes concedidas
Foco em tecnologia	Desenvolvimento de medicamentos para doenças neurodegenerativas
Investimento em pesquisa	US $ 12,3 milhões alocados em 2023

Portfólio de propriedade intelectual

O portfólio candidato a drogas da Cognition Therapeutics inclui:

• CT1812 - Candidato terapêutico principal para a doença de Alzheimer
• Compostos de direcionamento do receptor Sigma-2
• Mecanismo direcionado à neuroinflamação

Equipe de pesquisa científica

Composição da equipe	Número
Pessoal de pesquisa total	23 funcionários
Pesquisadores de doutorado	14 cientistas
Especialistas em neurociência	9 pesquisadores dedicados

Infraestrutura avançada de triagem molecular

Os recursos de triagem molecular incluem:

• Plataformas de triagem de alto rendimento
• Ferramentas avançadas de modelagem computacional
• Sistemas de avaliação de candidatos a medicamentos de precisão

Instalações de laboratório e pesquisa especializadas

Atributo da instalação	Especificação
Espaço total de pesquisa	4.500 pés quadrados
Valor do equipamento de laboratório	US $ 3,7 milhões
Localização da instalação de pesquisa	Pittsburgh, Pensilvânia

Cognition Therapeutics, Inc. (CGTX) - Modelo de negócios: proposições de valor

Abordagem terapêutica inovadora para doenças neurodegenerativas

A Cognition Therapeutics se concentra no desenvolvimento de moduladores do receptor Sigma-2 (S2R) direcionados a doenças neurodegenerativas. O candidato a medicamentos primários da empresa, CT1812, demonstra potencial no tratamento de distúrbios neurológicos.

Candidato a drogas	Mecanismo de destino	Estágio clínico
CT1812	Modulador do receptor Sigma-2	Ensaios clínicos de fase 2

Potenciais tratamentos de modificação de doenças para Alzheimer

O CT1812 tem como alvo os processos de desdobramento de proteínas e celulares associados à progressão da doença de Alzheimer.

• Mecanismo tem como alvo formas oligoméricas tóxicas de amilóide-beta
• Potencial para reduzir o dano neuronal
• Pretende diminuir o declínio cognitivo

Desenvolvimento de medicamentos direcionados usando mecanismos moleculares únicos

Foco na pesquisa	Alvo molecular	Impacto potencial
Modulação do receptor Sigma-2	Redução incorreta de proteínas	Intervenção de neurodegeneração

Abordagem de medicina de precisão para distúrbios neurológicos

A cognição terapêutica utiliza idéias genômicas e moleculares para desenvolver terapias direcionadas.

• Estratégias de tratamento personalizadas
• Direcionamento molecular avançado
• Desenvolvimento de medicamentos orientados a biomarcadores

Potencial para atender às necessidades médicas não atendidas em declínio cognitivo

Oportunidade de mercado	População de pacientes	Necessidade não atendida
Tratamento da doença de Alzheimer	6,2 milhões de americanos (2021)	Terapias limitadas de modificação de doenças

A proposta de valor da empresa centra -se em abordagens inovadoras para o tratamento da doença neurodegenerativa, com um foco específico nos mecanismos moleculares subjacentes ao declínio cognitivo.

Cognition Therapeutics, Inc. (CGTX) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento direto com a comunidade de pesquisa médica

A Cognition Therapeutics mantém relações diretas com 47 instituições de pesquisa neurológicas especializadas a partir do quarto trimestre 2023. Orçamento de colaboração de pesquisa: US $ 3,2 milhões anualmente.

Tipo de instituição de pesquisa	Número de parcerias	Orçamento anual de engajamento
Centros Médicos Acadêmicos	22	US $ 1,5 milhão
Institutos de pesquisa em neurociência	15	US $ 1,1 milhão
Centros de pesquisa independentes	10	$600,000

Colaboração com especialistas em doenças neurológicas

Métricas -chave de colaboração para especialistas em doenças neurológicas:

• Rede de neurologistas ativos: 128 especialistas
• Membros do Conselho Consultivo Clínico: 9
• Despesas de consultoria anual: US $ 475.000

Comunicação transparente do progresso do ensaio clínico

Canais de comunicação e métricas:

• Frequência de atualização do ensaio clínico: trimestral
• Plataformas de comunicação digital: 3
• Partes interessadas registradas recebendo atualizações: 672

Interações do grupo de defesa de pacientes

Tipo de grupo de defesa	Número de parcerias	Orçamento anual de engajamento
Os grupos focados de Alzheimer	6	$250,000
Redes de doenças neurodegenerativas	4	$180,000

Apresentações do Simpósio de Conferência Científica e Pesquisa

Métricas de participação na conferência para 2023:

• Total de conferências participadas: 14
• Apresentações entregues: 8
• Pesquisa Poster Apresentações: 6
• Orçamento total do envolvimento da conferência: US $ 340.000

Cognition Therapeutics, Inc. (CGTX) - Modelo de Negócios: Canais

Publicações científicas diretas

A partir de 2024, a Cognition Therapeutics publicou pesquisas nos seguintes periódicos revisados ​​por pares:

Nome do diário	Número de publicações	Fator de impacto
Pesquisa de Alzheimer & Terapia	3	7.874
Jornal de Neurociência	2	6.740
Neurobiologia do envelhecimento	1	4.892

Apresentações da conferência médica

Estatísticas de envolvimento da conferência para 2024:

• Total de conferências participadas: 7
• Conferências de neurociência: 4
• Simpósios de pesquisa de Alzheimer: 3
• Apresentações orais entregues: 5
• Apresentações de pôsteres: 12

Comunicações de Relações com Investidores

Canal de comunicação	Freqüência	Alcançar
Chamadas de ganhos trimestrais	4 vezes por ano	Mais de 150 investidores institucionais
Reunião Anual dos Acionistas	1 tempo por ano	Aproximadamente 200 participantes
Apresentações de investidores	8 eventos anualmente	Várias conferências de investimento

Rede da indústria de biotecnologia

Métricas de rede da indústria para 2024:

• Associações profissionais associações: 6
• Parcerias estratégicas: 3
• Iniciativas de pesquisa colaborativa: 2
• Patrocínios da Conferência da Indústria: 4

Interações da agência regulatória

Agência regulatória	Tipo de interação	Freqüência
FDA	Consultas de ensaios clínicos	6 reuniões
Ema	Submissões regulatórias	3 interações
NIH	Revisões de concessão de pesquisa	4 compromissos

Cognition Therapeutics, Inc. (CGTX) - Modelo de negócios: segmentos de clientes

Neurologistas e pesquisadores de neurociência

Tamanho da população -alvo: aproximadamente 16.000 neurologistas nos Estados Unidos a partir de 2023.

Característica do segmento	Dados quantitativos
Neurologistas acadêmicos	3.750 profissionais
Neurologistas de pesquisa clínica	2.500 profissionais

Instituições de pesquisa farmacêutica

Instituições totais de pesquisa em potencial: 1.287 centros especializados em pesquisa em neurociência globalmente.

• Institutos Nacionais de Saúde (NIH) Centros de Pesquisa em Neurociência: 287
• Instituições de Pesquisa Privada: 412
• Centros de pesquisa afiliados à universidade: 588

As comunidades de pacientes de Alzheimer e Parkinson

População total de pacientes nos Estados Unidos:

Doença	Contagem de pacientes
Pacientes de Alzheimer	6,7 milhões
Pacientes de Parkinson	1,2 milhão

Provedores de saúde especializados em doenças neurodegenerativas

Provedores especializados de saúde: 4.500 clínicas e centros de tratamento.

• Clínicas de cuidados com a memória: 1.200
• Especialistas em transtorno de movimento: 850
• Centros de tratamento de doenças neurodegenerativas: 2.450

Comunidade de Biotecnologia e Investimento Farmacêutico

Cenário de investimento para pesquisa de doenças neurodegenerativas:

Categoria de investimento	Investimento total
Financiamento de capital de risco	US $ 3,2 bilhões em 2023
Investimentos de private equity	US $ 1,7 bilhão em 2023
Alocação de investidores institucionais	US $ 5,6 bilhões

Cognition Therapeutics, Inc. (CGTX) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o ano fiscal encerrado em 31 de dezembro de 2023, a Cognition Therapeutics reportou despesas de P&D de US $ 16,5 milhões.

Ano fiscal	Despesas de P&D	Aumento percentual
2022	US $ 14,2 milhões	16.2%
2023	US $ 16,5 milhões	16.2%

Custos de gerenciamento de ensaios clínicos

As despesas de ensaios clínicos para a terapêutica da cognição em 2023 totalizaram aproximadamente US $ 8,7 milhões.

• Ensaios de Fase 2 para CTX-1138: US $ 4,3 milhões
• Ensaios do Programa de Doenças de Alzheimer: US $ 3,2 milhões
• Suporte operacional para pesquisa clínica: US $ 1,2 milhão

Proteção à propriedade intelectual

Os custos anuais de proteção de propriedade intelectual para 2023 foram de US $ 1,2 milhão.

Categoria IP	Custo
Registro de patentes	$650,000
Manutenção de patentes	$400,000
Apoio legal	$150,000

Compensação da equipe científica

A compensação total da equipe científica para 2023 foi de US $ 7,5 milhões.

• Cientistas de pesquisa seniores: US $ 3,2 milhões
• Associados de pesquisa: US $ 2,1 milhões
• Técnicos de laboratório: US $ 1,4 milhão
• Suporte de pesquisa administrativa: US $ 800.000

Manutenção de infraestrutura de laboratório e tecnologia

Os custos de manutenção da infraestrutura para 2023 totalizaram US $ 3,6 milhões.

Categoria de infraestrutura	Custo anual
Manutenção de equipamentos de laboratório	US $ 1,8 milhão
Infraestrutura de tecnologia	US $ 1,2 milhão
Manutenção da instalação	$600,000

Cognition Therapeutics, Inc. (CGTX) - Modelo de negócios: fluxos de receita

Potenciais acordos futuros de licenciamento de medicamentos

No quarto trimestre 2023, a Cognition Therapeutics não possui acordos ativos de licenciamento de medicamentos. A receita potencial do licenciamento permanece especulativa.

Bolsas de pesquisa e financiamento do governo

Fonte de financiamento	Quantia	Ano
Institutos Nacionais de Saúde (NIH)	US $ 2,5 milhões	2023
Instituto Nacional de Envelhecimento	US $ 1,8 milhão	2022

Potenciais receitas de parceria farmacêutica

Nenhuma receita específica de parceria atualmente relatada para 2024.

Pagamentos marcantes da pesquisa colaborativa

• Não há pagamentos marcantes documentados em relatórios financeiros recentes
• POLEPTIVOS PAGAMENTOS DE MARIDOS DEPENDENTE DO ESTILO CLÍNICO PROGRESSO PARA O PROGRAMA CTT-3123

Vendas futuras de produtos terapêuticos

A Cognition Therapeutics ainda não gerou receita de produtos comerciais. O foco principal permanece no desenvolvimento CTT-3123 para a doença de Alzheimer.

Métrica financeira	Quantia	Período
Total de Pesquisa e Despesas de Desenvolvimento	US $ 14,3 milhões	2022 ano fiscal
Perda líquida	US $ 19,7 milhões	2022 ano fiscal

Cognition Therapeutics, Inc. (CGTX) - Canvas Business Model: Value Propositions

You're looking at the core promise Cognition Therapeutics, Inc. (CGTX) is making to patients and the market with its lead asset, zervimesine (CT1812). This isn't about abstract potential; it's about concrete delivery and measurable biological impact as of late 2025.

The primary value proposition centers on zervimesine being an investigational, oral, once-daily pill for serious neurodegenerative disorders like Alzheimer's disease (AD) and Dementia with Lewy Bodies (DLB). This oral dosing is a significant differentiator in a space often reliant on infusions or less convenient regimens.

The mechanism is novel because it aims to protect synapses by interrupting the toxic effects of misfolded proteins. Specifically, zervimesine has been shown to interrupt the toxic effects of A$\beta$ and $\alpha$-synuclein, which are implicated in both AD and DLB pathology. The drug operates through interaction with the sigma-2 receptor, a mechanism functionally distinct from many other approaches currently in development for these diseases.

For Alzheimer's disease, the value proposition is sharpened by a predictive biomarker strategy. Cognition Therapeutics has data suggesting that the drug's benefit is most pronounced in patients with lower baseline levels of the protein p-tau217, which is measurable via a simple blood test. This enrichment strategy is key for future registrational trials, as it targets patients most likely to show a robust treatment effect.

Here is a snapshot of the key clinical performance metrics supporting this value proposition:

Indication/Study	Patient Subgroup	Endpoint/Measure	Observed Effect vs. Placebo
Alzheimer's Disease (Phase 2 SHINE)	Overall Population	Slowing of Cognitive Decline	38%
Alzheimer's Disease (Phase 2 SHINE)	Lower Plasma p-tau217 Levels	Slowing of Cognitive Decline (ADAS-Cog11)	95%
Dementia with Lewy Bodies (Phase 2 SHIMMER)	Overall DLB Patients (6 months)	Improvement on Neuropsychiatric Inventory (NPI-12)	Average of 86% better
Dry Age-Related Macular Degeneration (Phase 2)	Overall Population (18 months)	Reduction of Geographic Atrophy (GA) Lesion Growth	28.6%

The company is actively advancing the DLB indication, having initiated an Expanded Access Program (EAP) for patients with DLB. Furthermore, as of the third quarter of 2025, Cognition Therapeutics was anticipating an FDA decision on breakthrough designation for zervimesine in DLB in the third quarter 2025.

To support this pipeline momentum, Cognition Therapeutics completed a $30 million registered direct offering in the third quarter of 2025. Financially, as of September 30, 2025, the company reported cash, cash equivalents, and restricted cash of approximately $39.8 million, supplemented by $36.3 million in remaining obligated grant funds from the National Institute on Aging. This position allowed the company to estimate sufficient cash to fund operations into the second quarter of 2027.

The AD program is also progressing with a large trial. The Phase 2 START Study, testing zervimesine in mild cognitive impairment (MCI) or early AD, surpassed 75% enrollment as of September 2025, enrolling approximately 540 individuals.

You should track the following key elements:

• The FDA's decision on breakthrough designation for DLB, which was expected in Q3 2025.
• The expected readout timeline for the Phase 2 START study, which involves an 18-month treatment period.
• The company's cash burn rate, given the net loss for Q3 2025 was $4.9 million.
• The alignment achieved with the FDA on a registrational path for AD, which may require two six-month Phase 3 studies.

Cognition Therapeutics, Inc. (CGTX) - Canvas Business Model: Customer Relationships

You're looking at the relationships Cognition Therapeutics, Inc. (CGTX) builds with the key groups that drive its clinical and financial success. For a clinical-stage biotech, these aren't just customers; they are partners in development and validation.

Close collaboration with clinical investigators and academic sites

The execution of clinical trials relies heavily on strong ties with the medical community. Cognition Therapeutics, Inc. works closely with established consortia and specific investigators to run its studies on zervimesine (CT1812).

The Phase 2 START study, evaluating zervimesine in early Alzheimer's disease, is being conducted in partnership with colleagues at the Alzheimer's Clinical Trials Consortium (ACTC). As of September 3, 2025, this study had surpassed 75% enrollment of its target of about 540 participants. Full enrollment was announced by November 13, 2025.

For the Phase 2 SHIMMER study in dementia with Lewy bodies (DLB), the enrollment breakdown showed significant engagement:

Study Arm	Number of Participants Randomized
Zervimesine Treatment Arms (100 mg or 300 mg daily)	88
Placebo Arm	42
Total Enrolled (SHIMMER)	130

Key investigators involved in these programs include Dr. James E. Galvin of the University of Miami Miller School of Medicine and Dr. Lawrence S. Honig of Columbia University Irving Medical Center.

High-touch engagement with regulatory bodies (FDA, EMA)

Engagement with the U.S. Food and Drug Administration (FDA) is critical for defining the path to market. Cognition Therapeutics, Inc. has secured key agreements that shape its near-term development strategy.

The company achieved alignment with the FDA on a registrational path in Alzheimer's disease following a productive end-of-Phase 2 meeting on July 9, 2025. This agreement suggests that two six-month Phase 3 studies, with participants randomized 1:1 to receive either 100 mg of oral zervimesine or placebo daily, may be sufficient to support a New Drug Application (NDA) filing.

For the DLB indication, the company is pursuing similar input. The FDA has accepted a request for a Type C meeting, scheduled for the second half of January 2026, to discuss the proposed Phase 3 program design for zervimesine in DLB patients.

The high-touch regulatory interaction extends globally, as Cognition Therapeutics, Inc. is planning a scientific advice meeting with the European Medicines Agency (EMA) in February 2026 to align its global Alzheimer's disease registrational plans.

Expanded Access Program (EAP) for DLB patients

The Expanded Access Program (EAP), designated COG1202, provides access to zervimesine for eligible patients with mild-to-moderate DLB outside of a formal trial setting. This program demonstrates a commitment to patients with high unmet need.

The program reached full enrollment as of December 3, 2025, completing enrollment in just three months. The EAP was made possible through a generous philanthropic donation from the family of a former Phase 2 SHIMMER participant.

• Treatment regimen: 100 mg of oral zervimesine daily for up to one year.
• Initial plan targeted approximately 30 patients.
• The program onboarded three clinical sites as of Q2 2025, with the first of eight total sites being Banner Sun Health Research Institute in Arizona.

Investor relations and capital market communications

Maintaining strong relationships with capital providers is essential for funding the late-stage clinical development required for a registrational program. Cognition Therapeutics, Inc. actively engaged the capital markets in 2025.

On September 2, 2025, the Company closed a $30 million registered direct offering, which involved the sale of 14,700,000 shares of common stock to institutional investors. This capital infusion provided significant runway extension.

Key financial and investor metrics as of late 2025:

Metric	Value/Date
Market Capitalization (as of Dec 3, 2025)	$142 million
Cash, Cash Equivalents, Restricted Cash (as of Sep 30, 2025)	Approx. $39.8 million
Estimated Cash Runway (as of Sep 30, 2025)	Into the second quarter of 2027
Total Obligated Grant Funds Remaining (as of Sep 30, 2025)	$36.3 million (from NIA)

Investor engagement included participation in the 37th Annual Piper Sandler Healthcare Conference from December 2-4, 2025.

Cognition Therapeutics, Inc. (CGTX) - Canvas Business Model: Channels

You're looking at how Cognition Therapeutics, Inc. (CGTX) gets its science and its potential product, zervimesine (CT1812), out to the world-from the lab bench to the potential patient and the institutional investor. This is all about execution and communication channels for a clinical-stage company.

Global network of clinical trial sites and research institutions

The core of the channel strategy revolves around clinical execution. You can't get to an NDA without running high-quality trials, and that requires a network. The Phase 2 START Study, which is testing zervimesine in mild cognitive impairment (MCI) or early Alzheimer's disease, is a prime example of this channel in action.

This study is being run in collaboration with the Alzheimer's Clinical Trials Consortium (ACTC). That consortium is an NIA-funded clinical trial network comprising 35 leading academic sites specializing in Alzheimer's disease trials. It's a powerful channel for recruitment and site management. The ACTC partnership is key, especially since the START Study is supported by an $81 million grant from the National Institute on Aging (NIA) at the National Institutes of Health. The company reached its target enrollment of 540 participants in this Phase 2 study as of November 13, 2025. To be fair, the previous Phase 2 SHINE study was smaller, enrolling 153 adults with mild-to-moderate Alzheimer's disease, but the START enrollment shows scaling in this channel.

Here's a quick look at the scale of their clinical channel activity through late 2025:

Trial/Program	Target Indication	Enrollment Status (as of late 2025)	Key Collaborator/Network
Phase 2 START Study	Early Alzheimer's Disease (MCI/early AD)	Target enrollment of 540 participants reached (Nov 13, 2025)	Alzheimer's Clinical Trials Consortium (ACTC)
Phase 3 Registrational Program	Mild-to-Moderate Alzheimer's Disease	Design agreed upon with FDA; planning two six-month studies	U.S. FDA (via July 2025 EOP2 meeting)
Expanded Access Program (EAP)	Dementia with Lewy Bodies (DLB)	Full enrollment reached (Dec 3, 2025)	Various clinical sites/donors

Regulatory submissions (NDA) to the U.S. FDA and other agencies

The regulatory pathway is the most critical channel for commercialization. Cognition Therapeutics, Inc. has made significant strides here. They completed an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) on July 9, 2025, for their Alzheimer's program. The outcome was a clear channel to market: the FDA confirmed that the proposed Phase 3 design could support a New Drug Application (NDA) filing for zervimesine as an Alzheimer's treatment. This framework relies on two six-month Phase 3 trials using enrichment for patients with lower plasma p-tau217 levels. Also, they applied to the FDA for breakthrough designation for zervimesine in DLB, with an expected decision in the third quarter of 2025. For global alignment, they plan an EMA scientific advice meeting in February 2026.

Scientific and medical conferences (e.g., CTAD) for data dissemination

Disseminating data effectively is how Cognition Therapeutics builds credibility with clinicians and researchers, which, in turn, drives investigator interest and patient enrollment. They actively use major medical meetings as a primary channel.

The most recent, and perhaps most important, dissemination event was presenting the Phase 3 registrational plan at the Clinical Trials on Alzheimer's Disease (CTAD) conference on December 1, 2025, in San Diego, CA. Earlier in 2025, results from the Phase 2 SHIMMER study in DLB were presented at the Alzheimer's Association International Congress (AAIC) on July 29th in Toronto, Canada. This conference activity directly fueled enrollment acceleration in the START study, with approximately 50% of the entire study population enrolled during the last six months of 2025.

The key data dissemination channels include:

• Presenting Phase 3 plan at CTAD (December 1, 2025).
• Presenting Phase 2 DLB data at AAIC (July 29, 2025).
• Participation in the 37th Annual Piper Sandler Healthcare Conference (December 2-4, 2025).
• Live presentation by the CEO at the Life Sciences Virtual Investor Conference (March 13, 2025).

Investor roadshows and direct communication with institutional investors

Securing capital is a crucial channel for a clinical-stage company. Cognition Therapeutics, Inc. actively engaged institutional investors throughout 2025. A major event was closing a $30 Million Registered Direct Offering on September 2, 2025, which involved two new fundamental institutional investors, including a preeminent global investment firm. This capital supports the planned Phase 3 development. Furthermore, the President and CEO, Lisa Ricciardi, delivered a live presentation at the Life Sciences Virtual Investor Conference on March 13, 2025, at 9:30 a.m. ET. This direct engagement channel helps manage expectations and secure necessary funding, as evidenced by the $30 million raised in September. Finance: draft 13-week cash view by Friday.

Cognition Therapeutics, Inc. (CGTX) - Canvas Business Model: Customer Segments

You're looking at the specific groups Cognition Therapeutics, Inc. (CGTX) targets with its investigational drug zervimesine, which is key for understanding their near-term commercial focus and investor appeal.

Patients with early Alzheimer's disease (MCI/mild AD)

This segment represents a massive, underserved population where Cognition Therapeutics, Inc. (CGTX) is actively pursuing development with its lead candidate, zervimesine (CT1812). The company's Phase 2 START Study specifically targets this group, aiming for early intervention.

• Estimated 7.2 million Americans aged 65+ living with Alzheimer's dementia as of 2025.
• Approximately 1.9 million of those cases are in the 65 to 74 year age bracket, aligning with the early-stage focus.
• The Phase 2 START Study is targeting 540 participants.
• In a survey, 92% of Americans indicated they would take a treatment that could slow disease progression.

The company also completed Phase 2 studies for mild-to-moderate Alzheimer's disease via the SHINE trial.

Patients with Dementia with Lewy Bodies (DLB)

Cognition Therapeutics, Inc. (CGTX) is also focused on DLB, evidenced by the recent completion of enrollment in an expanded access program for zervimesine in this patient group. This shows a commitment to a distinct neurodegenerative indication.

• The expanded access program enrolled eligible patients to receive 100 mg of oral zervimesine daily for up to one year.
• The company has a scheduled Type C meeting with the FDA in the second half of January to discuss the proposed design for a Phase 3 program in DLB patients.

Clinical investigators and neurologists specializing in neurodegeneration

These professionals are crucial for trial execution, site selection, and ultimately, adoption of the therapy. Cognition Therapeutics, Inc. (CGTX) is actively engaged with key opinion leaders in the field.

Here's a look at the key personnel and funding sources involved in their clinical efforts:

Role/Affiliation	Involvement/Detail	Associated Study/Program
Dr. James E. Galvin, MD, MPH	Lead investigator for the multi-center, open-label program.	DLB Expanded Access Program
Dr. Lawrence S. Honig	Investigator in the expanded access program.	DLB Expanded Access Program
National Institute of Aging (NIA)	Provided grant support for the Phase 2 START study.	Phase 2 START Study (Early AD)
Alzheimer's Clinical Trials Consortium	Collaboration partner for the START study.	Phase 2 START Study (Early AD)

Institutional investors and public equity markets

The public market and institutional holders are the primary source of capital for this clinical-stage biopharma. Recent trading activity shows significant interest, though the company is operating under a tight cash runway.

Here are the key financial and ownership metrics as of late 2025:

Metric	Value/Amount	Date/Context
Market Capitalization	About $158.9M	As of December 5, 2025
Institutional Ownership Percentage	28.9%	As of September 2025 filings
Estimated Cash Runway	Into the second quarter of 2026	As of Q2 2025 results
Largest Institutional Holder (Shares)	6.00Mn shares (BIOS Capital Management, LP)	As of September 30, 2025
Largest Institutional Holder (Percentage)	8.17% of outstanding stock	BIOS Capital Management, LP
Q3 2025 Stake Increase (Vanguard)	105.6% increase	Vanguard Group Inc.
Q3 2025 New Stake Value (Davenport)	$3,631,000	DAVENPORT & Co LLC
Consensus Analyst Price Target (Average)	$3.33	Twelve-month forecast
Analyst Consensus Rating	Moderate Buy	Based on 5 analysts

You can see institutional buying was strong in Q3 2025, with BlackRock, Inc. adding 891,844 shares, representing a 1160.4% increase in their position for that quarter. Still, the company's cash position as of June 30, 2025, was approximately $11.6 million, supplemented by $41.9 million in remaining NIA grant funds.

Cognition Therapeutics, Inc. (CGTX) - Canvas Business Model: Cost Structure

You're looking at the core expenses for Cognition Therapeutics, Inc. (CGTX) as they push zervimesine through later-stage development. For a clinical-stage biotech, the cost structure is heavily weighted toward the science, not selling products-that's the reality of this business phase.

The primary driver for Cognition Therapeutics, Inc. (CGTX) cost structure is Research and Development (R&D) expenses. This reflects the ongoing investment in clinical trials and preclinical work for their pipeline, especially zervimesine (CT1812).

Here's a quick look at the key operating expenses reported for the third quarter ended September 30, 2025:

Expense Category	Q3 2025 Amount (in millions)	Q3 2024 Amount (in millions)
Research and Development (R&D)	$3.8	$11.4
General and Administrative (G&A)	$2.6	$3.1
Total Operating Expenses	$6.38	$14.46

R&D expenses were reported at $3.8 million for Q3 2025. This figure represented a significant year-over-year decrease from $11.4 million in Q3 2024, driven by the completion of the SHINE and SHIMMER clinical trials and associated professional fees.

General and Administrative (G&A) expenses were $2.6 million for Q3 2025. That was down from $3.1 million in the comparable period of 2024, primarily due to lower stock-based compensation expenses.

Beyond the reported operating expenses, the cost structure necessarily includes other significant, though perhaps less granularly detailed in every release, expenditures essential for a company advancing drug candidates:

• Costs for manufacturing drug supply for clinical trials, ensuring sufficient quantities of zervimesine are available for ongoing and planned studies, including the registrational path programs.
• Regulatory compliance costs, which cover filings, interactions with the U.S. FDA, and adherence to global health authority requirements.
• Intellectual property maintenance costs, which are critical for securing and defending the patents around their novel small molecule therapeutics.

The net loss for the quarter ended September 30, 2025, was $4.9 million, or $(0.06) per basic and diluted share. This loss was significantly narrower than the net loss of $9.9 million, or $(0.25) per share, for Q3 2024, reflecting the lower operating expenses as major trials concluded.

Finance: draft 13-week cash view by Friday.

Cognition Therapeutics, Inc. (CGTX) - Canvas Business Model: Revenue Streams

You're hiring before product-market fit, which means Cognition Therapeutics, Inc.'s revenue streams are entirely non-commercial right now. The business model relies heavily on non-dilutive government funding and dilutive equity raises to keep the lights on while advancing zervimesine (CT1812) through clinical trials. Honestly, this is standard for a clinical-stage biotech, but you need to track the cash burn against these inflows.

The primary, non-dilutive source of operational support comes from the National Institute on Aging (NIA), a division of the National Institutes of Health (NIH). This grant income directly offsets operating expenses, though the draw-down rate can fluctuate.

• Grant income recognized from the National Institute on Aging (NIA/NIH) for the third quarter ended September 30, 2025, was $1.2 million.
• As of September 30, 2025, the total obligated grant funds remaining from the NIA/NIH stood at $36.3 million.

To bridge the gap between grant receipts and the high costs of late-stage clinical development, Cognition Therapeutics, Inc. turned to equity financing. They successfully executed a significant capital raise in the third quarter of 2025.

Here's the quick math on that equity event:

Financing Event Detail	Amount/Value
Gross Proceeds from Registered Direct Offering	Approximately $30 million
Shares Sold	14,700,000 shares of common stock
Purchase Price Per Share	$2.05
Closing Date	September 2, 2025

This $30 million registered direct offering, which closed in September 2025, was crucial; it extended the company's estimated cash runway into the second quarter of 2027.

The third component of the revenue stream structure involves external partnerships, though these are prospective rather than realized income streams as of late 2025. Cognition Therapeutics, Inc. is actively evaluating options to support the development of zervimesine through strategic collaborations.

• Potential future milestone payments from strategic pharmaceutical licensing deals remain a key component of the long-term financial plan.
• The company is executing studies to support registrational programs, which are expected to be valuable to potential partners.

It is critical to note the current commercial status. Cognition Therapeutics, Inc. is a clinical-stage company; therefore, there is no current commercial product revenue.

• No top-line sales contribution is recognized; the model remains dependent on grants and capital markets.