Executive Summary / Key Takeaways

• Anixa Biosciences is a clinical-stage biotechnology company strategically focused on developing innovative therapies and vaccines for critical unmet needs in oncology, transitioning from its historical patent licensing business.
• The company's pipeline features two lead programs: a novel CAR-T therapy for ovarian cancer utilizing a chimeric endocrine receptor approach and a pioneering vaccine targeting triple-negative breast cancer (TNBC) and other high-risk populations.
• Recent progress includes advancing the ovarian cancer CAR-T trial into the fourth dose escalation cohort (30x initial dose) and nearing completion of the Phase 1 breast cancer vaccine trial, with final data anticipated in December 2025 and preparation for a Phase 2 trial underway.
• Anixa operates with a collaborative model, leveraging partnerships with institutions like Moffitt Cancer Center, Cleveland Clinic, and the NCI PREVENT program to conserve capital while advancing its pipeline.
• Financially, Anixa is a development-stage company with no product revenue, reporting a net loss of $6.026 million for the six months ended April 30, 2025. It maintains a solid liquidity position with $15.60 million in cash, cash equivalents, and short-term investments as of April 30, 2025, which management believes is sufficient to fund operations for significantly longer than 12 months, supplemented by an available $97 million under its ATM facility.

Setting the Scene: From Patent Licensing to Oncology Innovation

Anixa Biosciences, Inc. (NASDAQ:ANIX) represents a strategic evolution from its origins. Historically, the company's financial lifeblood flowed from technology licensing and the monetization of patent portfolios, including revenue derived from litigation settlements. This era, characterized by "legacy operations," provided the foundation upon which Anixa is now building a new identity: a focused biotechnology company dedicated to tackling significant unmet needs in cancer treatment and prevention.

This transformation is not merely a shift in focus but a fundamental change in business model. Anixa has moved away from relying on patent enforcement for revenue towards a collaborative, R&D-intensive approach. Its current strategy centers on developing a pipeline of novel oncology assets, primarily through partnerships with leading research institutions. This model allows Anixa to advance complex therapeutic and vaccine candidates while managing the substantial costs typically associated with drug development.

Within the vast and competitive oncology landscape, Anixa is carving out a niche through differentiated technological approaches. While large pharmaceutical companies like Merck (MRK), Bristol-Myers Squibb (BMY), Gilead Sciences (GILD), and Pfizer (PFE) dominate the market with broad portfolios spanning chemotherapy, targeted therapies, and established immunotherapies like checkpoint inhibitors and approved CAR-T products, Anixa is concentrating on potentially disruptive modalities: a novel CAR-T platform for solid tumors and therapeutic/preventive cancer vaccines targeting specific, often overlooked, antigens. This positions Anixa as an innovator seeking to address patient populations or cancer types where existing treatments are insufficient.

The Technological Edge: Targeting Unmet Needs

At the heart of Anixa's strategic pivot lies its differentiated technology platforms, particularly its chimeric endocrine receptor-T cell (CER-T) therapy and its "retired protein" vaccine approach. These technologies represent Anixa's primary competitive moat, aiming to offer distinct advantages over existing treatments.

The CAR-T program, developed through its subsidiary Certainty Therapeutics in collaboration with The Wistar Institute and Moffitt Cancer Center, focuses on a novel form of CAR-T technology. Unlike many approved CAR-T therapies that target antigens on blood cancers, Anixa's CER-T is initially directed at recurrent epithelial ovarian cancer, a solid tumor indication where CAR-T has faced significant challenges. The technology targets a specific endocrine receptor, aiming for precise recognition and killing of cancer cells while minimizing off-target effects on healthy tissues. While specific quantitative metrics on the degree of enhanced specificity or efficacy compared to other CAR-T approaches are not detailed, the strategic intent is clear: to overcome the limitations of applying CAR-T to solid tumors, which include poor T-cell infiltration, the immunosuppressive tumor microenvironment, and the lack of suitable tumor-specific targets. The ongoing Phase 1 trial is designed to evaluate safety, persistence, expansion, and efficacy, with dose escalation being a critical step towards identifying a potentially therapeutic dose.

Anixa's vaccine programs, developed in partnership with Cleveland Clinic, utilize a distinct mechanism targeting "retired proteins." These are proteins expressed during specific developmental stages or conditions (like lactation) but are generally absent in healthy adult tissue, only to reappear in certain cancers. The lead vaccine candidate targets α-lactalbumin for triple-negative breast cancer (TNBC). The rationale is that vaccinating against such a protein can induce an immune response that targets cancer cells expressing it, potentially preventing recurrence or even the initial development of cancer in high-risk individuals. Preclinical studies in mice showed this approach prevented breast cancer. The Phase 1 human trial, funded by a U.S. Department of Defense grant, is evaluating safety and immune response across different patient populations (early-stage TNBC, high-risk mutation carriers, and TNBC patients on Keytruda). Data presented to date indicates antigen-specific T cell responses at all dose levels tested and a favorable safety profile, with only injection site irritation reported as an adverse effect. This suggests the vaccine is successfully stimulating the desired immune response. The strategic "so what" for investors is that this novel approach could offer a new paradigm in cancer prevention and treatment, potentially addressing significant markets like TNBC where treatment options are limited and recurrence rates are high (42% recurrence in early-stage TNBC patients within three years).

Furthermore, Anixa and Cleveland Clinic are leveraging this "retired protein" concept in a vaccine discovery program, aiming to identify targets for other high-incidence cancers like lung, colon, and prostate. This expands the potential applicability of their platform technology. The recent letter of intent with VERDI Solutions to explore AI-guided personalized and off-the-shelf peptide vaccines indicates a strategic move to potentially broaden their vaccine platform capabilities and target a wider range of cancer types and patient needs.

These technological differentiators form the bedrock of Anixa's long-term vision. While still in early clinical stages, the potential for a highly specific CAR-T for solid tumors and novel preventive/therapeutic cancer vaccines could, if successful, create significant value and establish a strong competitive position in specific oncology niches, potentially commanding premium pricing or enabling broad market penetration through licensing.

Pipeline Progress: Milestones and Momentum

Anixa's narrative is currently driven by progress in its clinical pipeline. The company's operational focus is squarely on advancing its lead programs through human trials.

The ovarian cancer CAR-T trial, conducted at Moffitt Cancer Center, is a critical operational priority. It's structured as a dose-escalation study with two delivery routes (intraperitoneal and intravenous) in patients with recurrent epithelial ovarian cancer who have received at least two prior lines of chemotherapy. The trial has systematically progressed through dose cohorts. Following the initial cohort treated in 2022 and early 2023, the second cohort received a three-times higher dose in early 2024, and the third cohort received a ten-times higher dose from November 2024 to February 2025. Importantly, treatment at all dose levels tested to date has been reported as well-tolerated. Anecdotal signs of efficacy, such as possible tumor necrosis, were observed in two of the first six patients, with one patient remaining alive two years and another one year past initial treatment. The FDA's approval for re-dosing the patient two years out, and the administration of that second dose in October 2024, highlights the potential observed in early patients. As of the May 28, 2025 filing date, Anixa was preparing to enroll patients in the fourth dose cohort, which will administer a 30-times higher dose than the original. This systematic dose escalation is crucial for determining the maximum tolerated dose and identifying a dose level where therapeutic effects might become more pronounced. The trial is estimated to be completed in two to three years, a timeline dependent on factors like the rate of patient enrollment and when the maximum tolerated dose is reached.

The breast cancer vaccine program is also showing tangible progress. The Phase 1 trial, underway at Cleveland Clinic and funded by a U.S. Department of Defense grant, has completed vaccination of expanded cohorts in Phase 1a (early-stage TNBC). Vaccination has also commenced in Phase 1b (high-risk mutation carriers) and Phase 1c (TNBC patients on Keytruda). The presentation of immunological data in December 2023 and November 2024, demonstrating antigen-specific T cell responses across all dose levels and patient groups, is a key operational achievement. The finding that the vaccine combined with Keytruda did not show additional or more severe adverse effects is particularly relevant for potential future combination strategies. The trial is nearing enrollment completion, with treatment and monitoring expected to continue for the next three to four months. The anticipated reporting of final Phase 1 data at the San Antonio Breast Cancer Symposium in December 2025 is a significant near-term catalyst. Based on the promising Phase 1 findings, Anixa is already preparing to initiate a Phase 2 clinical trial in the neo-adjuvant setting (pre-surgery) to investigate the vaccine's therapeutic effect. This forward planning underscores management's confidence in the program's potential.

Beyond these lead candidates, the ovarian cancer vaccine program is benefiting from significant support through the NCI's PREVENT program, which is funding and conducting preclinical development, manufacturing, and IND-enabling studies. This collaboration is a strategic win, allowing Anixa to advance this program towards the clinic without incurring substantial internal costs. The Joint Development and Option Agreement with Cleveland Clinic for new vaccine target discovery further strengthens the pipeline's future potential.

Recent patent allowances for both the CAR-T technology (April 14, 2025) and breast cancer vaccine technology (April 9, 2025) demonstrate the company's commitment to protecting its intellectual property, which is vital for potential future licensing deals.

Financial Snapshot: Investing in the Future

As a clinical-stage biotechnology company focused on R&D, Anixa's financial profile is characterized by significant operating expenses and no product revenue. For the three and six months ended April 30, 2025, the company reported no revenue, consistent with the prior year periods. This underscores that the investment thesis is entirely predicated on the future success and potential monetization of its pipeline assets, likely through licensing agreements.

Operating expenses consist primarily of research and development (R&D) and general and administrative (G&A) costs. For the six months ended April 30, 2025, total operating expenses were $6.389 million, a decrease from $7.076 million in the same period of 2024.

R&D expenses decreased by $121,000 to $2.87 million for the six months ended April 30, 2025, compared to $3.00 million in the prior year period. This decrease was primarily driven by lower outside R&D costs for the ovarian cancer CAR-T therapeutic ($232,000 decrease) and lower employee stock-based compensation ($165,000 decrease). However, these decreases were partially offset by increased outside R&D expenses related to the new vaccine discovery program ($113,000 increase) and the breast cancer vaccine ($107,000 increase), as well as higher clinical consulting fees ($51,000 increase). This reflects a strategic reallocation of R&D resources, with reduced spending on the CAR-T program in the reported period while increasing investment in the vaccine pipeline and new discovery efforts.

G&A expenses saw a more significant decrease, falling by $566,000 to $3.52 million for the six months ended April 30, 2025, from $4.08 million in the prior year period. This reduction was mainly attributable to decreases in investor and public relations expense ($442,000 decrease), director stock-based compensation ($182,000 decrease), and consulting fees ($62,000 decrease), partially offset by increases in employee compensation ($87,000 increase) and patent-related costs ($62,000 increase). The reduction in G&A reflects cost management efforts, particularly in areas like investor outreach and non-cash compensation.

Interest income decreased due to lower short-term investment balances and interest rates, contributing to the overall net loss. The net loss attributable to common shareholders for the six months ended April 30, 2025, was $5.974 million, or $0.19 per share, compared to $6.394 million, or $0.20 per share, for the same period in 2024. The slightly lower net loss is primarily a result of the decrease in operating expenses.

Liquidity and Capital Strategy

Maintaining sufficient liquidity is paramount for a company like Anixa, which is reliant on external funding to advance its pipeline. As of April 30, 2025, Anixa held $1.91 million in cash and cash equivalents and $13.687 million in short-term investments, totaling $15.60 million. This represents a decrease of approximately $4.33 million from the $19.92 million held at October 31, 2024.

The primary use of cash is for operating activities, which consumed $4.41 million during the six months ended April 30, 2025. This cash burn reflects the ongoing R&D expenditures and G&A costs necessary to support the clinical trials and discovery programs. Investing activities provided $5.04 million, primarily due to maturities of short-term investments ($29.97 million) exceeding purchases ($24.93 million). Financing activities provided a nominal $1,000, mainly from employee stock purchases offset by ATM offering expenses.

Management stated as of May 28, 2025, their belief that existing cash, cash equivalents, and short-term investments are sufficient to fund activities for at least the next twelve months, and significantly longer than 12 months from the filing date. This assessment is based on the current operational plan, which emphasizes conserving funds through collaborations.

A key component of Anixa's capital strategy is its at-the-market (ATM) equity offering program. As of April 30, 2025, the company had approximately $97 million of common stock available for sale under this program. This provides a flexible mechanism to raise additional capital as needed to fund ongoing operations, support further clinical development (such as the planned Phase 2 breast cancer trial), or potentially pursue new opportunities. While the ATM was used minimally in the most recent six-month period, its availability is a significant factor in the company's liquidity outlook and ability to fund operations beyond the current cash runway.

Competitive Landscape: A Niche Innovator Among Giants

Anixa operates within the highly competitive oncology market, dominated by large, well-capitalized pharmaceutical companies. While direct, head-to-head comparisons with the specific technologies of giants like Merck, BMY, Gilead, and Pfizer are complex due to the early stage and novel nature of Anixa's programs, a qualitative and quantitative comparison of their market positioning and financial scale is illustrative.

Large pharma competitors possess vast resources, extensive R&D budgets (often billions annually), established global commercial infrastructures, and diversified pipelines. They have approved oncology products generating billions in revenue (e.g., Merck's Keytruda, BMY's Opdivo and CAR-T portfolio, Gilead's CAR-T assets, Pfizer's broad oncology franchise). Their financial metrics reflect this scale: positive gross, operating, and net margins, significant free cash flow generation, and substantial asset bases. For example, recent TTM data shows Merck with a Gross Profit Margin of 76% and Net Profit Margin of 27%, BMY with 71% and -19% (impacted by specific charges), Gilead with 78% and 2%, and Pfizer with 74% and 13%. In stark contrast, Anixa, as a development-stage company, has TTM Gross, Operating, and Net Profit Margins of 0% due to lack of product revenue, and negative operating and free cash flow.

Anixa's competitive strategy is not to compete directly across the broad oncology market but to target specific, high-unmet-need areas with potentially disruptive technologies. Its focus on a CAR-T for solid tumors like ovarian cancer differentiates it from many currently approved CAR-T therapies focused on hematological malignancies. Its "retired protein" vaccine approach offers a novel mechanism distinct from traditional cancer vaccines or immunotherapies.

Anixa's competitive advantages lie in the potential novelty and specificity of its technologies. If the CER-T can demonstrate efficacy and safety in solid tumors, it could address a significant market gap. If the breast cancer vaccine proves effective in preventing recurrence or onset, it could open up a large preventive market. The collaborative model, while limiting direct control, allows Anixa to leverage the expertise and resources of partners like Moffitt, Cleveland Clinic, and the NCI, enabling it to advance programs that would be prohibitively expensive otherwise. The NCI PREVENT program's funding and execution of preclinical work for the ovarian cancer vaccine is a prime example of this, providing a significant cost advantage in that specific program's early development.

However, Anixa faces significant disadvantages compared to large pharma. Its limited financial resources mean it cannot independently fund large-scale, late-stage clinical trials or build a global commercial infrastructure. It relies heavily on successful clinical trial outcomes to attract licensing partners with the necessary capital and capabilities. The R&D process is inherently risky, and failure in clinical trials would severely impact the investment thesis. While Anixa has secured patent protection, large competitors also possess extensive IP portfolios and the legal resources to defend their market positions. The competitive landscape is dynamic, with large players constantly acquiring or developing new technologies, including in areas like CAR-T and vaccines.

Anixa's customer base (eventual patients) and supplier dynamics (CROs, CMOs, research partners) are typical for a biotech at this stage. Its strategic partnerships are crucial "suppliers" of R&D capability and funding (in the case of the DoD grant and NCI PREVENT). Its positioning is one of a technology innovator seeking to become an attractive licensing partner for larger players who can navigate the late-stage development, regulatory, and commercialization hurdles.

Outlook and Key Catalysts

Anixa's outlook is tied directly to the successful progression of its clinical pipeline. The company does not anticipate generating revenue from its current programs in the near term, meaning profitability remains a distant prospect, dependent on future licensing deals.

Key catalysts for the stock in the coming quarters include:

• Progression of the ovarian cancer CAR-T trial: Successful enrollment and treatment of patients in the higher dose cohorts (starting with the 30x dose in the fourth cohort) and the reporting of safety and preliminary efficacy data from these cohorts. The estimated two-to-three-year completion timeline for the Phase 1 trial means ongoing updates on dose escalation and patient responses will be critical.
• Final Phase 1 breast cancer vaccine data: The anticipated presentation of final Phase 1 data in December 2025 at the San Antonio Breast Cancer Symposium is a major event. Positive data on safety and immune response across all cohorts will be crucial.
• Initiation of Phase 2 breast cancer vaccine trial: The commencement of the planned Phase 2 trial in the neo-adjuvant setting will signal the program's advancement and provide the next stage for evaluating therapeutic effect.
• Progress in the vaccine discovery program: Updates on the identification of new "retired protein" targets for lung, colon, and prostate cancers could expand the long-term potential of the vaccine platform.
• Developments from the VERDI AI collaboration: Progress in developing AI-guided personalized and off-the-shelf vaccines could open new avenues.

Management's confidence in funding operations for significantly longer than 12 months provides a degree of stability, but the availability of the $97 million ATM facility highlights that future capital raises are likely necessary to fund later-stage trials or potential independent development efforts, which could lead to dilution.

Risks to Consider

Investing in a clinical-stage biotechnology company like Anixa involves significant risks. The most prominent risks include:

• Clinical Trial Risk: The success of the CAR-T and vaccine candidates in human clinical trials is not guaranteed. Phase 1 trials primarily assess safety, and even positive Phase 1 results do not assure success in larger, later-stage efficacy trials (Phase 2 and Phase 3). The majority of drug candidates fail in clinical development.
• Regulatory Risk: Even with positive clinical data, there is no guarantee that the FDA or other regulatory agencies will approve the candidates for commercial sale.
• Funding Risk: While management believes current funds are sufficient for over 12 months, advancing multiple programs through costly clinical trials will require substantial additional capital. The ability to raise funds through equity offerings (like the ATM) depends on market conditions and the company's clinical progress. Failure to secure future funding could delay or halt development programs.
• Competition: The oncology market is intensely competitive. Large pharmaceutical companies and other biotechs are also developing novel therapies and vaccines. Competitors may develop more effective, safer, or cheaper treatments, or reach the market sooner.
• Dependence on Collaborations: Anixa relies heavily on its partnerships with research institutions. The success and pace of its programs are influenced by the resources, priorities, and effectiveness of its collaborators. Termination of key agreements could significantly impact development.
• Intellectual Property Risk: While Anixa has received patent allowances, its ability to protect its technology and prevent infringement is critical for future licensing value and subject to legal challenges.

These risks are inherent in the biotech sector, particularly for companies with early-stage pipelines. Investors must weigh the potential rewards of successful clinical development and commercialization against the high probability of failure.

Conclusion

Anixa Biosciences is undergoing a compelling transformation, leveraging its foundation to pursue innovative oncology solutions in the high-stakes fight against cancer. By focusing on novel approaches like CER-T for solid tumors and "retired protein" vaccines, Anixa is attempting to carve out valuable niches within a competitive landscape dominated by pharmaceutical giants. The strategic shift towards a collaborative R&D model allows the company to advance its promising pipeline, marked by tangible progress in its ovarian cancer CAR-T and breast cancer vaccine clinical trials.

While the financial reality of a development-stage biotech means no near-term revenue and ongoing losses, the company's current liquidity position, coupled with the available ATM facility, provides a runway to reach key clinical milestones. The anticipated final Phase 1 breast cancer vaccine data in December 2025 and the continued dose escalation in the ovarian cancer CAR-T trial represent critical near-term catalysts that could significantly impact the investment narrative.

The core investment thesis hinges on the successful clinical validation of Anixa's differentiated technologies and the potential for future licensing partnerships. While substantial risks remain, particularly related to clinical trial outcomes, regulatory hurdles, and future funding needs, the potential upside associated with novel, effective cancer therapies and vaccines targeting unmet needs positions Anixa as a speculative but intriguing opportunity for investors willing to accept the inherent volatility and uncertainty of early-stage biotechnology. The ability to execute on its clinical timelines and deliver positive data will be paramount in determining whether Anixa can translate its technological innovation into long-term shareholder value.