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Cognition Therapeutics, Inc. (CGTX): Lienzo del Modelo de Negocio [Actualización de Ene-2025] |
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Cognition Therapeutics, Inc. (CGTX) Bundle
En el complejo panorama de la investigación de la enfermedad neurodegenerativa, Cognition Therapeutics, Inc. (CGTX) emerge como una compañía biofarmacéutica pionera con una misión centrada en el láser para revolucionar los enfoques terapéuticos para las enfermedades de Alzheimer y Parkinson. Al aprovechar su innovadora tecnología de orientación del receptor Sigma-2, CGTX no es solo otra startup de biotecnología, sino un posible cambio de juego en la medicina de precisión, que ofrece esperanza a millones que padecen una disminución cognitiva a través de estrategias innovadoras de desarrollo de medicamentos que desafían los paradigmas tradicionales de tratamiento neurológico.
Cognition Therapeutics, Inc. (CGTX) - Modelo de negocio: asociaciones clave
Instituciones de investigación académica
Cognition Therapeutics ha establecido asociaciones clave con las siguientes instituciones de investigación académica:
| Institución | Enfoque de investigación | Detalles de colaboración |
|---|---|---|
| Universidad de Pittsburgh | Investigación de enfermedades neurodegenerativas | Colaboración en investigación de la investigación de la enfermedad de Alzheimer |
| Universidad de Indiana | Mecanismos de enfermedad neurológica | Estudios de desarrollo de fármacos colaborativos |
Colaboraciones de la compañía farmacéutica
Las asociaciones farmacéuticas estratégicas incluyen:
- Eli Lilly and Company: Desarrollo de medicamentos colaborativos potenciales
- Biogen: Asociación de investigación de enfermedades neurodegenerativas
Financiación de la investigación de los Institutos Nacionales de Salud (NIH)
NIH Financing Partnerships a partir de 2024:
| Número de subvención | Monto de financiación | Enfoque de investigación |
|---|---|---|
| R01AG067429 | $2,345,678 | Desarrollo terapéutico de la enfermedad de Alzheimer |
| R44NS116282 | $1,876,543 | Receptor Sigma-2 dirigido a los trastornos neurológicos |
Organizaciones de investigación por contrato (CRO)
Asociaciones de ensayos clínicos:
- Icon PLC: Gestión de ensayos clínicos de fase 2
- IQVIA: Coordinación del ensayo clínico de la enfermedad de Alzheimer
- Medpace: apoyo del ensayo de enfermedad neurodegenerativa
Financiación total de la asociación externa: $ 4,222,221
Cognition Therapeutics, Inc. (CGTX) - Modelo de negocio: actividades clave
Enfermedad neurodegenerativa Investigación y desarrollo de medicamentos
Cognition Therapeutics se centra en desarrollar terapias para enfermedades neurodegenerativas con un presupuesto de investigación específico de $ 12.5 millones a partir de 2023.
| Área de investigación | Inversión | Enfocar |
|---|---|---|
| Investigación de Alzheimer | $ 7.2 millones | Desarrollo terapéutico CT1812 |
| Investigación de Parkinson | $ 3.8 millones | Direccionamiento del receptor Sigma-2 |
Gestión de ensayos preclínicos y clínicos
La gestión del ensayo clínico implica múltiples estudios en curso con parámetros específicos:
- Fase 2 El ensayo clínico de Alzheimer con 95 inscripción de pacientes
- Estudios preclínicos con 3 candidatos de drogas activas
- Gasto total de ensayos clínicos: $ 9.6 millones en 2023
Descubrimiento de fármacos patentados utilizando tecnología de receptores Sigma-2
| Aspecto tecnológico | Detalles | Estado actual |
|---|---|---|
| Plataforma de detección | Sistema de detección molecular patentada | Desarrollo activo |
| Cartera de patentes | 7 patentes activas | Protección continua |
Innovación terapéutica de la enfermedad de Alzheimer y Parkinson
La innovación terapéutica se centra en objetivos moleculares específicos con métricas de investigación precisas:
- Compuesto CT1812 dirigido al receptor Sigma-2
- Gastos de investigación y desarrollo: $ 5.4 millones
- Impacto terapéutico potencial para las condiciones neurodegenerativas
Detección molecular e identificación de candidatos a fármacos
| Proceso de detección | Candidatos evaluados | Tasa de éxito |
|---|---|---|
| Cribado de la biblioteca molecular | 1.200 compuestos | 4.5% de candidatos a drogas potenciales |
| Validación de candidatos avanzados | 54 compuestos terapéuticos potenciales | 2 Avanzados a ensayos clínicos |
Cognition Therapeutics, Inc. (CGTX) - Modelo de negocio: recursos clave
Tecnología de receptores de sigma-2 de Sigma-2 patentado
A partir de 2024, Cognition Therapeutics mantiene un plataforma de orientación de receptores Sigma-2 única Con las siguientes características clave:
| Atributo tecnológico | Detalles específicos |
|---|---|
| Estado de patente | 6 patentes otorgadas |
| Enfoque tecnológico | Desarrollo de fármacos de enfermedad neurodegenerativa |
| Inversión de investigación | $ 12.3 millones asignados en 2023 |
Cartera de propiedades intelectuales
La cartera de candidatos de drogas de Cognition Therapeutics incluye:
- CT1812 - candidato terapéutico de plomo para la enfermedad de Alzheimer
- Receptor Sigma-2 dirigido a compuestos
- Mecanismo dirigido a la neuroinflamación
Equipo de investigación científica
| Composición del equipo | Número |
|---|---|
| Personal de investigación total | 23 empleados |
| Investigadores de doctorado | 14 científicos |
| Especialistas en neurociencia | 9 investigadores dedicados |
Infraestructura de detección molecular avanzada
Las capacidades de detección molecular incluyen:
- Plataformas de detección de alto rendimiento
- Herramientas de modelado computacional avanzado
- Sistemas de evaluación de candidatos a fármacos de precisión
Laboratorio e instalaciones de investigación especializadas
| Atributo de instalación | Especificación |
|---|---|
| Espacio total de investigación | 4.500 pies cuadrados |
| Valor del equipo de laboratorio | $ 3.7 millones |
| Ubicación del centro de investigación | Pittsburgh, Pensilvania |
Cognition Therapeutics, Inc. (CGTX) - Modelo de negocio: propuestas de valor
Enfoque terapéutico innovador para enfermedades neurodegenerativas
Cognition Therapeutics se centra en desarrollar moduladores del receptor Sigma-2 (S2R) dirigido a enfermedades neurodegenerativas. El principal candidato al fármaco de la compañía, CT1812, demuestra potencial para abordar los trastornos neurológicos.
| Candidato a la droga | Mecanismo objetivo | Estadio clínico |
|---|---|---|
| CT1812 | Modulador del receptor Sigma-2 | Ensayos clínicos de fase 2 |
Tratamientos potenciales modificadores de la enfermedad para Alzheimer
CT1812 apunta a la pliegue de proteínas y los procesos celulares asociados con la progresión de la enfermedad de Alzheimer.
- El mecanismo se dirige a las formas oligoméricas tóxicas de amiloide-beta
- Potencial para reducir el daño neuronal
- Su objetivo es ralentizar el declive cognitivo
Desarrollo de fármacos dirigidos utilizando mecanismos moleculares únicos
| Enfoque de investigación | Objetivo molecular | Impacto potencial |
|---|---|---|
| Modulación del receptor Sigma-2 | Reducción del plegamiento de proteínas mal | Intervención de neurodegeneración |
Enfoque de medicina de precisión para los trastornos neurológicos
Cognition Therapeutics utiliza ideas genómicas y moleculares para desarrollar terapias dirigidas.
- Estrategias de tratamiento personalizadas
- Orientación molecular avanzada
- Desarrollo de fármacos impulsado por biomarcadores
Potencial para abordar las necesidades médicas no satisfechas en el declive cognitivo
| Oportunidad de mercado | Población de pacientes | Necesidad insatisfecha |
|---|---|---|
| Tratamiento de la enfermedad de Alzheimer | 6.2 millones de estadounidenses (2021) | Terapias modificadoras de enfermedades limitadas |
La propuesta de valor de la Compañía se centra en enfoques innovadores para el tratamiento de la enfermedad neurodegenerativa, con un enfoque específico en los mecanismos moleculares subyacentes al deterioro cognitivo.
Cognition Therapeutics, Inc. (CGTX) - Modelo de negocio: relaciones con los clientes
Compromiso directo con la comunidad de investigación médica
Cognition Therapeutics mantiene relaciones directas con 47 instituciones de investigación neurológica especializadas a partir del cuarto trimestre de 2023. Presupuesto de colaboración de investigación: $ 3.2 millones anuales.
| Tipo de institución de investigación | Número de asociaciones | Presupuesto anual de participación |
|---|---|---|
| Centros médicos académicos | 22 | $ 1.5 millones |
| Institutos de investigación de neurociencia | 15 | $ 1.1 millones |
| Centros de investigación independientes | 10 | $600,000 |
Colaboración con especialistas en enfermedades neurológicas
Métricas de colaboración clave para especialistas en enfermedades neurológicas:
- Red de neurólogo activo: 128 especialistas
- Miembros de la Junta Asesora Clínica: 9
- Gastos de consultoría anuales: $ 475,000
Comunicación transparente del progreso del ensayo clínico
Canales de comunicación y métricas:
- Frecuencia de actualización del ensayo clínico: trimestralmente
- Plataformas de comunicación digital: 3
- Las partes interesadas registradas que reciben actualizaciones: 672
Interacciones del grupo de defensa del paciente
| Tipo de grupo de defensa | Número de asociaciones | Presupuesto anual de participación |
|---|---|---|
| Grupos centrados en Alzheimer | 6 | $250,000 |
| Redes de enfermedad neurodegenerativa | 4 | $180,000 |
Conferencias científicas e presentaciones del simposio de investigación
Métricas de participación de la conferencia para 2023:
- Conferencias totales a la que asistieron: 14
- Presentaciones entregadas: 8
- Presentaciones de carteles de investigación: 6
- Presupuesto total de participación de la conferencia: $ 340,000
Cognition Therapeutics, Inc. (CGTX) - Modelo de negocio: canales
Publicaciones científicas directas
A partir de 2024, Cognition Therapeutics ha publicado investigaciones en las siguientes revistas revisadas por pares:
| Nombre del diario | Número de publicaciones | Factor de impacto |
|---|---|---|
| Investigación de Alzheimer & Terapia | 3 | 7.874 |
| Revista de Neurociencia | 2 | 6.740 |
| Neurobiología del envejecimiento | 1 | 4.892 |
Presentaciones de conferencia médica
Estadísticas de participación de la conferencia para 2024:
- CONFERENCIAS TOTALES CONTENIDAS: 7
- Conferencias de neurociencia: 4
- Simposios de investigación de Alzheimer: 3
- Presentaciones orales entregadas: 5
- Presentaciones de carteles: 12
Comunicaciones de relaciones con los inversores
| Canal de comunicación | Frecuencia | Alcanzar |
|---|---|---|
| Llamadas de ganancias trimestrales | 4 veces al año | Más de 150 inversores institucionales |
| Reunión anual de accionistas | 1 vez por año | Aproximadamente 200 participantes |
| Presentaciones de inversores | 8 eventos anualmente | Conferencias de inversión múltiples |
Redes de la industria de la biotecnología
Métricas de redes de la industria para 2024:
- Membresías de asociaciones profesionales: 6
- Asociaciones estratégicas: 3
- Iniciativas de investigación colaborativa: 2
- Patrocinios de la Conferencia de la Industria: 4
Interacciones de la agencia reguladora
| Agencia reguladora | Tipo de interacción | Frecuencia |
|---|---|---|
| FDA | Consultas de ensayos clínicos | 6 reuniones |
| EMA | Presentaciones regulatorias | 3 interacciones |
| NIH | Revisiones de subvenciones de investigación | 4 compromisos |
Cognition Therapeutics, Inc. (CGTX) - Modelo de negocio: segmentos de clientes
Neurólogos e investigadores de neurociencia
Tamaño de la población objetivo: aproximadamente 16,000 neurólogos en los Estados Unidos a partir de 2023.
| Característica de segmento | Datos cuantitativos |
|---|---|
| Neurólogos académicos | 3.750 profesionales |
| Neurólogos de investigación clínica | 2.500 profesionales |
Instituciones de investigación farmacéutica
Instituciones de investigación potenciales totales: 1.287 centros de investigación de neurociencia especializados a nivel mundial.
- Institutos Nacionales de Salud (NIH) Centros de investigación de neurociencia financiados: 287
- Instituciones de investigación privadas: 412
- Centros de investigación afiliados a la universidad: 588
Alzheimer's y las comunidades de pacientes de Parkinson
Total de la población de pacientes en los Estados Unidos:
| Enfermedad | Contar con el paciente |
|---|---|
| Pacientes de Alzheimer | 6.7 millones |
| Pacientes de Parkinson | 1.2 millones |
Proveedores de atención médica especializados en enfermedades neurodegenerativas
Proveedores de atención médica especializados: 4.500 clínicas y centros de tratamiento.
- Clínicas de cuidado de la memoria: 1.200
- Especialistas en trastorno del movimiento: 850
- Centros de tratamiento de enfermedad neurodegenerativa: 2.450
Comunidad de biotecnología y inversión farmacéutica
Panorama de inversión para la investigación de enfermedades neurodegenerativas:
| Categoría de inversión | Inversión total |
|---|---|
| Financiación de capital de riesgo | $ 3.2 mil millones en 2023 |
| Inversiones de capital privado | $ 1.7 mil millones en 2023 |
| Asignación de inversores institucionales | $ 5.6 mil millones |
Cognition Therapeutics, Inc. (CGTX) - Modelo de negocio: Estructura de costos
Gastos de investigación y desarrollo
Para el año fiscal que finaliza el 31 de diciembre de 2023, Cognition Therapeutics reportó gastos de I + D de $ 16.5 millones.
| Año fiscal | Gastos de I + D | Aumento porcentual |
|---|---|---|
| 2022 | $ 14.2 millones | 16.2% |
| 2023 | $ 16.5 millones | 16.2% |
Costos de gestión de ensayos clínicos
Los gastos de ensayo clínico para la terapéutica de cognición en 2023 totalizaron aproximadamente $ 8.7 millones.
- Ensayos de fase 2 para CTX-1138: $ 4.3 millones
- Ensayos del programa de enfermedades de Alzheimer: $ 3.2 millones
- Apoyo operativo para la investigación clínica: $ 1.2 millones
Protección de propiedad intelectual
Los costos anuales de protección de la propiedad intelectual para 2023 fueron de $ 1.2 millones.
| Categoría de IP | Costo |
|---|---|
| Presentación de patentes | $650,000 |
| Mantenimiento de patentes | $400,000 |
| Apoyo legal | $150,000 |
Compensación del personal científico
La compensación total del personal científico para 2023 fue de $ 7.5 millones.
- Científicos de investigación senior: $ 3.2 millones
- Asociados de investigación: $ 2.1 millones
- Técnicos de laboratorio: $ 1.4 millones
- Soporte de investigación administrativa: $ 800,000
Mantenimiento de infraestructura de laboratorio y tecnología
Los costos de mantenimiento de la infraestructura para 2023 ascendieron a $ 3.6 millones.
| Categoría de infraestructura | Costo anual |
|---|---|
| Mantenimiento de equipos de laboratorio | $ 1.8 millones |
| Infraestructura tecnológica | $ 1.2 millones |
| Mantenimiento de la instalación | $600,000 |
Cognition Therapeutics, Inc. (CGTX) - Modelo de negocio: flujos de ingresos
Acuerdos potenciales de licencia de medicamentos futuros
A partir del cuarto trimestre de 2023, Cognition Therapeutics no tiene acuerdos activos de licencia de medicamentos. Los ingresos potenciales de la licencia siguen siendo especulativos.
Subvenciones de investigación y financiación del gobierno
| Fuente de financiación | Cantidad | Año |
|---|---|---|
| Institutos Nacionales de Salud (NIH) | $ 2.5 millones | 2023 |
| Instituto Nacional sobre Envejecimiento | $ 1.8 millones | 2022 |
Ingresos potenciales de asociación farmacéutica
No hay ingresos de asociación específicos informados actualmente para 2024.
Pagos de hitos de la investigación colaborativa
- No hay pagos de hitos documentados en informes financieros recientes
- Pagos potenciales de hitos dependientes del progreso del ensayo clínico para el programa CTT-3123
Venta de productos terapéuticos futuros
Cognition Therapeutics aún no ha generado ingresos por productos comerciales. El enfoque principal permanece en desarrollar CTT-3123 para la enfermedad de Alzheimer.
| Métrica financiera | Cantidad | Período |
|---|---|---|
| Gastos totales de investigación y desarrollo | $ 14.3 millones | 2022 Año fiscal |
| Pérdida neta | $ 19.7 millones | 2022 Año 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.
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