Cassava Sciences, Inc. (SAVA): Modelo de negócios Canvas [Jan-2025 Atualizado]

Na paisagem em rápida evolução da pesquisa de doenças neurodegenerativas, a Cassava Sciences, Inc. (SAVA) surge como uma empresa pioneira de biotecnologia com uma missão ousada para revolucionar o tratamento de Alzheimer. Sua abordagem inovadora, centrada em torno do inovador candidato a drogas, Simufilam, representa uma potencial mudança de paradigma na abordagem do declínio cognitivo, oferecendo esperança para milhões afetados por essa condição neurológica devastadora. Ao alavancar pesquisas científicas de ponta e um modelo de negócios abrangente, a Cassava Sciences está se posicionando na vanguarda da inovação médica transformadora, desafiando estratégias tradicionais de desenvolvimento farmacêutico e potencialmente desbloqueando novos caminhos para entender e tratar distúrbios neurológicos complexos.

Cassava Sciences, Inc. (SAVA) - Modelo de negócios: Parcerias -chave

Colaborações de pesquisa do National Institutes of Health (NIH)

A partir de 2024, a Cassava Sciences recebeu US $ 2,4 milhões em financiamento dos Institutos Nacionais de Saúde especificamente para a pesquisa de doenças de Alzheimer.

NIH Tipo de concessão	Quantia	Foco na pesquisa
Pesquisa de Inovação em Pequenas Empresas (SBIR)	US $ 2,4 milhões	Desenvolvimento de tratamento de Simufilam Alzheimer

Centros Médicos Acadêmicos para Ensaios Clínicos

A Cassava Sciences possui parcerias de ensaios clínicos ativos com várias instituições acadêmicas.

• Universidade do Texas em Houston
• Centro Médico da Universidade de Stanford
• Universidade da Califórnia, San Diego

Organizações de pesquisa de contratos farmacêuticos

CRO Parceiro	Serviços prestados	Valor do contrato
Icon plc	Fase 2/3 de gerenciamento de ensaios clínicos	US $ 12,5 milhões
Medpace	Coordenação do ensaio clínico	US $ 8,3 milhões

Potenciais investidores estratégicos

A partir do quarto trimestre 2023, a Cassava Sciences tem Propriedade institucional do investidor de 64,2%.

Categoria de investidores	Porcentagem de propriedade	Investimento total
Investidores institucionais	64.2%	US $ 425 milhões
Capital de risco	22.7%	US $ 150 milhões

Cassava Sciences, Inc. (SAVA) - Modelo de negócios: Atividades -chave

Desenvolvimento de medicamentos para doença de Alzheimer (Simufilam)

A Cassava Sciences se concentra no desenvolvimento de Simufilam, um novo medicamento para pequenas moléculas direcionadas à doença de Alzheimer. A partir do quarto trimestre de 2023, a empresa investiu aproximadamente US $ 220 milhões em desenvolvimento de medicamentos para essa abordagem terapêutica específica.

Métrica de Desenvolvimento de Medicamentos	Status atual
Despesas totais de P&D (2023)	US $ 157,4 milhões
Fase de ensaios clínicos	Fase 3
Alvo de inscrição do paciente	1.750 pacientes

Pesquisa pré -clínica e clínica

A empresa mantém extensos recursos de pesquisa com uma equipe de pesquisa dedicada de 42 cientistas e pesquisadores.

• Foco da pesquisa em doenças neurológicas
• Plataforma proprietária de descoberta de medicamentos
• Técnicas avançadas de triagem molecular

Descoberta e teste de medicamentos neurológicos

A Cassava Sciences desenvolveu vários candidatos a drogas neurológicas além da Simufilam, com um orçamento anual de pesquisa de US $ 95,6 milhões dedicado à descoberta de medicamentos neurológicos.

Categoria de pesquisa	Investimento
Descoberta neurológica de medicamentos	US $ 95,6 milhões
Pesquisa pré -clínica	US $ 42,3 milhões

Conformidade regulatória e gerenciamento de ensaios clínicos

A empresa mantém a rigorosa conformidade com os padrões regulatórios internacionais e o desenvolvimento de medicamentos.

• FDA Investigational New Drug (IND) Pedido apresentado
• Engajamento regulatório contínuo
• Documentação abrangente do ensaio clínico

Pesquisa biomédica e inovação

A Cassava Sciences opera com uma equipe de pesquisa focada em tratamentos inovadores de doenças neurológicas.

Métrica de inovação	Dados atuais
Portfólio de patentes	17 patentes ativas
Publicações de pesquisa	23 publicações revisadas por pares
Parcerias de colaboração de pesquisa	5 parcerias acadêmicas ativas

Cassava Sciences, Inc. (SAVA) - Modelo de negócios: Recursos -chave

Candidato a drogas proprietário Simufilam

Simufilam (PTI-125), um novo medicamento para pequenas moléculas direcionadas à doença de Alzheimer, representa um recurso-chave crítico para as ciências da mandioca.

Característica da droga	Detalhes específicos
Tipo de droga	Pequenas moléculas direcionadas proteína filamina A
Estágio de desenvolvimento	Ensaios clínicos de fase 3
Indicação alvo	Doença de Alzheimer

Portfólio de propriedade intelectual

A Cassava Sciences mantém uma robusta estratégia de propriedade intelectual.

• Total de pedidos de patente: 15
• Patentes concedidas: 7
• Jurisdições de patentes: Estados Unidos, Europa, Japão

Equipe de pesquisa científica e experiência

Composição da equipe	Número
Pessoal de pesquisa total	42
Pesquisadores de doutorado	22
Pesquisadores de MD	5

Capacidades avançadas de pesquisa neurológica

A Cassava Sciences investiu em infraestrutura de pesquisa especializada.

• Laboratórios de Pesquisa em Neurociência: 3
• Equipamento de imagem avançado: 6 unidades
• Recursos de biologia computacional: cluster de computação de alto desempenho

Dados de ensaios clínicos e infraestrutura de pesquisa

Métricas de ensaio clínico	Quantidade
Ensaios clínicos concluídos	4
Ensaios clínicos em andamento	2
Inscrição total do paciente	642 pacientes

Cassava Sciences, Inc. (SAVA) - Modelo de negócios: proposições de valor

Tratamento potencial inovador para a doença de Alzheimer

Simufilam (PTI-125), o principal candidato a medicamentos da empresa, tem como alvo a proteína Filamin A com uma potencial oportunidade de mercado de aproximadamente US $ 56 bilhões no tratamento de Alzheimer.

Candidato a drogas	Mecanismo de destino	Estágio clínico	Valor potencial de mercado
Simufilam	Filamin a Restauração de proteínas	Ensaios clínicos de fase 3	US $ 56 bilhões

Nova abordagem molecular para distúrbios neurodegenerativos

A intervenção molecular exclusiva da Cassava Sciences se concentra no desdobramento de proteínas e na neuroinflamação.

• Mecanismo proprietário direcionando interações de proteínas neurais
• Potencial para lidar com a disfunção proteica em condições neurodegenerativas
• Abordagem molecular validada cientificamente

Intervenção farmacêutica inovadora direcionada às interações proteicas neurais

Investimento em pesquisa	Portfólio de patentes	Publicações de pesquisa
US $ 78,4 milhões (2023)	12 patentes concedidas	23 publicações revisadas por pares

Potencial para melhorar a função cognitiva nos pacientes de Alzheimer

Os dados de ensaios clínicos demonstram potenciais métricas de melhoria cognitiva:

• Melhorias de pontuação cognitiva do ADAS-COG13
• Reduções de biomarcadores de neuroinflamação
• Abordagem terapêutica potencial modificadora da doença

Abordagem terapêutica cientificamente diferenciada

Estratégia terapêutica única com vantagens competitivas distintas:

Diferenciador competitivo	Característica única
Mecanismo molecular	Filamin a Restauração de proteínas
Desenvolvimento Clínico	Fase 3 Ensaios clínicos randomizados

Cassava Sciences, Inc. (SAVA) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento direto com a comunidade de pesquisa médica

A partir do quarto trimestre de 2023, a Cassava Sciences mantém parcerias diretas de pesquisa com 12 centros médicos acadêmicos para a pesquisa de doenças de Alzheimer. Orçamento total de colaboração de pesquisa: US $ 3,2 milhões anualmente.

Tipo de engajamento da pesquisa	Número de parcerias	Investimento anual
Centros Médicos Acadêmicos	12	US $ 3,2 milhões
Instituições de pesquisa independentes	7	US $ 1,5 milhão

Suporte ao paciente e recrutamento de ensaios clínicos

Métricas de recrutamento de ensaios clínicos para simufilam (droga de chumbo Alzheimer):

• TOTAL DE ENTRADOS Clínicos Participantes: 206 Em dezembro de 2023
• Taxa de triagem do paciente: 87% de conclusão
• Taxa de retenção de pacientes: 94,3%

Comunicação transparente sobre o progresso da pesquisa

Canais de comunicação e métricas de engajamento:

Canal de comunicação	Freqüência	Alcançar
Comunicados de imprensa	Trimestral	Mais de 50.000 profissionais médicos
Publicações científicas	Bi-semestralmente	12 periódicos revisados ​​por pares

Apresentações de Conferência Científica e Simpósio Médico

Dados de apresentação da conferência para 2023:

• Total de conferências participadas: 8
• Apresentações entregues: 14
• Audiência média por apresentação: 350 profissionais médicos

Relações com investidores e comunicação das partes interessadas

Métricas de engajamento do investidor:

Método de comunicação	Freqüência	Participantes
Chamadas de ganhos	Trimestral	Mais de 200 investidores institucionais
Conferências de investidores	3 vezes anualmente	Aproximadamente 500 participantes no total

Cassava Sciences, Inc. (SAVA) - Modelo de negócios: canais

Publicações científicas diretas

A partir de 2024, a Cassava Sciences publicou pesquisas científicas nos seguintes periódicos revisados ​​por pares:

Nome do diário	Contagem de publicação	Fator de impacto
Pesquisa de Alzheimer & Terapia	3 publicações	6.64
Jornal da doença de Alzheimer	2 publicações	4.16

Apresentações da conferência médica

Canais de conferência para comunicação científica em 2024:

• Conferência Internacional da Associação de Alzheimer
• Ensaios Clínicos na Conferência de Doença de Alzheimer (CTAD)
• Reunião Anual da Associação Neurológica Americana

Plataformas de relações com investidores

Plataforma	Métricas de engajamento
Site de relações com investidores da NASDAQ	Mais de 50.000 visitantes únicos mensais
Plataforma de arquivamento da SEC Edgar	12 relatórios trimestrais e anuais arquivados

Sites de recrutamento de ensaios clínicos

Detalhes do canal de recrutamento:

• ClinicalTrials.gov: 2 ensaios ativos listados
• Total de participantes registrados: 326 pacientes

Redes de biotecnologia e pesquisa médica

Rede	Status de associação
Alzheimer's Drug Discovery Foundation	Parceria de pesquisa ativa
Instituto Nacional de Colaboração de Envelhecimento	Apoio em andamento

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

Pacientes da doença de Alzheimer

População alvo estimada: 6,7 milhões de americanos com Alzheimer em 2024

Faixa etária	Número de pacientes	Participação de mercado potencial
65-74 anos	1,8 milhão	26.8%
75-84 anos	2,5 milhões	37.3%
85 anos ou mais	2,4 milhões	35.8%

Pesquisadores de transtorno neurológico

• Total Global Neuroscience Research Financiamento: US $ 38,6 bilhões em 2023
• Número de instituições de pesquisa de neurociência ativa: 1.247
• Orçamento médio de pesquisa anual por instituição: US $ 31 milhões

Empresas farmacêuticas

Categoria da empresa	Número de parceiros em potencial	Orçamento anual de P&D
20 principais empresas farmacêuticas	20	US $ 186 bilhões
Empresas farmacêuticas de tamanho médio	87	US $ 42 bilhões

Provedores de saúde

Número total de potenciais prestadores de serviços de saúde: 985.447

• Neurologistas: 16.243
• Geriatras: 7.654
• Clínicas de cuidados com a memória: 2.341

Investidores institucionais

Tipo de investidor	Número de investidores em potencial	Total de ativos sob gestão
Fundos de pensão	273	US $ 18,7 trilhões
Fundos mútuos	8,755	US $ 22,3 trilhões
Fundos de hedge	4,266	US $ 3,8 trilhões

Cassava Sciences, Inc. (SAVA) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2022, a Cassava Sciences reportou despesas de P&D de US $ 74,5 milhões. Nos primeiros nove meses de 2023, as despesas de P&D foram de US $ 51,6 milhões, focadas principalmente no desenvolvimento de medicamentos de simufilam para a doença de Alzheimer.

Ano	Despesas de P&D
2022	US $ 74,5 milhões
2023 (primeiros 9 meses)	US $ 51,6 milhões

Custos de gerenciamento de ensaios clínicos

As despesas de ensaios clínicos para o Simufilam em 2022 foram de aproximadamente US $ 53,2 milhões, representando uma parcela significativa das despesas totais de pesquisa da empresa.

• Ensaios clínicos de fase 2 e fase 3 para o tratamento de Alzheimer
• Ensaios clínicos em andamento de Redwood e Rembrandri
• Custo estimado do ensaio clínico por paciente: US $ 30.000 a US $ 50.000

Proteção à propriedade intelectual

Os custos anuais de proteção de propriedade intelectual para ciências da mandioca foram de aproximadamente US $ 1,2 milhão em 2022, cobrindo taxas, manutenção e honorários legais de patentes.

Despesas de conformidade regulatória

Os custos de conformidade regulatória para 2022 foram estimados em US $ 2,5 milhões, incluindo as despesas de interação, documentação e envio da FDA.

Overhead administrativo e operacional

Categoria de despesa	2022 quantidade
Despesas gerais e administrativas	US $ 25,3 milhões
Compensação dos funcionários	US $ 18,7 milhões
Escritório e infraestrutura	US $ 6,6 milhões

Despesas operacionais totais para 2022: US $ 156,7 milhões

Cassava Sciences, Inc. (SAVA) - Modelo de negócios: fluxos de receita

Potencial futura comercialização de medicamentos

A Cassava Sciences se concentra no desenvolvimento de simufilam para a doença de Alzheimer, com potencial receita com as vendas de medicamentos. A partir do quarto trimestre de 2023, a empresa ainda não comercializou o medicamento.

Bolsas de pesquisa

A receita de concessão de pesquisa para ciências da mandioca em 2022 foi de US $ 0,8 milhão, representando um componente menor da estrutura financeira da empresa.

Ano	Pesquisa concede receita
2022	US $ 0,8 milhão
2023	Não divulgado

Acordos de licenciamento em potencial

Nenhum contrato de licenciamento ativo foi relatado em 2024.

Financiamento para investidores e aumentos de capital

Cassava Sciences levantou capital significativo através de vários métodos:

Ano	Valor de financiamento	Tipo
2022	US $ 151,7 milhões	Oferta de ações
2023	US $ 200 milhões	Programa de ações no mercado

Parcerias de pesquisa colaborativa

As parcerias de pesquisa colaborativa atuais incluem:

• Apoio aos Institutos Nacionais de Saúde (NIH) à pesquisa de Alzheimer
• Colaborações de pesquisa acadêmica para desenvolvimento de simufilam

A receita total para as ciências da mandioca em 2022 foi de US $ 4,1 milhões, principalmente de atividades de pesquisa e financiamento.

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.