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Item 1. Business

2026-01-12 compared with 2025-01-10 · 406 added, 397 removed, 14 unchanged (98% of the section changed)

Anixa Biosciences, Inc.

is a biotechnology

company developing therapies and vaccines that are focused on critical unmet needs in oncology.

Our therapeutics programs include (i)

the development of a chimeric endocrine receptor-T cell therapy, a novel form of chimeric antigen receptor-T cell (“CAR-T”)

technology, initially focused on treating ovarian cancer, which is being developed at our subsidiary, Certainty Therapeutics, Inc.

Biosciences, Inc.

is a biotechnology company developing therapies and vaccines that are focused on critical unmet needs in oncology.

Our therapeutics program consists of the development of liraltagene autoleucel (“lira-cel”), a chimeric endocrine receptor-T

cell therapy, which is a novel form of chimeric antigen receptor-T cell (“CAR-T”) technology, initially focused on treating

ovarian cancer, that is being developed at our subsidiary, Certainty Therapeutics, Inc.

(“Certainty”).

and (ii) until March 2023, the development of anti-viral drug candidates for the treatment of COVID-19.

Our vaccine programs include (i)

the development of a vaccine against breast cancer, initially focused on triple negative breast cancer (“TNBC”), the most

lethal form of breast cancer, (ii) the development of a vaccine against ovarian cancer, and (iii) a vaccine discovery program utilizing

the same mechanism as our breast and ovarian cancer vaccines, to develop additional cancer vaccines to address many intractable cancers,

including high incidence malignancies in lung, colon and prostate.

Our subsidiary, Certainty, is

developing immuno-therapy drugs against cancer.

Certainty holds an exclusive worldwide, royalty-bearing license to use certain intellectual

property owned or controlled by The Wistar Institute (“Wistar”), the nation’s first independent biomedical research

institute and a leading NCI designated cancer research center, relating to Wistar’s chimeric endocrine receptor targeted therapy

We have initially focused on the development of a treatment for ovarian cancer, but we also may pursue applications of the

technology for the development of treatments for additional solid tumors.

The license agreement requires Certainty to make certain cash

and equity payments to Wistar upon achievement of specific development milestones.

With respect to Certainty’s equity obligations

to Wistar, Certainty issued to Wistar shares of its common stock equal to five percent (5%) of the common stock of Certainty, such equity

stake subject to dilution by further funding of Certainty’s activities by the Company.

Due to such Company funding, Wistar’s

equity stake in Certainty was 4.4% as of October 31, 2024.

Certainty, in collaboration with

Our vaccine programs

include (i) the development of a vaccine against breast cancer, (ii) the development of a vaccine against ovarian cancer, and (iii) a

vaccine discovery program utilizing the same mechanism as our breast and ovarian cancer vaccines to develop additional cancer vaccines

to address many intractable cancers, including high incidence malignancies in lung, colon and prostate.

subsidiary, Certainty, is developing immuno-therapy drugs against cancer.

Certainty holds an exclusive worldwide, royalty-bearing license

to use certain intellectual property owned or controlled by The Wistar Institute (“Wistar”), the nation’s first independent

biomedical research institute and a leading National Cancer Institute (“NCI”) designated cancer research center, relating

to Wistar’s chimeric endocrine receptor targeted therapy technology.

We have initially focused on the development of a treatment

for ovarian cancer, but we also may pursue applications of the technology for the development of treatments for additional solid tumors.

The license agreement requires Certainty to make certain cash and equity payments to Wistar upon achievement of specific development

With respect to Certainty’s equity obligations to Wistar, Certainty issued to Wistar shares of its common stock equal

to five percent (5%) of the common stock of Certainty, such equity stake is subject to dilution by further funding of Certainty’s

activities by the Company.

Due to such Company funding, Wistar’s equity stake in Certainty was 4.1% as of October 31, 2025.

in collaboration with the H.

Lee Moffitt Cancer Center and Research Institute, Inc.

(“Moffitt”), has begun human clinical testing of the CAR-T technology

licensed by Certainty from Wistar aimed initially at treating ovarian cancer.

After receiving authorization from the FDA, we commenced

enrollment of patients in a Phase 1 clinical trial and treated the first patient in August 2022.

Further, in May 2023 and August 2023,

we treated the second and third patients in the trial, respectively, at the same dose level as the first patient, and the treatment was

well-tolerated by the patients.

In February 2024, May 2024 and June 2024, we treated the three patients, respectively, of the second dose

cohort, where the patients were administered a three-times higher dose of cells than the patients in the first cohort.

The treatment at

this dose level has also been well-tolerated by the patients.

While the dose levels in the first two cohorts were expected to be sub-therapeutic,

two of the six patients exhibited some anecdotal signs of efficacy.

Both have shown possible signs of tumor necrosis, and one is 20 months

past initial treatment.

In the case of this patient, due to the encouraging results with her initial treatment, we sought single patient

Investigational New Drug (“IND”) application permission from the FDA to re-dose her.

This re-dosing was approved by the FDA,

and we administered her second treatment in October 2024.

This second treatment appears to have been well-tolerated by the patient.

November 2024, we treated the first patient in the third dose cohort, where patients are administered a ten-times higher dose of cells

(“Moffitt”), has begun human clinical

testing of lira-cel, the CAR-T technology licensed by Certainty from Wistar aimed initially at treating ovarian cancer.

After receiving

authorization from the U.S.

Food and Drug Administration (“FDA”), we commenced enrollment of patients in a Phase 1 clinical

trial and treated the first patient in August 2022.

Further, in May 2023 and August 2023, we treated the second and third patients in

the trial, respectively, at the same dose level as the first patient, and the treatment was well-tolerated by the patients.

Between February

and June 2024, we treated the three patients of the second dose cohort, where the patients were administered a three-times higher dose

of cells than the patients in the first cohort.

The treatment at this dose level was also well-tolerated by the patients.

From November

2024 to February 2025, we treated three patients in the third dose cohort, where they were administered a ten-times higher dose of cells

than the patients in the first dose cohort.

As of January 10, 2025, we have treated two patients in this dose cohort and the treatment

at this dose level appears to be well-tolerated by the patients.

We anticipate completing treatment of patients in the third dose cohort

in February 2025, and commencing treatment of the fourth dose cohort—at a three-times higher dose than the third dose cohort—shortly

This study is a dose-escalation

trial with two arms based on route of delivery—intraperitoneal or intravenous—to determine the maximum tolerated dose in patients

with recurrent epithelial ovarian cancer and to assess persistence, expansion and efficacy of the modified T cells.

The study is being

conducted at Moffitt and will consist of up to 24 to 48 patients who have received at least two prior lines of chemotherapy.

is estimated to be completed in two to three years depending on multiple factors including when the maximum tolerated dose is reached,

the rate of patient enrollment, the significance of efficacy data and how long we maintain the two different delivery methods.

We hold an exclusive worldwide,

royalty-bearing license to use certain intellectual property owned or controlled by The Cleveland Clinic Foundation (“Cleveland

Clinic”) relating to certain breast cancer vaccine technology developed at Cleveland Clinic.

The license agreement requires us to

make certain cash payments to Cleveland Clinic upon achievement of specific development milestones.

Utilizing this technology, we are

working in collaboration with Cleveland Clinic to develop a method to vaccinate women against breast cancer, focused initially on TNBC.

The focus of this vaccine is a specific protein, α-lactalbumin, that is only expressed during lactation in a healthy woman’s

mammary tissue.

This protein disappears when the woman is no longer lactating, but reappears in many forms of breast cancer, especially

Studies have shown that vaccinating against this protein prevents breast cancer in mice.

In October 2021, following the

Food and Drug Administration’s (“FDA”) authorization to proceed, we commenced dosing patients in a Phase 1 clinical

trial of our breast cancer vaccine.

This study, which is being fully funded by a U.S.

Department of Defense grant to Cleveland Clinic,

is a multiple-ascending dose Phase 1 trial to determine the maximum tolerated dose (“MTD”) of the vaccine in patients with

early-stage, triple-negative breast cancer as well as monitor immune response.

The study is being conducted at Cleveland Clinic.

the course of the Phase 1 study, participants will receive three vaccinations, each two weeks apart, and will be closely monitored for

side effects and immune response.

The first segment of the study, Phase 1a, will consist of approximately 24 patients who have completed

treatment for early-stage, triple-negative breast cancer within the past three years and are currently tumor-free but at high risk for

Studies show that 42% of TNBC patients will have a recurrence of their cancer, with most of the recurrences occurring in the

first two to three years after standard of care treatment.

In January 2023, the number of participants in each dose cohort was expanded,

and as of August 2023, we had completed vaccinating all patients in these expanded cohorts.

In December 2023, we presented the immunological

data collected to date at the San Antonio Breast Cancer Symposium.

The data presented show that in the vaccinated women who had been tested

to date, various levels of antigen-specific T cell responses were observed at all dose levels.

Subsequently, we began vaccinating participants

in additional dose cohorts at varying dose levels of the different key components of the vaccine.

Further, in November 2023, we commenced

vaccination of participants in the second segment of the trial, Phase 1b, that includes participants who have never had cancer, but carry

certain mutations in genes such as BRCA1, BRCA2 or PALB2, that indicate a greater risk of developing TNBC in the future, and have elected

to have a prophylactic mastectomy.

Finally, in January 2024, we commenced vaccination of participants in the third segment of the trial,

Phase 1c, that includes post-operative TNBC patients that have residual disease following treatment and are currently undergoing treatment

with pembrolizumab (Keytruda®).

In November 2024, we presented the most recent data from each of the three arms of the trial at the

Society for Immunotherapy of Cancer (SITC) Annual Meeting.

Key findings presented include i) patients exhibited antigen-specific immune

responses at all dose levels and in all three patient groups (Phase 1a, 1b and 1c), ii) patients receiving our vaccine in combination

with Keytruda are not showing any additional or more severe adverse side effects, and iii) no adverse side effects were seen other than

varying degrees of injection site irritation.

These findings are promising, and as we continue the Phase 1 trial, we are preparing to

initiate a Phase 2 clinical trial in the neo-adjuvant setting (pre-surgery) to determine possible therapeutic effect of the vaccine.

anticipate commencing the Phase 2 trial in 2025.

We hold an exclusive worldwide,

royalty-bearing license to use certain intellectual property owned or controlled by Cleveland Clinic relating to certain ovarian cancer

vaccine technology.

The license agreement requires us to make certain cash payments to Cleveland Clinic upon achievement of specific development

This technology pertains to among other things, the use of vaccines for the treatment or prevention of ovarian cancers which

express the anti-Mullerian hormone receptor 2 protein containing an extracellular domain (“AMHR2-ED”).

In healthy tissue,

this protein regulates growth and development of egg-containing follicles in the ovary.

While expression of AMHR2-ED naturally and markedly

declines during menopause, this protein is expressed at high levels in the ovaries of postmenopausal women with ovarian cancer.

at Cleveland Clinic believe that a vaccine targeting AMHR2-ED could prevent the occurrence of ovarian cancer.

In May 2021, Cleveland Clinic

was granted acceptance for our ovarian cancer vaccine technology into the National Cancer Institute’s (“NCI”) PREVENT

The NCI is a part of the National Institutes of Health (“NIH”).

The PREVENT program is a peer-reviewed agent development

program designed to support pre-clinical development of innovative interventions and biomarkers for cancer prevention and interception

towards clinical trials.

Consistent with the lower dose cohorts, the treatment was well-tolerated by the patients.

Subsequently, we treated the patients in the fourth dose cohort, administering a 30-times higher dose of cells than the patients in the

first dose cohort, and again the treatment appears to have been well-tolerated.

the dose levels in the first three cohorts were expected to be sub-therapeutic, multiple patients have exhibited anecdotal signs of efficacy,

including possible signs of T cell infiltration and tumor necrosis.

For example, many patients have survived beyond expectations, including

one patient that survived over two years past initial treatment and three other patients that survived over one year past treatment.

In the case of the patient that survived over two years past initial treatment, due to the encouraging results with her initial treatment,

we sought single patient Investigational New Drug (“IND”) application permission from the FDA to re-dose her.

This re-dosing

was approved by the FDA, and we administered her second treatment in October 2024.

This second treatment was well-tolerated by the patient.

study is a dose-escalation trial with two arms based on route of delivery—intraperitoneal or intravenous—to determine the

maximum tolerated dose in patients with recurrent epithelial ovarian cancer and to assess persistence, expansion and efficacy of the

modified T cells.

The study is being conducted at Moffitt and will consist of up to 24 to 48 patients who have received at least two

prior lines of chemotherapy.

The study is estimated to be completed in two to three years depending on multiple factors including when

the maximum tolerated dose is reached, the rate of patient enrollment, the significance of efficacy data and how long we maintain the

two different delivery methods.

hold an exclusive worldwide, royalty-bearing license to use certain intellectual property owned or controlled by The Cleveland Clinic

Foundation (“Cleveland Clinic”) relating to certain breast cancer vaccine technology developed at Cleveland Clinic.

agreement requires us to make certain cash payments to Cleveland Clinic upon achievement of specific development milestones.

this technology, we are working in collaboration with Cleveland Clinic to develop a method to vaccinate women against breast cancer,

focused initially on triple-negative breast cancer (“TNBC”), the most lethal form of the disease.

The focus of this vaccine

is a specific protein, α-lactalbumin, that is only expressed during lactation in a healthy woman’s mammary tissue.

disappears when the woman is no longer lactating, but reappears in many forms of breast cancer, especially TNBC.

Studies have shown that

vaccinating against this protein prevents breast cancer in mice.

October 2021, following the FDA’s authorization to proceed, we commenced dosing patients in a Phase 1 clinical trial of our breast

cancer vaccine.

This study, which has been fully funded by a U.S.

Department of Defense grant to Cleveland Clinic, is a multiple-ascending

dose Phase 1 trial to determine the maximum tolerated dose (“MTD”) of the vaccine in patients with early-stage, triple-negative

breast cancer as well as monitor immune response.

The study has been conducted at Cleveland Clinic.

During the course of the Phase 1

study, participants received three vaccinations, each two weeks apart, and have been closely monitored for side effects and immune response.

The first patient cohort in the study, Cohort Ia, consisted of patients who had completed treatment for early-stage, triple-negative

breast cancer within the past three years and were currently tumor-free but at high risk for recurrence.

Studies show that 42% of TNBC

patients will have a recurrence of their cancer, with most of the recurrences occurring in the first two to three years after standard

of care treatment.

In January 2023, the number of participants in each dose cohort was expanded, and as of August 2023, we had completed

vaccinating all patients in these expanded cohorts.

Subsequently, we began vaccinating participants in additional dose cohorts at varying

dose levels of the different key components of the vaccine.

Further, in November 2023, we commenced vaccination of participants in the

second patient cohort in the trial, Cohort Ib, that included participants who have never had cancer, but carry certain mutations in genes

such as BRCA1, BRCA2 or PALB2, that indicate a greater risk of developing TNBC in the future, and had elected to have a prophylactic

Finally, in January 2024, we commenced vaccination of participants in the third patient cohort in the trial, Cohort Ic, that

includes post-operative TNBC patients that have residual disease following treatment and are currently undergoing treatment with pembrolizumab

In June 2025, we completed enrollment in the Phase 1 trial and in October 2025, we completed all patient clinical visits.

December 11, 2025, we presented the final data from the Phase 1 clinical trial of our investigational breast cancer vaccine at the San

Antonio Breast Cancer Symposium.

The key results presented were that i) all primary study endpoints were met, ii) protocol defined immune

responses were observed in 74% of the study subjects, iii) the vaccine was safe and well-tolerated by study participants at the MTD,

with adverse events primarily injection-site irritation and iv) preliminary immunohistochemistry (IHC) of the subjects’ primary

tumors for alpha-lactalbumin protein revealed a range of expression from absent to strong—analysis and correlation to immune response

and clinical outcomes is ongoing.

Consenting participants will be followed for five years after completing the study.

Combination of

Keytruda and the vaccine also generated antigen-specific T cell responses and showed no major additional side effect.

The data from the

Phase 1 trial will inform planned Phase 2 study design, including a potential Phase 2 combination study with Keytruda in the neoadjuvant

setting among newly diagnosed breast cancer patients.

Phase 1 study evaluated safety and monitored immune response to an investigational vaccine targeting α-lactalbumin.

The trial enrolled

35 participants across three cohorts:

Cohort Ia (n=26), women who completed standard-of-care treatment, including surgery, for early-stage

TNBC within three years and were tumor-free but at elevated risk of recurrence;

Cohort Ib (n=4), cancer-free women with BRCA1, BRCA2,

or PALB2 mutations who elected preventive mastectomy and were vaccinated prior to surgery;

and Cohort Ic (n=5), women with TNBC receiving

pembrolizumab (Keytruda) in the adjuvant (post-surgery) setting, with evaluation of safety of combination administration and immune responses.

In Cohort Ia, at the MTD, the vaccine was reported as safe, with no flu-like symptoms (fever and myalgias), no abnormal clinical laboratory

tests, and no other observed adverse side effects in this cohort;

the primary notable adverse event was injection-site irritation.

demonstrated α-lactalbumin-specific T cell responses, including production of interferon gamma and interleukin-17.

In Cohort Ib,

safety and tolerability were similar to Cohort Ia.

Immunohistochemistry analyses of resected breast tissue are ongoing and will be presented

in a future scientific presentation.

In Cohort Ic, a key objective was to assess whether administration of the investigational vaccine

in combination with pembrolizumab could create intolerable side effects.

No major adverse side effects were reported;

as in other cohorts,

the primary adverse event was injection-site irritation.

Two participants in Cohort Ic experienced Grade 3 adverse events consisting

of greater irritation at an injection site.

hold an exclusive worldwide, royalty-bearing license to use certain intellectual property owned or controlled by Cleveland Clinic relating

to certain ovarian cancer vaccine technology.

The license agreement requires us to make certain cash payments to Cleveland Clinic upon

achievement of specific development milestones.

This technology pertains to, among other things, the use of vaccines for the treatment

or prevention of ovarian cancers which express the anti-Mullerian hormone receptor 2 protein containing an extracellular domain (“AMHR2-ED”).

In healthy tissue, this protein regulates growth and development of egg-containing follicles in the ovary.

While expression of AMHR2-ED

naturally and markedly declines during menopause, this protein is expressed at high levels in the ovaries of postmenopausal women with

ovarian cancer.

Researchers at Cleveland Clinic believe that a vaccine targeting AMHR2-ED could prevent the occurrence of ovarian cancer.

May 2021, Cleveland Clinic was granted acceptance for our ovarian cancer vaccine technology into the NCI’s PREVENT program.

NCI is a part of the National Institutes of Health (“NIH”).

The PREVENT program is a peer-reviewed agent development program

designed to support pre-clinical development of innovative interventions and biomarkers for cancer prevention and interception towards

clinical trials.

The scientific and financial resources of the PREVENT program are being used for our ovarian cancer vaccine technology

to perform virtually all pre-clinical research and development, manufacturing and IND enabling studies.

This work is being performed at

NCI facilities, by NCI scientific staff and with NCI financial resources and will require no material financial expenditures by the Company,

nor the payment of any future consideration by the Company to NCI.

In May 2024, based on the positive

clinical results to date in the development of our breast cancer vaccine, we entered into a Joint Development and Option Agreement with

Cleveland Clinic to collaborate in efforts to develop additional vaccines for the prevention or treatment of cancers.

Working with Cleveland

Clinic researchers, we are focusing on the same novel scientific mechanism as in our breast and ovarian cancer vaccines, and working to

discover additional retired proteins that may be associated with other forms of cancer, specifically high incidence malignancies in the

lung, colon and prostate.

Over the next several quarters,

we expect the development of our therapeutics and vaccines to be the primary focus of the Company.

As part of our legacy operations, the

Company remains engaged in limited patent licensing activities of its various patent portfolios.

We do not expect these activities to

be a significant part of the Company’s ongoing operations nor do we expect these activities to require material financial resources

or attention of senior management.

Over the past several years, our

revenue was derived from technology licensing and the sale of patented technologies, including revenue from the settlement of litigation.

We have not generated any revenue to date from our vaccine or therapeutics programs.

In addition, while we pursue our vaccine and therapeutics

programs, we may also make investments in and form new companies to develop additional emerging technologies.

We do not expect to begin

generating revenue with respect to any of our current vaccine or therapy programs in the near term.

We hope to achieve a profitable outcome

by eventually licensing our technologies to large pharmaceutical companies that have the resources and infrastructure in place to manufacture,

market and sell our technologies as vaccines or therapeutics.

The eventual licensing of any of our technologies may take several years,

if it is to occur at all, and may depend on positive results from human clinical trials.

CAR-T therapeutics

Certainty was formed to develop

immuno-therapy drugs against cancer, and in November 2017, we entered into a license with Wistar whereby we obtained rights to certain

intellectual property surrounding Wistar’s chimeric endocrine receptor targeted therapy technology.

CAR-T therapeutics have demonstrated

positive results in B cell cancers, but very little progress has been made on solid tumors.

Our CAR-T technology is initially focused

on ovarian cancer and is based on engineering killer T cells with the Follicle Stimulating Hormone (“FSH”) to target ovarian

cells that express the FSH-Receptor.

Data on this technology, including the animal studies showing efficacy, was published in January

2017 in the journal, Clinical Cancer Research.

The FSH-Receptor has been shown to be a very exclusive protein found on a large percentage

of ovarian cancer cells, but not on a significant number of non-ovarian healthy tissues in adult females.

Studies have shown that the FSH-Receptor

is also expressed in endothelial cells of the vasculature of neoplasias.

We anticipate performing further studies to evaluate the ability

of our CAR-T to disrupt the vasculature of other cancers, after we have analyzed data from clinical trials of this technology against

ovarian cancer.

We have been working with researchers

at Moffitt to develop our CAR-T therapy.

Moffitt is one of the top cancer centers in the country with pre-clinical and clinical expertise

with CAR-T technology.

This work is being performed

at NCI facilities, by NCI scientific staff and with NCI financial resources and will require no material financial expenditures by the

Company, nor the payment of any future consideration by the Company to NCI.

May 2024, based on the positive clinical results to date in the development of our breast cancer vaccine, we entered into a Joint Development

and Option Agreement with Cleveland Clinic to collaborate in efforts to develop additional vaccines for the prevention or treatment of

Working with Cleveland Clinic researchers, we are focusing on the same novel scientific mechanism as in our breast and ovarian

cancer vaccines, and working to discover additional retired proteins that may be associated with other forms of cancer, specifically

high incidence malignancies in the lung, colon and prostate.

the next several quarters, we expect the development of our therapeutics and vaccines to be the primary focus of the Company.

of our legacy operations, the Company remains engaged in limited patent licensing activities of its various patent portfolios.

not expect these activities to be a significant part of the Company’s ongoing operations nor do we expect these activities to require

material financial resources or attention of senior management.

the past several years, our revenue was derived from technology licensing and the sale of patented technologies, including revenue from

the settlement of litigation.

We have not generated any revenue to date from our therapeutics or vaccine programs.

In addition, while

we pursue our therapeutics and vaccine programs, we may also make investments in and form new companies to develop additional emerging

technologies.

We do not expect to begin generating revenue with respect to any of our current therapeutics or vaccine programs in the

We hope to achieve a profitable outcome by eventually licensing our technologies to large pharmaceutical companies that have

the resources and infrastructure in place to manufacture, market and sell our technologies as therapeutics or vaccines.

licensing of any of our technologies may take several years, if it is to occur at all, and may depend on positive results from human

clinical trials.

was formed to develop immuno-therapy drugs against cancer, and in November 2017, we entered into a license with Wistar whereby we obtained

rights to certain intellectual property surrounding Wistar’s chimeric endocrine receptor targeted therapy technology.

therapeutics have demonstrated positive results in B cell cancers, but very little progress has been made on solid tumors.

technology, lira-cel, is initially focused on ovarian cancer and is based on engineering killer T cells with the Follicle Stimulating

Hormone (“FSH”) to target cells that express the FSH-Receptor.

Data on this technology, including the animal studies showing

efficacy, was published in January 2017 in the journal, Clinical Cancer Research.

The FSH-Receptor has been shown to be a very exclusive

protein found on a large percentage of ovarian cancer cells, but not on a significant number of non-ovarian healthy tissues in adult

have shown that the FSH-Receptor is also expressed in endothelial cells of the vasculature of neoplasias.

We anticipate performing further

studies to evaluate the ability of lira-cel to disrupt the vasculature of other cancers, after we have analyzed data from clinical trials

of this technology against ovarian cancer.

have been working with researchers at Moffitt to develop lira-cel.

Moffitt is one of the top cancer centers in the country with pre-clinical

and clinical expertise with CAR-T technology.

Moffitt has conducted many of the highest profile CAR-T trials in the world.

In August 2022, Moffitt began

treating patients in a Phase 1 clinical trial of our CAR-T therapy.

While the results to date have been positive, there are many uncertainties

in drug development, and most drugs fail to reach commercialization.

In the future, we hope to achieve a profitable outcome by eventually

licensing our technology to a large pharmaceutical company that has the resources and infrastructure in place to manufacture, market and

sell our technology as a cancer treatment.

We believe that our CAR-T technology

may be used as an effective treatment against multiple solid tumor types, however, we have initially focused on ovarian cancer.

to American Cancer Society statistics, in the U.S., ovarian cancer accounts for just 2% of all female cancer cases, but nearly 5% of cancer

August 2022, Moffitt began treating patients in a Phase 1 clinical trial of lira-cel.

While the results to date have been positive, there

are many uncertainties in drug development, and most drugs fail to reach commercialization.

In the future, we hope to achieve a profitable

outcome by eventually licensing lira-cel to a large pharmaceutical company that has the resources and infrastructure in place to manufacture,

market and sell lira-cel as a cancer treatment.

believe that lira-cel may be used as an effective treatment against multiple solid tumor types, however, we have initially focused on

ovarian cancer.

According to American Cancer Society statistics, in the U.S., ovarian cancer accounts for just 2% of all female cancer

cases, but over 4% of cancer deaths in women due to the disease’s low survival rate.

It has been estimated that in 2025, approximately

21,000 new cases of ovarian cancer would be diagnosed in the U.S.

and approximately 13,000 women would die from this disease.

continuous advances made in the field of cancer research every year, there remains a significant unmet medical need, as the overall five-year

relative survival rate for ovarian cancer patients is 51%, but ranges from 43% among Black women to 61% among Asian American/Pacific

Islander women, and ranges from 92% to 31% based on whether it is first diagnosed at a local stage or a distant stage, respectively.

licensed certain technology from Cleveland Clinic to develop vaccines for the treatment or prevention of TNBC and other breast cancers

which express the α-lactalbumin protein.

This protein is only expressed during lactation in healthy women, but may also be expressed

in individuals with certain breast cancers, most notably TNBC, the most lethal form of breast cancer.

Further, we have licensed certain

technology from Cleveland Clinic to develop vaccines for the treatment or prevention of ovarian cancers which express AMHR2-ED.

protein regulates growth and development of egg-containing follicles in the ovary and its expression naturally and markedly declines

after menopause.

However, AMHR2-ED is expressed at high levels in the ovaries of postmenopausal women with ovarian cancer.

we have entered into a Joint Development and Option Agreement with Cleveland Clinic to collaborate in efforts to develop additional vaccines

for the prevention or treatment of cancers.

Working with Cleveland Clinic researchers, we are focusing on the same novel scientific mechanism

as in our breast and ovarian cancer vaccines, and working to discover additional retired proteins that may be associated with other forms

of cancer, specifically high incidence malignancies in the lung, colon and prostate.

vaccines harness the immune system to protect people from infectious diseases.

Broad-based vaccination programs have essentially eliminated

some of the most deadly and debilitating diseases in history, small pox and polio among them.

However, there has been little success

developing a preventative (prophylactic) vaccine against cancer.

work by exposing a benign form of a disease agent to an individual’s immune system.

The immune system identifies the agent and

learns to attack and destroy it, retaining a memory of the agent so the immune system knows to react quickly if an individual is exposed

to the disease agent months or years later.

vaccines attack pathogens, such as viruses and bacteria.

The immune system is better able to assail these agents because they come from

outside the body.

Cancer, however, is caused by aberrant cells that arise out of our resident cells, which can make it difficult for

our immune system to find the diseased cells, especially as advancing age weakens our immune system.

Once these aberrant cells gain critical

mass, they become cancer.

the lack of success with cancer vaccines, recently gained knowledge about the human immune system has led to the development, approval

and commercialization of revolutionary immuno-therapy drugs.

These drugs do not attack cancer directly, but rather modulate the immune

system in ways that enable it to destroy or dramatically impair cancer cells.

breast cancer vaccine technology licensed from Cleveland Clinic has identified a protein, alpha-lactalbumin, that is present in healthy

breast tissue only when a woman is lactating and disappears when she stops nursing her child.

Alpha-lactalbumin is never present on any

other cell in the body.

However, it does show up in many types of breast cancer, including TNBC, an aggressive and deadly form of the

By developing a vaccine that targets alpha-lactalbumin, we feel the immune system can destroy these breast cancer cells as they

arise and ultimately prevent breast tumors from forming.

Clinic researchers have demonstrated in animal studies that vaccination against alpha-lactalbumin completely prevented breast cancer

in mice that were specifically bred to develop breast cancer.

Data on this technology, including the animal studies showing efficacy,

was published in July 2016 in the journal, Nature Medicine.

ovarian cancer vaccine technology licensed from Cleveland Clinic has identified the AMHR2-ED protein, the expression of which is involved

in egg production in the ovaries and is no longer expressed after menopause.

AMHR2-ED is not meaningfully present on any other cell in

However, it does appear in many cases of epithelial ovarian cancers, the most common type of ovarian cancer.

By developing

a vaccine that targets AMHR2-ED, we feel the immune system can destroy these ovarian cancer cells as they arise and ultimately prevent

tumors from forming.

Data on this technology, including animal studies showing efficacy, was published in November 2017 in the journal,

Cancer Prevention Research.

December 2025, the final data from the recently completed Phase 1 clinical trial of our breast cancer vaccine was presented at the San

Antonio Breast Cancer Symposium.

While the reported results have been positive, there are many uncertainties in drug development, and

most drugs fail to reach commercialization.

In addition, we and our partners at Cleveland Clinic continue working with the NCI who are

or will be performing pre-clinical research and development, manufacturing and IND-enabling studies to advance our ovarian cancer vaccine

technology toward human clinical testing.

Further, the vaccine discovery program focused on discovering vaccine targets for lung, colon

and prostate cancer is in its early stages, and there can be no assurance that appropriate vaccine targets may be identified or developed.

Breast Cancer Market

to American Cancer Society statistics, in the U.S., breast cancer accounts for over 30% of all female cancer cases, and nearly 15% of

cancer deaths in women.

It has been estimated that in 2025, approximately 317,000 new cases of breast cancer would be diagnosed in the

and approximately 42,000 women would die from this disease.

Despite continuous advances made in the field of cancer research every

year, invasive female breast cancer incidence rates have been increasing by 1% per year since the mid-2000s.

market for prophylactic cancer vaccines is sizable—bigger in fact than the market for any type of cancer therapeutic.

Cancer therapies

are only administered after a patient has been diagnosed, while a prophylactic vaccine may be administered to all people who have a possibility

of developing the disease.

in the U.S., approximately 317,000 women were estimated to be diagnosed with breast cancer in 2025, there are approximately 84 million

women age 40 and over—the time in life when women face an increased risk of developing breast cancer.

Worldwide, the number is

dramatically larger.

Ovarian Cancer Market

to American Cancer Society statistics, in the U.S., ovarian cancer accounts for just 2% of all female cancer cases, but over 4% of cancer

deaths in women due to the disease’s low survival rate.

4 unchanged sentences

the field of cancer research every year, there remains a significant unmet medical need, as the overall five-year relative survival rate

for ovarian cancer patients is 51%, but ranges from 42% among Black women to 61% among Asian American/Pacific Islander women.

Cancer vaccines

We licensed certain technology

from Cleveland Clinic to develop vaccines for the treatment or prevention of TNBC and other breast cancers which express the α-lactalbumin

This protein is only expressed during lactation in healthy women, but may also be expressed in individuals with certain breast

cancers, most notably TNBC, the most lethal form of breast cancer.

Further, we have licensed certain technology from Cleveland Clinic

to develop vaccines for the treatment or prevention of ovarian cancers which express AMHR2-ED.

This protein regulates growth and development

of egg-containing follicles in the ovary and its expression naturally and markedly declines after menopause.

However, AMHR2-ED is expressed

at high levels in the ovaries of postmenopausal women with ovarian cancer.

In addition, we have entered into a Joint Development and Option

Agreement with Cleveland Clinic to collaborate in efforts to develop additional vaccines for the prevention or treatment of cancers.

with Cleveland Clinic researchers, we are focusing on the same novel scientific mechanism as in our breast and ovarian cancer vaccines,

and working to discover additional retired proteins that may be associated with other forms of cancer, specifically high incidence malignancies

in the lung, colon and prostate.

Typically, vaccines harness the

immune system to protect people from infectious diseases.

Broad-based vaccination programs have essentially eliminated some of the most

deadly and debilitating diseases in history, small pox and polio among them.

However, there has been little success developing a preventative

(prophylactic) vaccine against cancer.

Vaccines work by exposing a benign

form of a disease agent to an individual’s immune system.

The immune system identifies the agent and learns to attack and destroy

it, retaining a memory of the agent so the immune system knows to react quickly if an individual is exposed to the disease agent months

or years later.

Most vaccines attack pathogens,

such as viruses and bacteria.

The immune system is better able to assail these agents because they come from outside the body.

however, is caused by aberrant cells that arise out of our resident cells, which can make it difficult for our immune system to find the

diseased cells, especially as advancing age weakens our immune system.

Once these aberrant cells gain critical mass, they become cancer.

Despite the lack of success with

cancer vaccines, recently gained knowledge about the human immune system has led to the development, approval and commercialization of

revolutionary immuno-therapy drugs.

These drugs do not attack cancer directly, but rather modulate the immune system in ways that enable

it to destroy or dramatically impair cancer cells.

The breast cancer vaccine technology

licensed from Cleveland Clinic has identified a protein, alpha-lactalbumin, that is present in healthy breast tissue only when a woman

is lactating and disappears when she stops nursing her child.

Alpha-lactalbumin is never present on any other cell in the body.

it does show up in many types of breast cancer, including TNBC, an aggressive and deadly form of the disease.

By developing a vaccine

that targets alpha-lactalbumin, we feel the immune system can destroy these breast cancer cells as they arise and ultimately prevent breast

tumors from forming.

Cleveland Clinic researchers have

demonstrated in animal studies that vaccination against alpha-lactalbumin completely prevented breast cancer in mice that were specifically

bred to develop breast cancer.

Data on this technology, including the animal studies showing efficacy, was published in March 2016 in

the journal, Cancers.

The ovarian cancer vaccine technology

licensed from Cleveland Clinic has identified the AMHR2-ED protein, the expression of which is involved in egg production in the ovaries

and is no longer expressed after menopause.

AMHR2-ED is not meaningfully present on any other cell in the body.

However, it does appear

in many cases of epithelial ovarian cancers, the most common type of ovarian cancer.

By developing a vaccine that targets AMHR2-ED, we

feel the immune system can destroy these ovarian cancer cells as they arise and ultimately prevent tumors from forming.

Data on this technology,

including animal studies showing efficacy, was published in November 2017 in the journal, Cancer Prevention Research.

In October 2021, Cleveland Clinic

began treating patients in a Phase 1 clinical trial of our breast cancer vaccine.

While the results to date have been positive, there

are many uncertainties in drug development, and most drugs fail to reach commercialization.

In addition, we and our partners at Cleveland

Clinic continue working with the NCI who are or will be performing pre-clinical research and development, manufacturing and IND-enabling

studies to advance our ovarian cancer vaccine technology toward human clinical testing.

Further, the vaccine discovery program focused

on discovering vaccine targets for lung, colon and prostate cancer is in its early stages, and there can be no assurance that appropriate

vaccine targets may be identified or developed.

The Breast Cancer Market

According to American Cancer Society

statistics, in the U.S., breast cancer accounts for over 30% of all female cancer cases, and 15% of cancer deaths in women.

estimated that in 2024, approximately 314,000 new cases of breast cancer would be diagnosed in the U.S.

and approximately 42,000 women

for ovarian cancer patients is 51%, but ranges from 43% among Black women to 61% among Asian American/Pacific Islander women, and ranges

from 92% to 31% based on whether it is first diagnosed at a local stage or a distant stage, respectively.

market for prophylactic cancer vaccines is sizable—bigger in fact than the market for any type of cancer therapeutic.

the U.S., approximately 21,000 women were estimated to be diagnosed with ovarian cancer in 2024, there are approximately 42 million women

age 60 and over—the time in life when women face an increased risk of developing ovarian cancer.

Worldwide, the number is dramatically

Lung Cancer Market

to American Cancer Society statistics, lung cancer accounts for 11% of all cancer cases, and 20% of cancer deaths.

It is the third most

common form of cancer, after breast and prostate cancers, but it accounts for more deaths than any other form of cancer.

estimated that in 2025, approximately 227,000 new cases of lung cancer would be diagnosed in the U.S.

and approximately 125,000 people

would die from this disease.

Despite continuous advances made in the field of cancer research every year, invasive female breast cancer

incidence rates have been increasing by approximately 0.6% per year over the past 20 years.

The market for prophylactic cancer

vaccines is sizable—bigger in fact than the market for any type of cancer therapeutic.

Cancer therapies are only administered after

a patient has been diagnosed, while a prophylactic vaccine may be administered to all people who have a possibility of developing the

While in the U.S., approximately

314,000 women were estimated to be diagnosed with breast cancer in 2024, there are approximately 84 million women age 40 and over—the

time in life when women face an increased risk of developing breast cancer.

Worldwide, the number is dramatically larger.

The Ovarian Cancer Market

According to American Cancer Society

statistics, in the U.S., ovarian cancer accounts for just 2% of all female cancer cases, but nearly 5% of cancer deaths in women due to

the disease’s low survival rate.

It has been estimated that in 2024, approximately 20,000 new cases of ovarian cancer would be diagnosed

and approximately 13,000 women would die from this disease.

Despite continuous advances made in the field of cancer research

every year, there remains a significant unmet medical need, as the overall five-year relative survival rate for ovarian cancer patients

is 51%, but ranges from 42% among Black women to 61% among Asian American/Pacific Islander women.

The market for prophylactic cancer

vaccines is sizable—bigger in fact than the market for any type of cancer therapeutic.

While in the U.S., approximately 20,000 women

were estimated to be diagnosed with ovarian cancer in 2024, there are approximately 42 million women age 60 and over—the time in

life when women face an increased risk of developing ovarian cancer.

Worldwide, the number is dramatically larger.

The Lung Cancer Market

According to American Cancer Society

statistics, lung cancer accounts for 12% of all cancer cases, and over 20% of cancer deaths.

It is the third most common form of cancer,

after breast and prostate cancers, but it accounts for more deaths than any other form of cancer.

It has been estimated that in 2024,

approximately 235,000 new cases of lung cancer would be diagnosed in the U.S.

and approximately 125,000 people would die from this disease.

Despite declining incidence and mortality rates, largely due to reductions in smoking, the 5-year relative survival rate for lung cancer

The Colon Cancer Market

According to American Cancer Society

statistics, colon cancer, including rectal cancer, accounts for 8% of all cancer cases, and 9% of cancer deaths.

It is the fourth most

common form of cancer, after breast, prostate and lung cancers, but it is second only to lung cancer in terms of deaths.

It has been estimated

that in 2024, approximately 153,000 new cases of colon cancer would be diagnosed in the U.S.

and approximately 53,000 people would die

from this disease.

While incidence rates have been declining, primarily due to improved screening, these reduced incidence rates have

been confined to individuals 65 and older.

Incidence rates have been increasing in individuals younger than 55, and have been stable for

those between 55 and 65.

Despite declining incidence and mortality rates, largely due to reductions in smoking, the 5-year relative

survival rate for lung cancer is only 27%.

Colon Cancer Market

to American Cancer Society statistics, colon cancer, including rectal cancer, accounts for 8% of all cancer cases, and 9% of cancer deaths.

It is the fourth most common form of cancer, after breast, prostate and lung cancers, but it is second only to lung cancer in terms of

It has been estimated that in 2025, approximately 154,000 new cases of colon cancer would be diagnosed in the U.S.

and approximately

53,000 people would die from this disease.

While incidence rates have been declining, primarily due to improved screening, these reduced

incidence rates have been confined to individuals 65 and older.

Incidence rates have been increasing in individuals younger than 50,

and have been stable for those between 50 and 64.

Similar trends have been seen in mortality rates.

The Prostate Cancer Market

According to American Cancer Society

statistics, prostate cancer accounts for nearly 30% of all male cancer cases, and 11% of cancer deaths in men.

It has been estimated that

in 2024, approximately 299,000 new cases of prostate cancer would be diagnosed in the U.S.

and approximately 35,000 men would die from

this disease.

While overall incidence rates have been increasing by 3% per year over the last 10 years, mortality rates are relatively

The 5-year relative survival rate is nearly 100% for men diagnosed with localized- or regional-stage prostate cancer, but drops

to 34% for those diagnosed with distant-stage disease.

The biopharmaceutical industry

is characterized by intense and dynamic competition to develop new technologies and proprietary therapies.

Any product candidates that

we successfully develop and commercialize will have to compete with existing therapies and new therapies that may become available in

While we believe that our proprietary FSH-Receptor targeted immuno-therapy platform for treating solid tumors, our proprietary

cancer vaccine technologies and our scientific expertise in the field of cell therapy provide us with competitive advantages, we face

potential competition from various sources, including larger and better-funded pharmaceutical and biotechnology companies, as well as

from academic institutions, governmental agencies and public and private research institutions.

Many of our competitors, either

alone or with their strategic partners, have substantially greater financial, technical and human resources than we do and significantly

greater experience in the discovery and development of product candidates, obtaining FDA and other regulatory approvals of therapies and

vaccines and commercializing those therapies and vaccines.

Accordingly, our competitors may be more successful than us in obtaining approval

for therapies and vaccines and achieving widespread market acceptance.

Our competitors’ therapies and vaccines may be more effective,

or more effectively marketed and sold, than any therapy or vaccine we may commercialize and may render our therapies and vaccines obsolete

or non-competitive before we can recover the expenses of developing and commercializing any of our therapies and vaccines.

Mergers and acquisitions in the

biotechnology and pharmaceutical industries may result in even more resources being concentrated among a smaller number of our competitors.

These competitors also compete with us in recruiting and retaining qualified scientific and management personnel and establishing clinical

study sites and subject registration for clinical studies, as well as in acquiring technologies complementary to, or necessary for, our

Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements

with large and established companies.

We anticipate that we will face

intense and increasing competition as new drugs and vaccines enter the market and advanced technologies become available.

We expect any

therapies and vaccines that we develop and commercialize to compete on the basis of, among other things, efficacy, safety, convenience

of administration and delivery, price and the availability of reimbursement from government and other third-party payers.

Our commercial opportunities could

be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective, have fewer or less severe

side effects, are more convenient or are less expensive than any products that we may develop.

Our competitors also may obtain FDA or

other regulatory approvals for their products more rapidly than we may obtain approvals for ours, which could result in our competitors

establishing a strong market position before we are able to enter the market.

As of October 31, 2024, we had

five full-time employees working for our Company and subsidiaries.

In addition, we work with research teams at Moffitt and Cleveland Clinic,

as well as their and our subcontractors, to develop each of our projects.

Summary Risk Factors

The risk factors described below

are a summary of the principal risk factors associated with an investment in us.

These are not the only risks we face.

You should carefully

consider these risk factors, together with the risk factors set forth in Item 1A.

of this Report and the other reports and documents filed

by us with the SEC.

Risks Relating to Our Financial Condition and Operations

We have a history of losses and may incur additional losses in the future.

We will need additional funding in the future which may not be available on acceptable terms, or at all, and, if available, may result in dilution to our stockholders.

We may have difficulty in raising capital and may consume resources faster than expected.

Risks Related to our Research & Development,

Clinical and Commercialization Activities

Our therapeutic and vaccine programs are pre-revenue, and subject to the risks of an early-stage biotechnology company.

Our current business model relies on strategic collaborations with commercial partners to provide the resources and infrastructure to manufacture and ultimately market and/or sell our technologies.

We may have difficulty in timing the establishment of these partnerships to achieve the greatest economic benefit for the Company, or in establishing these partnerships at all.

If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates.

We have never generated any revenue from biotechnology and pharmaceutical product sales and our biotechnology and pharmaceutical products may never be profitable.

The therapeutics and vaccines that we are developing are novel and present significant challenges to successfully reaching market.

While pre-clinical testing and the limited human clinical testing of our product candidates has been positive, we may experience unfavorable results once we collect statistically significant data from human clinical trials.

We are dependent on third parties to conduct our pre-clinical and clinical trials.

If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.

We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively.

Risks Related to our Intellectual Property

We rely on licenses from Wistar for our CAR-T technology and Cleveland Clinic for our breast and ovarian cancer vaccine technologies, and if we lose any of these licenses it may remove or limit our ability to develop and commercialize products and technology covered by these license agreements and we may be subjected to future litigation.

Risks Related to our Common Stock

The issuance or sale of shares in the future, including in connection with our current at-the-market offering program, to raise money or for strategic purposes could reduce the market price of our common stock.

We have issued a significant number of securities pursuant to our incentive plans and may continue to do so in the future.

The vesting and, if applicable, exercise of these securities and the sale of the shares of common stock issuable thereunder may dilute stockholders’ percentage ownership interest and may also result in downward pressure on the price of our common stock.

We were incorporated on November

5, 1982 under the laws of the State of Delaware.

Our principal executive offices are located at 3150 Almaden Expressway, San Jose, California

95118, our telephone number is (408) 708-9808 and our Internet website address is www.anixa.com .

We make available free of charge

on or through our Internet website our annual report on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, proxy

statements on Schedule 14A, and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act

as soon as reasonably practicable after we electronically file such materials with, or furnish them to, the Securities and Exchange Commission

Alternatively, you may also access our reports at the SEC’s website at www.sec.gov .

Prostate Cancer Market

to American Cancer Society statistics, prostate cancer accounts for nearly 30% of all male cancer cases, and 11% of cancer deaths in

It has been estimated that in 2025, approximately 314,000 new cases of prostate cancer would be diagnosed in the U.S.

and approximately

36,000 men would die from this disease.

While overall incidence rates have been increasing by 3% per year over the last 10 years, mortality

rates are relatively unchanged.

The 5-year relative survival rate is nearly 100% for men diagnosed with localized- or regional-stage

prostate cancer, but drops to 37% for those diagnosed with distant-stage disease.

biopharmaceutical industry is characterized by intense and dynamic competition to develop new technologies and proprietary therapies.

Any product candidates that we successfully develop and commercialize will have to compete with existing therapies and new therapies

that may become available in the future.

While we believe that our proprietary FSH-Receptor targeted immuno-therapy platform for treating

solid tumors, our proprietary cancer vaccine technologies and our scientific expertise in the field of cell therapy provide us with competitive

advantages, we face potential competition from various sources, including larger and better-funded pharmaceutical and biotechnology companies,

as well as from academic institutions, governmental agencies and public and private research institutions.

of our competitors, either alone or with their strategic partners, have substantially greater financial, technical and human resources

than we do and significantly greater experience in the discovery and development of product candidates, obtaining FDA and other regulatory

approvals of therapies and vaccines and commercializing those therapies and vaccines.

Accordingly, our competitors may be more successful

than us in obtaining approval for therapies and vaccines and achieving widespread market acceptance.

Our competitors’ therapies

and vaccines may be more effective, or more effectively marketed and sold, than any therapy or vaccine we may commercialize and may render

our therapies and vaccines obsolete or non-competitive before we can recover the expenses of developing and commercializing any of our

therapies and vaccines.

and acquisitions in the biotechnology and pharmaceutical industries may result in even more resources being concentrated among a smaller

number of our competitors.

These competitors also compete with us in recruiting and retaining qualified scientific and management personnel

and establishing clinical study sites and subject registration for clinical studies, as well as in acquiring technologies complementary

to, or necessary for, our programs.

Smaller or early-stage companies may also prove to be significant competitors, particularly through

collaborative arrangements with large and established companies.

anticipate that we will face intense and increasing competition as new drugs and vaccines enter the market and advanced technologies

become available.

We expect any therapies and vaccines that we develop and commercialize to compete on the basis of, among other things,

efficacy, safety, convenience of administration and delivery, price and the availability of reimbursement from government and other third-party

commercial opportunities could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective,

have fewer or less severe side effects, are more convenient or are less expensive than any products that we may develop.

Our competitors

also may obtain FDA or other regulatory approvals for their products more rapidly than we may obtain approvals for ours, which could

result in our competitors establishing a strong market position before we are able to enter the market.

of October 31, 2025, we had four full-time employees working for our Company and subsidiaries.

In addition, we work with research teams

at Moffitt and Cleveland Clinic, as well as their and our subcontractors, to develop each of our projects.

risk factors described below are a summary of the principal risk factors associated with an investment in us.

These are not the only

risks we face.

You should carefully consider these risk factors, together with the risk factors set forth in Item 1A.

of this Report

and the other reports and documents filed by us with the SEC.

Relating to Our Financial Condition and Operations

We have a history of losses

and may incur additional losses in the future.

We will need additional

funding in the future which may not be available on acceptable terms, or at all, and, if available, may result in dilution to our

stockholders.

We may have difficulty

in raising capital and may consume resources faster than expected.

Related to our Research & Development, Clinical and Commercialization Activities

Our therapeutic and vaccine

programs are pre-revenue, and subject to the risks of an early-stage biotechnology company.

Our current business model

relies on strategic collaborations with commercial partners to provide the resources and infrastructure to manufacture and ultimately

market and/or sell our technologies.

We may have difficulty in timing the establishment of these partnerships to achieve the greatest

economic benefit for the Company, or in establishing these partnerships at all.

If product liability lawsuits

are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates.

We have never generated

any revenue from biotechnology and pharmaceutical product sales and our biotechnology and pharmaceutical products may never be profitable.

The therapeutics and vaccines

that we are developing are novel and present significant challenges to successfully reaching market.

While pre-clinical testing

and the limited human clinical testing of our product candidates has been positive, we may experience unfavorable results once we

collect statistically significant data from human clinical trials.

We are dependent on third

parties to conduct our pre-clinical and clinical trials.

If we encounter difficulties

enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.

We face significant competition

from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively.

Related to our Intellectual Property

We rely on licenses from

Wistar for our CAR-T technology and Cleveland Clinic for our breast and ovarian cancer vaccine technologies, and if we lose any of

these licenses it may remove or limit our ability to develop and commercialize products and technology covered by these license agreements

and we may be subjected to future litigation.

Related to our Common Stock

The issuance or sale of

shares in the future, including in connection with our current at-the-market offering program, to raise money or for strategic purposes

could reduce the market price of our common stock.

We have issued a significant

number of securities pursuant to our incentive plans and may continue to do so in the future.

The vesting and, if applicable, exercise

of these securities and the sale of the shares of common stock issuable thereunder may dilute stockholders’ percentage ownership

interest and may also result in downward pressure on the price of our common stock.

were incorporated on November 5, 1982 under the laws of the State of Delaware.

Our principal executive offices are located at 3150 Almaden

Expressway, San Jose, California 95118, our telephone number is (408) 708-9808 and our Internet website address is www.anixa.com .

We make available free of charge on or through our Internet website our annual report on Form 10-K, quarterly reports on Form 10-Q, current

reports on Form 8-K, proxy statements on Schedule 14A, and amendments to those reports filed or furnished pursuant to Section 13(a) or

15(d) of the Exchange Act as soon as reasonably practicable after we electronically file such materials with, or furnish them to, the

Securities and Exchange Commission (the “SEC”).

Alternatively, you may also access our reports at the SEC’s website

at www.sec.gov .

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business