Anixa Biosciences, Inc. (ANIX): History, Ownership, Mission, How It Works & Makes Money

Anixa Biosciences, Inc. (ANIX): History, Ownership, Mission, How It Works & Makes Money

US | Healthcare | Biotechnology | NASDAQ

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How does a clinical-stage biotechnology company with virtually no product revenue become one of the year's top performers, gaining about 71.1% year-to-date by November 2025? Anixa Biosciences, Inc. (ANIX) is not your typical small-cap biotech, operating with a lean, partner-driven model focused on high-impact oncology programs like its pioneering breast cancer vaccine, which just had its foundational intellectual property (IP) protection extended into the mid-2040s. You need to understand how a company with a market capitalization of roughly $144.51 million is tackling a disease projected to strike over 297,000 women in the U.S. this year alone. Let's break down the history, mission, and unique financial engine driving this innovative approach to cancer prevention and treatment.

Anixa Biosciences, Inc. (ANIX) History

Given Company's Founding Timeline

Year established

The corporate entity has a long history, tracing its incorporation back to 1982 in Delaware, initially operating under the name CopyTele, Inc.. The current identity, Anixa Biosciences, Inc., was established much later in 2018 to reflect its dedicated focus on biotechnology.

Original location

While the company was incorporated in Delaware, its operational base has shifted over time. Today, its principal executive offices are located in San Jose, California.

Founding team members

Given the company's dramatic pivot away from its original technology focus, the team most relevant to the current biotech mission is the one that executed the strategic change. This is centered on Dr. Amit Kumar, who took the helm as CEO in 2015 and guided the shift. He is currently the Chairman and CEO, working alongside key executives like Michael J. Catelani, the President, COO, and CFO.

Initial capital/funding

The company operates with a notably lean, capital-efficient model for a development-stage biotech firm. For the 2024 fiscal year, the total cash utilized was only $7 million. A significant capital infusion in the current biotech phase was the $22.5 million bought deal offering of common stock in March 2021. As of May 2025, the company reported having over $17 million in cash and investments, plus a clean balance sheet with no debt. That's a strong cash runway for a company with no revenue.

Given Company's Evolution Milestones

Year Key Event Significance
1982 Incorporated in Delaware as CopyTele, Inc. Marks the legal origin; business model was entirely different from today's oncology focus.
2015 Rebranded as ITUS Corporation; Dr. Amit Kumar appointed CEO. The definitive, transformative shift toward healthcare and biotechnology began here.
Oct 2018 Rebranded as Anixa Biosciences, Inc. Solidified the new identity, focusing exclusively on cancer and infectious diseases.
2018 Licensed Ovarian Cancer Vaccine technology from Cleveland Clinic. Established the core cancer vaccine pipeline, a key current asset.
2023 First patient dosed in Phase 1 trial of Breast Cancer Vaccine. Advanced a second major preventative vaccine candidate into clinical development.
Oct 2025 Completed final patient visit in Phase 1 Breast Cancer Vaccine trial (35 women). Achieved a major clinical milestone, paving the way for full data analysis and a planned Phase 2 trial.
Nov 2025 Awarded key U.S. Patent for Breast Cancer Vaccine IP. Strengthened intellectual property, securing protection for the core technology into the 2040s.

Given Company's Transformative Moments

The most crucial moment in Anixa Biosciences, Inc.'s history wasn't the 1982 founding, but the strategic pivot that began around 2015. Honestly, the company was essentially rebuilt from the ground up, moving from disparate technology ventures to a focused, clinical-stage oncology firm. This was a defintely necessary move to create shareholder value.

This transformation was characterized by two main strategic decisions:

  • The Outsourced R&D Model: Rather than building massive, expensive in-house labs, Anixa chose a capital-efficient model. They license promising, cutting-edge technologies-like the cancer vaccines from Cleveland Clinic and the chimeric endocrine receptor-T cell (CER-T) therapy for ovarian cancer from Moffitt Cancer Center-and then partner with these institutions to run the early clinical trials. This minimizes their cash burn, which averaged only $5-6 million annually before 2024.
  • Focus on Unmet Needs: The company specifically targets high-risk, underserved areas in oncology, such as preventative vaccines for ovarian and triple-negative breast cancer (TNBC) and novel CAR-T therapies for solid tumors. This focus means they are aiming for disruptive, high-impact technologies rather than crowded therapeutic spaces.

The advancement of their pipeline is the main driver of their valuation, especially since the consensus revenue forecast for the entire 2025 fiscal year is $0. You can see a deeper dive into how they manage their cash and risk in Breaking Down Anixa Biosciences, Inc. (ANIX) Financial Health: Key Insights for Investors. What this estimate hides, of course, is the massive potential upside if a Phase 2 trial, like the one planned for the breast cancer vaccine in 2025, yields positive data.

Anixa Biosciences, Inc. (ANIX) Ownership Structure

Anixa Biosciences, Inc. is a publicly-traded company, which means its shares are available to the general public, but the control of the company is highly concentrated with its insiders and strategic entities. This structure is defintely something you need to understand, as it dictates who holds the power in strategic decision-making.

Anixa Biosciences' Current Status

Anixa Biosciences is a clinical-stage biotechnology company, publicly listed on the NASDAQ Capital Market under the ticker symbol ANIX. This public status gives the company access to capital markets, but the ownership profile shows a tight grip by a few major stakeholders. As of November 5, 2025, the stock price was around $4.06 per share, reflecting a market capitalization based on approximately 32.20 million shares outstanding. That's a relatively small float, so price movements can be volatile.

Anixa Biosciences' Ownership Breakdown

When you break down the share registry, the picture is clear: a single strategic insider holds a majority stake, overshadowing the institutional and retail investors. This is a crucial factor when assessing governance risk and long-term strategy. You can dive deeper into the market activity here: Exploring Anixa Biosciences, Inc. (ANIX) Investor Profile: Who's Buying and Why?

Shareholder Type Ownership, % Notes
Insiders & Strategic Entities 82.89% This high percentage is driven primarily by Mars Overseas Ltd, which holds a majority stake of approximately 60.76%.
Institutional Investors 16.25% Includes major index funds and investment advisors like Vanguard Group Inc and D.a. Davidson & Co.
Retail / General Public 0.86% The remaining shares held by individual investors not classified as insiders.

Here's the quick math: with over 82% of the company controlled by insiders and a single corporate entity, the public float is tiny. This means the strategic direction is firmly set by the core leadership and the largest shareholder, not swayed by typical institutional or retail pressure.

Anixa Biosciences' Leadership

The company's strategy is steered by a lean, experienced executive team, which is typical for a clinical-stage biotech focused on R&D (Research and Development). The leadership has deep roots in both biotechnology and financial management.

  • Amit Kumar, Ph.D.: Chairman & Chief Executive Officer (CEO). Dr. Kumar is the principal voice, having led other technology enterprises through the public market process, including CombiMatrix Corporation.
  • Michael Catelani: President, Chief Operating Officer (COO) & Chief Financial Officer (CFO). Mr. Catelani manages both operational execution and the financial health of the company, a critical dual role in a development-stage firm.
  • Pamela D. Garzone, Ph.D.: Chief Development Officer (CDO). Dr. Garzone brings over 25 years of pharmaceutical experience, focusing on clinical and regulatory strategy, which is the lifeblood of a biotech company.

The board is also anchored by figures like Lew Titterton, the Lead Independent Director, and Arnold Baskies, MD, a surgical oncologist and former Chairman of the American Cancer Society's national Board of Directors. This mix of financial, operational, and clinical expertise is essential for navigating the high-stakes environment of cancer drug development.

Anixa Biosciences, Inc. (ANIX) Mission and Values

Anixa Biosciences, Inc.'s core purpose transcends standard pharmaceutical profits; their mission is to fundamentally change the oncology landscape by focusing on the treatment and, critically, the prevention of cancer, which drives their lean, partner-driven operating model.

Anixa Biosciences' Core Purpose

As a seasoned analyst, I look past the quarterly numbers to see the 'why'-the cultural DNA that dictates resource allocation. For Anixa Biosciences, this DNA is rooted in scientific innovation and a remarkable financial discipline, especially for a clinical-stage biotechnology company.

Official Mission Statement

The company's mission is to develop innovative therapies and vaccines to combat cancer, specifically targeting areas with high unmet needs like triple-negative breast cancer (TNBC) and recurrent ovarian cancer. They are a clinical-stage biotechnology company focused on the treatment and prevention of cancer.

  • Develop next-generation preventive immunotherapies for high-incidence malignancies.
  • Advance a CAR-T program for treatment-resistant ovarian cancer with Moffitt Cancer Center.
  • Utilize a unique business model of partnering with world-renowned research institutions like Cleveland Clinic.

Here's the quick math: their average annual cash burn has been approximately $5-6 million, a rate significantly lower than that of their peers in the development-stage biotech sector, showing their commitment to capital efficiency.

Vision Statement

Anixa Biosciences' vision is to reshape the oncology treatment landscape by advancing their clinical programs to transformative milestones. They aim to move beyond treatment into true prevention, which would fundamentally change the disease paradigm.

  • Pioneer a breast cancer vaccine that could prevent the disease in healthy, high-risk women.
  • Establish their chimeric endocrine receptor-T cell (CER-T) technology as a novel cell therapy for solid tumors.
  • Strengthen their intellectual property portfolio, which now extends foundational patent protection for the breast cancer vaccine into the mid-2040s.

They believe 2025 marks an inflection point as programs like the breast cancer vaccine Phase 1 trial near completion and a Phase 2 study is planned to commence.

Anixa Biosciences' Slogan/Tagline

While Anixa Biosciences does not use a single, canonical marketing tagline, their internal focus and communication consistently center on the goal of delivering transformative, next-generation solutions for cancer. The closest summation of their work is the phrase used in their corporate updates: Advancing Toward Prevention and Cure.

The company's actions reflect this focus: they ended the most recent quarter in 2025 with over $17 million in cash and no debt, giving them strategic flexibility to pursue these ambitious goals. They defintely prioritize scientific rigor over high burn rates. For a deeper dive into their formal statements, you can review the Mission Statement, Vision, & Core Values of Anixa Biosciences, Inc. (ANIX).

Anixa Biosciences, Inc. (ANIX) How It Works

Anixa Biosciences operates as a clinical-stage biotechnology company, primarily focused on identifying, acquiring, and advancing novel cancer therapies and vaccines through early-stage human clinical trials (Investigational New Drug or IND stage). The company does not generate revenue from product sales yet, but creates value by de-risking its intellectual property (IP) portfolio through rigorous scientific validation and strategic partnerships with world-class research institutions like the Cleveland Clinic and Moffitt Cancer Center.

You need to see Anixa as an R&D engine, not a manufacturing one. They are running a lean model, which is why they reported a net loss of only -$2.3 million in Q3 2025, despite the high cost of drug development. Breaking Down Anixa Biosciences, Inc. (ANIX) Financial Health: Key Insights for Investors

Anixa Biosciences, Inc.'s Product/Service Portfolio

Product/Service Target Market Key Features
Breast Cancer Vaccine High-risk women and patients with Triple Negative Breast Cancer (TNBC) Targets $\alpha$-lactalbumin, a retired protein re-expressed in tumors; aims for both prevention and treatment; completed Phase 1 trial.
CAR-T (CER-T) Therapy Patients with treatment-resistant Ovarian Cancer and other solid tumors Novel Chimeric Endocrine Receptor-T cell (CER-T) technology; engineers patient's T-cells to target specific endocrine receptors.
Ovarian Cancer Vaccine Patients at high risk for or diagnosed with Ovarian Cancer Uses the same retired protein mechanism as the breast cancer vaccine to stimulate an immune response against cancer cells.
Lung, Colon, & Prostate Cancer Vaccines Patients with high-incidence malignancies in these cancer types Discovery-stage programs utilizing the core retired protein vaccine platform; broadest future market potential.

Anixa Biosciences, Inc.'s Operational Framework

Anixa's operational model is built on capital efficiency and scientific rigor, a necessary approach for a pre-revenue biotech firm. They keep their in-house team small-only 5 employees as of late 2025-and outsource the heavy lifting of discovery and early-stage trials to their partners.

  • IP Acquisition: Identify and exclusively license promising, novel technologies from academic and medical centers, securing foundational patents.
  • Strategic Collaboration: Partner with institutions like Cleveland Clinic and Moffitt Cancer Center to manage preclinical research and Phase 1/2 clinical trials. This minimizes the need for Anixa to build expensive, large-scale in-house labs or hire extensive research teams.
  • Program Management: Focus internal resources on overseeing the clinical development process, managing regulatory filings (like the upcoming Phase 2 IND transfer for the breast cancer vaccine), and protecting the patent portfolio.
  • Monetization Path: Value creation is tied to successful clinical milestones, which lead to lucrative licensing deals with larger pharmaceutical companies or eventual commercialization.

Here's the quick math: the company's average annual cash burn is approximately $5-6 million, which is significantly lower than most development-stage peers. Still, they ended the most recent quarter in 2025 with over $17 million in cash, giving them a defintely solid operational runway.

Anixa Biosciences, Inc.'s Strategic Advantages

The company's competitive edge comes from its unique technology and its disciplined financial structure, which is rare in early-stage biotech.

  • Novel Immunotherapy Platform: The cancer vaccine platform targets 'retired' proteins (like $\alpha$-lactalbumin) that are only expressed in tumors and during specific non-disease states (like lactation). This approach offers a highly specific target for the immune system, potentially minimizing the severe side effects associated with traditional chemotherapy or broader immunotherapies.
  • Strong Intellectual Property (IP): Anixa was recently awarded a key U.S. patent in November 2025, which extends the foundational patent protection for its breast cancer vaccine technology well into the mid-2040s. This long patent life secures future revenue streams.
  • Fiscal Discipline and Balance Sheet Strength: The asset-light, partnership-heavy model results in a very clean balance sheet. The company has essentially no debt and a high Current Ratio of 8.45 as of the latest data in 2025, indicating exceptional liquidity and financial stability to fund its pipeline without immediate dilution risk.
  • Clinical Validation: Preliminary Phase 1 data for the breast cancer vaccine showed over 70% of participants exhibiting the desired immune response, a crucial early sign of potential efficacy that de-risks the program for a Phase 2 trial.

Anixa Biosciences, Inc. (ANIX) How It Makes Money

Anixa Biosciences, Inc. is a clinical-stage biotechnology company that currently generates no revenue from product sales or services, operating as a pre-revenue entity as of November 2025. The company's financial engine is built on securing capital through equity financing and grants to fund its research and development (R&D) pipeline, with the ultimate goal of generating substantial revenue from future licensing agreements and royalties on its therapeutics and vaccines once they achieve regulatory approval and commercialization.

Anixa Biosciences' Revenue Breakdown

To be clear, Anixa Biosciences reported $0.000 in revenue for the first three quarters of the 2025 fiscal year, and the analyst consensus for Q4 2025 is also $0.000. The table below reflects the current reality: the company has no commercial revenue streams. The only non-zero income stream is interest earned on its cash and investments, which is a financial, not an operational, income source.

Revenue Stream % of Total Growth Trend
Product/Service Revenue 0% Stable (at zero)
Licensing & Royalties (Future) 0% N/A (Pre-commercial)
Interest Income (Non-Operating) 100% Decreasing

Here's the quick math: since total revenue is zero, the minimal interest income represents 100% of the reported income. For Q1 2025, that interest income was approximately $173,000, which was a significant decline from the prior year. This decrease in interest income is a clear signal of shrinking cash reserves, which you should defintely monitor.

Business Economics

The economics of Anixa Biosciences are typical for a clinical-stage biotech firm: high fixed costs for R&D and zero variable costs from sales, since there are no products on the market. The entire business model is a high-risk, high-reward bet on intellectual property (IP) development.

  • R&D as the Core Cost: The primary expense is R&D, which was $1.552 million in Q1 2025, an increase of about 15% year-over-year as the breast cancer vaccine and ovarian cancer immunotherapy programs advance.
  • IP-Driven Value: The company's value is tied not to current sales, but to its patent portfolio and clinical trial progress. A new U.S. patent for the breast cancer vaccine, for example, extends IP protection into the mid-2040s, which is the real asset here.
  • Pricing Strategy (Future): The anticipated revenue model is not direct sales but a licensing and royalty structure. Anixa Biosciences partners with institutions like Cleveland Clinic and Moffitt Cancer Center, then plans to license its technologies to large pharmaceutical companies who can handle the manufacturing, marketing, and sales. This shifts the massive commercialization risk and cost to the partner in exchange for milestone payments and a percentage of future product sales (royalties).
  • Funding Mechanism: The company sustains operations primarily through equity financing, like the at-the-market offering capacity of up to $97 million, and non-dilutive grants, not commercial sales.

To understand the full scope of their work, you should review their Mission Statement, Vision, & Core Values of Anixa Biosciences, Inc. (ANIX).

Anixa Biosciences' Financial Performance

The key financial metrics for Anixa Biosciences in 2025 reflect its status as a company in the heavy investment phase of drug development, not commercial operations. The focus is on cash burn and R&D efficiency, not profit.

  • Net Loss: The net loss for the trailing twelve months (TTM) ending July 31, 2025, was -$11.12 million. This loss is expected to continue as clinical trials progress.
  • Cash Position: As of January 31, 2025, the company held $18.686 million in total current assets, with cash and cash equivalents at $1.053 million. The good news is the company is debt-free and has a sufficient cash runway to fund operations for over a year, as of November 2025.
  • Expense Management: General and Administrative (G&A) expenses saw a positive trend, decreasing by about 19% to $1.834 million in Q1 2025, largely due to reduced investor relations costs. This shows a focus on conserving capital where possible, even as R&D costs rise.
  • Earnings Per Share (EPS): The consensus forecast for the full fiscal year ending October 2025 is a diluted EPS of -$0.35. This is a metric of capital consumption, not profitability, in this stage of the business.

Anixa Biosciences, Inc. (ANIX) Market Position & Future Outlook

Anixa Biosciences, Inc. is a high-risk, high-reward clinical-stage oncology company whose future hinges on its dual-platform pipeline, particularly the first-in-class breast cancer vaccine and the novel CAR-T therapy for ovarian cancer. The company is currently pre-revenue, but its strategic focus on novel, non-traditional cancer targets positions it for a potential inflection point in 2025 as key clinical trials advance to later stages.

You're looking at a company that is defintely a technology play, not a commercial one right now. Their entire valuation-a market capitalization of approximately $151.42 million as of November 2025-is based on the intellectual property and clinical data from these two programs, not on sales. Breaking Down Anixa Biosciences, Inc. (ANIX) Financial Health: Key Insights for Investors

Competitive Landscape

In the competitive oncology market, Anixa Biosciences, Inc. is not competing for commercial market share yet. Instead, it competes for intellectual property dominance and clinical trial success against established giants. Their advantage lies in targeting solid tumors and using unique mechanisms where current blockbuster therapies fall short.

Company Market Share, % Key Advantage
Anixa Biosciences, Inc. 0% First-in-class cancer prevention vaccines (e.g., breast cancer) and CAR-T for solid tumors.
Gilead Sciences (Kite Pharma) Approx. 35% (CAR-T Market) Established market leadership in commercial CAR-T cell therapy (Yescarta) for hematological cancers.
Merck & Co., Inc. Approx. 40% (Cancer Vaccine Market) Massive scale, commercialization muscle, and dominance in blockbuster immunotherapy (Keytruda) and preventive vaccines (Gardasil).

Opportunities & Challenges

The company's near-term trajectory is defined by its ability to execute on its 2025 clinical milestones, which will either validate its technology or necessitate a significant capital raise. Here's the quick math: with over $17 million in cash as of May 2025, and a projected runway of over two years, they have the capital to execute their current plan, but any delay changes that dramatically.

Opportunities Risks
Initiate Phase 2 neoadjuvant trial for Breast Cancer Vaccine in 2025. Pre-revenue status and reliance on future licensing/partnerships for commercialization.
New U.S. Patent (U.S. Patent Number 12,472,205) extending breast cancer vaccine IP into the mid-2040s. High R&D costs; Q1 2025 R&D expenses were approximately $1,552,000.
Positive Phase 1 CAR-T data on ovarian cancer, with one patient surviving over 24 months. Intense competition from larger pharma with superior financial resources and commercial infrastructure.
Expanding CAR-T pre-clinical studies to other solid tumors (e.g., lung, prostate). Ongoing net loss, which was $3,213,000 for Q1 2025.

Industry Position

Anixa Biosciences, Inc. is positioned as a niche, high-potential innovator in the immuno-oncology sector, focusing on areas that large pharma has historically struggled with: solid tumors and cancer prevention.

  • Technology Differentiation: The company's chimeric endocrine receptor-T cell (CER-T) technology is a novel form of chimeric antigen receptor-T cell (CAR-T) therapy specifically designed to target solid tumors, which is a major challenge for existing CAR-T products.
  • Prevention Leader: They are a front-runner in developing a vaccine for triple-negative breast cancer (TNBC) prevention, a critical unmet need given the projected 297,000+ new invasive breast cancer cases in the U.S. in 2025.
  • Partner-Driven Model: Their capital-disciplined approach relies heavily on collaborations with world-renowned institutions like Cleveland Clinic and Moffitt Cancer Center, which allows them to advance programs without the typical high infrastructure costs of a large biotech.
  • Financial Stance: The company maintains a clean balance sheet with no debt, which is a significant strength for a clinical-stage biotech.

Their success is tied to clinical data readouts in late 2025 and 2026. If the Phase 2 breast cancer vaccine trial starts strong, the company's valuation will move quickly.

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