Anixa Biosciences, Inc. (ANIX) Business Model Canvas

Anixa Biosciences, Inc. (ANIX): Business Model Canvas [Dec-2025 Updated]

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You're looking for a clear-eyed view of Anixa Biosciences, Inc.'s operational framework as a clinical-stage biotech, and honestly, the Business Model Canvas is the perfect tool to map out their high-risk, high-reward strategy. This company is betting big on novel cancer immunotherapy-think a first-in-class breast cancer vaccine and a differentiated CAR-T for solid tumors, built on partnerships with places like Cleveland Clinic and Moffitt Cancer Center. Right now, as of the start of 2025, they are pre-revenue, burning cash on Research and Development (R&D)-we're talking about roughly $1,552,000 in R&D costs for the quarter ended January 31, 2025-but they hold over $17 million in cash and investments to fund those critical Phase 1/2 trials. Dive below to see exactly how Anixa Biosciences, Inc. plans to turn these scientific assets and strategic alliances into future royalty streams and major licensing deals; it's a classic biotech gamble, defintely worth unpacking.

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

You're hiring before product-market fit, so your partnerships are everything right now. Anixa Biosciences, Inc. (ANIX) clearly leans on a partner-driven model, using world-renowned institutions to advance its pipeline while maintaining a lean capital structure. Honestly, this is how many clinical-stage biotechs survive.

Strategic collaboration with Cleveland Clinic for vaccine development and clinical trials

Anixa Biosciences, Inc. (ANIX) has a deep, ongoing collaboration with the Cleveland Clinic for its breast cancer vaccine program. This relationship is formalized through a Joint Development and Option Agreement entered into on May 3, 2024. The Phase 1 trial for the breast cancer vaccine, which evaluated safety and immunogenicity, was conducted at the Cleveland Clinic. As of November 2025, Anixa Biosciences, Inc. (ANIX) executed a data transfer agreement (DTA) with the Cleveland Clinic on November 5, 2025, to support the transfer of the Investigational New Drug (IND) sponsorship to Anixa Biosciences, Inc. (ANIX) ahead of Phase 2 planning.

Moffitt Cancer Center partnership for the CAR-T ovarian cancer program

The ovarian cancer immunotherapy program utilizes novel chimeric endocrine receptor-T cell (CER-T) technology and is being developed in collaboration with Moffitt Cancer Center. As of November 2025, Anixa Biosciences, Inc. (ANIX) completed dosing in the fourth cohort of its Phase 1 CAR-T therapy trial targeting recurrent ovarian cancer with Moffitt Cancer Center. Furthermore, Anixa Biosciences, Inc. (ANIX) announced the World Health Organization (WHO) approval of an International Non-Proprietary Name for its CAR-T therapy on November 17, 2025, marking a milestone toward future commercialization.

U.S. Department of Defense (DoD) grant funding for the breast cancer vaccine Phase 1 trial

The Phase 1 clinical trial for the breast cancer vaccine is entirely supported by external funding, specifically a U.S. Department of Defense (DoD) grant awarded to the Cleveland Clinic. This institutional backing is a key validation point for the technology. The final results from this DoD-funded Phase 1 trial are scheduled for presentation at the San Antonio Breast Cancer Symposium on December 11, 2025.

Licensing agreements with academic institutions for core technology rights

Anixa Biosciences, Inc. (ANIX)'s business model relies on exclusive licensing from its academic partners. The Cleveland Clinic exclusively licensed the breast cancer vaccine technology and is entitled to royalties and other commercialization revenues from Anixa Biosciences, Inc. (ANIX) related to these vaccine technologies. The Joint Development and Option Agreement with the Cleveland Clinic Foundation (CCF) requires development funding in three tranches, with the third payment due on January 31, 2026. Anixa Biosciences, Inc. (ANIX) also secured a Notice of Allowance for a patent in China covering its breast cancer vaccine technology, which provides protection until the 2040s.

Here's a quick look at the structure of these key academic relationships:

Partner Institution Program/Technology Financial/Structural Detail IP Protection Milestone
Cleveland Clinic Breast Cancer Vaccine (aLA) Entitled to royalties and other commercialization revenues Canadian patent allowance; China patent protection into the 2040s
Moffitt Cancer Center Ovarian Cancer CER-T Collaboration for development New U.S. patent for CAR-T technology extending protection until 2045
Cleveland Clinic Foundation (CCF) Joint Development & Option Agreement Development funding in three tranches; third tranche due January 31, 2026 Agreement effective May 3, 2024

Future large pharmaceutical/biotech companies for commercialization and scale

Anixa Biosciences, Inc. (ANIX)'s current business model relies on strategic collaborations with commercial partners to provide the infrastructure for manufacturing, marketing, and sales, as its therapeutic and vaccine programs are pre-revenue. The company's average annual cash burn has been approximately $5-6 million, with a burn limited to just $7 million in the most recent fiscal year (ending October 31, 2024). As of late 2025, the company maintains a healthy current ratio of 8.45, with more cash than debt on its balance sheet, supporting its lean, partner-driven approach.

The path to commercialization for both the breast cancer vaccine and the CAR-T therapy is contingent on securing these future large-scale partnerships. Key upcoming data points that will inform these discussions include:

  • Final Phase 1 data (Breast Cancer Vaccine) presentation at SABCS, December 11, 2025.
  • Anticipated FDA interaction and protocol development for Phase 2 following data readout.
  • Ongoing patient monitoring across trials throughout the second half of 2025.

Finance: draft 13-week cash view by Friday.

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

You're looking at the core engine of Anixa Biosciences, Inc. (ANIX) right now-the activities that consume capital but are designed to generate massive future value through successful clinical translation. Honestly, for a pre-revenue biotech, this section is where the real action is, and it's all about execution on the science.

Conducting and sponsoring Phase 1/2 clinical trials for the cancer vaccine and CAR-T programs.

The breast cancer vaccine program is definitely leading the charge. You should know that the Phase 1 trial enrollment wrapped up on October 7, 2025. That study involved 35 women in total. Specifically, that broke down into 26 patients in the triple-negative breast cancer (TNBC) cohort, 4 in the prevention cohort, and 5 receiving the vaccine alongside pembrolizumab. Preliminary data showed that over 70% of participants achieved the protocol-defined immune responses. The next big step is presenting the final Phase 1 data on December 11, 2025, at the San Antonio Breast Cancer Symposium, right before Anixa Biosciences, Inc. plans to assume full IND (Investigational New Drug) sponsorship to advance into a Phase 2 trial.

For the CAR-T therapy, targeting ovarian cancer, the Phase 1 trial is moving into its later stages. As of mid-November 2025, the company was expecting to start the 5th dose cohort soon. A major milestone was achieved on November 17, 2025, when the World Health Organization approved the International Non-Proprietary Name, liraltagene autoleucel. This is key for global recognition.

Here's a quick snapshot of the trial progress:

Program Trial Phase Status (Late 2025) Key Metric/Target Next Major Milestone
Breast Cancer Vaccine Phase 1 Enrollment Complete 35 total patients enrolled Phase 2 initiation planned after December 11, 2025 data presentation
Ovarian Cancer CAR-T Phase 1 Ongoing Approaching 5th dose cohort start Global recognition via WHO INN approval (liraltagene autoleucel)

Research and development (R&D) to advance pre-clinical solid tumor CAR-T candidates.

While the ovarian cancer CAR-T is in Phase 1, Anixa Biosciences, Inc. is already looking ahead. The plan for 2025 included kicking off pre-clinical studies to test the CAR-T platform's effectiveness against other solid tumors. This shows you they are focused on platform expansion, not just a single indication. The R&D expenses reflect this work; for the quarter ending January 31, 2025, R&D expenses were approximately $1,552,000.

Global intellectual property (IP) management, securing patents until the mid-2040s.

Protecting the science is a critical activity, and Anixa Biosciences, Inc. has been successful here. They recently secured a key U.S. patent, Number 12,472,205, set to be issued on November 18, 2025. This patent, along with others, locks down foundational protection for the breast cancer vaccine program into the mid-2040s. To be fair, they also secured a Chinese patent extending protection into the 2040s. This long IP runway is what makes future licensing deals valuable.

Securing non-dilutive funding, like grants, to offset R&D costs.

Anixa Biosciences, Inc. is actively trying to keep its capital structure clean, meaning they prefer non-equity funding sources. The breast cancer vaccine trial itself is fully funded by a U.S. Department of Defense grant. Furthermore, management has confirmed they have applied for additional grant funding from the U.S. government. This focus on grants helps them manage their cash burn, which resulted in a trailing twelve months net loss of -$11.12 million as of July 31, 2025. As of January 31, 2025, the company held $18,686,000 in total current assets, with cash and cash equivalents at $1,053,000. They are definitely prioritizing operational discipline.

You should keep an eye on their non-dilutive efforts, as they are a core part of the strategy to avoid shareholder dilution.

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

You're looking at the core assets Anixa Biosciences, Inc. (ANIX) relies on to drive its value proposition forward. These aren't just ideas; they are protected, tangible, and financial assets that anchor the entire business structure.

The foundation of Anixa Biosciences, Inc.'s therapeutic pipeline rests on two distinct, licensed technology platforms, each backed by significant intellectual property.

Key Resource Category Specific Asset/Detail Associated Partner/Origin Key Numerical/Date Data Point
Proprietary Technology Platform Chimeric Endocrine Receptor-T cell (CER-T) technology The Wistar Institute (licensed) Currently in a Phase 1 clinical trial at Moffitt Cancer Center for ovarian cancer
Exclusive License Alpha-lactalbumin breast cancer vaccine technology Cleveland Clinic (exclusively licensed) New U.S. Patent No. 12,472,205 issued November 18, 2025, extending IP protection into the mid-2040s
Intellectual Property Patent Portfolio Multiple (Wistar Institute, Cleveland Clinic) Portfolio includes protection for both CER-T and vaccine programs across multiple tumor types
Financial Strength Cash and Investments Internal Balance Sheet Over $17 million in cash and no debt as of May 2025

The CER-T platform is specifically engineered to overcome challenges in solid tumors, differentiating itself by targeting the follicle-stimulating hormone receptor (FSHR) using its natural ligand, FSH, rather than an antibody fragment. This approach is currently being tested in recurrent ovarian cancer patients.

The vaccine technology, which targets the $\alpha$-lactalbumin protein, has seen recent IP reinforcement. A key patent issuance on November 18, 2025, strengthens the foundational protection for this program, which is being advanced toward a Phase 2 clinical trial.

Financially, Anixa Biosciences, Inc. has maintained a lean operation. While the company reported a net loss of $6.47 million for Q3 2025 and generated no revenue for that quarter, the balance sheet as of April 30, 2025, showed approximately $15,597,000 in cash, cash equivalents, and short-term investments. The CEO noted in May 2025 that this provided more than two years of operational runway.

The human capital is centered around specialized expertise through strategic partnerships, which is a core part of the business model to conserve internal resources. Key personnel and institutions involved include:

  • Specialized scientific and clinical development personnel through partnerships with Moffitt Cancer Center for CER-T development.
  • Inventors and researchers at Cleveland Clinic for the vaccine technology.
  • The technology itself was licensed from The Wistar Institute for the CER-T program.

The company's capital structure is also a key resource, with approximately 32 million common shares outstanding as of May 28, 2025, and no warrants, which is described as a very clean structure.

Finance: review the Q3 2025 operating costs ($4.08M SG&A and $2.99M R&D) against the current cash position to project runway into Q4 2026 by next Tuesday.

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.


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