Item 1. Business
Item
1. Business.
Overview
Anixa
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.
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 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.
In
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. 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. 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®).
In
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”). 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.
In
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.
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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 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. 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 4.6% as of October 31, 2023.
Certainty,
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 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. This
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
T cells. 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.
In
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
available. 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. We continue
to prosecute our U.S. patent applications of this technology and may decide to restart development at some time in the future.
Over
the next several quarters, we expect the development of our vaccines and therapeutics 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 (during the year ended October 31, 2023, we derived approximately $210,000 of revenue from these activities).
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.
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Breast
and Ovarian 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 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. 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.
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. 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.
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. However, 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.
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While
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.
In
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.
The
Breast Cancer Market
According
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.
The
market for prophylactic cancer vaccines is sizable—bigger in fact than the market for any type of cancer therapeutic. After all,
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.
While
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
larger.
The
Ovarian Cancer Market
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, 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
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%.
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., 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. Worldwide, the number is dramatically larger.
Competition
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 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.
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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 vaccines and commercializing those 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.
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 programs. 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 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.
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.
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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.
We
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:
●
No
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.
●
The
treated mice did not show any weight loss. Control mice also did not show any weight loss.
●
One
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.
●
Serum
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.
●
Histological
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.
While
these results are 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.
The
Market
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. 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%.
Competition
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 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.
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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 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.
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 program. 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 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
of administration and delivery, price and the availability of reimbursement from government and other third-party payers.
Our
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.
Employees
As
of October 31, 2023, we had five employees, four full-time and one part time, 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.
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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.
Other
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 (the “SEC”). Alternatively, you may also access our reports at the SEC’s website
at www.sec.gov .
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