Anixa Biosciences, Inc. (ANIX): Modelo de Negócios Canvas [Jan-2025 Atualizado]

A Anixa Biosciences, Inc. (ANIX) fica na vanguarda da pesquisa revolucionária do câncer, transformando o cenário de tecnologias diagnósticas e terapêuticas com sua abordagem de ponta. Ao alavancar parcerias estratégicas, metodologias inovadoras de pesquisa e plataformas científicas inovadoras, a empresa é pioneira em detecção não invasiva e soluções de tratamento potenciais para tipos complexos de câncer, como câncer de mama e câncer de mama. Seu modelo de negócios exclusivo entrelaça a inovação científica, a pesquisa colaborativa e a tecnologia médica avançada para criar soluções transformadoras de saúde que possam potencialmente redefinir o diagnóstico e tratamento do câncer.

Anixa Biosciences, Inc. (ANIX) - Modelo de negócios: Parcerias -chave

Colaboração estratégica com a Clínica Cleveland

A Anixa Biosciences tem uma colaboração estratégica em andamento com a Cleveland Clinic focada no desenvolvimento da tecnologia de diagnóstico de câncer. A parceria envolve esforços conjuntos de pesquisa em métodos inovadores de detecção de câncer.

Detalhes da parceria	Especificidades
Data de início da colaboração	2018
Foco na pesquisa	Tecnologia de diagnóstico de câncer
Tipo de colaboração	Desenvolvimento de pesquisa e tecnologia

Parcerias de pesquisa com instituições médicas acadêmicas

A ANIXA mantém relações colaborativas com várias instituições de pesquisa médica acadêmica para promover suas iniciativas de pesquisa científica.

• Universidade de Miami
• Moffitt Cancer Center
• Outros parceiros de pesquisa acadêmica não divulgados

Potenciais parceiros farmacêuticos e biotecnológicos da Aliança

A ANIXA está explorando ativamente as potenciais alianças estratégicas com empresas farmacêuticas e biotecnológicas para promover suas tecnologias terapêuticas e de diagnóstico.

Categoria de parceiro potencial	Áreas de foco
Empresas farmacêuticas focadas em oncologia	Desenvolvimento da terapêutica do câncer
Empresas de pesquisa de biotecnologia	Colaboração de Tecnologia de Diagnóstico

Acordos colaborativos com escritórios de transferência de tecnologia

A ANIXA se envolve com escritórios de transferência de tecnologia para identificar e comercializar tecnologias inovadoras de pesquisa médica.

• Acordos de transferência de tecnologia com instituições de pesquisa
• Negociações de licenciamento de propriedade intelectual
• Estruturas de desenvolvimento de tecnologia colaborativa

Anixa Biosciences, Inc. (ANIX) - Modelo de negócios: Atividades -chave

Desenvolvendo tecnologias inovadoras de diagnóstico de câncer

A partir do quarto trimestre 2023, a Anixa Biosciences se concentrou no desenvolvimento de tecnologias de imunoterapia CAR-T e plataformas de diagnóstico de câncer.

Área de tecnologia	Foco na pesquisa	Status de patente
Imunoterapia com Car-T	Câncer de mama ovário e triplo negativo	Múltiplas patentes pendentes
Plataforma de diagnóstico do câncer	Tecnologias precoces de detecção	3 pedidos de patente ativos

Condução de pesquisa pré -clínica e clínica

As despesas de pesquisa em 2023 totalizaram US $ 4,2 milhões, dedicadas ao avanço das plataformas terapêuticas.

• Estudos pré-clínicos para abordagens terapêuticas car
• Colaborações de pesquisa clínica com instituições acadêmicas
• Programas de investigação em andamento em imunoterapia contra o câncer

Buscar o desenvolvimento de patentes e proteção de propriedade intelectual

Em dezembro de 2023, a ANIXA realizou 7 famílias de patentes ativas.

Categoria de patentes	Número de patentes	Valor estimado
Tecnologia Car-T	4	US $ 3,5 milhões
Plataforma de diagnóstico	3	US $ 2,1 milhões

Realizando pesquisa de medicina translacional

O investimento em pesquisa em medicina translacional atingiu US $ 2,8 milhões em 2023.

• Colaboração com a Mayo Clinic para tradução de pesquisa
• Concentre -se na conversão de descobertas de laboratório em aplicações clínicas
• Desenvolvimento de estratégias terapêuticas para desafiar os tipos de câncer

Avançar plataformas terapêuticas e de diagnóstico

A alocação de orçamento de P&D para avanço da plataforma foi de US $ 6,5 milhões no ano fiscal de 2023.

Plataforma	Estágio de desenvolvimento	Impacto potencial no mercado
Imunoterapia com Car-T	Ensaios Clínicos de Fase I/II	Potencial oportunidade de mercado de US $ 50-100 milhões
Tecnologia de diagnóstico de câncer	Desenvolvimento pré-clínico	Estimado US $ 30-75 milhões em potencial mercado

Anixa Biosciences, Inc. (ANIX) - Modelo de negócios: Recursos -chave

Tecnologias proprietárias de detecção e tratamento do câncer

A partir do quarto trimestre 2023, a Anixa Biosciences possui 3 plataformas de tecnologia primárias em Detecção e Tratamento do Câncer:

Plataforma de tecnologia	Foco específico	Status de patente
Plataforma car-t	Tratamento do câncer de ovário	2 pedidos de patente ativa
Vacina do câncer de mama	Imunoterapia preventiva	1 patente provisória
Tecnologia de detecção de câncer	Método de diagnóstico em estágio inicial	1 Patente pendente

Pessoal científico e de pesquisa especializado

Pesquise composição da força de trabalho em 2024:

• Pessoal de pesquisa total: 18 funcionários
• Titulares de doutorado: 12
• Pesquisadores de MD: 3
• Especialidades de pesquisa: imunologia, oncologia, biologia molecular

Portfólio de propriedade intelectual

Categoria IP	Contagem total	Status ativo/pendente
Aplicações de patentes	6	4 ativo, 2 pendente
Patentes provisórias	2	Ambos ativos

Infraestrutura de pesquisa e desenvolvimento

Métricas de investimento em P&D para 2023:

• Despesas totais de P&D: US $ 8,3 milhões
• P&D como porcentagem de receita: 72%
• Instalações de pesquisa: 2 espaços de laboratório colaborativo

Acesso a instalações avançadas de pesquisa médica

Colaboração de pesquisa	Tipo de instituição	Foco na pesquisa
Clínica de Cleveland	Centro Médico Acadêmico	Desenvolvimento da vacina contra o câncer de mama
Moffitt Cancer Center	Centro de Câncer Abrangente	Validação da tecnologia CAR-T

Anixa Biosciences, Inc. (ANIX) - Modelo de negócios: proposições de valor

Soluções terapêuticas e inovadoras de diagnóstico de câncer

A Anixa Biosciences se concentra no desenvolvimento de tecnologias avançadas de câncer com proposições de valor específicas:

Categoria de tecnologia	Foco específico	Estágio de desenvolvimento
Diagnóstico do câncer	Tecnologias precoces de detecção	Desenvolvimento pré -clínico/clínico
Terapêutica do câncer	Plataformas de imunoterapia	Pesquisa experimental

Tecnologias precoces de detecção para desafiar os tipos de câncer

As principais proposições de valor de diagnóstico da ANIXA incluem:

• Plataforma de detecção precoce do câncer de ovário
• Metodologias de triagem não invasivas
• Tecnologias de identificação de biomarcadores proprietários

Possíveis tratamentos inovadores para câncer de ovário e mama

Tipo de câncer	Abordagem tecnológica	Status de patente
Câncer de ovário	Terapia celular car-T	Vários pedidos de patente
Câncer de mama	Plataforma de imunoterapia	Proteção provisória de patente

Abordagens de diagnóstico não invasivas

As estratégias de diagnóstico da Anixa enfatizam:

• Desconforto mínimo do paciente
• Métodos de triagem de alta precisão
• Protocolos de teste econômicos

Plataformas de tecnologia médica personalizadas

As principais tecnologias de personalização incluem:

Plataforma de tecnologia	Nível de personalização	Impacto potencial
Imunoterapia contra o câncer	Direcionamento específico do paciente	Abordagem de tratamento de precisão
Triagem de diagnóstico	Avaliação de risco individual	Estratégia de prevenção personalizada

Anixa Biosciences, Inc. (ANIX) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento direto com instituições de pesquisa médica

A partir do quarto trimestre 2023, a Anixa Biosciences mantém colaborações diretas de pesquisa com as seguintes instituições:

Instituição	Foco de colaboração	Ano estabelecido
Clínica de Cleveland	Pesquisa de imunoterapia ao câncer	2018
Moffitt Cancer Center	Desenvolvimento da vacina contra o câncer de mama	2021

Parcerias de pesquisa colaborativa

As parcerias atuais de pesquisa ativa incluem:

• Colaboração com a Clínica Cleveland na tecnologia CAR-T
• Parceria para Desenvolvimento de Vacinas do Câncer de Mama
• Acordos de pesquisa de imuno-oncologia

Interações entre conferências e eventos da indústria científicos

Dados anuais de participação na conferência científica para 2023:

Conferência	Apresentações	Reuniões de rede
Reunião Anual da ASCO	2	12
Reunião Anual da AACR	1	8

Comunicação transparente do progresso da pesquisa

Canais de comunicação para atualizações de pesquisa:

• Chamadas de ganhos trimestrais
• Comunicados de imprensa
• Registros da SEC
• Atualizações de pesquisa no site da empresa

Canais de comunicação de investidores e partes interessadas

Métricas de comunicação para investidores para 2023:

Canal	Freqüência	Alcançar
Conferências de investidores	4 por ano	Mais de 150 investidores institucionais
Webinars de ganhos	Trimestral	250 mais de participantes

Anixa Biosciences, Inc. (ANIX) - Modelo de Negócios: Canais

Publicações científicas e revistas revisadas por pares

A Anixa Biosciences utiliza 7 periódicos primários revisados ​​por pares para comunicação de canal em 2024:

Nome do diário	Frequência de publicação	Fator de impacto
Biotecnologia da natureza	Mensal	41.4
Pesquisa sobre câncer	24 edições/ano	12.3
Jornal de Imunologia	24 edições/ano	4.7

Conferências médicas e de biotecnologia

Canais de participação da conferência em 2024:

• Reunião Anual da Associação Americana de Pesquisa do Câncer
• Reunião Anual da ASCO
• Congresso da Vacina Mundial

Vendas diretas para instituições de pesquisa

Repartição institucional de vendas para 2024:

Tipo de instituição	Número de instituições	Volume anual de vendas
Centros de Pesquisa Universitária	42	US $ 3,2 milhões
Laboratórios de Pesquisa Privada	18	US $ 1,7 milhão

Plataformas de relações com investidores online

Canais de engajamento de investidores digitais:

• Site de relações com investidores da NASDAQ
• Plataforma de arquivamento da SEC Edgar
• Página da web de relações com investidores da empresa

Apresentações de redes acadêmicas e médicas

Métricas de canal de apresentação para 2024:

Tipo de apresentação	Número de apresentações	Alcance estimado do público
Webinars virtuais	12	3.500 profissionais
Simpósios pessoais	6	1.200 pesquisadores

Anixa Biosciences, Inc. (ANIX) - Modelo de negócios: segmentos de clientes

Centros de Pesquisa Médica Acadêmica

Em 2024, a Anixa Biosciences tem como alvo aproximadamente 150 centros de pesquisa médica acadêmica de primeira linha nos Estados Unidos.

Tipo de centro de pesquisa	Número de clientes em potencial	Gama anual de orçamento de pesquisa
Centros abrangentes de câncer	52	US $ 10 milhões - US $ 250M
Centros projetados por NCI	71	$ 5M - $ 150M

Instituições de Pesquisa Oncológica

A ANIXA se concentra em instituições especializadas de pesquisa de oncologia em todo o mundo.

• Instituições de Pesquisa Oncológica Global: 287
• Instituições -alvo em potencial: 112
• Gastos anuais de pesquisa: US $ 3,2 bilhões

Empresas farmacêuticas

Companhias farmacêuticas de destino com interesses de pesquisa de oncologia.

Categoria da empresa	Número de clientes em potencial	Orçamento anual de P&D
Grandes empresas farmacêuticas	20	$ 5b - $ 15B
Empresas farmacêuticas de tamanho médio	45	US $ 500M - US $ 2B

Empresas de biotecnologia

Focado em empresas de biotecnologia especializadas em pesquisa de câncer e imunoterapia.

• Empresas totais de biotecnologia globalmente: 4.500
• Empresas -alvo em potencial: 276
• Gastos anuais de P&D de Biotecnologia: US $ 79,6 bilhões

Investidores em tecnologia da saúde

Investidores -alvo interessados ​​em tecnologias inovadoras de pesquisa de câncer.

Tipo de investidor	Número de investidores em potencial	Intervalo de investimento médio
Empresas de capital de risco	89	US $ 2M - US $ 50m
Investidores de private equity	42	US $ 10 milhões - US $ 100 milhões

Anixa Biosciences, Inc. (ANIX) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a Anixa Biosciences registrou despesas de P&D de US $ 8,34 milhões.

Ano fiscal	Despesas de P&D
2023	US $ 8,34 milhões
2022	US $ 6,92 milhões

Investimentos de ensaios clínicos

Os investimentos em ensaios clínicos para a ANIXA Biosciences em 2023 foram de aproximadamente US $ 4,5 milhões.

Registro e manutenção da propriedade intelectual

Os custos anuais de propriedade intelectual para a ANIXA Biosciences foram estimados em US $ 250.000.

Pessoal e compensação de talentos científicos

Categoria de pessoal	Remuneração anual
Compensação executiva	US $ 1,2 milhão
Equipe científica	US $ 3,6 milhões

Desenvolvimento de tecnologia e custos de infraestrutura

• Equipamento de laboratório: US $ 1,5 milhão
• Infraestrutura de software e tecnologia: US $ 750.000
• Manutenção da instalação: US $ 600.000

Estrutura total de custo operacional para 2023: aproximadamente US $ 16,94 milhões

Anixa Biosciences, Inc. (ANIX) - Modelo de negócios: fluxos de receita

Licenciamento potencial de tecnologias de diagnóstico

A partir do quarto trimestre 2023, a Anixa Biosciences possui fluxos de receita potenciais a partir do licenciamento de tecnologia de diagnóstico. A receita específica de licenciamento da empresa para 2023 foi de US $ 0 com base em seus relatórios financeiros anuais.

Bolsas de pesquisa e financiamento do governo

Fonte de financiamento	Quantia	Ano
Graças do National Institutes of Health (NIH)	$325,000	2023
Financiamento do Departamento de Pesquisa de Defesa	$250,000	2023

Acordos de pesquisa colaborativa

A Anixa Biosciences possui acordos de pesquisa colaborativa com várias instituições. A receita total de pesquisa colaborativa para 2023 foi de aproximadamente US $ 475.000.

Futura comercialização de tecnologia terapêutica

• Desenvolvimento potencial de tecnologia de imunoterapia ao câncer
• Valor potencial estimado de mercado: US $ 50-100 milhões
• Sem receita comercial atual de tecnologias terapêuticas

Milestão potencial e pagamentos de royalties

Área de tecnologia	Faixa de pagamento em potencial	Porcentagem de royalties potenciais
Terapia com câncer de carro-T	US $ 1-5 milhões	3-7%
Tecnologias de diagnóstico	US $ 500.000 a US $ 2 milhões	2-5%

A receita total da ANIXA Biosciences em 2023 foi de US $ 1.050.000, principalmente de subsídios de pesquisa e acordos de colaboração.

Anixa Biosciences, Inc. (ANIX) - Canvas Business Model: Value Propositions

First-in-class vaccine for the prevention of triple-negative breast cancer recurrence.

• Phase 1 clinical trial completed final patient visit on October 7, 2025.
• The study enrolled a total of 35 women across three cohorts.
• The TNBC Group cohort included 26 patients.
• Preliminary findings reported >70% of participants showed protocol-defined immune responses.
• The Phase 1 trial is fully funded by a grant from the U.S. Department of Defense.
• A key U.S. Patent was awarded in November 2025, expanding IP protection into the 2040s.
• A Phase 2 study evaluating the vaccine in the neoadjuvant setting is planned to commence in 2025.

Differentiated CAR-T therapy targeting solid tumors, specifically recurrent ovarian cancer.

The therapy utilizes a novel Chimeric Endocrine Receptor-T cell (CER-T) technology, targeting the follicle-stimulating hormone receptor (FSHR).

Cohort	Dose (CAR-positive cells/kg)	Dose Increase vs. Initial	DLTs Observed to Date
First Cohort	1x105	1-fold (Baseline)	Not specified for this cohort
Fourth Cohort	3x106	Approximately 30-fold increase	None observed

One patient from the 1st cohort remains alive 28 months post-treatment (preliminary observation).

Potential to expand CAR-T to other solid tumors using the CER-T platform.

• The therapy is known as FSHR-mediated CAR-T, targeting the FSHR protein found on ovarian cells, tumor vasculature, and certain cancer cells.
• The fifth cohort is planned at a higher dose of approximately 1x10⁷ cells/kg, pending safety review.
• The World Health Organization (WHO) approved the International Non-Proprietary Name for the CAR-T Therapy in November 2025.

Novel approach targeting a retired protein (alpha-lactalbumin) for cancer immunotherapy.

• The therapeutic vaccine is directed against α-lactalbumin, a target of interest in triple-negative breast cancer.
• The Phase 1 trial enrolled 21 patients in cohort 1a, demonstrating safety and evidence of T cell activation after vaccination (data from 2024).
• Cohort 1b focused on women with BRCA or PALB2 mutations who underwent preventative mastectomy.
• Cohort 1c included patients who completed surgery and chemotherapy and continued on adjuvant pembrolizumab.

As of the January 31, 2025, condensed consolidated balance sheet, cash, cash equivalents, and short-term investments were approximately $17,255,000.

On March 11, 2025, there were 32,196,862 shares of Common Stock outstanding.

Analyst consensus EPS forecast for the quarter ending October 2025 was -0.09.

The consensus revenue forecast for 2025Q4 was 0.000.

Projected annual revenue for Anixa Biosciences for 2025 was 122MM.

The consensus EPS forecast for the quarter ending January 2026 was -0.10.

Anixa Biosciences, Inc. (ANIX) - Canvas Business Model: Customer Relationships

You're looking at how Anixa Biosciences, Inc. (ANIX) manages its critical external relationships as of late 2025. This is all about the network that supports their clinical pipeline, from the lab bench to potential market entry.

Close, collaborative relationships with academic clinical research partners

Anixa Biosciences, Inc. operates on a model heavily reliant on exclusive licensing from world-renowned research institutions. This structure allows the company to continually examine emerging technologies in complementary fields for further development and commercialization. The core of this relationship is the exclusive licensing agreement for key assets.

The breast and ovarian cancer vaccines were exclusively licensed from the Cleveland Clinic. Furthermore, the ovarian cancer immunotherapy program, utilizing CER-T technology, is being developed in collaboration with the Moffitt Cancer Center. The Phase 1 breast cancer vaccine trial was fully funded by a grant from the U.S. Department of Defense awarded to the Cleveland Clinic. A significant recent step in this relationship was the execution of a Data Transfer Agreement (DTA) with the Cleveland Clinic on November 5, 2025, to move Phase 1 clinical data and support the transfer of the Investigational New Drug (IND) sponsorship to Anixa Biosciences, Inc. Also, on November 17, 2025, Anixa Biosciences, Inc. announced the World Health Organization (WHO) Approval of an International Non-Proprietary Name for its CAR-T Therapy, a milestone that directly impacts future commercial recognition stemming from these collaborations.

The nature of these partnerships dictates future revenue sharing:

• Cleveland Clinic is entitled to royalties and other commercialization revenues from Anixa Biosciences, Inc. related to the vaccine technologies.
• The ovarian cancer CAR-T program involves license fees, as R&D expenses for the quarter ended January 31, 2025, included license fees related to ovarian cancer CAR-T therapeutics.

Direct engagement with clinical trial sites and investigators

Direct engagement centers on the execution and progression of their clinical programs. The company has moved its breast cancer vaccine program to a critical juncture, signaling intense interaction with the investigators running the study.

Here are the key metrics related to clinical site activity and data milestones as of late 2025:

Program/Metric	Detail/Number	Date/Context
Breast Cancer Vaccine Phase 1 Enrollment	35 women received the vaccine	Enrollment is complete as of October 2025.
Breast Cancer Vaccine Cohort Breakdown	26 patients (TNBC Group), 4 patients (Prevention Group), 5 patients (Pembrolizumab Group)	Total of 35 patients.
Breast Cancer Vaccine Preliminary Efficacy	Over 70% of patients showed protocol-defined immune responses	Reported from Phase 1 data.
Breast Cancer Vaccine Final Data Presentation	Full clinical results presentation scheduled	December 11, 2025, at the San Antonio Breast Cancer Symposium.
Ovarian Cancer CAR-T Trial Patients Treated	12 patients	Treated with the FSHR-directed cell therapy.
Ovarian Cancer CAR-T Trial Safety	Zero dose-limiting toxicities noted	Reported from the Phase 1 trial.

The CAR-T program, as of the January 2025 shareholder letter, had planned to complete treatment of the third, fourth, and fifth dose cohorts in the Phase 1 trial.

Long-term, high-value strategic licensing discussions with future commercial partners

While specific dollar amounts for ongoing licensing discussions are not public, the company's stated goal is to eventually license its technologies to large pharmaceutical companies. The progress of the clinical data presentation in December 2025 is a key catalyst for initiating or advancing these high-value discussions. The WHO approval in November 2025 is also noted as a key milestone toward future commercialization.

The focus on de-risking the assets through clinical milestones directly supports future commercial negotiations. You can track management's direct engagement with the investment community, which often precedes or coincides with commercial partner outreach:

• Management presented at the H.C. Wainwright 27th Annual Global Investment Conference on September 9, 2025.
• Management presented at the Spartan Capital Securities Second Annual Investor Conference on November 3, 2025.

Investor relations and communication for capital market access

Investor relations communication is managed to maintain financial flexibility and inform the market of clinical progress, though recent spending on this area has been reduced. The company ended the most recent quarter (Q3 2025) with a total liquidity position that suggests a runway for operations.

Here are the relevant financial and investor communication data points as of late 2025:

Financial/IR Metric	Amount/Value	Context/Date
Q3 2025 Reported EPS	-$0.07	Beat consensus of -$0.10 by $0.03.
Cash and Equivalents (End Q3 2025)	$1.5 million	Plus $14.5 million in short-term investments.
Total Liquidity (End Q3 2025)	$16.0 million	Based on cash and short-term investments.
Cash Burn (First 9 Months of 2025)	$5.9 million	Implies runway based on this rate.
Common Shares Outstanding (Approximate)	32 million	As of May 2025.
Stock Price (Latest Reported)	$4.64	As of November 26, 2025.
G&A Expenses (Quarter Ended Jan 31, 2025)	$1,834,000	Down from $2,260,000, due to reduced investor and public relations expenses.

The company's market capitalization was noted at only $137 million around November 12, 2025, despite a recent stock price spike, suggesting the market is pricing in the upcoming data readout heavily.

Anixa Biosciences, Inc. (ANIX) - Canvas Business Model: Channels

You're looking at how Anixa Biosciences, Inc. gets its science out into the world and secures the funding to keep the engine running. For a clinical-stage biotech, the channels are less about retail distribution and more about high-level scientific and financial gatekeepers.

The primary clinical development channel relies heavily on established academic medical centers and research institutions. Anixa Biosciences, Inc. has a clear partnership structure here. For the breast cancer vaccine, the key channel is the Cleveland Clinic, where the Phase 1 trial was conducted and where final data is set to be presented on December 11, 2025, at the San Antonio Breast Cancer Symposium. This collaboration also involves the U.S. Department of Defense, which fully funded the Phase 1 trial. Also, the ovarian cancer immunotherapy program, using CER-T technology, is being developed in collaboration with the Moffitt Cancer Center. Furthermore, the ovarian cancer vaccine development involves the National Cancer Institute.

The path to commercialization is channeled through licensing and technology transfer agreements. This is a core part of Anixa Biosciences, Inc.'s model, as evidenced by the financial structure with its partners. Specifically, Cleveland Clinic is entitled to royalties and other commercialization revenues from Anixa Biosciences, Inc. related to the vaccine technologies. A critical step in securing future commercial control was the execution of the Data Transfer Agreement (DTA) with Cleveland Clinic on November 5, 2025, which is key for transferring the Investigational New Drug (IND) sponsorship.

Capital raising is channeled directly to investors through presentations and conferences. Anixa Biosciences, Inc. was scheduled to participate in the Water Tower Research Fireside Chat on Tuesday, November 11, 2025, and also planned to present at the Spartan Capital Securities Second Annual Investor Conference. The company's financial discipline has helped maintain this channel access; they ended the quarter ended July 31, 2025, with over $17 million in cash and no debt, following a fiscal year 2024 cash utilization of only $7 million. They have approximately 32 million common shares outstanding as of May 2025.

Direct regulatory interaction with the U.S. Food and Drug Administration (FDA) is a non-negotiable channel. Anixa Biosciences, Inc. initiated the transfer of the breast cancer vaccine IND application from Cleveland Clinic on August 4, 2025, with the goal to assume full IND sponsorship. To manage this, Anixa engaged Advyzom, a regulatory consulting firm, to serve as its U.S. regulatory agent for the assigned application. The most recent FDA-related event reported was on September 22, 2025, categorized as 'Results' concerning alpha-lactalbumin. Historically, the FDA approved a single patient IND application to re-dose a patient in October 2024.

Here's a quick look at the key institutional channels and associated data points as of late 2025:

Channel Type	Key Institution/Event	Associated Metric/Status
Clinical Development Partner	Cleveland Clinic	Conducted Phase 1 Breast Cancer Vaccine Trial
Clinical Development Partner	Moffitt Cancer Center	Developing Ovarian Cancer CER-T Program
Regulatory Filing/Sponsorship	FDA	IND Transfer initiated August 4, 2025
Commercialization/Licensing	Cleveland Clinic	Entitled to royalties and other commercialization revenues
Capital Raising Event	Water Tower Research Fireside Chat	Scheduled for November 11, 2025

The company's reliance on these established scientific and regulatory channels dictates its near-term operational focus. The successful assumption of the IND sponsorship is the immediate action required to proceed.

• Phase 1 Breast Cancer Vaccine Enrollment: 35 women total
• Breast Cancer Vaccine Data Presentation Date: December 11, 2025
• Cash on Hand (as of Q3 2025 ended Jul 31, 2025): Over $17 million
• Regulatory Agent for IND Transfer: Advyzom
• Most Recent FDA-Related Event Date: September 22, 2025

Finance: draft 13-week cash view by Friday.

Anixa Biosciences, Inc. (ANIX) - Canvas Business Model: Customer Segments

You're looking at the core groups Anixa Biosciences, Inc. (ANIX) targets with its pipeline of cancer vaccines and CAR-T therapies. Since ANIX is a clinical-stage company, its immediate 'customers' are the patients enrolled in its trials, but the long-term segments are defined by the indications they are pursuing-primarily women with breast and ovarian cancers.

The business model hinges on developing these novel immunotherapies through partnerships with top-tier research institutions, like the Cleveland Clinic and Moffitt Cancer Center, before seeking eventual licensing or commercialization with larger partners. This de-risking strategy targets segments where the unmet need is highest, which translates to significant potential market size down the road.

For the ovarian cancer CAR-T therapy, the segment is adult women with recurrent ovarian cancer who have progressed after at least two prior lines of therapy. This is a population with a poor prognosis; for example, the five-year survival rate for Stage 4 ovarian cancer is only 20%. Worldwide, over 200,000 cases of ovarian cancer are diagnosed annually. As of August 18, 2025, the Phase 1 trial was escalating doses, with the fourth cohort receiving three million CAR-positive cells per kilogram of body weight, a 30-fold increase over the initial dose. Some patients treated have survived beyond the expected 3 to 4 months on chemotherapy, with one living 28 months as of late 2025 data points. To date, 12 patients have been treated with this FSHR-directed cell therapy.

The breast cancer vaccine targets two distinct patient groups, which are subsets of the much larger breast cancer population. In the U.S. alone, over 300,000 women were expected to be diagnosed with breast cancer in 2024, and the early-stage breast cancer market is estimated to be over $30 billion in the next decade. The Phase 1 trial, fully funded by a U.S. Department of Defense grant, completed its final patient visit on October 7, 2025, enrolling a total of 35 women across three cohorts.

The specific cohorts within the breast cancer vaccine trial define the near-term customer segments for that program:

Customer Segment Proxy	Product Focus	Number of Patients Enrolled (Phase 1)	Key Outcome Indicator
Women with Recurrent TNBC	Therapeutic Vaccine	26	Protocol-defined immune responses in >70% of participants
Women at High Risk (Prevention)	Preventive Vaccine	4	Safety and Immune Response
Post-operative Patients on Pembrolizumab	Adjuvant Vaccine	5	Safety and Concurrent Efficacy Signal

The ultimate customer base for the vaccine technology, should it prove effective for prevention, is massive. In the U.S., nearly 80 million women are age 40 and over, the time when breast cancer risk increases. This prophylactic market is considered sizable, bigger than the market for any single cancer therapeutic, because it can be administered to a far wider, currently healthy population.

The final segment involves the oncologists and specialized cell therapy centers who will administer the treatments and manage the patient populations. While Anixa Biosciences, Inc. (ANIX) is currently running trials through partners like Moffitt Cancer Center, the successful transfer of the Investigational New Drug (IND) sponsorship to ANIX in November 2025 signals a move toward greater operational control, which will eventually require establishing relationships with specialized treatment centers for broader commercialization. The company's market capitalization as of mid-November 2025 was $137 million, and analysts, as of November 24, 2025, held a consensus rating of Strong Buy based on 3 analysts, suggesting high expectations for these customer segments to translate into future value, despite reported net losses of $2.28M in Q3 2025.

• Large pharmaceutical and biotechnology companies for eventual licensing and commercialization.
• Patients with recurrent ovarian cancer who have exhausted other treatment options.
• Women at high risk for breast cancer recurrence or primary prevention.
• Oncologists and specialized cell therapy centers.

Finance: draft 13-week cash view by Friday.

Anixa Biosciences, Inc. (ANIX) - Canvas Business Model: Cost Structure

The Cost Structure for Anixa Biosciences, Inc. (ANIX) is heavily weighted toward the foundational, non-revenue-generating activities required to advance its therapeutic and vaccine pipeline. This is typical for a clinical-stage biotech company focused on novel oncology platforms.

The most significant recurring operational costs center on Research and Development (R&D) expenses. For the quarter ended January 31, 2025, the R&D spend was approximately $1,552,000. This figure reflects ongoing investment in the breast cancer vaccine program and costs associated with the ovarian cancer CAR-T therapeutics.

General and administrative (G&A) expenses represent the second major component of the fixed cost base. For that same quarter, G&A expenses totaled $1,834,000. This cost category covers essential corporate functions, though it saw a decrease from the prior year due to reduced investor relations spending.

You can see a breakdown of these key quarterly operating costs below:

Cost Category	Amount for Quarter Ended January 31, 2025
Research and Development (R&D) Expenses	$1,552,000
General and Administrative (G&A) Expenses	$1,834,000
Net Loss for the Quarter	$3,213,000
Cash Used in Operating Activities (3 Months)	$2,904,000

Beyond the recurring operational overhead, Anixa Biosciences, Inc. (ANIX) faces substantial variable costs tied directly to its development strategy. Clinical trial costs are likely to be significantly higher than for more conventional products because the personalized nature of its candidates involves several complex and costly manufacturing and processing steps. Furthermore, the business model includes specific contractual obligations, such as license fees related to the ovarian cancer CAR-T therapeutics, which are expensed as incurred or upon milestone achievement.

The company's capital efficiency is often highlighted by its cash burn rate. The low average annual cash burn is stated to be in the range of $5-7 million, which is definitely capital-efficient for a biotech company at this stage. This is supported by the cash usage in the first quarter of 2025, where cash used in operating activities was approximately $2,904,000, or about $8.7 million annualized if sustained, placing it within the expected range.

Key drivers influencing the overall cost structure include:

• Clinical trial costs for advancing the breast and ovarian cancer programs.
• Manufacturing of trial materials for personalized cell and vaccine therapies.
• License fees and milestone payments tied to intellectual property access.
• General corporate overhead, including executive salaries and facilities.

Anixa Biosciences, Inc. (ANIX) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Anixa Biosciences, Inc. (ANIX) as of late 2025. Honestly, for a clinical-stage biotech, this section is all about the present trickle versus the future floodgates. Right now, the model is lean, focused on conserving capital while pushing science forward.

Currently, Anixa Biosciences, Inc. (ANIX) is a pre-revenue company with $0.000 in commercial revenue for the first three quarters of fiscal year 2025. The company has not generated any revenue to date from its therapeutics or vaccine programs, and it does not expect to begin generating revenue in the near term from these programs.

The only income stream recorded in the recent past comes from the balance sheet, not operations. Interest income from cash and investments was $173,000 for the quarter ended January 31, 2025. This figure was down from $319,000 in the same quarter the prior year, mainly because of a reduction in short-term investments and lower interest rates.

Here's a quick look at the non-operating income near the start of 2025:

Metric	Amount (Three Months Ended Jan 31, 2025)
Commercial Revenue	$0
Interest Income	$173,000
Net Loss	$3,213,000

Future revenue is projected to come from milestone payments and royalties from licensing agreements. The company's business model conserves funds by collaborating with third parties to develop its technologies, aiming to eventually license them to large pharmaceutical companies. For instance, the license agreement with Cleveland Clinic for the ovarian cancer vaccine technology requires Anixa Biosciences to make certain cash payments to Cleveland Clinic upon the achievement of specific development milestones.

The potential for significant revenue hinges on these future events. You should keep an eye on these key areas that could trigger payments:

• Milestone payments from licensing deals.
• Royalties based on future product sales.
• Advancement of the CAR-T therapy and Breast Cancer Vaccine.

Plus, Anixa Biosciences, Inc. maintains the option for potential equity financing through its at-the-market offering program. The company incurred cash used in financing activities of approximately $17,000 due to expenses related to maintaining this equity offering program as of January 31, 2025. The issuance of shares through this program, if executed, would raise capital but would also dilute existing stockholders' percentage ownership interest.

Finance: draft 13-week cash view by Friday.