Annvis Bio, Inc. (ANVS): Modelo de negócios Canvas [Jan-2025 Atualizado]

Na paisagem em rápida evolução da pesquisa de doenças neurodegenerativas, a Annvis Bio, Inc. (ANVS) surge como uma força pioneira, exercendo um sofisticado modelo de negócios que promete revolucionar abordagens de tratamento para Alzheimer e Parkinson. Com um foco nítido em intervenções moleculares inovadoras e uma infraestrutura de pesquisa robusta, esta empresa de biotecnologia está estrategicamente posicionada para potencialmente transformar a maneira como entendemos e combate distúrbios neurológicos devastadores. Sua tela comercial meticulosamente criada revela uma estratégia abrangente que abrange o desenvolvimento de medicamentos de ponta, parcerias estratégicas e um compromisso de atender às necessidades médicas críticas não atendidas no ecossistema de tratamento neurológico.

Annisis Bio, Inc. (ANVS) - Modelo de negócios: Parcerias -chave

Colaborações com instituições de pesquisa acadêmica

Instituição	Foco na pesquisa	Status de colaboração
Universidade da Pensilvânia	Pesquisa de doenças neurodegenerativas	Parceria ativa
Universidade de Cornell	Estudos de Alzheimer e Parkinson	Colaboração de pesquisa em andamento

Redes de pesquisa e desenvolvimento farmacêuticos

Principais parcerias de rede de P&D:

• Michael J. Fox Foundation for Parkinson's Research
• Alzheimer's Drug Discovery Foundation
• Rede Colaborativa do Instituto Nacional de Envelhecimento (NIA)

Potenciais parcerias estratégicas com centros de tratamento de doenças neurodegenerativas

Centro de tratamento	Especialidade	Área de colaboração potencial
Departamento de Neurologia da Clínica Mayo	Distúrbios neurodegenerativos	Coordenação do ensaio clínico
Centro de Pesquisa de Johns Hopkins Alzheimer	Pesquisa de doença de Alzheimer	Apoio ao desenvolvimento de medicamentos

Organizações de pesquisa contratada (CROs) para ensaios clínicos

Parcerias CRO ativas:

• ICON PLC - Fase II/III de gerenciamento de ensaios clínicos
• Medpace - Coordenação do ensaio da doença neurodegenerativa
• IQVIA - Suporte global de pesquisa clínica

Estatísticas de parceria de ensaios clínicos:

Métrica	Valor
Total de parcerias CRO	3
Ensaios clínicos ativos	2
Orçamento anual de ensaio clínico	US $ 8,2 milhões

Annisis Bio, Inc. (ANVS) - Modelo de negócios: Atividades -chave

Pesquisa e desenvolvimento de medicamentos para doenças neurodegenerativas

Annvis Bio se concentra no desenvolvimento de ANVS401 para as doenças de Alzheimer e Parkinson. A partir do quarto trimestre de 2023, a empresa investiu US $ 12,3 milhões em despesas de pesquisa e desenvolvimento.

Foco na pesquisa	Valor do investimento	Estágio de pesquisa
Doença de Alzheimer	US $ 7,2 milhões	Ensaios clínicos de fase 2
Doença de Parkinson	US $ 5,1 milhões	Desenvolvimento pré -clínico

Gerenciamento de ensaios pré -clínicos e clínicos

A empresa conduziu vários ensaios clínicos com parâmetros específicos:

• Sites de ensaios clínicos totais: 15 nos Estados Unidos
• Inscrição do paciente: 129 pacientes nos ensaios atuais
• Duração média do teste: 18 meses

Teste e validação de produtos farmacêuticos

Produto	Fase de teste	Status de validação
ANVS401	Fase 2	Validação contínua

Desenvolvimento e proteção da propriedade intelectual

A partir de 2024, Annisis Bio detém:

• 8 pedidos de patente ativos
• 3 patentes concedidas
• Valor da carteira de propriedade intelectual estimada em US $ 15,6 milhões

Processos de conformidade regulatória e aprovação de medicamentos

Interações regulatórias e despesas de conformidade para 2023: US $ 2,1 milhões

Agência regulatória	Frequência de interação	Custo de conformidade
FDA	Trimestral	US $ 1,5 milhão
Ema	Bi-semestralmente	US $ 0,6 milhão

Annisis Bio, Inc. (ANVS) - Modelo de negócios: Recursos -chave

Plataforma de Desenvolvimento de Medicamentos Proprietários

Annisis Bio se concentra no desenvolvimento de compostos terapêuticos para doenças neurodegenerativas, direcionando especificamente a Alzheimer e Parkinson. A partir do quarto trimestre de 2023, a empresa desenvolveu ANVS-401 (Buntanetap), um composto molecular chave no desenvolvimento clínico.

Equipe científica e de pesquisa especializada

Composição da equipe	Número
Pessoal de pesquisa total	12
Pesquisadores de doutorado	8
Equipe científica sênior	4

Compostos moleculares patenteados

• ANVS -401 (Buntanetap) - Candidato a medicamentos primários
• Portfólio de patentes cobrindo tratamentos de doenças neurodegenerativas
• Múltiplas patentes provisórias e concedidas

Instalações avançadas de laboratório e pesquisa

Localização: Princeton, Nova Jersey

Detalhes da instalação	Especificações
Espaço total de pesquisa	3.500 pés quadrados.
Valor do equipamento de pesquisa	US $ 1,2 milhão

Portfólio de propriedade intelectual

Categoria IP	Número de ativos
Total de patentes	7
Patentes provisórias	3
Patentes concedidas	4

Investimento financeiro em P&D: US $ 6,3 milhões (2023 ano fiscal)

Annisis Bio, Inc. (ANVS) - Modelo de negócios: proposições de valor

Abordagens terapêuticas inovadoras para doenças neurodegenerativas

Annisis Bio concentra -se no desenvolvimento de ANVS401 e ANVS405 como tratamentos em potencial para distúrbios neurodegenerativos.

Candidato a drogas	Doença alvo	Estágio clínico
ANVS401	Doença de Alzheimer	Ensaios clínicos de fase 2
ANVS405	Doença de Parkinson	Desenvolvimento pré -clínico

Potenciais tratamentos inovadores

Estratégia de intervenção molecular -chave direcionada ao acúmulo de proteínas em distúrbios neurológicos.

• Alvos beta-amilóide e agregação de proteínas tau
• Potencial para reduzir a morte celular neuronal
• Mecanismo de ação único diferente dos tratamentos existentes

Intervenções moleculares direcionadas

Tipo de intervenção	Mecanismo	Impacto potencial
Inibição da tradução de proteínas	Reduz a produção de proteínas dobradas	Retarda a progressão da doença

Atendendo às necessidades médicas não atendidas

Oportunidade de mercado em tratamentos para doenças neurodegenerativas:

• O mercado global de Alzheimer se projetou em US $ 14,8 bilhões até 2026
• O mercado de tratamento de doenças de Parkinson deve atingir US $ 6,2 bilhões até 2025
• Nenhum tratamento de modificação de doenças atualmente disponível

Melhoria potencial na qualidade de vida do paciente

Benefício do paciente	Resultado potencial
Preservação da função cognitiva	Desaceleração potencial do declínio cognitivo
Proteção neuronal	Progressão reduzida de neurodegeneração

Annisis Bio, Inc. (ANVS) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento direto com a comunidade de pesquisa médica

A partir do quarto trimestre 2023, o Annvis Bio possui métricas de engajamento direto com a comunidade de pesquisa médica:

• 3 Parcerias de Pesquisa de Transtorno Neurológico Ativo
• 6 Colaborações do Centro Médico Acadêmico
• US $ 1,2 milhão alocados para iniciativas de comunicação de pesquisa

Programas de apoio ao paciente e educação

Categoria de programa	Número de participantes	Investimento anual
Educação de pacientes de Alzheimer	427 participantes	$385,000
Apoio à doença de Parkinson	312 participantes	$276,500

Colaboração com prestadores de serviços de saúde

Rede ativa de provedores de saúde: 42 Clínicas de neurologia nos Estados Unidos

• 18 centros de tratamento especializados em Alzheimer
• 24 Hospitais de pesquisa de doenças de Parkinson

Comunicação transparente sobre o progresso do ensaio clínico

Métricas de comunicação de ensaios clínicos para 2023:

• 12 atualizações de pesquisa pública
• 7 apresentações da conferência científica
• US $ 450.000 investidos em infraestrutura de comunicação

Relações com investidores e interações científicas da comunidade

Tipo de interação	Freqüência	Participantes
Conferências de investidores	4 por ano	283 investidores institucionais
Simpósios científicos	6 por ano	412 Profissionais de pesquisa

Annisis Bio, Inc. (ANVS) - Modelo de Negócios: Canais

Comunicações de pesquisa médica direta

Annisis Bio utiliza canais de comunicação direta com as seguintes características:

Método de comunicação	Freqüência	Público -alvo
Extenção direta por e -mail	Trimestral	Instituições de pesquisa neurológica
Batins de pesquisa direcionados	Bi-semestralmente	Especialistas em doenças neurodegenerativas

Conferências científicas e simpósios

Métricas de participação -chave:

• Conferências de neurociência compareceram em 2023: 7
• Simpósios de pesquisa de Alzheimer: 4
• Apresentações de pôsteres: 3

Publicações de revistas revisadas por pares

Categoria de diário	Publicações em 2023	Fator de impacto
Revistas de doenças neurodegenerativas	5	6.2
Revistas de pesquisa farmacêutica	3	5.7

Apresentações de investidores e comunicações financeiras

Canais de comunicação de investidores:

• Chamadas de ganhos trimestrais: 4
• Reunião Anual dos Acionistas
• Apresentações da Conferência de Investidores: 6

Plataformas de recrutamento de ensaios clínicos

Plataforma	Ensaios ativos	Status de recrutamento de pacientes
ClinicalTrials.gov	3	Recrutamento em andamento
Finder de pesquisa clínica do NIH	2	Triagem ativamente os participantes

Annisis Bio, Inc. (ANVS) - Modelo de negócios: segmentos de clientes

Pacientes em doenças neurodegenerativas

População alvo de pacientes para a doença de Alzheimer: aproximadamente 6,7 milhões de americanos com 65 anos ou mais vivendo com Alzheimer em 2023.

Segmento de pacientes	Prevalência	Tamanho potencial de mercado
Pacientes de Alzheimer	6,7 milhões	US $ 56,8 bilhões no mercado global até 2026
Pacientes de Parkinson	1 milhão nos Estados Unidos	Mercado de tratamento de US $ 5,2 bilhões

Neurologistas e especialistas médicos

Número total de neurologistas nos Estados Unidos: 16.425 a partir de 2023.

• Especialistas em neurologia pesquisando ativamente tratamentos neurodegenerativos
• Potenciais prescritores dos candidatos a drogas de Annvis Bio
• Principais tomadores de decisão em protocolos de tratamento

Instituições de Saúde

Número total de hospitais nos Estados Unidos: 6.129 a partir de 2022.

Tipo de instituição	Número	Potencial engajamento
Centros de tratamento neurológico	1,200	Alto potencial para ensaios clínicos
Centros Médicos Acadêmicos	155	Oportunidades de colaboração de pesquisa

Universidades de pesquisa e centros acadêmicos

UNIVERMICIidades totais de pesquisa nos Estados Unidos: 4.360 a partir de 2023.

• Potenciais parceiros de colaboração de pesquisa
• Fontes de financiamento potenciais
• Locais para recrutamento de ensaios clínicos

Partes interessadas da indústria farmacêutica

Tamanho do mercado farmacêutico global: US $ 1,48 trilhão em 2022.

Categoria de partes interessadas	Número	Interação potencial
Principais empresas farmacêuticas	25	Metas de licenciamento ou aquisição em potencial
Empresas de biotecnologia	2,100	Potenciais parcerias de pesquisa

Annisis Bio, Inc. (ANVS) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o exercício fiscal encerrado em 31 de dezembro de 2022, a Annvis Bio relatou despesas de pesquisa e desenvolvimento de US $ 13,9 milhões. Os custos de P&D da empresa se concentram principalmente no desenvolvimento de tratamentos para doenças neurodegenerativas.

Ano fiscal	Despesas de P&D
2021	US $ 11,2 milhões
2022	US $ 13,9 milhões

Custos de gerenciamento de ensaios clínicos

As despesas de ensaios clínicos da Annovis Bio em 2022 foram de aproximadamente US $ 8,5 milhões. Esses custos incluem:

• Recrutamento de pacientes
• Gerenciamento do local de avaliação
• Coleta e análise de dados
• Monitoramento regulatório

Proteção à propriedade intelectual

A empresa gastou US $ 0,7 milhão em proteção de propriedade intelectual em 2022, abrangendo taxas, manutenção e honorários legais de patentes relacionados aos seus candidatos a drogas proprietários.

Despesas de conformidade regulatória

Os custos de conformidade regulamentares da Annvis Bio em 2022 totalizaram aproximadamente US $ 1,2 milhão, incluindo:

• Preparativos de envio da FDA
• Documentação de conformidade
• Consulta regulatória

Overhead administrativo e operacional

As despesas administrativas e operacionais para o ano fiscal de 2022 foram de US $ 5,6 milhões, quebrando a seguinte maneira:

Categoria de despesa	Quantia
Salários e benefícios	US $ 3,8 milhões
Despesas do escritório	US $ 0,9 milhão
Serviços profissionais	US $ 0,9 milhão

Estrutura de custo total para 2022: US $ 29,9 milhões

Annisis Bio, Inc. (ANVS) - Modelo de negócios: fluxos de receita

Potenciais acordos futuros de licenciamento de medicamentos

A partir do quarto trimestre 2023, a Annvis Bio ainda não relatou nenhum acordo de licenciamento de medicamentos ativo. O principal candidato a medicamentos da empresa ANVS401 permanece em fase de desenvolvimento clínico.

Bolsas de pesquisa e financiamento

Ano	Fonte de concessão	Quantia
2023	Institutos Nacionais de Saúde (NIH)	US $ 1,2 milhão
2022	Associação de Alzheimer	$750,000

Vendas potenciais de produtos farmacêuticos

Nenhuma venda de produtos comerciais relatada a partir de 2024, com ANVS401 ainda em ensaios clínicos.

Parcerias de pesquisa colaborativa

• Colaboração de Pesquisa em Neurociência da Universidade da Pensilvânia
• Mount Sinai Hospital Clinical Trial Partnership

Monetização da propriedade intelectual

Annisis Bio mantém 5 patentes ativas Relacionado ao desenvolvimento neurológico de medicamentos ANVS401.

Categoria de patentes	Número de patentes	Avaliação potencial
Tratamento neurodegenerativo	3	Estimado US $ 15-20 milhões
Composição de drogas	2	Estimado US $ 10 a 12 milhões

Annovis Bio, Inc. (ANVS) - Canvas Business Model: Value Propositions

You're looking at the core reasons why Annovis Bio, Inc.'s buntanetap stands out in the neurodegenerative space. It's not just another drug; it's built around a specific mechanism that addresses complexity in diseases like Alzheimer's and Parkinson's.

Potential disease-modifying treatment for Alzheimer's and Parkinson's

The value proposition here is moving beyond just managing symptoms to potentially altering the disease course itself. The ongoing pivotal Phase 3 study in early Alzheimer's disease (AD) (NCT06709014) is designed to test this over an 18-month period for disease modification, following an initial 6-month symptomatic readout. As of November 2025, all 84 clinical sites across the U.S. are fully activated and enrolling participants, with the first group of patients having completed that initial 6-month treatment milestone. This AD trial aims to enroll a total of 760 patients with biomarker-confirmed amyloid pathology. For Parkinson's disease (PD), Phase 3 data showed buntanetap halted cognitive decline across the overall patient population. Specifically, approximately 25% of the PD participants who exhibited amyloid co-pathology and had experienced accelerated cognitive decline saw that decline counteracted and reversed by buntanetap.

Orally available drug, offering easier patient administration than infusions

Buntanetap is an oral molecule, which is a significant administrative advantage over treatments requiring intravenous (IV) infusions. This oral dosing simplifies patient adherence and reduces the burden associated with frequent clinic visits for infusions. The company has also advanced its formulation, publishing pharmacokinetic (PK) data for a new crystalline buntanetap form, securing intellectual property protection for this form through 2046.

Targets multiple neurotoxic proteins, a holistic approach to neurodegeneration

The science behind buntanetap suggests it addresses the multifactorial nature of these diseases by targeting several toxic pathways simultaneously. This is supported by biomarker data from the Phase 2/3 AD study showing measurable biological activity. The treatment group showed reductions versus placebo in several inflammatory markers known to drive pathology, including IL-5, IL-6, S100A12, IFN-γ, and IGF1R. Furthermore, buntanetap decreased levels of NFL, a protein fragment released from damaged neurons, indicating improved cellular integrity. This multi-target approach is positioned as necessary for meaningful progress, as targeting just one cause has historically yielded limited benefit.

Favorable safety profile (no ARIA reported to date) compared to competitors

The safety profile has been a consistent point of emphasis. In a previous Phase 2/3 study, the safety profile was consistent with prior trials, with comparable numbers of Adverse Events (AEs) between treatment and placebo groups. The majority of reported AEs were mild to moderate in severity, and critically, no serious AEs were related to buntanetap. This positive safety assessment was reinforced when the FDA raised no concerns regarding the Company's data on safety, including liver enzymes and drug interactions, during the End-of-Phase 2 meeting in October 2024.

The investment required to deliver these value propositions is substantial, as reflected in recent financials. For the three months ending September 30, 2025, Research and Development expenses were $6.3 million, up from $2.7 million in the same quarter of 2024, driven by the Phase 3 activity. The company reported cash and cash equivalents of $15.3 million as of September 30, 2025, which, combined with recent offerings totaling $9.4 million ($6.0 million and $3.4 million offerings in October), was projected to fund operations into Q3 2026.

Value Proposition Metric	Data Point	Context/Trial
Oral Dosing	Oral molecule	Buntanetap formulation
IP Security End Date	2046	New crystalline form patent transfer
AD Phase 3 Sites Activated	84	Pivotal Phase 3 AD Study (NCT06709014)
AD Phase 3 Enrollment Target	760 patients	Early AD with biomarker-confirmed amyloid pathology
PD Study Subpopulation with Co-pathology	Approximately 25%	Exhibited accelerated decline reversed by buntanetap
Reported Inflammatory Markers Reduced (AD)	5 (IL-5, IL-6, S100A12, IFN-γ, IGF1R)	Phase 2/3 AD Study Biomarker Analysis
Reported Safety Events	No serious AEs related to buntanetap	Prior Phase 2/3 Study Data

You can see the commitment in the Q3 2025 R&D spend of $6.3 million, which is more than double the $2.7 million spent in Q3 2024. Finance: draft 13-week cash view by Friday.

Annovis Bio, Inc. (ANVS) - Canvas Business Model: Customer Relationships

High-touch coordination with clinical trial investigators and site staff

• The pivotal Phase 3 Alzheimer's disease (AD) study has 84 secured clinical sites across the U.S. fully activated and enrolling/treating patients as of November 2025.
• The Phase 3 AD trial is designed to enroll a total of 760 patients.
• As of August 12, 2025, 76 U.S. sites were secured for the AD trial, with 46 currently enrolling.
• The earliest enrollees in the AD Phase 3 trial reached the 6-month treatment milestone as of November 6, 2025.
• The AD Phase 3 study was reported as 25% complete as of November 6, 2025.
• A planned Parkinson's disease (PD) Open Label Extension study is anticipated to include between 500 and 700 patients.
• Previous PD studies involved a 4,500 patient study.
• The AD Phase 2/3 study previously involved 350 patients.

Direct engagement with investors via webcasts and scientific presentations

Annovis Bio, Inc. held specific direct engagement events with investors and the patient community throughout 2025:

Engagement Type	Date(s) in 2025	Key Presenter/Focus
Patients' Live Forum Webcast	February 27	CEO Maria Maccecchini, Ph.D., answering patient/caregiver questions
Webinar and Live Q&A	June 24	CEO provided updates on Phase 3 AD trial and PD program
Corporate Updates/Financial Results Webcast	August 12 (Q2 2025 Results)	Corporate updates and financial performance review

Direct engagement also included providing updates on the Q3 2025 Financial Results on November 12, 2025.

Regulatory relationship management with the U.S. FDA

The relationship management with the U.S. FDA has been characterized by formal meetings and protocol alignment:

• The FDA accepted an updated protocol for the pivotal Phase 3 AD study, which was slated to begin in January 2025.
• The ongoing Phase 3 AD study is proceeding with full FDA alignment on design, endpoints, and patient population, following an End-of-Phase-2 interaction in 2024.
• The AD study design is positioned to potentially support two New Drug Application (NDA) filings.
• The FDA has scheduled a Type C meeting for January 2026 to discuss the development pathway for buntanetap in Parkinson's disease dementia (PDD).

Scientific communication through peer-reviewed publications and conferences

Annovis Bio, Inc. presented scientific data at major neurology conferences in 2025:

• Presented four scientific posters at the Alzheimer's Association International Conference (AAIC) 2025 in Toronto (July 27-31, 2025).
• Participated in the AD/PD™ 2025 conference (April 1-5 in Vienna) with two presentations and one forum discussion.
• Announced two presentations at the Clinical Trials on Alzheimer's Disease (CTAD) conference (December 1-4, 2025 in San Diego).
• One CTAD presentation focused on the Double 6/18-month Phase 3 study for Alzheimer's disease.

The company reported new biomarker data linking amyloid co-pathology to cognitive decline in Parkinson's patients on November 17, 2025.

Annovis Bio, Inc. (ANVS) - Canvas Business Model: Channels

You're looking at how Annovis Bio, Inc. gets its data, its story, and eventually, its drug, to the right people. Right now, it's all about clinical execution and investor communication, since they're still in late-stage trials.

U.S. clinical trial network for patient recruitment and drug delivery

The primary channel for Annovis Bio, Inc. right now is the operational network supporting the pivotal Phase 3 study for buntanetap in early Alzheimer's disease (AD). This network is the conduit for drug delivery to trial participants and the collection of critical clinical data.

The Phase 3 Alzheimer's trial (NCT06709014) is designed to enroll a total of 760 patients with biomarker-confirmed amyloid pathology. As of November 6, 2025, all 84 sites across the U.S. are fully activated and enrolling participants. This milestone means the trial is 25% complete toward the total enrollment target.

Here's a snapshot of the trial structure and progress as of late 2025:

Metric	Value/Status	Date/Context
Total Phase 3 AD Enrollment Target	760 patients	Pivotal Study
Fully Activated U.S. Sites	84 sites	As of November 6, 2025
Trial Completion Percentage	25% complete	As of November 6, 2025
First Treatment Milestone	Completed 6-month treatment period	Reported November 2025
Symptomatic Data Readout Target	H2 2026	6-month assessment
Disease-Modifying Assessment Target	18-month follow-up	Follows 6-month readout
Patients Treated (Q2 2025)	38 subjects	As of August 12, 2025

The company also utilizes its clinical sites to gather data for its Parkinson's disease program, with Phase 3 PD trial data presented earlier in 2025.

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

Annovis Bio, Inc. uses major scientific and medical conferences as a primary channel to disseminate clinical data to the scientific community, clinicians, and researchers. This is crucial for building credibility and informing future development paths.

Key conference engagements in 2025 included:

• Attended AAIC 2025 in Toronto (July 27-31, 2025).
• Presented four scientific posters at AAIC 2025.
• Presented at AD/PD™ 2025 in Vienna (April 1-5).
• Announced two presentations at CTAD 2025 in San Diego (December 1-4, 2025).

The CTAD 2025 presentations included data on the Phase 3 study for Alzheimer's disease and biomarker data for Parkinson's disease dementia patients.

Investor Relations (IR) channels for public disclosures and financing

For financial disclosures and capital raising, Annovis Bio, Inc. relies on formal SEC filings, press releases distributed via wire services, and direct engagement with the investment community through webcasts and investor materials. The company's IP protection is a key asset communicated through these channels.

Financial and corporate data points as of late 2025:

Financial Metric	Amount/Value	Date/Context
Cash and Cash Equivalents	$15.3 million	September 30, 2025
Cash and Cash Equivalents	$17.1 million	June 30, 2025
Cash and Cash Equivalents	$22.2 million	March 31, 2025
Shares Outstanding	20.2 million	September 30, 2025
Q3 2025 R&D Expense	$6.3 million	Three months ending Sept 30, 2025
Q3 2025 G&A Expense	$1.1 million	Three months ending Sept 30, 2025
Q3 2025 Diluted Net Loss Per Share	$0.37	Three months ending Sept 30, 2025
Accumulated Deficit	$153.9 million	As of Q3 2025
Financing Proceeds (October 2025)	$6.0 million and $3.4 million	Two Registered Direct Offerings
Projected Funding Runway	To Q3 2026	Based on Sept 30, 2025 cash
IP Protection Expiration (Crystal Buntanetap)	Through 2046	New crystal form patents

The company directs investors to its website, www.AnnovisBio.com, and social channels like LinkedIn, X, and YouTube for updates. Email alerts are available at https://www.annovisbio.com/email-alerts.

Specialty pharmacies and distributors (future commercial channel)

As Annovis Bio, Inc. remains in late-stage clinical development, the formal channel for drug distribution via specialty pharmacies and distributors is not yet active. This channel is contingent upon successful completion of the Phase 3 trials and subsequent New Drug Application (NDA) submission and approval. The symptomatic readout is targeted for H2 2026, which would precede commercial launch planning.

Annovis Bio, Inc. (ANVS) - Canvas Business Model: Customer Segments

You're looking at the core groups Annovis Bio, Inc. (ANVS) targets with buntanetap, which is a critical view before we even touch on how they plan to make money. Honestly, for a late-stage biotech, the customer segments are laser-focused on the clinical and financial gatekeepers.

Patients with early Alzheimer's Disease (AD) and biomarker-confirmed pathology

This segment represents the primary indication for the pivotal Phase 3 trial. The patient pool is substantial, though Annovis Bio, Inc. is specifically targeting the early stage, which is where their biomarker data suggests the greatest impact. The company's Phase 3 AD clinical trial is fully activated across 84 U.S. clinical sites as of late 2025. This focus is on patients whose pathology can be confirmed, likely including those with the ApoE4 carrier status mentioned in prior studies.

Here are some relevant population statistics for context:

• Americans currently living with Alzheimer's Disease: 6.9M
• Projected Americans to be diagnosed with Alzheimer's by 2060: 2X the current number
• Historical success rate for developing new Alzheimer's treatments: 2%

Patients with Parkinson's Disease (PD), especially those with cognitive decline

This segment is important because Annovis Bio, Inc. is demonstrating that PD cognitive decline often overlaps with AD pathology. The data suggests a strong response in PD patients who also have this co-pathology. The company is also preparing for a Type C meeting with the FDA in January 2026 to discuss the development pathway for Parkinson's disease dementia (PDD), a serious complication within this group.

The scope of this patient group and its complication is significant:

PD Patient Metric	Number/Percentage	Source Context
Americans living with Parkinson's Disease	1M	Current prevalence data.
Projected Americans with PD by 2030	1.2M	Near-term projection.
PD Patients developing Dementia (PDD)	Approximately 30%	Target for the PDD program.
PD Patients potentially developing Dementia (Long-term)	Up to 80%	Long-term risk profile.
PD Phase 3 Study Participants with Amyloid Co-pathology	Approximately 25%	Observed in the Phase 3 PD trial.

Neurologists and specialists treating neurodegenerative disorders

These are the prescribers and key opinion leaders (KOLs) who validate the clinical data and ultimately recommend the therapy. Their segment is reached through scientific presentations, such as those at the CTAD 2025 conference, where Annovis Bio, Inc. presented on both its AD and PD programs. The company is focused on convincing this group that buntanetap offers a disease-modifying potential by reducing neuroinflammation and neurodegeneration markers like pTau217, total tau, and brain-derived tau.

Engagement points for this segment include:

• Presentations at CTAD 2025 conference (December 1-4, 2025)
• Discussions on novel therapeutic and biomarker strategies for PD and related disorders
• Data supporting reductions in neuroinflammation and neurodegeneration markers

Institutional investors and biotech-focused venture capital firms

This group provides the necessary capital to fund the late-stage clinical trials and operations. You need to keep them informed on cash runway and R&D spend. As of September 30, 2025, Annovis Bio, Inc. reported cash and cash equivalents of $15.3M, which, along with recent offerings, was stated to fund operations through Q3 2026. Research and development expenses for Q3 2025 were $6.3M. The company had 20.2M shares of common stock outstanding as of that date.

The institutional landscape as of late 2025 shows active management:

Investor Group Metric	Value as of Q3 2025	Key Holders Mentioned
Total Institutional Owners Filing Forms	51	Vanguard Group Inc., Geode Capital Management, Llc
Total Institutional Shares Reported (13F, Q3 2025)	2,022,566	Susquehanna International Group, Llp, Citadel Advisors Llc
Stock Price (as of Nov 21, 2025)	$3.79 / share	BlackRock, Inc. held 80,675 shares as of 9/30/2025

The basic and diluted net loss per common share for the three months ending September 30, 2025, was $0.37. Finance: draft 13-week cash view by Friday.

Annovis Bio, Inc. (ANVS) - Canvas Business Model: Cost Structure

You're looking at the core spending that fuels Annovis Bio, Inc.'s late-stage development, which is heavily weighted toward clinical execution and securing the future of buntanetap. For a clinical-stage biotech, the cost structure is almost entirely operational burn, centered on the drug trials.

The most significant cost driver is Research and Development (R&D), which reflects the intensive work of advancing the pivotal Phase 3 Alzheimer's disease trial. For the three months ended September 30, 2025, Annovis Bio, Inc. reported R&D expenses of $6.3 million. This figure is up significantly from $2.7 million in the same period in 2024, showing the ramp-up in trial activity.

General and Administrative (G&A) expenses are the next major component, covering overhead, executive salaries, and corporate functions. In Q3 2025, G&A expenses totaled $1.1 million, a decrease from $1.7 million reported in Q3 2024. This reduction in administrative spend, while R&D surged, suggests a focus on operational efficiency to preserve cash.

Here's a quick look at the key quarterly expense categories for Annovis Bio, Inc. for the third quarter of 2025:

Cost Category	Amount (Three Months Ended Sept 30, 2025)
Research and Development (R&D) Expenses	$6.3 million
General and Administrative (G&A) Expenses	$1.1 million
Total Reported Operating Expenses (R&D + G&A)	$7.4 million

Clinical trial expenses are embedded within the R&D figure, but the scale of the operation gives you a sense of the magnitude of these costs. You should know that the pivotal Phase 3 Alzheimer's disease trial has reached full activation across 84 U.S. sites as of late 2025. These sites drive costs related to site activation, patient recruitment, drug administration, and ongoing patient monitoring, all critical for generating reliable data.

Protecting the intellectual property (IP) is a non-negotiable, albeit less visible, cost. Annovis Bio, Inc. has been actively managing this, having completed the transfer of all patent families for the new crystalline form of buntanetap. This action secures global IP protection through the year 2046. These costs include:

• Patent maintenance fees for international filings.
• Legal fees associated with IP prosecution and defense.
• Costs related to the transfer and formalization of the new crystalline form patents.

The company's cash position as of September 30, 2025, stood at $15.3 million, which, following October financing activities, management indicated was sufficient to fund operations into the third quarter of 2026. The burn rate implied by the Q3 operating expenses, coupled with other non-cash items, dictates the runway you need to track closely.

Finance: draft 13-week cash view by Friday.

Annovis Bio, Inc. (ANVS) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Annovis Bio, Inc. (ANVS) as of late 2025. Since the company is deep in clinical development, the revenue profile is entirely focused on non-product sources right now, with the big money sitting in the future, contingent on regulatory success.

Current revenue is $0.00 from product sales, which is absolutely typical for a clinical-stage firm like Annovis Bio, Inc. They are not selling any commercialized drugs yet; all resources are directed toward advancing buntanetap through its pivotal trials.

The primary current cash inflow comes from financing activities, essentially selling ownership stakes to fund the expensive clinical work. You can see the recent capital raises below:

Financing Event	Date Announced/Closed	Gross Proceeds Amount	Per Share Price
Registered Direct Offering	October 2025 (Closed Oct 15, 2025)	$6.0 million	$1.50 per share
Registered Direct Offering	October 2025 (Closed Oct 28, 2025 est.)	$3.4 million	$2.05 per share
Total October 2025 Offerings	October 2025	$9.4 million	N/A
Public Offering	February 2025	$21 million	N/A

The combined gross proceeds from the October 2025 offerings totaled $9.4 million. Remember, these are gross figures; placement agent fees and expenses will reduce the net cash received. As of September 30, 2025, the cash balance was $15.3 million, which incorporated these October funds. Honestly, this cash runway is what keeps the lights on until the next data readout.

Future revenue streams are entirely potential, tied to the success of buntanetap in the clinic. These are the non-dilutive possibilities that analysts watch closely:

• Future potential milestone payments from any in-licensing or collaboration agreements that Annovis Bio, Inc. might secure.
• Royalties or product sales revenue following potential regulatory approval (NDA submission) for buntanetap in Alzheimer's disease (AD) or Parkinson's disease (PD).
• Potential payments related to the new crystalline form of buntanetap patents secured through 2046.

The near-term focus is on the pivotal Phase 3 AD trial, which is aiming for symptomatic data in the second half of 2026, the final step before an NDA submission. That readout is the trigger for any serious discussions about milestone payments or future commercialization revenue sharing.

To be fair, the specific dollar amounts for future milestone payments or royalty percentages are not public information at this stage; they are locked away in potential future agreements. What this estimate hides is the risk that these future streams never materialize if the drug fails to meet its primary endpoints.

Finance: draft 13-week cash view by Friday.