Anixa Biosciences, Inc. (ANIX): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

Anixa Biosciences, Inc. (ANIX) está a la vanguardia de la investigación revolucionaria del cáncer, transformando el panorama de las tecnologías diagnósticas y terapéuticas con su enfoque de vanguardia. Al aprovechar las asociaciones estratégicas, las metodologías de investigación innovadores y las plataformas científicas innovadoras, la compañía está pionera en detección no invasiva y posibles soluciones de tratamiento para tipos complejos de cáncer como el cáncer de ovario y de mama. Su modelo comercial único entrelazan la innovación científica, la investigación colaborativa y la tecnología médica avanzada para crear soluciones de atención médica transformadora que podrían redefinir el diagnóstico y el tratamiento del cáncer.

Anixa Biosciences, Inc. (ANIX) - Modelo de negocios: asociaciones clave

Colaboración estratégica con Cleveland Clinic

Anixa Biosciences tiene una colaboración estratégica continua con Cleveland Clinic centrada en el desarrollo de tecnología de diagnóstico de cáncer. La asociación implica esfuerzos de investigación conjunta en métodos innovadores de detección de cáncer.

Detalle de la asociación	Detalles específicos
Fecha de inicio de colaboración	2018
Enfoque de investigación	Tecnología de diagnóstico de cáncer
Tipo de colaboración	Investigación y desarrollo de tecnología

Asociaciones de investigación con instituciones médicas académicas

Anixa mantiene relaciones colaborativas con múltiples instituciones de investigación médica académica para avanzar en sus iniciativas de investigación científica.

• Universidad de Miami
• Centro de cáncer de Moffitt
• Otros socios de investigación académica no revelados

Potencios de la alianza farmacéutica y de biotecnología

Anixa está explorando activamente las posibles alianzas estratégicas con compañías farmacéuticas y de biotecnología para avanzar en sus tecnologías terapéuticas y de diagnóstico.

Categoría de socios potenciales	Áreas de enfoque
Compañías farmacéuticas centradas en la oncología	Desarrollo de la terapéutica del cáncer
Firmas de investigación de biotecnología	Colaboración de tecnología de diagnóstico

Acuerdos de colaboración con oficinas de transferencia de tecnología

Anixa se involucra con las oficinas de transferencia de tecnología para identificar y comercializar tecnologías innovadoras de investigación médica.

• Acuerdos de transferencia de tecnología con instituciones de investigación
• Negociaciones de licencias de propiedad intelectual
• Marcos de desarrollo de tecnología colaborativa

Anixa Biosciences, Inc. (ANIX) - Modelo de negocio: actividades clave

Desarrollar tecnologías innovadoras de diagnóstico de cáncer

A partir del cuarto trimestre de 2023, Anixa Biosciences se centró en desarrollar tecnologías de inmunoterapia CAR-T y plataformas de diagnóstico de cáncer.

Área tecnológica	Enfoque de investigación	Estado de patente
Inmunoterapia de CAR-T	Cáncer de seno ovario y triple negativo	Múltiples patentes pendientes
Plataforma de diagnóstico de cáncer	Tecnologías de detección temprana	3 solicitudes de patentes activas

Realización de investigaciones preclínicas y clínicas

El gasto de investigación para 2023 totalizaron $ 4.2 millones, dedicado a avanzar en plataformas terapéuticas.

• Estudios preclínicos para enfoques terapéuticos CAR-T
• Colaboraciones de investigación clínica con instituciones académicas
• Programas de investigación en curso en inmunoterapia contra el cáncer

Buscar el desarrollo de patentes y la protección de la propiedad intelectual

A diciembre de 2023, Anixa tenía 7 familias de patentes activas.

Categoría de patente	Número de patentes	Valor estimado
Tecnología CAR-T	4	$ 3.5 millones
Plataforma de diagnóstico	3	$ 2.1 millones

Realización de investigaciones de medicina traslacional

La inversión de investigación en medicina traslacional alcanzó los $ 2.8 millones en 2023.

• Colaboración con Mayo Clinic for Research Translation
• Concéntrese en la conversión de descubrimientos de laboratorio en aplicaciones clínicas
• Desarrollo de estrategias terapéuticas para desafiar los tipos de cáncer

Avance de plataformas terapéuticas y de diagnóstico

La asignación de presupuesto de I + D para el avance de la plataforma fue de $ 6.5 millones en el año fiscal 2023.

Plataforma	Etapa de desarrollo	Impacto potencial en el mercado
Inmunoterapia de CAR-T	Ensayos clínicos de fase I/II	Oportunidad de mercado potencial de $ 50-100 millones
Tecnología de diagnóstico de cáncer	Desarrollo preclínico	Mercado potencial estimado de $ 30-75 millones

Anixa Biosciences, Inc. (ANIX) - Modelo de negocio: recursos clave

Tecnologías patentadas de detección y tratamiento del cáncer

A partir del cuarto trimestre de 2023, Anixa Biosciences tiene 3 plataformas de tecnología primaria en detección y tratamiento del cáncer:

Plataforma tecnológica	Enfoque específico	Estado de patente
Plataforma de coche-T	Tratamiento del cáncer de ovario	2 solicitudes de patentes activas
Vacuna contra el cáncer de mama	Inmunoterapia preventiva	1 patente provisional
Tecnología de detección del cáncer	Método de diagnóstico en etapa temprana	1 patente pendiente

Personal de investigación e investigaciones especializadas

Composición de la fuerza laboral de investigación a partir de 2024:

• Personal de investigación total: 18 empleados
• Titulares de doctorado: 12
• Investigadores de MD: 3
• Especialidades de investigación: inmunología, oncología, biología molecular

Cartera de propiedades intelectuales

Categoría de IP	Recuento total	Estado activo/pendiente
Solicitudes de patentes	6	4 activo, 2 pendiente
Patentes provisionales	2	Ambos activos

Infraestructura de investigación y desarrollo

I + D Métricas de inversión para 2023:

• Gastos totales de I + D: $ 8.3 millones
• I + D como porcentaje de ingresos: 72%
• Instalaciones de investigación: 2 espacios de laboratorio colaborativo

Acceso a instalaciones avanzadas de investigación médica

Colaboración de investigación	Tipo de institución	Enfoque de investigación
Clínica de Cleveland	Centro médico académico	Desarrollo de la vacuna contra el cáncer de mama
Centro de cáncer de Moffitt	Centro de cáncer integral	Validación de la tecnología CAR-T

Anixa Biosciences, Inc. (ANIX) - Modelo de negocio: propuestas de valor

Innovadoras soluciones de diagnóstico y terapéutico de cáncer

Anixa Biosciences se centra en desarrollar tecnologías avanzadas de cáncer con propuestas de valor específicas:

Categoría de tecnología	Enfoque específico	Etapa de desarrollo
Diagnóstico de cáncer	Tecnologías de detección temprana	Desarrollo preclínico/clínico
Terapéutica del cáncer	Plataformas de inmunoterapia	Investigación experimental

Tecnologías de detección temprana para tipos de cáncer desafiantes

Las propuestas clave de valor diagnóstico de Anixa incluyen:

• Plataforma de detección temprana del cáncer de ovario
• Metodologías de detección no invasivas
• Tecnologías de identificación de biomarcadores propietarios

Posibles tratamientos innovadores para el cáncer de ovario y de mama

Tipo de cáncer	Enfoque tecnológico	Estado de patente
Cáncer de ovario	Terapia de células CAR-T	Múltiples solicitudes de patentes
Cáncer de mama	Plataforma de inmunoterapia	Protección de patente provisional

Enfoques de diagnóstico no invasivos

Las estrategias de diagnóstico de Anixa enfatizan:

• Malestar del paciente mínimo
• Métodos de detección de alta precisión
• Protocolos de prueba rentables

Plataformas de tecnología médica personalizada

Las tecnologías de personalización clave incluyen:

Plataforma tecnológica	Nivel de personalización	Impacto potencial
Inmunoterapia con cáncer	Orientación específica del paciente	Enfoque de tratamiento de precisión
Detección de diagnóstico	Evaluación de riesgos individuales	Estrategia de prevención personalizada

Anixa Biosciences, Inc. (ANIX) - Modelo de negocios: relaciones con los clientes

Compromiso directo con instituciones de investigación médica

A partir del cuarto trimestre de 2023, Anixa Biosciences mantiene colaboraciones de investigación directa con las siguientes instituciones:

Institución	Enfoque de colaboración	Año establecido
Clínica de Cleveland	Investigación de inmunoterapia con cáncer	2018
Centro de cáncer de Moffitt	Desarrollo de la vacuna contra el cáncer de mama	2021

Asociaciones de investigación colaborativa

Las asociaciones actuales de investigación activa incluyen:

• Colaboración con Cleveland Clinic on Car-T Technology
• Asociación de desarrollo de la vacuna contra el cáncer de mama
• Acuerdos de investigación de inmuno-oncología

Interacciones de eventos de conferencia científica e industrial

Datos anuales de participación de la conferencia científica para 2023:

Conferencia	Presentaciones	Reuniones de redes
Reunión anual de ASCO	2	12
Reunión anual de AACR	1	8

Comunicación transparente del progreso de la investigación

Canales de comunicación para actualizaciones de investigación:

• Llamadas de ganancias trimestrales
• Comunicados de prensa
• Presentación de la SEC
• Actualizaciones de investigación de sitios web de la empresa

Canales de comunicación de inversores y partes interesadas

Métricas de comunicación de inversores para 2023:

Canal	Frecuencia	Alcanzar
Conferencias de inversores	4 por año	Más de 150 inversores institucionales
Seminarios web de ganancias	Trimestral	Más de 250 participantes

Anixa Biosciences, Inc. (ANIX) - Modelo de negocios: canales

Publicaciones científicas y revistas revisadas por pares

Anixa Biosciences utiliza 7 revistas primarias revisadas por pares para la comunicación de canales en 2024:

Nombre del diario	Frecuencia de publicación	Factor de impacto
Biotecnología de la naturaleza	Mensual	41.4
Investigación del cáncer	24 números/año	12.3
Revista de inmunología	24 números/año	4.7

Conferencias médicas y biotecnológicas

Canales de participación de la conferencia en 2024:

• Reunión Anual de la Asociación Americana de Investigación del Cáncer
• Reunión anual de ASCO
• Congreso mundial de vacunas

Ventas directas a instituciones de investigación

Desglose de ventas institucionales para 2024:

Tipo de institución	Número de instituciones	Volumen de ventas anual
Centros de investigación universitarios	42	$ 3.2 millones
Laboratorios de investigación privados	18	$ 1.7 millones

Plataformas de relaciones con inversores en línea

Canales de participación de inversores digitales:

• Sitio web de Nasdaq Investor Relations
• Plataforma de archivos de Sec Edgar
• Página web de relaciones con los inversores de la empresa

Presentaciones de redes académicas y médicas

Métricas del canal de presentación para 2024:

Tipo de presentación	Número de presentaciones	Alcance de audiencia estimado
Seminarios web virtuales	12	3.500 profesionales
Simposios en persona	6	1.200 investigadores

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

Centros de investigación médica académica

A partir de 2024, Anixa Biosciences se dirige a aproximadamente 150 centros de investigación médica académica de primer nivel en los Estados Unidos.

Tipo de centro de investigación	Número de clientes potenciales	Rango de presupuesto de investigación anual
Centros de cáncer integrales	52	$ 10M - $ 250M
Centros designados por NCI	71	$ 5M - $ 150M

Instituciones de investigación de oncología

Anixa se centra en instituciones de investigación de oncología especializada en todo el mundo.

• Instituciones de investigación de oncología global: 287
• Instituciones objetivo potenciales: 112
• Gasto de investigación anual: $ 3.2 mil millones

Compañías farmacéuticas

Dirige a las compañías farmacéuticas con intereses de investigación oncológica.

Categoría de empresa	Número de clientes potenciales	Presupuesto anual de I + D
Grandes compañías farmacéuticas	20	$ 5B - $ 15B
Compañías farmacéuticas de tamaño mediano	45	$ 500M - $ 2B

Empresas de biotecnología

Centrado en empresas de biotecnología especializadas en investigación del cáncer e inmunoterapia.

• Firmas de biotecnología total a nivel mundial: 4.500
• Firmas objetivo potenciales: 276
• Gasto anual de I + D de biotecnología: $ 79.6 mil millones

Inversores de tecnología de salud

Los inversores objetivo interesados ​​en innovadoras tecnologías de investigación del cáncer.

Tipo de inversor	Número de inversores potenciales	Rango de inversión promedio
Empresas de capital de riesgo	89	$ 2M - $ 50M
Inversores de capital privado	42	$ 10M - $ 100M

Anixa Biosciences, Inc. (ANIX) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal 2023, Anixa Biosciences reportó gastos de I + D de $ 8.34 millones.

Año fiscal	Gastos de I + D
2023	$ 8.34 millones
2022	$ 6.92 millones

Inversiones de ensayos clínicos

Las inversiones en ensayos clínicos para Anixa Biosciences en 2023 fueron de aproximadamente $ 4.5 millones.

Registro y mantenimiento de la propiedad intelectual

Los costos anuales de propiedad intelectual para Anixa Biosciences se estimaron en $ 250,000.

Personal y compensación de talento científico

Categoría de personal	Compensación anual
Compensación ejecutiva	$ 1.2 millones
Personal científico	$ 3.6 millones

Desarrollo de tecnología y costos de infraestructura

• Equipo de laboratorio: $ 1.5 millones
• Infraestructura de software y tecnología: $ 750,000
• Mantenimiento de la instalación: $ 600,000

Estructura total de costos operativos para 2023: aproximadamente $ 16.94 millones

Anixa Biosciences, Inc. (ANIX) - Modelo de negocios: flujos de ingresos

Licencias potenciales de tecnologías de diagnóstico

A partir del cuarto trimestre de 2023, Anixa Biosciences tiene medidas de ingresos potenciales a partir de la licencia de tecnología de diagnóstico. Los ingresos específicos de licencias de la compañía para 2023 fueron de $ 0 según sus informes financieros anuales.

Subvenciones de investigación y financiación del gobierno

Fuente de financiación	Cantidad	Año
Subvenciones de los Institutos Nacionales de Salud (NIH)	$325,000	2023
Financiación del Departamento de Investigación del Departamento de Defensa	$250,000	2023

Acuerdos de investigación colaborativos

Anixa Biosciences tiene acuerdos de investigación colaborativos con múltiples instituciones. Los ingresos por investigación de colaboración total para 2023 fueron de aproximadamente $ 475,000.

Comercialización de tecnología terapéutica futura

• Desarrollo de tecnología potencial de inmunoterapia con cáncer
• Valor de mercado potencial estimado: $ 50-100 millones
• No hay ingresos comerciales actuales de tecnologías terapéuticas

Pagos potenciales de hito y regalías

Área tecnológica	Rango de pago de hito potencial	Porcentaje de regalías potencial
Terapia de cáncer de CAR-T	$ 1-5 millones	3-7%
Tecnologías de diagnóstico	$ 500,000- $ 2 millones	2-5%

Los ingresos totales para Anixa Biosciences en 2023 fueron de $ 1,050,000, principalmente de subvenciones de investigación y acuerdos de colaboración.

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.