Item 1. Business
Item 1.
Business.
Overview
Anixa
Biosciences, Inc., incorporated on November 5, 1982 under the laws of the State of Delaware, is a biotechnology company developing
therapies and vaccines that are focused on critical unmet needs in oncology and infectious disease. Our therapeutics programs
include the development of a chimeric endocrine receptor T-cell technology, a novel form of chimeric antigen receptor T-cell (“CAR-T”)
technology, initially focused on treating ovarian cancer, and the discovery and ultimately development of anti-viral drug candidates
for the treatment of COVID-19 focused on inhibiting certain viral protein functions of the virus. Our vaccine programs include
the development of a vaccine against triple negative breast cancer (“TNBC”), the most lethal form of breast cancer,
and a vaccine against ovarian cancer.
Our
subsidiary, Certainty Therapeutics, Inc. (“Certainty”), is developing immuno-therapy drugs against cancer. Certainty
holds an exclusive worldwide, royalty-bearing license to use certain intellectual property owned or controlled by The Wistar Institute
(“Wistar”), the nation’s first independent biomedical research institute and a leading National Cancer Institute
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 future 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.
Certainty,
in collaboration with the H. Lee Moffitt Cancer Center and Research Institute, Inc. (“Moffitt”), is advancing toward
human clinical testing the CAR-T technology licensed by Certainty from Wistar aimed initially at treating ovarian cancer. Certainty
is working with researchers at Moffitt to complete and submit an Investigational New Drug (“IND”) application with
the U.S. Food and Drug Administration (“FDA”) and to perform human clinical trials. In collaboration with researchers
at Moffitt, Certainty is currently performing tests on the clinical materials and assuming successful and timely completion of
those tests, we anticipate an IND application will be submitted with the FDA during the first calendar quarter of 2021.
In
April 2020, we entered into a collaboration with OntoChem GmbH (“OntoChem”) to discover and ultimately develop anti-viral
drug candidates against COVID-19. Through this collaboration, we utilized advanced computational methods, machine learning, and
molecular modeling techniques to perform in silico screening of over 1.2 billion compounds in chemical libraries (including
publicly available compounds and OntoChem’s proprietary libraries) to evaluate if any of these compounds could disrupt one
of two key enzymes of SARS-CoV-2, the virus that causes the disease COVID-19.
The
screening process resulted in identifiying over 30 potentially effective compounds that could disrupt either the function of a
viral enzyme called an endoribonuclease, known as Non-Structural Protein-15 (“NSP-15”), or the main protease (“M pro ”)
of the virus. Our in silico molecular modeling indicates that any of the NSP-15 or M pro inhibitors might disrupt
the virus’ ability to replicate in humans. Several of the most promising compounds have been synthesized and in vitro
biological assays of the compounds are ongoing. If the biological activity of any of these compounds is verified, they will
be tested in animal studies to further evaluate their candidacy as COVID-19 therapeutics.
While
a number of preventative vaccines have recently been or will soon be approved for emergency use by the FDA, we believe that there
is and will continue to be a need for effective treatments for COVID-19. There are a number of factors that may limit the effectiveness,
both in the near and long term, of the vaccines currently in use, including, but not limited to, vaccine persistence, viral escape
and long-term safety. Furthermore, all current treatments require administration in a hospital setting, thus potentially continuing
to overburden the healthcare system, while we anticipate our treatment to use an oral formulation and to be available at pharmacies.
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. This technology pertains to the use of vaccines for the treatment or prevention of TNBC and other breast cancers which
express the α-lactalbumin protein. The α-lactalbumin protein is only expressed during lactation in healthy women,
but may also be expressed in individuals with certain breast cancers, most notably TNBC.
Working
with researchers at Cleveland Clinic, in November 2020, we submitted an IND application with the FDA to begin human clinical trials
of the vaccine. In December 2020, we received authorization from the FDA to commence enrollment and treatment of patients in a
Phase 1a clinical trial. We have commenced activities necessary to prepare for treatment of patients in the Phase 1a trial, and
we anticipate being prepared to treat the first enrolled patient in the spring of 2021.
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. 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 after 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.
1
On
July 2, 2020, we implemented a strategic realignment of our business and redirected resources to exclusively focus on the development
of therapeutics and vaccines. Accordingly, we suspended operations of our subsidiary, Anixa Diagnostics Corporation, and the development
of the Cchek™ artificial intelligence driven platform of non-invasive blood tests for the early detection of cancer.
Over
the next several quarters, we expect the development of our breast and ovarian cancer vaccines, our COVID-19 therapeutic discovery
program and Certainty’s CAR-T technology to be the primary focus of the Company. As part of our legacy operations, the Company
remains engaged in limited patent licensing activities regarding the Cchek™ liquid biopsy platform, as well as in the area
of encrypted audio/video conference calling. 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 therapeutics or vaccine programs. In addition,
while we pursue our therapeutics and vaccine programs, we may also make investments in and form new companies to develop additional
emerging technologies. We do not expect to begin generating revenue with respect to any of our current therapy or vaccine 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 therapeutics or vaccines.
The eventual licensing of any of our technologies may take several years, if it is to occur at all, and may depend on positive
results from human clinical trials.
CAR-T
therapeutics
Certainty
was formed to develop immuno-therapy drugs against cancer, and in November 2017, we entered into a license with Wistar whereby
we obtained rights to certain intellectual property surrounding Wistar’s chimeric endocrine receptor targeted therapy technology.
CAR-T
therapeutics have demonstrated positive results in B-cell cancers, but very little progress has been made on solid tumors. Our
CAR-T technology is initially focused on ovarian cancer and is based on engineering killer T-cells with the Follicle Stimulating
Hormone (“FSH”) to target ovarian cells that express the FSH-Receptor. Data on this technology, including the animal
studies showing efficacy, was published in January 2017 in the journal, Clinical Cancer Research. The FSH-Receptor has been shown
to be a very exclusive protein found on a large percentage of ovarian cancer cells, but not on a significant number of non-ovarian
healthy tissues in adult females.
Studies
have shown that the FSH-Receptor is also expressed in endothelial cells of the vasculature of neoplasias We anticipate performing
further studies to evaluate the ability of our CAR-T to disrupt the vasculature of other cancers, after we commence clinical trials
of this technology against ovarian cancer.
We
are working with researchers at Moffitt to complete studies necessary to submit an IND application with the FDA. We then anticipate
taking this therapy into human clinical testing for patients suffering from ovarian cancer. 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.
2
We
have performed numerous studies in preparation for an IND application. 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.
In
October 2018, we attended a pre-IND meeting with the FDA to discuss numerous aspects of the planned clinical trial of our CAR-T
therapy for ovarian cancer. The FDA answered a number of questions, providing a good understanding of the design for the clinical
trial in our IND application.
We
have completed the manufacturing of the clinical grade vector and are in the process of testing the materials and completing the
IND application. We anticipate filing the IND in the first calendar quarter of 2021. The IND application, after review and approval
by the FDA, will enable us to begin testing our therapy in ovarian cancer patients. Assuming the FDA approves our IND application,
we anticipate beginning the human clinical trial as early as mid-2021.
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 2.4% of all female
cancer cases, but 5% of cancer deaths in women due to the disease’s low survival rate. It is estimated that in 2020, 22,000
new cases of ovarian cancer will be diagnosed and 14,000 American women will 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 48%. However, ovarian cancer survival varies substantially by age, with the overall
five-year survival rate for women 65 and older of only 31%.
3
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.
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.
COVID-19
therapeutics
Coronavirus
disease 2019 (“COVID-19”) is an infectious disease caused by the severe acute respiratory syndrome coronavirus 2 (“SARS-CoV-2”).
The disease was first identified in December 2019 in Wuhan, the capital of China’s Hubei province, and has since spread
globally, resulting in the ongoing coronavirus pandemic. SARS-CoV-2 is highly infectious, and while in the majority of cases results
in mild symptoms, in many cases the symptoms progress to viral pneumonia and multi-organ failure.
4
There
are currently no proven broadly effective treatments. Further, all treatments that are currently being employed require administration
in a hospital setting, thus continuing to overburden the healthcare system. In addition, nearly all treatments currently in clinical
trials were originally developed for other indications, and were not designed specifically against SARS-CoV-2, and therefore may
have limited effectiveness. We believe that newly designed drugs that are purposefully developed to specifically target SARS-CoV-2,
enabled by recent studies of the molecular biology of the virus, will have the potential to be far more effective than repurposing
existing drugs.
In
April 2020, we entered into a collaboration agreement with OntoChem for the purpose of discovering and ultimately developing anti-viral
drug candidates for COVID-19. Our collaboration has focused on two specific proteins of the coronavirus. The first protein is
the main protease (“M pro ”), which is an enzyme of the virus that severs a large poly-peptide into functional
proteins that enable the virus to replicate in a human host. Our program will attempt to identify molecules that inhibit the function
of this enzyme, and potentially stop or slow the virus’ ability to replicate and cause disease. Since this protease does
not have human analogs, potential inhibitors may not affect any human proteins and therefore toxic side effects may be minimized.
The
second target is an endoribonuclease, Non-Structural Protein-15 (“NSP-15”), which plays a role in breaking up the
ribonucleic acid, or the genetic content, of the virus. Recent studies have demonstrated that the endoribonuclease of many viruses,
including the SARS virus of 2003 and, it is believed the SARS-CoV-2, binds to a human host protein. This protein-protein interaction
appears to dramatically increase the infectivity of the virus. Because this interaction between a viral protein and a human protein
appears to be common to many viruses, compounds that are able to effectively disrupt this interaction, could function as broad
spectrum anti-virals in addition to addressing COVID-19.
Through
our collaboration, we utilized advanced computational methods, machine learning and molecular modeling techniques to perform in
silico screening of over 1.2 billion compounds in OntoChem’s chemistry and gene ontology database (including publicly
available compounds and OntoChem’s proprietary libraries) to evaluate if any of these compounds could disrupt M pro
or NSP-15 and to evaluate the molecules’ potential side effects, as well as their drug-like characteristics. This
screening process resulted in identifying a large number of compounds that could potentially be safe and effective against COVID-19.
We
selected the ten most promising compounds for synthesis and biological analysis. Biological testing of these compounds requires
use of live virus, which limits the laboratories qualified to perform the necessary assays to Biosafety Level 3 (“BSL-3”)
or Biosafety Level 4 labs. While availability of these labs is limited, we successfully established a relationship with a BSL-3
government lab in Europe, where biological assays, including binding assays, cellular assays, and viral activity assays, are currently
being performed. Further, this lab has animal facilities and upon completion of the biological testing, will be prepared to test
the compounds in animals to determine which compound may be appropriate for clinical evaluation.
The
Market
According
to U.S. Centers for Disease Control and Prevention (“CDC”) data, as of the date of this Report, in the U.S., there
have been over 20 million cases of COVID-19 and over 350,000 deaths. According to World Health Organization (“WHO”)
data, globally, there have been over 85 million cases and approximately 1.9 million people have died. Furthermore,
over the last three months, infections and deaths have increased.
Currently,
there are no broadly effective treatments for COVID-19. Further, the treatments that are currently being employed, such as Remdesivir
and various steroid and antibody treatments, are all in-patient therapeutics and require hospitalization, adding to the burden
on the healthcare system. A better approach, which we are employing, would be a therapeutic that can be formulated as a pill and
taken as soon as there is a positive test for COVID-19.
5
The
market for an orally delivered COVID-19 treatment that would dramatically reduce hospitalization rates would be significant given
the current infection rates. The most recent CDC predictions indicate that in the U.S. alone new infections will remain at over
1.3 million cases per week and deaths will be nearly 20,000 per week through January 2021.
Competition
Competition
in the COVID-19 treatment and prevention market is fierce, with hundreds of therapies and vaccines currently in development. Recently,
a number of preventative vaccines have received regulatory approvals in the U.S. and Europe. There are still many questions
about these vaccines, such as persistence and viral escape, and it will take time before it is known how well and for how long
they will provide protection from infection. Any product candidates that we successfully develop and commercialize will have to
compete with existing therapies and vaccines and new therapies and vaccines that may become available in the future. While we
believe that our proprietary compounds for treating COVID-19 and scientific expertise in the field of synthetic chemistry 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 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.
6
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 nearly all cases of ovarian epithelial 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.
7
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.
We
have been working with researchers at Cleveland Clinic to advance the breast cancer vaccine technology toward human clinical testing,
and recently submitted an IND application to the FDA. In December 2020, we received authorization from the FDA to commence enrollment
and treatment of patients in a Phase 1a clinical trial.
The
Breast Cancer Market
According
to American Cancer Society statistics, breast cancer accounts for 30% of all female cancer cases, and 15% of cancer deaths in
women. It is estimated that in 2020, 276,000 new cases of breast cancer will be diagnosed in the U.S. and 42,000 women will die
from this disease. Despite continuous advances made in the field of cancer research every year, there has been little change in
breast cancer incidence rate over the last ten 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., 276,000 women are estimated to be diagnosed with breast cancer this year, there are approximately 80 million women
over the age of 40—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 2.4% of all female cancer cases, but 5% of cancer deaths
in women due to the disease’s low survival rate. It is estimated that in 2020, 22,000 new cases of ovarian cancer will be
diagnosed and 14,000 American women will 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 48%. However, ovarian cancer survival varies substantially by age, with the overall five-year survival rate for women
65 and older of only 31%.
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., 22,000 women are estimated to be diagnosed with ovarian cancer this year, there are approximately 40 million women
over the age of 60—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.
8
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.
Employees
As
of October 31, 2020, we had four employees, three full-time and one part time, working for our Company and subsidiaries.
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.
●
Our
business activities are expected to be adversely affected by the global COVID-19 pandemic.
9
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 of our product candidates has been positive, we may experience unfavorable results once we commence 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 Propery
●
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 we may be subjected to future litigation.
Risks
Related to our Common Stock
●
The
issuance or sale of shares in the future to raise money or for strategic purposes, including through our current ATM program,
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 your percentage ownership interest and may also result in downward pressure on the price of our common stock.
Other
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.
10