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Item 1. Business

2025-01-10 compared with 2024-01-16 · 391 added, 356 removed, 20 unchanged (97% of the section changed)

Biosciences, Inc.

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

Our vaccine programs include (i) the development of a preventative vaccine against triple negative breast cancer (“TNBC”),

the most lethal form of breast cancer, as well other forms of breast cancer and (ii) the development of a preventative vaccine against

ovarian cancer.

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.

(“Certainty”), and (ii) until March 2023, the development of anti-viral drug

candidates for the treatment of COVID-19 focused on inhibiting certain protein functions of the virus.

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 contracting 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 mother’s mammary tissue.

This protein disappears when the mother 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 U.S.

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 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 first segment of the study, Phase 1a, will consist of 18 to 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 recurrence.

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.

During the course of the Phase 1a study, participants will receive three vaccinations, each two weeks

apart, and will be closely monitored for side effects and immune response.

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.

We have begun vaccinating

participants in up to three additional dose cohorts at dose levels higher than the currently determined MTD and lower than the highest

dose where we observed dose limiting toxicity.

Further, we have commenced vaccination of participants in the second segment of the trial,

Phase 1b, that includes participants who have never had cancer, but carry certain genetic mutations 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, we are currently

enrolling participants in the third segment of the trial, Phase 1c, that includes post-operative TNBC patients that have residual disease

following neoadjuvant chemo-immunotherapy and are currently undergoing treatment with pembrolizumab (Keytruda®).

November 2020, we executed a license agreement with Cleveland Clinic pursuant to which the Company was granted 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”).

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

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 National Cancer Institute’s

(“NCI”) PREVENT program.

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.

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 Investigational

New Drug (“IND”) application 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 transfer of any rights of the

Company’s assets.

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 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 milestones.

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.

(“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

3 unchanged sentences

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

in collaboration with the H.

Certainty, in collaboration with

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.

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 appears to have been well-tolerated by all patients treated to date.

We anticipate that we will begin enrolling

the successive patient cohort, that we expect to give a three-times higher dose of cells, in the first calendar quarter of 2024.

study is a dose-escalation trial with two arms based on delivery method—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

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

chemotherapy.

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

dose is reached, the rate of patient enrollment, and how long we maintain the two different delivery methods.

April 2020, we entered into a collaboration with OntoChem GmbH (“OntoChem”) which was later assigned to MolGenie GmbH, a

company spun-out from OntoChem focused on drug discovery and development, to discover and ultimately develop anti-viral drug candidates

against COVID-19.

Through this collaboration, we identified compounds that appeared to be effective in disrupting the main protease of

SARS-CoV-2, the virus that causes the disease COVID-19.

While our compounds have shown promise as an effective treatment, results of

animal studies indicate that there is not sufficient oral bioavailability, and it is unclear whether an orally delivered treatment may

be developed.

We do not currently believe that there is a viable market for an injectable treatment given the current oral treatments

Furthermore, we believe the needed additional investment in research for alternative delivery methods would divert resources

from more promising projects.

Therefore, in March 2023, we decided to pause further development of our COVID-19 therapeutic.

to prosecute our U.S.

patent applications of this technology and may decide to restart development at some time in the future.

the next several quarters, we expect the development of our vaccines and therapeutics 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 (during the year ended October 31, 2023, we derived approximately $210,000 of revenue from these activities).

(“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

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.

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.

8 unchanged sentences

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

and Ovarian Cancer vaccines

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.

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 March 2016 in the journal, Cancers.

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

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.

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

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 in the U.S.

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.

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.

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

Cancer Prevention Research.

the data thus far for both of our cancer vaccines has been positive, there are many uncertainties in drug development, and most drugs

fail to reach commercialization.

October 2021, Cleveland Clinic began treating patients in a Phase 1 clinical trial of our breast cancer vaccine.

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.

Breast Cancer Market

to American Cancer Society statistics, breast cancer accounts for over 30% of all female cancer cases, and 15% of cancer deaths in women.

It has been estimated that in 2023, 301,000 new cases of breast cancer would be diagnosed in the U.S.

and 43,000 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 approximately 0.5% per year over the past 15 years.

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

doctors administer cancer drugs only 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., 301,000 women were estimated to be diagnosed with breast cancer in 2023, there are approximately 82 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

Ovarian Cancer Market

to American Cancer Society statistics, 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 2023, 20,000 new cases of ovarian cancer would be

diagnosed and 13,000 American women would die from this disease.

Despite continuous advances made in the field of cancer research every

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

However, ovarian cancer survival varies substantially by age, with the overall five-year survival rate for women 65 and older

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

the U.S., 20,000 women were estimated to be diagnosed with ovarian cancer in 2023, there are approximately 41 million women age 60 and

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

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

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.

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 breast and ovarian cancer vaccine technologies and 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 vaccines and commercializing those vaccines.

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.

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 vaccines and achieving widespread market acceptance.

Our competitors’ vaccines may be more effective, or more effectively marketed

and sold, than any vaccine we may commercialize and may render our vaccines obsolete or non-competitive before we can recover the expenses

of developing and commercializing any of our 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 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.

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 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.

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.

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.

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

performed numerous studies in preparation for human clinical studies.

In those studies, several groups of tumor free, female mice were

intra-peritoneally infused with increasing concentrations of the murine CAR-T construct and their health status was monitored for up

to five months.

The following summarizes the results of these studies:

treated mice showed any signs of pain/stress, difficulty breathing or increased respiratory rate, reduced movement, reduced grooming

or feeding, dehydration, anorexia or any other sign of distress.

Control mice also did not show any distress.

treated mice did not show any weight loss.

Control mice also did not show any weight loss.

cohort of treated mice also had blood drawn periodically for measurement of markers for liver function (AST-Aspartate transaminase/ALT-Alanine

transaminase), kidney function (creatinine), and metabolic function (glucose).

No abnormal values were observed, as was the case

for control mice.

IL-6 (interleukin-6) increased in the treated mice, as well as mice treated with control T cells.

This indicated that the T cells

were inducing the expected inflammatory response.

analysis of the ovaries showed that 60% of the treated mice had significant reduction in ovarian mass, while the control mice exhibited

no reduction.

This observation confirms that the CAR-T was successfully attacking the ovaries, as we hoped and expected.

these results are positive, there are many uncertainties in drug development, and most drugs fail to reach commercialization.

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.

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.

According to American Cancer Society statistics, 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 2023, approximately

20,000 new cases of ovarian cancer would be diagnosed and 13,000 American 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 50%.

However, ovarian cancer survival varies substantially by age, with the overall five-year survival

rate for women 65 and older of only 32%.

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 and 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 treatments and commercializing those treatments.

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

approval for treatments and achieving widespread market acceptance.

Our competitors’ treatments may be more effective, or more

effectively marketed and sold, than any treatment we may commercialize and may render our treatments obsolete or non-competitive before

we can recover the expenses of developing and commercializing any of our treatments.

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 program.

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 enter the market and advanced technologies become available.

We expect any treatments that we develop and commercialize to compete on the basis of, among other things, efficacy, safety, convenience

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.

commercial opportunity 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 approval for their products more rapidly than we may obtain approval for ours, which could result

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

of October 31, 2023, we had five employees, four full-time and one part time, working for our Company and subsidiaries.

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

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

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.

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

Related to our Research & Development, Clinical and Commercialization Activities

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

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.

product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization

of our product candidates.

have never generated any revenue from biotechnology and pharmaceutical product sales and our biotechnology and pharmaceutical products

may never be profitable.

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

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.

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

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

adversely affected.

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

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

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.

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

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 .

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 .

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