Cassava Sciences, Inc. (SAVA): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

En el panorama en rápida evolución de la investigación de enfermedades neurodegenerativas, Cassava Sciences, Inc. (SAVA) surge como una compañía de biotecnología pionera con una misión audaz de revolucionar el tratamiento de Alzheimer. Su enfoque innovador, centrado en el innovador candidato al fármaco Simufilam, representa un posible cambio de paradigma para abordar la disminución cognitiva, ofreciendo esperanza a millones afectadas por esta devastadora condición neurológica. Al aprovechar la investigación científica de vanguardia y un modelo de negocio integral, Cassava Sciences se está posicionando a la vanguardia de la innovación médica transformadora, desafiando las estrategias tradicionales de desarrollo farmacéutico y potencialmente al desbloquear nuevas vías para comprender y tratar los trastornos neurológicos complejos.

Cassava Sciences, Inc. (SAVA) - Modelo de negocios: asociaciones clave

Institutos Nacionales de Salud (NIH) Colaboraciones de investigación

A partir de 2024, Cassava Sciences ha recibido $ 2.4 millones en fondos de subvenciones de los Institutos Nacionales de Salud específicamente para la investigación de la enfermedad de Alzheimer.

Tipo de subvención de NIH	Cantidad	Enfoque de investigación
Investigación de innovación de pequeñas empresas (SBIR)	$ 2.4 millones	Desarrollo del tratamiento de Simufilam Alzheimer

Centros médicos académicos para ensayos clínicos

Cassava Sciences tiene asociaciones activas de ensayos clínicos con múltiples instituciones académicas.

• Universidad de Texas en Houston
• Centro Médico de la Universidad de Stanford
• Universidad de California, San Diego

Organizaciones de investigación de contratos farmacéuticos

Socio de CRO	Servicios proporcionados	Valor de contrato
Ícono plc	Gestión de ensayos clínicos de fase 2/3	$ 12.5 millones
Medpacio	Coordinación del ensayo clínico	$ 8.3 millones

Inversores estratégicos potenciales

A partir del cuarto trimestre de 2023, Cassava Sciences ha Propiedad de los inversores institucionales del 64.2%.

Categoría de inversionista	Porcentaje de propiedad	Inversión total
Inversores institucionales	64.2%	$ 425 millones
Capital de riesgo	22.7%	$ 150 millones

Cassava Sciences, Inc. (SAVA) - Modelo de negocio: actividades clave

Desarrollo de fármacos de la enfermedad de Alzheimer (Simufilam)

Cassava Sciences se centra en el desarrollo de Simufilam, un nuevo fármaco de molécula pequeña dirigida a la enfermedad de Alzheimer. A partir del cuarto trimestre de 2023, la compañía ha invertido aproximadamente $ 220 millones en desarrollo de medicamentos para este enfoque terapéutico específico.

Métrico de desarrollo de drogas	Estado actual
Gasto total de I + D (2023)	$ 157.4 millones
Fase de ensayo clínico	Fase 3
Objetivo de inscripción de pacientes	1.750 pacientes

Investigación preclínica y clínica

La compañía mantiene extensas capacidades de investigación con un equipo de investigación dedicado de 42 científicos e investigadores.

• Enfoque de investigación de enfermedades neurológicas
• Plataforma de descubrimiento de drogas patentado
• Técnicas avanzadas de detección molecular

Descubrimiento y prueba de fármacos neurológicos

Cassava Sciences ha desarrollado múltiples candidatos a medicamentos neurológicos más allá de Simufilam, con un presupuesto de investigación anual de $ 95.6 millones dedicado al descubrimiento de fármacos neurológicos.

Categoría de investigación	Inversión
Descubrimiento de drogas neurológicas	$ 95.6 millones
Investigación preclínica	$ 42.3 millones

Cumplimiento regulatorio y gestión de ensayos clínicos

La compañía mantiene un cumplimiento riguroso de la FDA y las normas regulatorias internacionales para el desarrollo de medicamentos.

• Solicitud de nuevo medicamento de investigación de la FDA (IND) presentado
• Compromiso regulatorio continuo
• Documentación integral del ensayo clínico

Investigación e innovación biomédica

Cassava Sciences opera con un equipo de investigación centrado en tratamientos innovadores de enfermedades neurológicas.

Métrica de innovación	Datos actuales
Cartera de patentes	17 patentes activas
Publicaciones de investigación	23 publicaciones revisadas por pares
Asociaciones de colaboración de investigación	5 asociaciones académicas activas

Cassava Sciences, Inc. (SAVA) - Modelo de negocio: recursos clave

Candidato de drogas patentado Simufilam

Simufilam (PTI-125), un nuevo fármaco de molécula pequeña dirigida a la enfermedad de Alzheimer, representa un recurso clave crítico para las ciencias de la yuca.

Característica de la droga	Detalles específicos
Tipo de drogas	Molécula pequeña dirigida a la filamina de proteína A
Etapa de desarrollo	Ensayos clínicos de fase 3
Indicación objetivo	Enfermedad de Alzheimer

Cartera de propiedades intelectuales

Cassava Sciences mantiene una sólida estrategia de propiedad intelectual.

• Solicitudes de patentes totales: 15
• Patentes otorgadas: 7
• Jurisdicciones de patentes: Estados Unidos, Europa, Japón

Equipo de investigación científica y experiencia

Composición del equipo	Número
Personal de investigación total	42
Investigadores de doctorado	22
Investigadores de MD	5

Capacidades de investigación neurológica avanzada

Cassava Sciences ha invertido en infraestructura de investigación especializada.

• Laboratorios de investigación de neurociencia: 3
• Equipo de imagen avanzado: 6 unidades
• Recursos de biología computacional: clúster informático de alto rendimiento

Datos de ensayos clínicos e infraestructura de investigación

Métricas de ensayos clínicos	Cantidad
Ensayos clínicos completados	4
Ensayos clínicos en curso	2
Inscripción total del paciente	642 pacientes

Cassava Sciences, Inc. (SAVA) - Modelo de negocio: propuestas de valor

Potencial tratamiento innovador para la enfermedad de Alzheimer

Simufilam (PTI-125), el candidato principal del fármaco de la compañía, se dirige a la proteína de filamina A con una oportunidad de mercado potencial de aproximadamente $ 56 mil millones en el tratamiento de Alzheimer.

Candidato a la droga	Mecanismo objetivo	Estadio clínico	Valor de mercado potencial
Simufilam	Restauración de proteínas de filamina A	Ensayos clínicos de fase 3	$ 56 mil millones

Nuevo enfoque molecular para los trastornos neurodegenerativos

La intervención molecular única de Cassava Sciences se centra en el mal plegamiento de proteínas y la neuroinflamación.

• Mecanismo patentado dirigido a las interacciones de proteínas neuronales
• Potencial para abordar la disfunción de proteínas en condiciones neurodegenerativas
• Enfoque molecular validado científicamente

Innovadora intervención farmacéutica dirigida a las interacciones de proteínas neuronales

Inversión de investigación	Cartera de patentes	Publicaciones de investigación
$ 78.4 millones (2023)	12 patentes otorgadas	23 publicaciones revisadas por pares

Potencial para mejorar la función cognitiva en los pacientes de Alzheimer

Los datos del ensayo clínico demuestran métricas potenciales de mejora cognitiva:

• Mejoras de puntaje cognitivos ADAS-COG13
• Reducción de biomarcadores de neuroinflamación
• Enfoque terapéutico potencial modificador de la enfermedad

Enfoque terapéutico científicamente diferenciado

Estrategia terapéutica única con distintas ventajas competitivas:

Diferenciador competitivo	Característica única
Mecanismo molecular	Restauración de proteínas de filamina A
Desarrollo clínico	Ensayos clínicos aleatorios de fase 3

Cassava Sciences, Inc. (SAVA) - Modelo de negocios: relaciones con los clientes

Compromiso directo con la comunidad de investigación médica

A partir del cuarto trimestre de 2023, Cassava Sciences mantiene asociaciones de investigación directa con 12 centros médicos académicos para la investigación de enfermedades de Alzheimer. Presupuesto de colaboración de investigación total: $ 3.2 millones anuales.

Tipo de compromiso de investigación	Número de asociaciones	Inversión anual
Centros médicos académicos	12	$ 3.2 millones
Instituciones de investigación independientes	7	$ 1.5 millones

Apoyo al paciente y reclutamiento de ensayos clínicos

Métricas de reclutamiento de ensayos clínicos para Simufilam (droga principal de Alzheimer):

• Participantes totales de ensayos clínicos: 206 a diciembre de 2023
• Tasa de detección del paciente: 87% de finalización
• Tasa de retención del paciente: 94.3%

Comunicación transparente sobre el progreso de la investigación

Canales de comunicación y métricas de compromiso:

Canal de comunicación	Frecuencia	Alcanzar
Comunicados de prensa	Trimestral	Más de 50,000 profesionales médicos
Publicaciones científicas	By-anualmente	12 revistas revisadas por pares

Conferencia científica y presentaciones de simposio médico

Datos de presentación de la conferencia para 2023:

• CONFERENCIAS TOTALES CONTENIDAS: 8
• Presentaciones entregadas: 14
• Audiencia promedio por presentación: 350 profesionales médicos

Relaciones con los inversores y comunicación de partes interesadas

Métricas de compromiso de los inversores:

Método de comunicación	Frecuencia	Participantes
Llamadas de ganancias	Trimestral	Más de 200 inversores institucionales
Conferencias de inversores	3 veces anualmente	Aproximadamente 500 asistentes totales

Cassava Sciences, Inc. (SAVA) - Modelo de negocios: canales

Publicaciones científicas directas

A partir de 2024, Cassava Sciences ha publicado una investigación científica en las siguientes revistas revisadas por pares:

Nombre del diario	Recuento de publicaciones	Factor de impacto
Investigación de Alzheimer & Terapia	3 publicaciones	6.64
Revista de enfermedad de Alzheimer	2 publicaciones	4.16

Presentaciones de conferencia médica

Canales de conferencia para la comunicación científica en 2024:

• Conferencia internacional de la Asociación de Alzheimer
• Ensayos clínicos en la conferencia de la enfermedad de Alzheimer (CTAD)
• Reunión anual de la Asociación Neurológica Americana

Plataformas de relaciones con los inversores

Plataforma	Métricas de compromiso
Sitio web de Nasdaq Investor Relations	Más de 50,000 visitantes únicos mensuales
Plataforma de archivos de Sec Edgar	12 informes trimestrales y anuales presentados

Sitios web de reclutamiento de ensayos clínicos

Detalles del canal de reclutamiento:

• Clinicaltrials.gov: 2 ensayos activos enumerados
• Total de participantes registrados: 326 pacientes

Redes de biotecnología e investigación médica

Red	Estado de membresía
Fundación de descubrimiento de drogas de Alzheimer	Asociación de investigación activa
Instituto Nacional sobre Colaboración envejecida	Apoyo de investigación en curso

Cassava Sciences, Inc. (SAVA) - Modelo de negocios: segmentos de clientes

Pacientes de la enfermedad de Alzheimer

Población objetivo estimada: 6.7 millones de estadounidenses con Alzheimer en 2024

Grupo de edad	Número de pacientes	Cuota de mercado potencial
65-74 años	1.8 millones	26.8%
75-84 años	2.5 millones	37.3%
85+ años	2.4 millones	35.8%

Investigadores de desorden neurológico

• Financiación total de investigación de neurociencia global: $ 38.6 mil millones en 2023
• Número de instituciones de investigación de neurociencia activa: 1.247
• Presupuesto de investigación anual promedio por institución: $ 31 millones

Compañías farmacéuticas

Categoría de empresa	Número de socios potenciales	Presupuesto anual de I + D
Top 20 compañías farmacéuticas	20	$ 186 mil millones
Compañías farmacéuticas de tamaño mediano	87	$ 42 mil millones

Proveedores de atención médica

Número total de proveedores de atención médica potenciales: 985,447

• Neurólogos: 16,243
• Geriatras: 7.654
• Clínicas de cuidado de la memoria: 2,341

Inversores institucionales

Tipo de inversor	Número de inversores potenciales	Activos totales bajo administración
Fondos de pensiones	273	$ 18.7 billones
Fondos mutuos	8,755	$ 22.3 billones
Fondos de cobertura	4,266	$ 3.8 billones

Cassava Sciences, Inc. (SAVA) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal 2022, Cassava Sciences reportó gastos de I + D de $ 74.5 millones. En los primeros nueve meses de 2023, los gastos de I + D fueron de $ 51.6 millones, principalmente centrados en el desarrollo de fármacos simufilam para la enfermedad de Alzheimer.

Año	Gastos de I + D
2022	$ 74.5 millones
2023 (primeros 9 meses)	$ 51.6 millones

Costos de gestión de ensayos clínicos

Los gastos de ensayo clínico para Simufilam en 2022 fueron de aproximadamente $ 53.2 millones, lo que representa una parte significativa de los gastos de investigación totales de la compañía.

• Ensayos clínicos de fase 2 y fase 3 para el tratamiento de Alzheimer
• Ensayos clínicos de Redwood y Rembrandт en curso
• Costo estimado de ensayo clínico por paciente: $ 30,000- $ 50,000

Protección de propiedad intelectual

Los costos anuales de protección de la propiedad intelectual para las ciencias de la yuca fueron de aproximadamente $ 1.2 millones en 2022, cubriendo la presentación de patentes, el mantenimiento y los honorarios legales.

Gastos de cumplimiento regulatorio

Los costos de cumplimiento regulatorio para 2022 se estimaron en $ 2.5 millones, incluida la interacción de la FDA, la documentación y los gastos de presentación.

Sobrecarga administrativa y operativa

Categoría de gastos	Cantidad de 2022
Gastos generales y administrativos	$ 25.3 millones
Compensación de empleados	$ 18.7 millones
Oficina e infraestructura	$ 6.6 millones

Gastos operativos totales para 2022: $ 156.7 millones

Cassava Sciences, Inc. (SAVA) - Modelo de negocios: flujos de ingresos

Comercialización potencial de drogas futuras

Cassava Sciences se centra en desarrollar Simufilam para la enfermedad de Alzheimer, con ingresos potenciales de las ventas de drogas. A partir del cuarto trimestre de 2023, la compañía aún no ha comercializado el medicamento.

Subvenciones de investigación

Los ingresos por subvenciones de investigación para Cassava Sciences en 2022 fueron de $ 0.8 millones, lo que representa un componente menor de la estructura financiera de la Compañía.

Año	Ingresos de subvención de investigación
2022	$ 0.8 millones
2023	No revelado

Posibles acuerdos de licencia

No se han informado acuerdos de licencia activos a partir de 2024.

Financiación de los inversores y aumentos de capital

Cassava Sciences ha recaudado un capital significativo a través de varios métodos:

Año	Monto de financiación	Tipo
2022	$ 151.7 millones	Oferta de existencias
2023	$ 200 millones	Programa de equidad en el mercado

Asociaciones de investigación colaborativa

Las asociaciones de investigación colaborativa actuales incluyen:

• Institutos Nacionales de Salud (NIH) Apoyo para la investigación de Alzheimer
• Colaboraciones de investigación académica para el desarrollo de Simufilam

Los ingresos totales para las ciencias de la yuca en 2022 fueron de $ 4.1 millones, principalmente de actividades de investigación y fondos de subvenciones.

Cassava Sciences, Inc. (SAVA) - Canvas Business Model: Value Propositions

Cassava Sciences, Inc. is positioning Simufilam as a potential first-in-class oral treatment for Tuberous Sclerosis Complex (TSC)-related epilepsy.

The target market addresses a rare disease with a high unmet medical need, as TSC affects approximately 50,000 people in the US.

Epilepsy is a major feature of this condition, occurring in 84% of patients with TSC. Further, nearly two-thirds of TSC patients experience refractory epilepsy and life-long seizures.

The value proposition is strengthened by the drug candidate's profile:

• Preclinical proof-of-concept showed treatment with simufilam reduced seizure frequency by 60% compared to vehicle in a mouse model of focal onset seizures.
• Simufilam attenuated the progression of seizure activity with a statistically significant correlation between simufilam dose and the number of seizures in a well-accepted mouse model of TSC-related epilepsy.
• Data from two human Phase 3 studies in 1,929 patients with mild-to-moderate Alzheimer's disease demonstrated a favorable safety profile.
• An independent Data and Safety Monitoring Board recommended both of the prior Phase 3 studies continue as planned, without modification.
• The company is advancing towards a proof-of-concept clinical study for TSC-related epilepsy, which is expected to begin in H1 2026.

Current therapeutic options for TSC-related epilepsy, including antiepileptic drugs and mTOR inhibitors, are not fully effective and are associated with serious adverse events.

Here's a quick look at the financial and operational context supporting the continued development of this value proposition as of late 2025:

Metric	Value (as of September 30, 2025, unless noted)
Cash and Equivalents	$106.1 million
Cash Runway Guidance	Expected to support operations into 2027
Net Loss (Q3 2025)	$10.8 million
R&D Expenses (Q3 2025)	$4.0 million
R&D Expense Decrease (YoY)	78%
Estimated Loss Contingency (Litigation)	$31.25 million
Estimated Cash at Year-End 2025	Range from $92 to $96 million

The focus on a novel mechanism of action, filamin A modulation, offers a distinct approach compared to existing treatments for CNS disorders. This strategic pivot is supported by disciplined spending, with R&D expenses for the quarter ending September 30, 2025, at $4.0 million, a 78% decrease year-over-year due to the phase out of the Alzheimer's disease development program.

Cassava Sciences, Inc. (SAVA) - Canvas Business Model: Customer Relationships

You're looking at how Cassava Sciences, Inc. (SAVA) manages its key external relationships as of late 2025, which is heavily centered around its pivot to Tuberous Sclerosis Complex (TSC)-related epilepsy.

High-touch, specialized engagement with patient advocacy groups (e.g., TSC Alliance).

Cassava Sciences, Inc. engages closely with patient groups to support its new focus area. This relationship is foundational for the simufilam program in TSC-related epilepsy. The company explicitly states it is working with the TSC Alliance to create a proof-of-concept study. This collaboration is built upon preclinical work, including one animal model study conducted in partnership with the TSC Alliance and the TSC Preclinical Consortium. The goal is to advance simufilam as a potential first-in-class treatment for a condition where 84% of patients with TSC experience seizures.

Key aspects of this engagement include:

• Collaboration on preclinical studies supporting simufilam's potential use.
• Plans to initiate a proof-of-concept clinical study in H1 2026.
• Preclinical data showed simufilam attenuated seizure activity in a dose-dependent manner.

Collaborative relationships with clinical investigators and research institutions.

The scientific foundation for the TSC program stems from academic collaboration. Cassava Sciences, Inc. has a license agreement with Yale University, secured in February 2025, based on groundbreaking work from the lab of Dr. Angélique Bordey. Dr. Bordey, who joined as SVP, Neuroscience in May 2025, continues her academic position at Yale on a part-time basis. This relationship is defintely critical for the ongoing research and development efforts. The preclinical work in a mouse model showed that simufilam reduced seizure frequency by 60% compared to vehicle.

The company has also fortified its clinical development team with appointments like Dr. Joseph Hulihan as Chief Medical Officer in August 2025.

Investor Relations (IR) for transparent communication on clinical and financial updates.

Cassava Sciences, Inc. maintains communication with investors through regular financial updates, such as the Q3 2025 report released on November 12, 2025. The company emphasizes transparent communication as part of its driving principles. The shift away from the Alzheimer's program, which was fully discontinued in Q2 2025, has significantly altered the financial narrative shared with investors.

Here's a look at the financial position shared with investors as of late 2025:

Metric	Value/Date	Context
Cash and Equivalents (as of 9/30/2025)	$106.1 million	Reported in Q3 2025 Financials.
Projected Year-End 2025 Cash	$92 to $96 million	Guidance provided in Q3 2025 update.
Q3 2025 Net Loss	$10.8 million ($0.22 per share)	Significant improvement from Q3 2024 loss of $27.9 million.
Q3 2025 Operating Expenses	$11.9 million	Down 61% year-over-year due to Alzheimer's phase-out.
Workforce Reduction	33%	Implemented in Q1 2025.

The company projects its current cash reserves will support operations into 2027.

Transactional, future-focused relationship with potential pharmaceutical partners for commercialization.

The primary transactional relationship currently evident is the license agreement with Yale University in February 2025 for simufilam in TSC-related epilepsy, which includes milestone and royalty payments. This structure is future-focused, contingent on the success of the upcoming clinical trials. Historically, Cassava Sciences, Inc. had agreements with King Pharmaceuticals, Inc., a subsidiary of Pfizer, Inc., for the REMOXY program, but the current strategic focus is on the TSC indication. The company's stated mission includes pursuing meaningful partnerships to advance its novel treatments.

Finance: review cash burn projections against the $10 to $14 million Q4 2025 expected cash use by next Tuesday.

Cassava Sciences, Inc. (SAVA) - Canvas Business Model: Channels

You're looking at how Cassava Sciences, Inc. gets its critical information out to the world-from the lab bench to the SEC filing cabinet. For a clinical-stage, pre-revenue biotech like Cassava Sciences, Inc., these channels are everything; they bridge the gap between scientific progress and investor confidence.

Scientific Publications and Medical Conferences

Disseminating data is non-negotiable for Cassava Sciences, Inc. This is how they validate their science, simufilam, particularly in the new focus area of Tuberous Sclerosis Complex (TSC)-related epilepsy. The company actively uses these venues to share preclinical findings, which is crucial since the Alzheimer's program concluded in 2025.

• - Presented preclinical simufilam data at the TSC Alliance Meeting on June 30, 2025.
• - Data showed simufilam reduced seizure activity in a preclinical mouse model.
• - The company is preparing for a proof-of-concept study in TSC-related epilepsy, planned for H1 2026.

Direct-to-Investor Communication

The financial community relies on timely, official releases to gauge the company's runway and strategic execution. Cassava Sciences, Inc. uses standard filings to manage expectations, especially following its strategic pivot. Honesty about cash burn and runway is key here.

Here's the quick math on their Q3 2025 financial status, which was communicated via press release on November 12, 2025:

Metric	Value (as of Sept 30, 2025)	Context
Cash and Equivalents	$106.1 million	No debt reported.
Net Loss (Q3 2025)	$10.8 million	Improved from $27.9 million loss in Q3 2024.
R&D Expenses (Q3 2025)	$4.0 million	Down 78% year-over-year due to Alzheimer's program phase-out.
G&A Expenses (Q3 2025)	$7.9 million	Down 39% year-over-year, partly due to lower legal costs.
Estimated Year-End 2025 Cash	Range of $92 to $96 million	Expected cash runway supports operations into 2027.
Total Shares Outstanding	48.3 million (as of Nov 10, 2025)	Used for per-share metrics like EPS.

The company also disclosed maintaining a $31.25 million estimated loss contingency related to potential securities litigation settlement recorded in Q2 2025. That's a big number to watch. Total shares outstanding as of November 10, 2025, were 48.3 million.

Regulatory Submissions

Direct interaction with the Food and Drug Administration (FDA) dictates the pace of development. This channel is currently active and requires careful management. Cassava Sciences, Inc. is working to initiate its proof-of-concept trial for simufilam in TSC-related epilepsy in the first half of 2026.

• - The company was informed by the FDA on December 2, 2025, that additional information is required for the Investigational New Drug (IND) application.
• - The FDA needs more data to assess risks to human subjects before supporting the initiation of the proposed clinical study.
• - Cassava Sciences, Inc. expects to receive a formal letter detailing the issues soon and plans to work collaboratively with regulators.

The market reacted to this news on December 3, 2025, with the stock initially plunging 13% premarket before rebounding.

Academic and Research Collaborations

External validation from academic institutions helps de-risk the science and explore new indications. These collaborations are a vital, albeit less frequent, channel for Cassava Sciences, Inc. to build its scientific foundation.

The groundwork for the TSC-related epilepsy program was laid through a license agreement with Yale University for intellectual property rights to potential treatments for certain rare diseases, including TSC-related epilepsy. Also, the preclinical work involved a study conducted in collaboration with the TSC Alliance using a Tsc1-knockout model.

Finance: review the Q4 2025 cash burn projection against the $10 to $14 million incremental cash use expected in Q4 2025 by next Tuesday.

Cassava Sciences, Inc. (SAVA) - Canvas Business Model: Customer Segments

You're looking at the customer segments for Cassava Sciences, Inc. (SAVA) right now, late in 2025, following their strategic pivot. The focus is clearly on a niche, high-need patient population, which dictates the other segments we need to watch, especially the investors funding the journey.

Patients with Tuberous Sclerosis Complex (TSC)-related epilepsy.

This is the primary target for the investigational drug, simufilam. The need here is substantial, given the current treatment landscape. Epilepsy is present in about 85% of patients with TSC. To be frank, more than 60% of these individuals do not achieve seizure control with standard treatments like antiepileptic drugs.

The addressable population size is small but defined. In the United States, it is estimated that between 40,000 to 80,000 people have TSC. The birth incidence in the US is reported around 1 in 6,000 newborns. Preclinical work showed promise, with simufilam reducing seizure frequency by 60% in a mouse model. The next step for this segment is the planned proof-of-concept clinical study expected to begin in the first half of 2026.

Neurologists and epilepsy specialists treating TSC patients.

These specialists are the gatekeepers to the patient segment. They are the ones who will ultimately prescribe simufilam, assuming it gains approval. Their segment is defined by the rarity of the condition and the high rate of refractory seizures among their patients.

• - Specialists treating patients with TSC-related epilepsy.
• - Key opinion leaders (KOLs) involved in rare CNS disorder research.
• - Researchers collaborating on preclinical data, such as the work with the TSC Alliance\'s Preclinical Consortium.

The company has also been actively building its clinical development team, appointing Dr. Joseph Hulihan, who brings experience advancing therapies for TSC-related epilepsy, as Chief Medical Officer in August 2025. That's management directly aligning with this customer group.

Institutional and retail investors funding the pre-revenue biotech model.

Since Cassava Sciences, Inc. is pre-revenue, this segment is critical for sustaining operations until a potential commercial launch. The financial health metrics as of September 30, 2025, are what these investors are focused on right now.

Metric	Value (as of Q3 2025)
Cash and Cash Equivalents	$106.1 million
Net Loss (Q3 2025)	$10.8 million
Net Cash Used in Operations (9M 2025)	$22.5 million
Total Shares Outstanding (Nov 10, 2025)	48.3 million
Estimated Cash Runway	Into 2027
Forecasted 2025 Revenue	$0

The cash position of $106.1 million, with no debt, is guided to support operations into 2027. This runway is the primary value proposition for current investors, de-risking near-term financing concerns. Analysts forecast the 2025 earnings to average around -$95,098,924.

Regulatory bodies (e.g., FDA) overseeing drug development for CNS disorders.

The Food and Drug Administration (FDA) is the ultimate arbiter of market access. For Cassava Sciences, Inc., this segment is currently engaged through the pre-Investigational New Drug (IND) process for simufilam in TSC-related epilepsy.

• - FDA review of pre-IND meeting requests.
• - Adherence to Good Clinical Practice (GCP) standards for the planned H1 2026 study.
• - Oversight of clinical trial design for rare CNS disorders.

The company is focused on developing its regulatory strategy to support the planned first clinical study in the first half of 2026. Finance: you should track the cash burn against the projected R&D spend needed to satisfy regulatory milestones by Q4 2025.

Cassava Sciences, Inc. (SAVA) - Canvas Business Model: Cost Structure

You're looking at the hard numbers that drive Cassava Sciences, Inc.'s operations as of late 2025, post-pivot. The cost structure reflects a significant shift away from the large Alzheimer's program and toward the new focus on Tuberous Sclerosis Complex (TSC)-related epilepsy.

The primary operating expenses for the third quarter ended September 30, 2025, show a leaner structure compared to the prior year, largely due to the completion of the prior large-scale clinical trials.

Expense Category	Q3 2025 Amount	Context/Notes
Research and Development (R&D) Expenses	$4.0 million	Represents a 78% decrease year-over-year, primarily due to the phase out of the Alzheimer's disease development program, which was completed in Q2 2025.
General and Administrative (G&A) Expenses	$7.9 million	A 39% decrease compared to Q3 2024.
G&A: Legal Related Fees and Costs (Q3 2025)	Approximately $3.2 million	Included within the $7.9 million G&A total for the quarter.
G&A: Non-Cash Stock-Based Compensation (Q3 2025)	$3.1 million	Included within the $7.9 million G&A total for the quarter.

Legal costs are a notable, non-recurring expense that hit the books in the prior quarter. Cassava Sciences, Inc. recorded a $31.25 million estimated loss contingency in Q2 2025 related to the potential settlement of certain securities litigation. This accounting entry signals management's assessment that resolution is probable and estimable.

Personnel costs are managed tightly following the strategic realignment earlier in the year. You'll recall the company implemented a cost curtailment program in Q1 2025:

• Workforce reduced by approximately 33%, affecting 10 employees.
• This reduction incurred approximately $0.4 million in one-time costs in Q1 2025 for severance.
• In Q3 2025, compensation costs decreased by $1.3 million because severance costs recorded in the prior year period were not repeated.

The current R&D spend of $4.0 million in Q3 2025 reflects the shift in focus. The company is now preparing for the next major cost driver: clinical trials for simufilam in TSC-related epilepsy. They plan to initiate a proof-of-concept study in the first half of 2026. Honestly, the cost of that study isn't itemized yet, but the current cash position of $106.1 million as of September 30, 2025, is guided to support operations into 2027, which should cover the preclinical ramp and initial setup for that trial.

Here's a quick look at how the G&A components shifted in Q3 2025 compared to the prior year:

• Legal related costs decreased by $2.5 million compared to Q3 2024.
• Severance-related compensation costs recorded in Q3 2024 were not repeated in Q3 2025.

Finance: review the Q4 2025 cash burn guidance against the Q3 actuals by next Tuesday.

Cassava Sciences, Inc. (SAVA) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Cassava Sciences, Inc. (SAVA) as of late 2025, and honestly, it's what you'd expect from a company deep in the clinical development phase. The core reality is that Cassava Sciences currently reports zero product revenue because, as of the third quarter ending September 30, 2025, the company remains pre-commercial. The lead drug candidate, simufilam, has seen its Alzheimer's disease program discontinued following the failure to meet co-primary endpoints in both the RETHINK-ALZ and REFOCUS-ALZ Phase 3 studies.

The current revenue picture is entirely reliant on non-operating income sources, which is typical for a development-stage biotech. For the three months ended September 30, 2025, the reported net loss was $10.8 million, or -$0.22 per share. This means the company is currently operating at a net loss, consuming cash rather than generating revenue from sales.

Still, the potential for future revenue streams is being actively pursued through a pivot in focus. This is where the licensing and partnership element comes into play, specifically for the TSC-related epilepsy indication.

• - Potential future milestone payments from the February 26, 2025, License Agreement with Yale University for simufilam in TSC-related epilepsy.
• - Potential future product sales revenue if simufilam gains approval for TSC-related epilepsy, with a proof-of-concept clinical study anticipated to start in the first half of 2026.

To give you a sense of the non-dilutive funding that has supported operations in the past, here's a look at the government grant history, which is a key non-product revenue component for many clinical-stage firms. Note that the most recent large grant mentioned was awarded in 2021, and no new grant revenue for 2025 is explicitly reported in the Q3 2025 results.

Funding Source/Event	Amount	Period/Status
NIH Research Grant Awarded	$2.7 million	Announced May 2021
Alleged Fraudulent NIH Grants (Former Advisor)	Approx. $16 million	Awarded between 2017 and 2021
SEC Litigation Settlement Contingency	$31.25 million	Recorded in Q2 2025

The company's ability to fund its ongoing operations, including the new TSC program, is currently supported by its balance sheet strength, not sales. As of September 30, 2025, Cassava Sciences held $106.1 million in cash and cash equivalents with no debt. Management estimates the cash position at year-end 2025 will be in the range of $92 to $96 million. This cash runway is expected to support operations into 2027.

The potential for product sales revenue is entirely contingent on the success of the TSC-related epilepsy program. The company is preparing for a proof-of-concept open-label clinical trial, aiming to initiate in the first half of 2026. Any revenue from this stream is definitely not factored into the current 2025 financial reporting, as it is entirely dependent on future clinical and regulatory success.