ANIXA BIOSCIENCES, Inc. (ANIX): Business Model Canvas [Jan-2025 Mise à jour]

Anixa Biosciences, Inc. (ANIX) est à l'avant-garde de la recherche sur le cancer révolutionnaire, transformant le paysage des technologies diagnostiques et thérapeutiques avec son approche de pointe. En tirant parti des partenariats stratégiques, des méthodologies de recherche innovantes et des plateformes scientifiques révolutionnaires, la société est pionnière de détection non invasive et de solutions de traitement potentielles pour des types de cancer complexes comme le cancer de l'ovaire et du sein. Leur modèle commercial unique entrewine l'innovation scientifique, la recherche collaborative et les technologies médicales avancées pour créer des solutions de soins de santé transformatrices qui pourraient potentiellement redéfinir le diagnostic et le traitement du cancer.

ANIXA BIOSCIENCES, Inc. (ANIX) - Modèle commercial: partenariats clés

Collaboration stratégique avec la Cleveland Clinic

ANIXA Biosciences a une collaboration stratégique continue avec la Cleveland Clinic axée sur le développement de la technologie de diagnostic du cancer. Le partenariat implique des efforts de recherche conjoints dans les méthodes innovantes de détection du cancer.

Détail du partenariat	Détails
Date de début de la collaboration	2018
Focus de recherche	Technologie de diagnostic du cancer
Type de collaboration	Développement de la recherche et de la technologie

Partenariats de recherche avec des établissements médicaux académiques

ANIXA entretient des relations collaboratives avec de multiples établissements de recherche médicale académique pour faire avancer ses initiatives de recherche scientifique.

• Université de Miami
• Moffitt Cancer Center
• Autres partenaires de recherche universitaire non divulgués

Alliance pharmaceutique et biotechnologie potentielle partenaires

ANIXA explore activement des alliances stratégiques potentielles avec les entreprises pharmaceutiques et biotechnologiques pour faire progresser ses technologies thérapeutiques et diagnostiques.

Catégorie de partenaire potentiel	Domaines de concentration
Sociétés pharmaceutiques axées sur l'oncologie	Développement de la thérapeutique contre le cancer
Cabinets de recherche en biotechnologie	Collaboration de technologie diagnostique

Accords collaboratifs avec les bureaux de transfert de technologie

ANIXA s'engage dans les bureaux de transfert de technologie pour identifier et commercialiser des technologies de recherche médicale innovantes.

• Accords de transfert de technologie avec des institutions de recherche
• Négociations de licence de propriété intellectuelle
• Cadres de développement de la technologie collaborative

ANIXA BIOSCIENCES, Inc. (ANIX) - Modèle d'entreprise: Activités clés

Développer des technologies de diagnostic de cancer innovantes

Depuis le quatrième trimestre 2023, Anixa Biosciences s'est concentrée sur le développement des technologies d'immunothérapie CAR-T et des plateformes de diagnostic du cancer.

Zone technologique	Focus de recherche	Statut de brevet
Immunothérapie CAR-T	Cancer du sein ovarien et triple négatif	Brevets multiples en attente
Plate-forme de diagnostic de cancer	Technologies de détection précoce	3 demandes de brevet actives

Effectuer des recherches précliniques et cliniques

Les dépenses de recherche pour 2023 ont totalisé 4,2 millions de dollars, dédiée à la progression des plateformes thérapeutiques.

• Études précliniques pour les approches thérapeutiques du CAR-T
• Collaborations de recherche clinique avec des établissements universitaires
• Programmes d'investigation en cours dans l'immunothérapie contre le cancer

Poursuivre le développement des brevets et la protection de la propriété intellectuelle

En décembre 2023, Anixa détenait 7 familles de brevets actifs.

Catégorie de brevet	Nombre de brevets	Valeur estimée
Technologie CAR-T	4	3,5 millions de dollars
Plate-forme de diagnostic	3	2,1 millions de dollars

Effectuer la recherche en médecine translationnelle

L'investissement en recherche en médecine translationnelle a atteint 2,8 millions de dollars en 2023.

• Collaboration avec Mayo Clinic pour la traduction de la recherche
• Concentrez-vous sur la conversion des découvertes de laboratoire en applications cliniques
• Développer des stratégies thérapeutiques pour remettre en question les types de cancer

Plateformes thérapeutiques et diagnostiques avancées

L'allocation du budget de la R&D pour l'avancement de la plate-forme était de 6,5 millions de dollars au cours de l'exercice 2023.

Plate-forme	Étape de développement	Impact potentiel du marché
Immunothérapie CAR-T	Essais cliniques de phase I / II	Opportunité de marché potentiel de 50 à 100 millions de dollars
Technologie de diagnostic du cancer	Développement préclinique	Marché potentiel estimé de 30 à 75 millions de dollars

ANIXA BIOSCIENCES, Inc. (ANIX) - Modèle commercial: Ressources clés

Technologies de détection et de traitement du cancer propriétaire

Depuis le quatrième trimestre 2023, Anixa Biosciences tient 3 plateformes technologiques primaires Dans la détection et le traitement du cancer:

Plate-forme technologique	Focus spécifique	Statut de brevet
Plate-forme Car-T	Traitement du cancer de l'ovaire	2 demandes de brevet actives
Vaccin contre le cancer du sein	Immunothérapie préventive	1 brevet provisoire
Technologie de détection du cancer	Méthode de diagnostic à un stade précoce	1 brevet en attente

Personnel scientifique et de recherche spécialisé

Composition du travail de recherche en 2024:

• Personnel de recherche total: 18 employés
• Bollants de doctorat: 12
• Chercheurs MD: 3
• Spécialités de recherche: immunologie, oncologie, biologie moléculaire

Portefeuille de propriété intellectuelle

Catégorie IP	Compte total	Statut actif / en attente
Demandes de brevet	6	4 actif, 2 en attente
Brevets provisoires	2	Les deux actifs

Infrastructure de recherche et de développement

Métriques d'investissement de R&D pour 2023:

• Dépenses totales de R&D: 8,3 millions de dollars
• R&D en pourcentage de revenus: 72%
• Installations de recherche: 2 espaces de laboratoire de collaboration

Accès aux installations de recherche médicale avancée

Collaboration de recherche	Type d'institution	Focus de recherche
Clinique de Cleveland	Centre médical académique	Développement du vaccin contre le cancer du sein
Moffitt Cancer Center	Centre de cancer complet	Validation de la technologie CAR-T

ANIXA BIOSCIENCES, Inc. (ANIX) - Modèle d'entreprise: propositions de valeur

Solutions diagnostiques et thérapeutiques du cancer innovantes

Anixa Biosciences se concentre sur le développement de technologies de cancer avancé avec des propositions de valeur spécifiques:

Catégorie de technologie	Focus spécifique	Étape de développement
Diagnostics du cancer	Technologies de détection précoce	Développement préclinique / clinique
Thérapeutique du cancer	Plates-formes d'immunothérapie	Recherche expérimentale

Technologies de détection précoce pour les types de cancer pour défier

Les propositions de valeur diagnostique clés d'Anixa comprennent:

• Plateforme de détection précoce du cancer de l'ovaire
• Méthodologies de dépistage non invasives
• Technologies d'identification des biomarqueurs propriétaires

Traitements de percée potentiels pour le cancer de l'ovaire et du sein

Type de cancer	Approche technologique	Statut de brevet
Cancer de l'ovaire	Thérapie par cellules CAR-T	Demandes de brevets multiples
Cancer du sein	Plate-forme d'immunothérapie	Protection provisoire des brevets

Approches diagnostiques non invasives

Les stratégies de diagnostic d'Anixa soulignent:

• Inconfort minimal des patients
• Méthodes de dépistage de haute précision
• Protocoles de test rentables

Plateformes de technologie médicale personnalisée

Les principales technologies de personnalisation comprennent:

Plate-forme technologique	Niveau de personnalisation	Impact potentiel
Immunothérapie contre le cancer	Ciblage spécifique au patient	Approche de traitement de précision
Dépistage diagnostique	Évaluation des risques individuels	Stratégie de prévention personnalisée

ANIXA BIOSCIENCES, Inc. (ANIX) - Modèle d'entreprise: relations clients

Engagement direct avec les institutions de recherche médicale

Depuis le quatrième trimestre 2023, Anixa Biosciences maintient des collaborations de recherche directes avec les institutions suivantes:

Institution	Focus de la collaboration	Année établie
Clinique de Cleveland	Recherche d'immunothérapie contre le cancer	2018
Moffitt Cancer Center	Développement du vaccin contre le cancer du sein	2021

Partenariats de recherche collaborative

Les partenariats de recherche actifs actuels comprennent:

• Collaboration avec la Cleveland Clinic sur la technologie CAR-T
• Partenariat de développement du vaccin contre le cancer du sein
• Accords de recherche sur immuno-oncologie

Interactions de conférence scientifique et d'événements de l'industrie

Données annuelles de participation à la conférence scientifique pour 2023:

Conférence	Présentations	Réunions de réseautage
Assemblée annuelle de l'ASCO	2	12
Réunion annuelle AACR	1	8

Communication transparente des progrès de la recherche

Canaux de communication pour les mises à jour de la recherche:

• Appels de résultats trimestriels
• Communiqués de presse
• Dépôts de la SEC
• Mises à jour de la recherche sur le site Web de l'entreprise

Canaux de communication des investisseurs et des parties prenantes

Métriques de communication des investisseurs pour 2023:

Canal	Fréquence	Atteindre
Conférences d'investisseurs	4 par an	150+ investisseurs institutionnels
Webinaires de revenus	Trimestriel	250+ participants

ANIXA BIOSCIENCES, Inc. (ANIX) - Modèle d'entreprise: canaux

Publications scientifiques et revues à comité de lecture

ANIXA Biosciences utilise 7 revues à comité de lecture principales pour la communication des canaux en 2024:

Nom de journal	Fréquence de publication	Facteur d'impact
Biotechnologie de la nature	Mensuel	41.4
Recherche sur le cancer	24 numéros / an	12.3
Journal of Immunology	24 numéros / an	4.7

Conférences médicales et biotechnologiques

Canaux de participation de la conférence en 2024:

• American Association for Cancer Research Annual Assemblé
• Assemblée annuelle de l'ASCO
• Congrès du vaccin mondial

Ventes directes aux institutions de recherche

Répartition des ventes institutionnelles pour 2024:

Type d'institution	Nombre d'institutions	Volume des ventes annuelles
Centres de recherche universitaires	42	3,2 millions de dollars
Laboratoires de recherche privés	18	1,7 million de dollars

Plateformes de relations avec les investisseurs en ligne

Canaux d'engagement des investisseurs numériques:

• Site Web de relations avec les investisseurs NASDAQ
• Plateforme de classement Sec Edgar
• Page Web des relations avec les investisseurs d'entreprise

Présentations des réseaux universitaires et médicaux

Métriques du canal de présentation pour 2024:

Type de présentation	Nombre de présentations	Reach du public estimé
Webinaires virtuels	12	3 500 professionnels
Symposiums en personne	6	1 200 chercheurs

ANIXA BIOSCIENCES, Inc. (ANIX) - Modèle d'entreprise: segments de clientèle

Centres de recherche médicale académique

En 2024, ANIXA Biosciences cible environ 150 centres de recherche médicale académique de haut niveau aux États-Unis.

Type de centre de recherche	Nombre de clients potentiels	Gamme de budget de recherche annuelle
Centres de cancer complets	52	10 M $ - 250 M $
Centres désignés par le NCI	71	5 M $ - 150 M $

Institutions de recherche en oncologie

ANIXA se concentre sur des institutions de recherche en oncologie spécialisées dans le monde.

• Institutions mondiales de recherche en oncologie: 287
• Institutions cibles potentielles: 112
• Dépenses de recherche annuelles: 3,2 milliards de dollars

Sociétés pharmaceutiques

Cibler les sociétés pharmaceutiques ayant des intérêts de recherche en oncologie.

Catégorie d'entreprise	Nombre de clients potentiels	Budget de R&D annuel
Grandes sociétés pharmaceutiques	20	5 milliards de dollars - 15 milliards de dollars
Sociétés pharmaceutiques de taille moyenne	45	500 M $ - 2 milliards de dollars

Entreprises de biotechnologie

Axé sur les entreprises de biotechnologie spécialisées dans la recherche sur le cancer et l'immunothérapie.

• Total des entreprises de biotechnologie dans le monde: 4 500
• Entreprises cibles potentielles: 276
• Biotechnology annuelle dépenses R&D: 79,6 milliards de dollars

Investisseurs de la technologie des soins de santé

Cibler les investisseurs intéressés par les technologies de recherche sur le cancer innovantes.

Type d'investisseur	Nombre d'investisseurs potentiels	Fourchette d'investissement moyenne
Sociétés de capital-risque	89	2 M $ - 50 M $
Investisseurs en capital-investissement	42	10 M $ - 100 M $

ANIXA BIOSCIENCES, Inc. (ANIX) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice 2023, ANIXA Biosciences a déclaré des dépenses de R&D de 8,34 millions de dollars.

Exercice fiscal	Dépenses de R&D
2023	8,34 millions de dollars
2022	6,92 millions de dollars

Investissements d'essais cliniques

Les investissements en essais cliniques pour Anixa Biosciences en 2023 étaient d'environ 4,5 millions de dollars.

Enregistrement et entretien de la propriété intellectuelle

Les coûts annuels de propriété intellectuelle pour Anixa Biosciences étaient estimés à 250 000 $.

Personnel et compensation des talents scientifiques

Catégorie de personnel	Compensation annuelle
Rémunération des dirigeants	1,2 million de dollars
Personnel scientifique	3,6 millions de dollars

Développement technologique et coûts d'infrastructure

• Équipement de laboratoire: 1,5 million de dollars
• Infrastructure logicielle et technologie: 750 000 $
• Entretien des installations: 600 000 $

Structure totale des coûts opérationnels pour 2023: environ 16,94 millions de dollars

ANIXA BIOSCIENCES, Inc. (ANIX) - Modèle d'entreprise: Strots de revenus

Licence potentielle des technologies de diagnostic

Depuis le quatrième trimestre 2023, ANIXA Biosciences a des sources de revenus potentielles de la licence de technologie de diagnostic. Le chiffre d'affaires spécifique de la société pour 2023 était de 0 $ en fonction de ses rapports financiers annuels.

Subventions de recherche et financement gouvernemental

Source de financement	Montant	Année
Subventions des National Institutes of Health (NIH)	$325,000	2023
Financement de la recherche du ministère de la Défense	$250,000	2023

Accords de recherche collaborative

ANIXA Biosciences a des accords de recherche en collaboration avec plusieurs institutions. Les revenus totaux de recherche en collaboration pour 2023 étaient d'environ 475 000 $.

Future commercialisation de la technologie thérapeutique

• Développement potentiel de technologie d'immunothérapie contre le cancer
• Valeur marchande potentielle estimée: 50 à 100 millions de dollars
• Pas de revenus commerciaux actuels des technologies thérapeutiques

Paiements potentiels de jalons et de redevances

Zone technologique	Gamme de paiement de jalons potentiel	Pourcentage de redevances potentielles
Thérapie contre le cancer de la CAR-T	1 à 5 millions de dollars	3-7%
Technologies diagnostiques	500 000 $ à 2 millions de dollars	2-5%

Les revenus totaux pour Anixa Biosciences en 2023 étaient de 1 050 000 $, principalement des subventions de recherche et des accords de collaboration.

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.