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ANIX:Segments
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
10-K
☒ | ANNUAL
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the fiscal year ended October 31, 2023 |
or
☐ |
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from ___________ to ___________ |
Commission
file number: 001-37492
ANIXA
BIOSCIENCES, INC.
(Exact
Name of Registrant as Specified in its Charter)
Delaware |
|
11-2622630 |
(State
or Other Jurisdiction
of
Incorporation or Organization) |
|
(I.R.S.
Employer
Identification
No.) |
3150
Almaden Expressway, Suite
250
San
Jose, CA
95118
(408)
708-9808
(Address,
Including Zip Code, and Telephone Number, Including Area Code, of Registrant’s Principal Executive Offices)
Securities
registered pursuant to Section 12(b) of the Act:
Title
of Each Class: |
|
Trading
Symbol |
|
Name
of Each Exchange on Which Registered: |
Common
Stock, $0.01 par value |
|
ANIX |
|
The NASDAQ Stock
Market LLC |
Securities
registered pursuant to Section 12(g) of the Act:
None
Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No
☒
Indicate
by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No
☒
Indicate
by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. Yes
☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files). Yes
☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
|
Large
accelerated filer ☐ |
Accelerated
filer ☐ |
|
Non-accelerated
filer ☒ |
Smaller
reporting company ☒ |
|
Emerging
growth company ☐ |
|
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness
of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered
public accounting firm that prepared or issued its audit report. ☐
Indicate
by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously
issued financial statements. ☐
Indicate
by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation
received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No
☒
Aggregate
market value of the voting stock (which consists solely of shares of common stock) held by non-affiliates of the registrant as of April
28, 2023 (the last business day of the registrant’s most recently completed second fiscal quarter), computed by reference to the
closing sale price of the registrant’s common stock on the NASDAQ on such date ($4.08): $120,568,574.
On
January 16, 2024, the registrant had outstanding 31,699,701
shares of common stock, par value $0.01 per share,
which is the registrant’s only class of common stock.
DOCUMENTS
INCORPORATED BY REFERENCE:
NONE
TABLE
OF CONTENTS
CAUTIONARY
STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
Information
included in this Annual Report on Form 10-K (this “Report”) contains forward-looking statements within the meaning of Section
27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934,
as amended (the “Exchange Act”). Forward-looking statements are not statements of historical facts, but rather reflect our
current expectations concerning future events and results. We generally use the words “believes,” “expects,”
“intends,” “plans,” “anticipates,” “likely,” “will” and similar expressions
to identify forward-looking statements. Such forward-looking statements, including those concerning our expectations, involve risks,
uncertainties and other factors, some of which are beyond our control, which may cause our actual results, performance or achievements,
or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking
statements. These risks, uncertainties and factors include, but are not limited to, those factors set forth in this Report under “Item
1A. – Risk Factors” below. Except as required by applicable law, including the securities laws of the United States, we undertake
no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
You are cautioned not to unduly rely on such forward-looking statements when evaluating the information presented in this Report.
CERTAIN
TERMS USED IN THIS REPORT
References
in this Report to “we,” “us,” “our,” the “Company” or “Anixa” means Anixa
Biosciences, Inc. unless otherwise indicated.
PART
I
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.
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.
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.
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.
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.
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.
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. |
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.
Item
1A. Risk Factors.
Our
business involves a high degree of risk and uncertainty, including the following risks and uncertainties:
Risks
Related to Our Financial Condition and Operations
We
have a history of losses and may incur additional losses in the future.
On
a cumulative basis, we have sustained substantial losses and negative cash flows from operations since our inception. As of October 31,
2023, our accumulated deficit was approximately $228,196,000. As of October 31, 2023, we had approximately $23,844,000 in cash, cash
equivalents and short-term investments, and working capital of approximately $23,328,000. In fiscal year 2023, we incurred losses of
approximately $9,930,000 and we experienced negative cash flows from operations of approximately $6,209,000. We expect to continue incurring
material research and development and general and administrative expenses in connection with our operations. As a result, we anticipate
that we will incur 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.
Based
on currently available information as of January 16, 2024, we believe that our existing cash, cash equivalents and short-term investments
will be sufficient to fund our activities for at least the next 12 months. However, our projections of future cash needs and cash flows
may differ from actual results. If current cash on hand, cash equivalents and short-term investments are insufficient to continue to
operate our business, or if we elect to invest in or acquire a company or companies that are synergistic with or complementary to our
technologies, we may be required to obtain more working capital. We may seek to obtain working capital through sales of our equity securities,
including through our current at-the-market offering program, or through bank credit facilities or public or private debt from various
financial institutions where possible. We cannot be certain that additional funding will be available on acceptable terms, or at all.
If we do identify sources for additional funding, the sale of additional equity securities or convertible debt could result in dilution
to our stockholders. Additionally, the sale of equity securities or issuance of debt securities may be subject to certain security holder
approvals or may result in the downward adjustment of the exercise or conversion price of our outstanding securities. We can give no
assurance that we will generate sufficient cash flows in the future to satisfy our liquidity requirements or sustain future operations,
or that other sources of funding, such as sales of equity or debt, would be available or would be approved by our security holders, if
needed, on favorable terms or at all. If we fail to obtain additional working capital as and when needed, such failure could have a material
adverse impact on our business, results of operations and financial condition. Furthermore, such lack of funds may inhibit our ability
to respond to competitive pressures or unanticipated capital needs, or may force us to reduce operating expenses, which would significantly
harm the business and development of operations.
We
may have difficulty in raising capital and may consume resources faster than expected.
We
currently do not generate any revenue from our therapeutics or vaccines nor do we generate any other recurring revenues and as of October
31, 2023, the Company had approximately $23,844,000 in cash, cash equivalents and short-term investments. Therefore, we have a limited
source of cash to meet our future capital requirements, which may include the expensive process of obtaining FDA approvals for our CAR-T
ovarian cancer therapeutic and our breast and ovarian cancer vaccines. We do not expect to generate significant revenues for the foreseeable
future, which would leave us without resources to continue our operations and force us to resort to raising additional capital in the
form of equity or debt financings, which may not be available to us. We may have difficulty raising needed capital in the near or longer
term as a result of, among other factors, the very early stage of our therapeutics and vaccine businesses and our lack of revenues as
well as the inherent business risks associated with an early stage, biotechnology company and present and future market conditions. Also,
we may consume available resources more rapidly than currently anticipated, resulting in the need for additional funding sooner than
anticipated. Our inability to raise funds could lead to decreases in the price of our common stock and the failure of our therapeutics
and vaccine businesses which would have a material adverse effect on the Company.
Failure
to effectively manage our potential growth could place strains on our managerial, operational and financial resources and could adversely
affect our business and operating results.
Our
business strategy and potential growth may place a strain on managerial, operational and financial resources and systems. Although we
may not grow as we expect, if we fail to manage our growth effectively or to develop and expand our managerial, operational and financial
resources and systems, our business and financial results will be materially harmed.
We
may use our financial and human resources to pursue a particular research program or product candidate and fail to capitalize on programs
or product candidates that may be more profitable or for which there is a greater likelihood of success.
Because
we have limited resources, we may forego or delay pursuit of opportunities with certain programs or product candidates or for indications
that later prove to have greater commercial potential. Our resource allocation decisions may cause us to fail to capitalize on viable
commercial products or profitable market opportunities. Our spending on current and future research and development programs for product
candidates may not yield any commercially viable products. If we do not accurately evaluate the commercial potential or target market
for a particular product candidate, we may relinquish valuable rights to that product candidate through strategic collaboration, licensing
or other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization
rights to such product candidate, or we may allocate internal resources to a product candidate which it would have been more advantageous
to enter into a partnering arrangement.
Our
ability to use our net operating loss carryforwards and certain other tax attributes may be limited.
We
have incurred net losses since our inception and we may never achieve or sustain profitability. Generally, losses incurred will carry
forward until such losses expire (for losses generated prior to January 1, 2018) or are used to offset future taxable income, if any.
Under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended (the “Internal Revenue Code”), if a corporation
undergoes an “ownership change,” generally defined as a greater than 50 percentage point change (by value) in its equity
ownership by certain stockholders over a three-year period, the corporation’s ability to use its pre-change net operating loss,
or NOL, carryforwards and other pre-change tax attributes (such as research tax credits) to offset its post-change income or taxes may
be limited. We have not completed a study to assess whether an ownership change for purposes of Section 382 or 383 has occurred, or whether
there have been multiple ownership changes since our inception. We may have experienced ownership changes in the past and may experience
ownership changes in the future as a result of shifts in our stock ownership (some of which shifts are outside our control). As a result,
if we earn net taxable income, our ability to use our pre-change NOL carryforwards to offset such taxable income may be subject to limitations.
Similar provisions of state tax law may also apply to limit our use of accumulated state tax attributes. As a result, even if we attain
profitability, we may be unable to use a material portion of our NOL carryforwards and other tax attributes, which could adversely affect
our future cash flows.
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.
Since
the Company’s primary focus for the foreseeable future will likely be our therapeutics and vaccine businesses, shareholders should
understand that we are primarily an early-stage biotechnology company with no history of revenue-generating operations, and our only
assets consist of our proprietary and licensed technologies and the know-how of our officers and employees. Therefore, we are subject
to all the risks and uncertainties inherent in a new business, in particular new businesses engaged in CAR-T cancer therapeutics and
cancer vaccines, as well as whether our current business plan is sound. Our CAR-T ovarian cancer therapeutic and our breast and ovarian
cancer vaccines are in their early stages of development, and we still must establish and implement many important functions necessary
to commercialize the technologies.
Accordingly,
you should consider the Company’s prospects in light of the costs, uncertainties, delays and difficulties frequently encountered
by companies in their pre-revenue generating stages, particularly those in the biotechnology field. Shareholders should carefully consider
the risks and uncertainties that a business with limited operating history will face. In particular, shareholders should consider that
there is a significant risk that we will not be able to:
|
● |
successfully
enroll sufficient numbers of qualified patients to participate in our clinical trials; |
|
● |
obtain
sufficient quantity and quality of materials manufactured for use in our clinical trials; |
|
● |
successfully
meet the primary endpoints in our clinical trials; |
|
● |
implement
or execute our current business plan; |
|
● |
raise
sufficient funds in the capital markets or otherwise to fully effectuate our business plan; |
|
● |
maintain
our management team; |
|
● |
determine
that the processes and technologies that we have developed or will develop are commercially viable; and/or |
|
● |
attract,
enter into or maintain contracts with potential commercial partners such as licensors of technology and suppliers or licensees of
our technologies. |
Any
of the foregoing risks may adversely affect the Company and result in the failure of our business. In addition, we expect to encounter
unforeseen expenses, difficulties, complications, delays and other known and unknown factors. Over the next several quarters, we will
need to continue broadening our focus from a research and development company to a company capable of supporting clinical trials and
commercial activities, or enter into collaborations with partners that may provide those capabilities. We may not be able to reach such
achievements, which would have a material adverse effect on our 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.
We
do not currently have the resources and infrastructure to manufacture, market or sell our products or technologies. While our technologies
have generated interest from multiple potential strategic partners, due to the early stage of development of our technologies, we can
give no assurance that we will be able to successfully establish any strategic partnerships. Further, even if we elect to engage with
a potential strategic partner, development of these partnerships can take an extended period of time in which significant analysis is
performed by the potential strategic partner on our technologies and our intellectual property, as well as on the market opportunities
and how well our technologies may fit strategically with the partner’s existing business. Accordingly, it will be difficult for
us to time the establishment of a strategic partnership to achieve the greatest economic benefit for the Company.
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
will face an inherent risk of product liability as a result of the ongoing and upcoming human clinical testing and commercialization
of our product candidates. For example, we may be sued if our product candidates cause or are perceived to cause injury or are found
to be otherwise unsuitable during clinical testing, manufacturing, marketing or sale. Any such product liability claims may include allegations
of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product, negligence, strict liability or
a breach of warranties. Claims could also be asserted under state consumer protection acts. If we cannot successfully defend ourselves
against product liability claims, we may incur substantial liabilities or be required to limit or cease commercialization of our product
candidates. Even successful defense would require significant financial and management resources. Regardless of the merits or eventual
outcome, liability claims may result in:
|
● |
decreased
demand for our product candidates; |
|
● |
injury
to our reputation; |
|
● |
withdrawal
of clinical trial participants; |
|
● |
initiation
of investigations by regulators; |
|
● |
costs
to defend the related litigation; |
|
● |
a
diversion of management’s time and our resources; |
|
● |
substantial
monetary awards to clinical trial participants or patients; |
|
● |
product
recalls, withdrawals or labeling, marketing or promotional restrictions; |
|
● |
loss
of potential revenue; |
|
● |
exhaustion
of any available insurance and our capital resources; |
|
● |
the
inability to commercialize any product candidate; and |
|
● |
a
decline in our share price. |
While
we carry product liability insurance, claims could be asserted that could result in damages in excess of such insurance coverage. If
we do not maintain sufficient product liability insurance at an acceptable cost to protect against potential product liability claims,
the lack of sufficient coverage could prevent or inhibit the development and commercialization of any products we develop, alone or with
corporate collaborators.
If
we cannot license rights to use technologies on reasonable terms, we may not be able to commercialize new products in the future.
In
the future, we may identify third-party technology we need, including to develop or commercialize new products or services. In return
for the use of a third party’s technology, we may agree to pay the licensor royalties based on sales of our products or services.
Royalties are a component of cost of products or services and affect the margins on our products or services. We may also need to negotiate
licenses to patents or patent applications before or after introducing a commercial product. We may not be able to obtain necessary licenses
to patents or patent applications, and our business may suffer if we are unable to enter into the necessary licenses on acceptable terms
or at all, if any necessary licenses are subsequently terminated, if the licensors fail to abide by the terms of the licenses or fail
to prevent infringement by third parties, or if the licensed patents or other rights are found to be invalid or unenforceable.
Biotechnology
and pharmaceutical product development is a highly speculative undertaking and involves a substantial degree of uncertainty. We have
never generated any revenue from biotechnology and pharmaceutical product sales and our biotechnology and pharmaceutical products may
never be profitable.
We
are in the pre-clinical stage of developing our ovarian cancer vaccine technology and in the clinical stage with our CAR-T therapeutic
technology and with our breast cancer vaccine technology. Our ability to generate revenue depends in large part on our ability, alone
or with partners, to successfully complete the development of, obtain the necessary regulatory approvals for, and commercialize, product
candidates. We do not anticipate generating revenues from sales of such products for the foreseeable future. Our ability to generate
future revenues from product sales of our technologies depends heavily on our success in:
|
● |
progressing
our discovery stage programs into pre-clinical testing; |
|
● |
progressing
our pre-clinical programs into human clinical trials; |
|
● |
completing
requisite clinical trials through all phases of clinical development of our product candidates; |
|
● |
seeking
and obtaining marketing approvals for our product candidates that successfully complete clinical trials, if any; |
|
● |
launching
and commercializing our product candidates for which we obtain marketing approval, if any, with a partner or, if launched independently,
successfully establishing a manufacturing, sales force, marketing and distribution infrastructure; |
|
● |
identifying
and developing new product candidates; |
|
● |
establishing
and maintaining supply and manufacturing relationships with third parties; |
|
● |
maintaining,
protecting, expanding and enforcing our intellectual property; and |
|
● |
attracting,
hiring and retaining qualified personnel. |
Because
of the numerous risks and uncertainties associated with biologic and pharmaceutical product development, we are unable to predict the
likelihood or timing for when we may receive regulatory approval of our product candidates or when we will be able to achieve or maintain
profitability, if ever. If we are unable to establish a development and or commercialization partnership, or do not receive regulatory
approvals, our business, prospects, financial condition and results of operations will be adversely affected. Even if we or a partner
obtain the regulatory approvals to market and sell one or more of our product candidates, we may never generate significant revenues
from any commercial sales for several reasons, including because the market for our products may be smaller than we anticipate, or products
may not be adopted by physicians and payors or because our products may not be as efficacious or safe as other treatment options. If
we fail to successfully commercialize one or more products, by ourselves or through a partner, we may be unable to generate sufficient
revenues to sustain and grow our business and our business, prospects, financial condition and results of operations will be adversely
affected.
Cancer
vaccines are novel and present significant challenges.
The
development of preventive and therapeutic cancer vaccines is difficult, with very few cancer vaccines successfully reaching the market.
The only vaccines shown to be effective in preventing cancer have been vaccines against cancer causing agents, not the cancer itself.
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.
CAR-T
cell therapies are novel and present significant challenges.
CAR-T
product candidates represent a relatively new field of cellular immunotherapy. Advancing this novel and personalized therapy creates
significant challenges for us, or a partner, including:
|
● |
obtaining
regulatory approval, as the FDA and other regulatory authorities have limited experience with commercial development of T cell therapies
for cancer; |
|
● |
sourcing
clinical and, if approved, commercial supplies for the materials used to manufacture and process our product candidates; |
|
● |
developing
a consistent and reliable process, while limiting contamination risks, for engineering and manufacturing T cells ex vivo and
infusing the engineered T cells into the patient; |
|
● |
educating
medical personnel regarding the potential benefits, as well as the challenges, of incorporating our product candidates into their
treatment regimens; |
|
● |
establishing
sales and marketing capabilities upon obtaining any regulatory approval to gain market acceptance of a novel therapy; and |
|
● |
the
availability of coverage and adequate reimbursement from third-party payors for our novel and personalized therapy. |
Our
inability to successfully develop CAR-T cell therapies or develop processes related to the manufacture, sales and marketing of these
therapies would adversely affect our business, results of operations and prospects.
While
CAR-T technology has shown positive results in B-cell cancers by others, its safety and efficacy has not been seen in solid tumors and
we cannot guarantee our CAR-T technology will be safe or effective in ovarian or other cancers.
CAR-T
therapies function through the binding of a genetically engineered killer T cell to a cancer cell. However, these engineered T cells
destroy the cell they are bound to whether it is a cancer cell or a healthy cell. Therefore, the engineered T cells must be designed
to only bind to either cancer cells or other target cells to minimize toxicity. Our CAR-T technology relies on the natural affinity of
FSH to FSH-Receptor. Research by others has shown that in women the FSH-Receptor protein is found on ovary cells and generally in no
other healthy tissue, and therefore, we engineer our T cells with FSH. However, as the research in this field is still new, we cannot
guarantee that there is no FSH-Receptor on any other healthy tissue in the human body.
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
have limited human clinical data from our breast cancer vaccine and our CAR-T ovarian cancer therapeutic, and we have not initiated clinical
trials for our ovarian cancer vaccine and we may not be able to commence clinical trials on the time frames we expect. As our discovery
stage product candidate has only been tested in animals and our clinical stage candidates currently have limited human data, we face
significant uncertainty regarding how effective and safe they will be in human patients and the results from pre-clinical studies may
not be indicative of the results of clinical trials. Pre-clinical and clinical data are often susceptible to varying interpretations
and analyses, and many companies that have believed their product candidates performed satisfactorily in pre-clinical studies and clinical
trials have nonetheless failed to obtain marketing approval for their products.
Even
if clinical trials are successfully completed, the FDA or foreign regulatory authorities may not interpret the results as we do, and
more clinical trials could be required before we submit our product candidates for approval. To the extent that the results of our clinical
trials are not satisfactory to the FDA or foreign regulatory authorities for support of a marketing application, approval of our product
candidates may be significantly delayed, or we may be required to expend significant additional resources, which may not be available
to us, to conduct additional clinical trials in support of potential approval of our product candidates.
We
are dependent on third parties to conduct our pre-clinical studies and clinical trials.
We
depend and will continue to depend upon independent investigators and collaborators, such as universities, medical institutions, and
strategic partners such as Moffitt for our CAR-T therapy and Cleveland Clinic for our breast and ovarian cancer vaccines to conduct our
pre-clinical studies and clinical trials under agreements with us. Negotiations of budgets and contracts with study sites may result
in delays to our development timelines and increased costs. We will rely heavily on these third parties over the course of our clinical
trials, and we control only certain aspects of their activities. Nevertheless, we are responsible for ensuring that each of our studies
is conducted in accordance with applicable protocol, legal, regulatory and scientific standards, and our reliance on third parties does
not relieve us of our regulatory responsibilities. We and these third parties are required to comply with current good clinical practices,
or cGCPs, which are regulations and guidelines enforced by the FDA and comparable foreign regulatory authorities for product candidates
in clinical development. Regulatory authorities enforce these cGCPs through periodic inspections of clinical trial sponsors, principal
investigators and clinical trial sites. If we or any of these third parties fail to comply with applicable cGCP regulations, the clinical
data generated in our clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities could require
us to perform additional clinical trials before approving our marketing applications. It is possible that, upon inspection, such regulatory
authorities could determine that any of our clinical trials fail to comply with the cGCP regulations. In addition, our clinical trials
must be conducted with biologic product produced under current good manufacturing practices, or cGMPs, and will require a large number
of test patients. Our failure or any failure by these third parties to comply with these regulations or to recruit a sufficient number
of patients may require us to repeat clinical trials, which would delay the regulatory approval process. Moreover, our business may be
implicated if any of these third parties violates federal or state fraud and abuse or false claims laws and regulations or healthcare
privacy and security laws.
Any
third parties conducting our clinical trials are not and will not be our employees and, except for remedies available to us under our
agreements with these third parties, we cannot control whether they devote sufficient time and resources to our ongoing pre-clinical,
clinical and nonclinical programs. These third parties may also have relationships with other commercial entities, including our competitors,
for whom they may also be conducting clinical trials or other drug development activities, which could affect their performance on our
behalf. If these third parties do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they
need to be replaced or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our
clinical protocols or regulatory requirements or for other reasons, our clinical trials may be extended, delayed or terminated and we
may not be able to complete development of, obtain regulatory approval of or successfully commercialize our product candidates. As a
result, our financial results and the commercial prospects for our product candidates would be harmed, our costs could increase and our
ability to generate revenue could be delayed.
Switching
or adding third parties to conduct our clinical trials involves substantial cost and requires extensive management time and focus. In
addition, there is a natural transition period when a new third party commences work. As a result, delays occur, which can materially
impact our ability to meet our desired clinical development timelines.
If
we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise
adversely affected.
We
may experience difficulties in patient enrollment in our clinical trials for a variety of reasons. The timely completion of clinical
trials in accordance with their protocols depends, among other things, on our ability to enroll a sufficient number of patients who remain
in the study until its conclusion. The enrollment of patients depends on many factors, including:
|
● |
the
patient eligibility criteria defined in the clinical trial protocol; |
|
● |
the
size of the patient population required for analysis of the trial’s primary endpoints; |
|
● |
the
proximity of patients to the study site; |
|
● |
the
design of the clinical trial; |
|
● |
our
ability to retain clinical trial investigators with the appropriate competencies and experience; |
|
● |
our
ability to obtain and maintain patient consents; |
|
● |
the
risk that patients enrolled in clinical trials will drop out of the clinical trials before completion; and |
|
● |
competing
clinical trials and approved therapies available for patients. |
In
particular, our Phase 1 CAR-T ovarian cancer clinical trial is enrolling patients with late-stage ovarian cancer who have failed conventional
treatment, and are willing and able to be treated at Moffitt. Our Phase 1a breast cancer vaccine clinical trial is enrolling patients
who have undergone standard of care treatment for TNBC. Our Phase 1b breast cancer vaccine clinical trial is enrolling healthy women
who, as a result of, among other things, testing positive for the BRCA1, BRCA2 or PALB2 gene mutations which are leading predictors of
future incidence of breast cancer, have elected to have prophylactic mastectomies. Our Phase 1c breast cancer vaccine clinical trial
is enrolling post-operative TNBC patients who have residual disease following neoadjuvant chemo-immunotherapy and are being treated with
pembrolizumab (Keytruda®). These potential trial participants must be willing and able to undergo treatment at the Cleveland Clinic.
Our
clinical trials will compete with other companies’ clinical trials for product candidates that are in the same therapeutic areas
as our product candidates, and this competition will reduce the number and types of patients available to us, because some patients who
might have opted to enroll in our clinical trials may instead opt to enroll in a trial being conducted by one of our competitors. We
expect to conduct our clinical trials at the same clinical trial sites that some of our competitors may use, which will reduce the number
of patients who are available for our clinical trial in these clinical trial sites. Moreover, because our product candidates represent
a departure from more commonly used methods for cancer treatment, potential patients and their doctors may be inclined to use experimental
therapies that use conventional technologies, such as chemotherapy and antibody therapy, rather than enroll patients in our clinical
trials. Patients may also be unwilling to participate in our clinical trials because of negative publicity from adverse events in the
biotechnology or gene therapy industries.
Delays
in patient enrollment may result in increased costs or may affect the timing or outcome of our planned clinical trials, which could prevent
completion of the clinical trials and adversely affect our ability to advance the development of our ovarian cancer CAR-T therapy and
our breast cancer vaccine.
Any
adverse developments that occur during any clinical trials conducted by academic investigators, our collaborators or other entities conducting
clinical trials under independent IND applications may negatively affect the conduct of our clinical trials or our ability to obtain
regulatory approvals or commercialize our product candidates.
CAR-T,
vaccines and other immuno-therapy technologies are being used by third parties in clinical trials for which we are collaborating or in
clinical trials which are completely independent of our development programs. We have little to no control over the conduct of those
clinical trials. If serious adverse events occur during these or any other clinical trials using technologies similar to ours, the FDA
and other regulatory authorities may delay our clinical trial, or could delay, limit or deny approval of our product candidates or require
us to conduct additional clinical trials as a condition to marketing approval, which would increase our costs. If we receive regulatory
approval for any product candidate and a new and serious safety issue is identified in connection with clinical trials conducted by third
parties, the applicable regulatory authorities may withdraw their approval of our products or otherwise restrict our ability to market
and sell our products. In addition, treating physicians may be less willing to administer our products due to concerns over such adverse
events, which would limit our ability to commercialize our products.
Adverse
side effects or other safety risks associated with our product candidates could cause us to suspend or discontinue clinical trials or
delay or preclude approval.
In
third party clinical trials involving CAR-T cell therapies, the most prominent acute toxicities included symptoms thought to be associated
with the release of cytokines, such as fever, low blood pressure and kidney dysfunction. Some patients also experienced toxicity of the
central nervous system, such as confusion, cranial nerve dysfunction and speech impairment. Adverse side effects attributed to CAR-T
therapies were severe and life-threatening in some patients. The life-threatening events were related to kidney dysfunction and toxicities
of the central nervous system or other organ failure. Severe and life-threatening toxicities occurred primarily in the first two weeks
after cell infusion and generally resolved within three weeks. In the past, several patients have also died in clinical trials by others
involving CAR-T cell therapies.
Side
effects of our breast cancer vaccine may include mild effects such as injection site pain or irritation, or more severe side effects
such as fever, inflammation, organ failure or other adverse effects.
Undesirable
side effects observed in our clinical trials, whether or not they are caused by our product candidates, could result in the delay, suspension
or termination of clinical trials, by the FDA or other regulatory authorities or us for a number of reasons. In addition, because the
patients who will be enrolled in our clinical trials may be suffering from a life-threatening disease and may often be suffering from
multiple complicating conditions it may be difficult to accurately assess the relationship between our product candidate and adverse
events experienced by very ill patients. If we elect or are required to delay, suspend or terminate any of our clinical trials, the commercial
prospects of such therapy will be harmed and our ability to generate product revenues from such therapy will be delayed or eliminated.
In addition, serious adverse events observed in clinical trials could hinder or prevent market acceptance of the product candidate at
issue. Any of these occurrences may harm our business, prospects, financial condition and results of operations significantly.
Clinical
trials are expensive, time consuming and difficult to design and implement.
Human
clinical trials are expensive and difficult to design and implement, in part because they are subject to rigorous regulatory requirements.
Because our CAR-T ovarian cancer therapy is based on relatively new technology and engineered on a patient-by-patient basis, we expect
that it will require extensive research and development and have substantial manufacturing and processing costs. In addition, costs to
treat patients with relapsed/refractory cancer and to treat potential side effects that may result from therapies such as our current
and future product candidates can be significant. Accordingly, our clinical trial costs are likely to be significantly higher than for
more conventional therapeutic technologies or drug products. In addition, our proposed personalized product candidates involve several
complex and costly manufacturing and processing steps, the costs of which will be borne by us.
In
one of our breast cancer vaccine clinical trials, we will treat healthy women who, as a result of testing positive for certain gene mutations,
have elected to have prophylactic mastectomies. Delivering an experimental treatment to a healthy individual is more complex and subject
to more rigorous regulatory requirements and is more difficult to design and implement. In addition, in future clinical trials we will
need to determine efficacy of the breast cancer vaccine as a cancer prevention which will be a considerably more complex clinical trial
and will have significantly greater costs.
The
costs of our clinical trials may increase if the FDA does not agree with our clinical development plans or requires us to conduct additional
clinical trials to demonstrate the safety and efficacy of our product candidates.
We
face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail
to compete effectively.
The
biopharmaceutical industry is characterized by intense competition and rapid innovation. Our competitors may be able to develop other
compounds or drugs that are able to achieve similar or better results. Our potential competitors include major multinational pharmaceutical
companies, established biotechnology companies, specialty pharmaceutical companies and universities and other research institutions.
Many of our competitors have substantially greater financial, technical and other resources, such as larger research and development
staff and experienced marketing and manufacturing organizations and well-established sales forces. Smaller or early-stage companies may
also prove to be significant competitors, particularly through collaborative arrangements with large, established companies. Mergers
and acquisitions in the biotechnology and pharmaceutical industries may result in even more resources being concentrated in our competitors.
Competition may increase further as a result of advances in the commercial applicability of technologies and greater availability of
capital for investment in these industries. Our competitors, either alone or with collaborative partners, may succeed in developing,
acquiring or licensing on an exclusive basis drug or biologic products that are more effective, safer, more easily commercialized or
less costly than our product candidates or may develop proprietary technologies or secure patent protection that we may need for the
development of our technologies and products.
Cell-based
therapies rely on the availability of specialty raw materials, which may not be available to us on acceptable terms or at all.
Gene-modified
cell therapy manufacturing requires many specialty raw materials, some of which are manufactured by small companies with limited resources
and experience to support a commercial product. Some suppliers typically support biomedical researchers or blood-based hospital businesses
and may not have the capacity to support commercial products manufactured under cGMP by biopharmaceutical firms. The suppliers may be
ill-equipped to support our needs, especially in non-routine circumstances like FDA inspections or medical crises, such as widespread
contamination. We also do not have commercial supply arrangements with many of these suppliers, and may not be able to contract with
them on acceptable terms or at all. Accordingly, we may experience delays in receiving key raw materials to support clinical or commercial
manufacturing.
In
addition, some raw materials are currently available from a single supplier, or a small number of suppliers. We cannot be sure that these
suppliers will remain in business, or that they will not be purchased by one of our competitors or another company that is not interested
in continuing to produce these materials for our intended purpose.
We
may form or seek strategic alliances or enter into additional licensing arrangements in the future, and we may not realize the benefits
of such alliances or licensing arrangements.
We
may form or seek strategic alliances, create joint ventures or collaborations and enter into additional licensing arrangements with third
parties that we believe will complement or augment our development and commercialization efforts with respect to our product candidates
and any future product candidates that we may develop. Any of these relationships may require us to incur non-recurring and other charges,
increase our near and long-term expenditures, issue securities that dilute our existing stockholders or disrupt our management and business.
In addition, we face significant competition in seeking appropriate strategic partners and the negotiation process is time-consuming
and complex. Moreover, we may not be successful in our efforts to establish a strategic partnership or other alternative arrangements
for our product candidates because they may be deemed to be at too early of a stage of development for collaborative effort and third
parties may not view our product candidates as having the requisite potential to demonstrate safety and efficacy. If we license products
or businesses, we may not be able to realize the benefit of such transactions if we are unable to successfully integrate them with our
existing operations and company culture. It is possible that, following a strategic transaction or license, we may not achieve the revenue
or specific net income that justifies such transaction. Any delays in entering into new strategic partnership agreements related to our
product candidates could delay the development and commercialization of our product candidates in certain geographies for certain indications,
which would harm our business prospects, financial condition and results of operations.
The
FDA regulatory approval process is lengthy and time-consuming, and we may experience significant delays in the clinical development and
regulatory approval of our product candidates.
We
have not previously submitted a Biologics License Application (“BLA”) or a New Drug Application (“NDA”) to the
FDA, or similar approval filings to other foreign authorities. A BLA or NDA must include extensive pre-clinical and clinical data and
supporting information to establish the product candidate’s safety, purity and potency for each desired indication. It must also
include significant information regarding the chemistry, manufacturing and controls for the product. We expect the novel nature of our
product candidates to create further challenges in obtaining regulatory approval. For example, the FDA has limited experience with commercial
development of T cell therapies and vaccines for cancer. The regulatory approval pathway for our product candidates may be uncertain,
complex, expensive and lengthy, and approval may not be obtained.
We
may also experience delays in completing planned clinical trials for a variety of reasons, including delays related to:
|
● |
the
availability of financial resources to commence and complete our planned clinical trials; |
|
● |
reaching
agreement on acceptable terms with prospective clinical trial sites, the terms of which can be subject to extensive negotiation and
may vary significantly among different clinical trial sites; |
|
● |
recruiting
suitable patients to participate in a clinical trial; |
|
● |
having
patients complete a clinical trial or return for post-treatment follow-up; |
|
● |
clinical
trial sites deviating from clinical trial protocol, failing to follow cGCPs, or dropping out of a clinical trial; |
|
● |
adding
new clinical trial sites; or |
|
● |
manufacturing
sufficient quantities of qualified materials under cGMPs and applying them on a subject-by-subject basis for use in clinical trials. |
Also,
before a clinical trial can begin at an NIH-funded institution, that institution’s independent institutional review board, or IRB,
and its Institutional Biosafety Committee must review the proposed clinical trial to assess the safety of the trial. In addition, adverse
developments in clinical trials of gene therapy products conducted by others may cause the FDA or other regulatory bodies to change the
requirements for approval of any of our product candidates.
We
could also encounter delays if physicians encounter unresolved ethical issues associated with enrolling patients in clinical trials of
our product candidates in lieu of prescribing existing treatments that have established safety and efficacy profiles. Further, a clinical
trial may be suspended or terminated by us, the IRBs for the institutions in which such clinical trials are being conducted, the Data
Monitoring Committee for such clinical trial, or by the FDA or other regulatory authorities due to a number of factors, including failure
to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial
operations or clinical trial site by the FDA or other regulatory authorities resulting in the imposition of a clinical hold, unforeseen
safety issues or adverse side effects, failure to demonstrate a benefit from using a product candidate, changes in governmental regulations
or administrative actions or lack of adequate funding to continue the clinical trial. If we experience termination of, or delays in the
completion of, any clinical trial of our product candidates, the commercial prospects for our product candidates will be harmed, and
our ability to generate product revenue will be delayed. In addition, any delays in completing our clinical trials will increase our
costs, slow down our product development and approval process and jeopardize our ability to commence product sales and generate revenue.
Many
of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may ultimately lead to the denial
of regulatory approval of our product candidates.
Even
if we obtain regulatory approval of our product candidates, the products may not gain market acceptance among physicians, patients, hospitals,
cancer treatment centers, third-party payors and others in the medical community.
The
use of engineered T cells as a potential cancer treatment and the use of therapeutic and prophylactic cancer vaccines are recently developed
technologies and may not become broadly accepted by physicians, patients, hospitals, cancer treatment centers, third-party payors and
others in the medical community. Many factors will influence whether our product candidates are accepted in the market, including:
|
● |
the
clinical indications for which our product candidates are approved; |
|
● |
physicians,
hospitals, cancer treatment centers and patients considering our product candidates as a safe and effective treatment; |
|
● |
the
potential and perceived advantages of our product candidates over alternative treatments; |
|
● |
the
prevalence and severity of any side effects; |
|
● |
product
labeling or product insert requirements of the FDA or other regulatory authorities; |
|
● |
limitations
or warnings contained in the labeling approved by the FDA or other regulatory authorities; |
|
● |
the
extent and quality of the clinical evidence supporting the efficacy and safety of our product candidates; |
|
● |
the
timing of market introduction of our product candidates as well as competitive products; |
|
● |
the
cost of treatment in relation to alternative treatments; |
|
● |
the
availability of adequate reimbursement and pricing by third-party payors and government authorities; |
|
● |
the
willingness and ability of patients to pay out-of-pocket in the absence of coverage by third-party payors, including government authorities; |
|
● |
relative
convenience and ease of administration, including as compared to alternative treatments and competitive therapies; and |
|
● |
the
effectiveness of our or any of our strategic partners’ sales and marketing efforts. |
If
our product candidates are approved but fail to achieve market acceptance among physicians, patients, hospitals, cancer treatment centers
or others in the medical community, we will not be able to generate significant revenue. Even if our products achieve market acceptance,
we may not be able to maintain that market acceptance over time if new products or technologies are introduced that are more favorably
received than our products, are more cost effective or render our products obsolete.
Risks
Related to Our Intellectual Property
If
we are unable to obtain and maintain intellectual property protection, our competitive position will be harmed.
Our
ability to compete and to achieve sustained profitability will be impacted by our ability to protect our CAR-T cancer therapeutics technologies,
our breast cancer vaccine technologies, our ovarian cancer vaccine technologies and other proprietary discoveries and technologies. We
expect to rely on a combination of patent protection, copyrights, trademarks, trade secrets, know-how, and regulatory approvals to protect
our technologies. Our intellectual property strategy is intended to help develop and maintain our competitive position. While we have
been granted multiple patents related to our technologies, there is no assurance that we will be able to obtain further patent protection
for our technologies or any other technologies, nor can we be certain that the steps we will have taken will prevent the misappropriation
and unauthorized use of our technologies. If we are not able to obtain and maintain patent protection our competitive position may be
harmed, including our ability to license any product if we choose to have other parties commercialize them.
Third
parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would
be uncertain and could have a material adverse effect on the success of our business.
Our
commercial success depends upon our ability to develop, manufacture, market and sell our CAR-T therapeutics, our breast cancer vaccine,
our ovarian cancer vaccine and other proprietary discoveries and technologies without infringing, misappropriating or otherwise violating
the proprietary rights or intellectual property of third parties. We may become party to, or be threatened with, future adversarial proceedings
or litigation regarding intellectual property rights with respect to our CAR-T therapeutics, our breast cancer vaccine, our ovarian cancer
vaccine and other proprietary discoveries and technologies. Third parties may assert infringement claims against us based on existing
patents or patents that may be granted in the future. If we are found to infringe a third party’s intellectual property rights,
we could be required to obtain a license from such third party to continue developing our CAR-T therapeutics, our breast cancer vaccine,
our ovarian cancer vaccine and other proprietary discoveries and technologies. However, we may not be able to obtain any required license
on commercially reasonable terms or at all. Even if we were able to obtain a license, it could be non-exclusive, thereby giving our competitors
access to the same technologies licensed to us. We could be forced, including by court order, to cease developing the infringing technology
or product. In addition, we could be found liable for monetary damages. Claims that we have misappropriated the confidential information
or trade secrets of third parties can have a similar negative impact on our business.
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.
We
are party to royalty-bearing license agreements that grant us rights to use certain intellectual property, including patents and patent
applications. We may need to obtain additional licenses from others to advance our research, development and commercialization activities.
Our license agreements impose, and we expect that future license agreements if necessary will impose, various development, diligence,
commercialization and other obligations on us.
In
spite of our efforts, our licensors might conclude that we have materially breached our obligations under such license agreements and
might therefore terminate the license agreements, thereby removing or limiting our ability to develop and commercialize products and
technology covered by these license agreements. If these in-licenses are terminated, or if the underlying patents fail to provide the
intended exclusivity, competitors or other third parties might have the freedom to seek regulatory approval of, and to market, products
identical to ours and we may be required to cease our development and commercialization activities. Any of the foregoing could have a
material adverse effect on our competitive position, business, financial conditions, results of operations and prospects.
Moreover,
disputes may arise with respect to any one of our licensing agreements, including:
|
● |
the
scope of rights granted under the license agreement and other interpretation-related issues; |
|
● |
the
extent to which our product candidates, technology and processes infringe on intellectual property of the licensor that is not subject
to the licensing agreement; |
|
● |
the
sublicensing of patent and other rights under the licensing agreement and our collaborative development relationships; |
|
● |
our
diligence obligations under the license agreement and what activities satisfy those diligence obligations; |
|
● |
the
inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors
and us and our partners; and |
|
● |
the
priority of invention of patented technology. |
If
we do not prevail in such disputes, we may lose any of such license agreements.
In
addition, the agreements under which we currently license intellectual property or technology from third parties are complex, and certain
provisions in such agreements may be susceptible to multiple interpretations. The resolution of any contract interpretation disagreement
that may arise could narrow what we believe to be the scope of our rights to the relevant intellectual property or technology, or increase
what we believe to be our financial or other obligations under the relevant agreement, either of which could have a material adverse
effect on our business, financial condition, results of operations and prospects. Moreover, if disputes over intellectual property that
we have licensed prevent or impair our ability to maintain our current licensing arrangements on commercially acceptable terms, we may
be unable to successfully develop and commercialize the affected product candidates, which could have a material adverse effect on our
business, financial conditions, results of operations and prospects.
Our
failure to maintain such licenses could have a material adverse effect on our business, financial condition and results of operations.
Any of these licenses could be terminated, such as if either party fails to abide by the terms of the license, or if the licensor fails
to prevent infringement by third parties or if the licensed patents or other rights are found to be invalid or unenforceable. Absent
the license agreements, we may infringe patents subject to those agreements, and if the license agreements are terminated, we may be
subject to litigation by the licensor. Litigation could result in substantial costs and be a distraction to management. If we do not
prevail, we may be required to pay damages, including treble damages, attorneys’ fees, costs and expenses, royalties or, be enjoined
from selling our products, which could adversely affect our ability to offer products, our ability to continue operations and our financial
condition.
If
our efforts to protect the proprietary nature of our technologies are not adequate, we may not be able to compete effectively in our
market.
Any
disclosure to or misappropriation by third parties of our confidential proprietary information could enable competitors to quickly duplicate
or surpass our technological achievements, thus eroding our competitive position in our markets. Certain intellectual property which
is covered by our in-license agreements has been developed at academic institutions which have retained non-commercial rights to such
intellectual property.
There
are several pending U.S. and foreign patent applications in our portfolio, and we anticipate additional patent applications will be filed
both in the U.S. and in other countries, as appropriate. However, we cannot predict:
|
● |
if
and when patents will issue; |
|
● |
the
degree and range of protection any issued patents will afford us against competitors including whether third parties will find ways
to invalidate or otherwise circumvent our patents; |
|
● |
whether
or not others will obtain patents claiming aspects similar to those covered by our patents and patent applications; or |
|
● |
whether
we will need to initiate litigation or administrative proceedings which may be costly whether we win or lose. |
Composition
of matter patents for biological and pharmaceutical products are generally considered to be the strongest form of intellectual property.
We cannot be certain that the claims in our pending patent applications directed to compositions of matter for our product candidates
will be considered patentable by the U.S. Patent and Trademark Office (the “USPTO”) or by patent offices in foreign countries,
or that the claims in any of our issued patents will be considered valid by courts in the U.S. or foreign countries. Method of use patents
have claims directed to the use of a product for the specified method. This type of patent does not prevent a competitor from making
and marketing a product that is identical to our product for an indication that is outside the scope of the patented method. Moreover,
even if competitors do not actively promote their product for our targeted indications, physicians may prescribe these products “off-label.”
Although off-label prescriptions may infringe or contribute to the infringement of method of use patents, the practice is common and
such infringement is difficult to prevent or prosecute.
The
strength of patents in the biotechnology and pharmaceutical field involves complex legal and scientific questions and can be uncertain.
The patent applications that we own or in-license may fail to result in issued patents with claims that cover our product candidates
or uses thereof in the U.S. or in other foreign countries. Even if the patents do successfully issue, third parties may challenge the
validity, enforceability or scope thereof, which may result in such patents being narrowed, invalidated or held unenforceable. Furthermore,
even if they are unchallenged, patents in our portfolio may not adequately exclude third parties from practicing relevant technology
or prevent others from designing around our claims. If the breadth or strength of our intellectual property position with respect to
our product candidates is threatened, it could dissuade companies from collaborating with us to develop, and threaten our ability to
commercialize, our product candidates. Further, if we encounter delays in our clinical trials, the period of time during which we could
market our product candidates under patent protection would be reduced. Since patent applications in the U.S. and most other countries
are confidential for a period of time after filing, it is possible that patent applications in our portfolio may not be the first filed
patent applications related to our product candidates. Furthermore, for U.S. applications in which all claims are entitled to a priority
date before March 16, 2013, an interference proceeding can be provoked by a third-party or instituted by the USPTO, to determine who
was the first to invent any of the subject matter covered by the patent claims of our applications. For U.S. applications containing
a claim not entitled to priority before March 16, 2013, there is a greater level of uncertainty in the patent law with the passage of
the America Invents Act (2012) which brings into effect significant changes to the U.S. patent laws that are yet untried and untested,
and which introduces new procedures for challenging pending patent applications and issued patents. A primary change under this reform
is the creation of a “first to file” system in the U.S. This will require us to be cognizant going forward of the time from
invention to filing of a patent application.
Obtaining
and maintaining our patents depends on compliance with various procedural, document submission, fee payment and other requirements imposed
by governmental patent agencies, and our patent position could be reduced or eliminated for non-compliance with these requirements.
Periodic
maintenance fees on any issued patent are due to be paid to the USPTO and foreign patent agencies in several stages over the lifetime
of the patent. The USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary,
fee payment and other similar provisions during the patent application process. While an inadvertent lapse can in many cases be cured
by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result
in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction.
Noncompliance events that could result in abandonment or lapse of a patent or patent application include, but are not limited to, failure
to respond to official actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal
documents. Such noncompliance events are outside of our direct control for (1) non-U.S. patents and patent applications owned by us,
and (2) patents and patent applications licensed to us by another entity. In such an event, our competitors might be able to enter the
market, which would have a material adverse effect on our business.
Issued
patents covering our product candidates could be found invalid or unenforceable if challenged in court or the USPTO.
If
we or one of our licensing partners initiate legal proceedings against a third party to enforce a patent covering one of our product
candidates, the defendant could counterclaim that the patent covering our product candidate, as applicable, is invalid and/or unenforceable.
In patent litigation in the U.S., defendant counterclaims alleging invalidity and/or unenforceability are commonplace, and there are
numerous grounds upon which a third party can assert invalidity or unenforceability of a patent. Third parties may also raise similar
claims before administrative bodies in the U.S. or abroad, even outside the context of litigation. Such mechanisms include re-examination,
post grant review, and equivalent proceedings in foreign jurisdictions, for example, opposition proceedings. Any such proceedings could
result in revocation or amendment to our patents in such a way that they no longer cover our product candidates. The outcome following
legal assertions of invalidity and unenforceability is unpredictable. With respect to the validity question, for example, we cannot be
certain that there is no invalidating prior art and that prior art that was cited during prosecution, but not relied on by the patent
examiner, will not be revisited. If a defendant were to prevail on a legal assertion of invalidity and/or unenforceability, we would
lose at least part, and perhaps all, of the patents directed to our product candidates. A loss of patent rights could have a material
adverse impact on our business.
Changes
in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our products.
As
is the case with other biopharmaceutical companies, our success is heavily dependent on intellectual property, particularly patents.
Obtaining and enforcing patents in the biopharmaceutical industry involve both technological and legal complexity, and is therefore costly,
time-consuming and inherently uncertain. In addition, the U.S. has recently enacted and is currently implementing wide-ranging patent
reform legislation. Recent U.S. Supreme Court rulings have narrowed the scope of patent protection available in certain circumstances
and weakened the rights of patent owners in certain situations. In addition to increasing uncertainty with regard to our ability to obtain
patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained. Depending
on decisions by the U.S. Congress, the federal courts, and the USPTO, the laws and regulations governing patents could change in unpredictable
ways that would weaken our ability to obtain new patents or to enforce our existing patents and patents that we might obtain in the future.
For example, in the case, Assoc. for Molecular Pathology v. Myriad Genetics, Inc., the U.S. Supreme Court held that certain claims to
DNA molecules are not patentable. While we do not believe that any of the patents owned or licensed by us will be found invalid based
on this decision, we cannot predict how future decisions by the courts, the U.S. Congress or the USPTO may impact the value of our patents.
We
have limited foreign intellectual property rights and may not be able to protect our intellectual property rights throughout the world.
We
have limited intellectual property rights outside the U.S. Filing, prosecuting and defending patents on product candidates in all countries
throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the U.S. can be
less extensive than those in the U.S. In addition, the laws of some foreign countries do not protect intellectual property to the same
extent as federal and state laws in the U.S. Consequently, we may not be able to prevent third parties from practicing our inventions
in all countries outside the U.S., or from selling or importing products made using our inventions in and into the U.S. or other jurisdictions.
Competitors may use our technologies in jurisdictions where we have not obtained patents to develop their own products and further, may
export otherwise infringing products to territories where we have patents, but enforcement is not as strong as that in the U.S. These
products may compete with our products and our patents or other intellectual property rights may not be effective or sufficient to prevent
them from competing.
Many
companies have encountered significant problems in protecting and defending intellectual property in foreign jurisdictions. The legal
systems of certain countries, particularly China and certain developing countries, do not favor the enforcement of patents, trade secrets
and other intellectual property, particularly those relating to biopharmaceutical products, which could make it difficult for us to stop
the infringement of our patents or marketing of competing products in violation of our proprietary rights generally. To date, we have
not sought to enforce any issued patents in these foreign jurisdictions. Proceedings to enforce our patent rights in foreign jurisdictions
could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk
of being invalidated or interpreted narrowly and our patent applications at risk of not issuing and could provoke third parties to assert
claims against us. We may not prevail in any lawsuits that we initiate, and the damages or other remedies awarded, if any, may not be
commercially meaningful. The requirements for patentability may differ in certain countries, particularly developing countries. Furthermore,
generic drug manufacturers or other competitors may challenge the scope, validity or enforceability of our or our licensors’ patents,
requiring us or our licensors to engage in complex, lengthy and costly litigation or other proceedings. Certain countries in Europe and
developing countries, including China and India, have compulsory licensing laws under which a patent owner may be compelled to grant
licenses to third parties. In those countries, we and our licensors may have limited remedies if patents are infringed or if we or our
licensors are compelled to grant a license to a third party, which could materially diminish the value of those patents. This could limit
our potential revenue opportunities. Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate
to obtain a significant commercial advantage from the intellectual property that we develop or license.
Risks
Related to Our Common Stock
The
issuance or sale of shares in the future to raise money or for strategic purposes could reduce the market price of our common stock.
In
the future, we may issue securities to raise cash for operations, to pay down then existing indebtedness, as consideration for the acquisition
of assets, as consideration for receipt of goods or services, to pay for the development of our CAR-T cancer therapeutics, to pay for
the development of our breast cancer vaccine, to pay for the development of our ovarian cancer vaccine and for acquisitions of companies.
We have an at-the-market equity offering under which, as of January 16, 2024 we may issue up to approximately $98 million of common stock,
which is currently effective, and which may remain available to us in the future. We also have, and in the future may, issue securities
convertible into our common stock. Any of these events may dilute stockholders’ ownership interests in our company and have an
adverse impact on the price of our common stock.
In
addition, sales of a substantial amount of our common stock in the public market, or the perception that these sales may occur, could
reduce the market price of our common stock. This could also impair our ability to raise additional capital through the sale of our securities.
Any
actual or anticipated sales of shares by our stockholders may cause the trading price of our common stock to decline. The sale of a substantial
number of shares of our common stock by our stockholders, or anticipation of such sales, could make it more difficult for us to sell
equity or equity-related securities in the future at a time and at a price that we might otherwise wish to effect sales.
We
may fail to meet market expectations because of fluctuations in quarterly operating results, which could cause the price of our common
stock to decline.
Our
reported revenues and operating results have fluctuated in the past and may continue to fluctuate significantly from quarter to quarter
in the future, specifically as we continue to devote our resources towards our CAR-T cancer therapeutics and our breast and ovarian cancer
vaccines. It is possible that in future periods, we will have no revenue or, in any event, revenues could fall below or expenses could
rise above the expectations of securities analysts or investors, which could cause the market price of our common stock to decline. The
following are among the factors that could cause our operating results to fluctuate significantly from period to period:
|
● |
patient
enrollment rates for our clinical trials; |
|
● |
delays
with respect to our clinical trials; |
|
● |
clinical
trial results relating to our CAR-T cancer therapeutics; |
|
● |
clinical
trial results relating to our breast cancer vaccine; |
|
● |
results
of pre-clinical studies relating to our ovarian cancer vaccine; |
|
● |
progress
with regulatory authorities towards the certification/approval of our CAR-T cancer therapeutics, our breast cancer vaccine or our
ovarian cancer vaccine; and |
|
● |
costs
related to acquisitions, alliances and licenses. |
Biotechnology
company stock prices are especially volatile, and this volatility may depress the price of our common stock.
The
stock market has experienced significant price and volume fluctuations, and the market prices of biotechnology companies have been highly
volatile. We believe that various factors may cause the market price of our common stock to fluctuate, perhaps substantially, including,
among others, the following:
|
● |
announcements
of developments in the fields of CAR-T therapeutics or cancer vaccines; |
|
● |
developments
in relationships with third party vendors and laboratories; |
|
● |
developments
or disputes concerning our patents and other intellectual property; |
|
● |
our
or our competitors’ technological innovations; |
|
● |
variations
in our quarterly operating results; |
|
● |
our
failure to meet or exceed securities analysts’ expectations of our financial results; |
|
● |
a
change in financial estimates or securities analysts’ recommendations; |
|
● |
changes
in management’s or securities analysts’ estimates of our financial performance; |
|
● |
announcements
by us or our competitors of significant contracts, acquisitions, strategic partnerships, joint ventures, capital commitments, new
technologies, or patents; and |
|
● |
the
timing of or our failure to complete significant transactions. |
In
addition, we believe that fluctuations in our stock price during applicable periods can also be impacted by changes in governmental regulations
in the drug development industry and/or court rulings and/or other developments in our remaining patent licensing and enforcement actions.
In
the past, companies that have experienced volatility in the market price of their stock have been the objects of securities class action
litigation. If our common stock was the object of securities class action litigation due to volatility in the market price of our stock,
it could result in substantial costs and a diversion of management’s attention and resources, which could materially harm our business
and financial results.
Our
common stock is currently listed on NASDAQ Capital Market, however if our common stock is delisted for any reason, it will become subject
to the SEC’s penny stock rules which may make our shares more difficult to sell.
If
our common stock is delisted from NASDAQ Capital Market, our common stock will then fit the definition of a penny stock and therefore
would be subject to the rules adopted by the SEC regulating broker-dealer practices in connection with transactions in penny stocks.
The SEC rules may have the effect of reducing trading activity in our common stock making it more difficult for investors to sell their
shares. The SEC’s rules require a broker or dealer proposing to effect a transaction in a penny stock to deliver the customer a
risk disclosure document that provides certain information prescribed by the SEC, including, but not limited to, the nature and level
of risks in the penny stock market. The broker or dealer must also disclose the aggregate amount of any compensation received or receivable
by him in connection with such transaction prior to consummating the transaction. In addition, the SEC’s rules also require a broker
or dealer to make a special written determination that the penny stock is a suitable investment for the purchaser and receive the purchaser’s
written agreement to the transaction before completion of the transaction. The existence of the SEC’s rules may result in a lower
trading volume of our common stock and lower trading prices.
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.
As
of the date of this Report, we have issued and outstanding options to purchase 12,735,000 shares of our common stock with a weighted
average exercise price of $3.68. Further, as of the date of this Report, our Board of Directors and Compensation Committee have the authority
to issue awards totaling an additional 665,000 shares of our common stock which is replenished on a yearly basis in accordance with the
provisions of our plan. Additionally, we have registered for resale all of the shares of common stock issuable under our incentive plans.
Because the market for our common stock is thinly traded, the sales and/or the perception that those sales may occur, could adversely
affect the market price of our common stock. Furthermore, the mere existence of a significant number of shares of common stock issuable
upon vesting and, if applicable, exercise of these securities may be perceived by the market as having a potential dilutive effect, which
could lead to a decrease in the price of our common stock.
We
are a smaller reporting company and the reduced reporting requirements applicable to smaller reporting companies may make our common
stock less attractive to investors.
We
are a smaller reporting company (“SRC”) and a non-accelerated filer, which allows us to take advantage of exemptions from
various reporting requirements that are applicable to other public companies that are not SRCs or non-accelerated filers, including not
being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, as amended, reduced
disclosure obligations regarding executive compensation in our Annual Report and our periodic reports and proxy statements and providing
only two years of audited financial statements in our Annual Report and our periodic reports. We will remain an SRC until (a) the aggregate
market value of our outstanding common stock held by non-affiliates as of the last business day our most recently completed second fiscal
quarter exceeds $250 million or (b) (1) we have over $100 million in annual revenues and (2) the aggregate market value of our outstanding
common stock held by non-affiliates as of the last business day our most recently completed second fiscal quarter exceeds $700 million.
We cannot predict whether investors will find our common stock less attractive if we rely on certain or all of these exemptions. If some
investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and our stock
price may be more volatile and may decline.
We
do not anticipate declaring any cash dividends on our common stock which may adversely impact the market price of our stock.
We
have never declared or paid cash dividends on our common stock and do not plan to pay any cash dividends in the near future. Our current
policy is to retain all funds and any earnings for use in the operation and expansion of our business. If we do not pay dividends, our
stock may be less valuable to you because a return on your investment will only occur if our stock price appreciates.
Item
1B. Unresolved Staff Comments.
None.
Item
1C. Cybersecurity.
We
will provide the disclosure required under this Item 1C in our annual report for the year ended October 31, 2024 which is the first annual
report for a fiscal year ending on or after December 15, 2023, the date on which disclosure under Item 106 of Regulation S-K is required.
Item
2. Properties.
We
lease approximately 2,000 square feet of office space at 3150 Almaden Expressway, San Jose, California (our principal executive offices)
from an unrelated party pursuant to a lease that expires September 30, 2024. Our base rent is approximately $5,000 per month and the
lease provides for annual increases of approximately 3% and an escalation clause for increases in certain operating costs.
Item
3. Legal Proceedings.
Other
than lawsuits we bring to enforce our patent rights, we are not a party to any material pending legal proceedings, nor are we aware of
any pending litigation or legal proceeding against us that would have a material adverse effect on our financial position or results
of operations.
Item
4. Mine Safety Disclosures.
Not
applicable.
PART
II
Item
5. |
Market for the Registrant’s
Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. |
Market
Information
Our
common stock trades on the NASDAQ Capital Market under the symbol “ANIX”.
Holders
As
of January 12, 2024, the approximate number of record holders of our common stock was 312 and the closing price of our common
stock was $4.39 per share.
Securities
Authorized for Issuance Under Equity Compensation Plans
The
following is information as of October 31, 2023 about shares of our common stock that may be issued upon the exercise of options, warrants
and rights under all equity compensation plans in effect as of that date, including our 2010 Share Incentive Plan and our 2018 Share
Incentive Plan. See Note 4 to our Consolidated Financial Statements for more information on these plans.
Plan category | |
Number
of securities to be issued upon exercise of outstanding options, warrants and rights (a) | | |
Weighted
average exercise price of outstanding options, warrants and rights | | |
Number
of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a)) | |
Equity compensation plans not approved
by security holders (1) | |
| 1,189,000 | | |
$ | 2.94 | | |
| - | |
Equity compensation plans approved by security
holders (2) | |
| 10,241,000 | | |
$ | 3.67 | | |
| 750,000 | |
|
(1) |
On
July 14, 2010, the Board adopted the 2010 Share Incentive Plan. Officers, key employees and non-employee directors of, and consultants
to, the Company or any of its subsidiaries and affiliates were eligible to participate in the 2010 Share Incentive Plan. The 2010
Share Incentive Plan provided for the grant of stock options, stock appreciation rights, stock awards, and performance awards and
stock units. The 2010 Share Incentive Plan terminated with respect to additional grants on July 14, 2020. |
|
(2) |
The
2018 Share Incentive Plan was adopted by the Board on January 25, 2018 and approved by our shareholders on March 29, 2018. Officers,
key employees and non-employee directors of, and consultants to, the Company or any of its subsidiaries and affiliates are eligible
to participate in the 2018 Share Incentive Plan. The 2018 Share Incentive Plan provides for the grant of incentive stock options,
nonqualified stock options, stock appreciation rights, stock awards, performance awards and stock units (the “2018 Benefits”).
The maximum number of shares of common stock available for issuance under the 2018 Share Incentive Plan was initially 5,000,000 shares.
Additionally, commencing on the first business day in January 2019 and on the first business day of each calendar year thereafter,
the maximum aggregate number of shares available for issuance shall be replenished such that, as of such first business day, the
maximum aggregate number of shares available for issuance shall be 2,000,000 shares. The 2018 Share Incentive Plan is administered
by the Compensation Committee, which determines the option price, term and provisions of the 2018 Benefits. The 2018 Share Incentive
Plan terminates with respect to additional grants on March 28, 2028. The Board may amend, suspend or terminate the 2018 Share Incentive
Plan at any time, subject in certain respects to obtaining shareholder approval. |
Dividend
Policy
No
cash dividends have been paid on our common stock since our inception. We have no present intention to pay any cash dividends in the
foreseeable future.
Recent
Sales of Unregistered Securities
During
the three months ended October 31, 2023, the Company issued an aggregate of 6,756 unregistered shares of our common stock to a company
in payment of investor relations services. The common stock was issued in reliance on an exemption from registration under Section 4(a)(2)
of the Securities Act as they were issued in a private transaction to investors, without a view to distribution, and were not issued
through any general solicitation or advertisement.
Item
6. [Reserved]
Item
7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
General
In
reviewing Management’s Discussion and Analysis of Financial Condition and Results of Operations, you should refer to our Consolidated
Financial Statements and the notes related thereto.
Results
of Operations
Fiscal
Year ended October 31, 2023 compared with Fiscal Year ended October 31, 2022
Revenue
In
fiscal year 2023, we recorded revenue of approximately $210,000 from one license agreement related to our encrypted audio/video conference
calling technology. The license agreement provided for a one-time, non-recurring, lump sum payment in exchange for a non-exclusive retroactive
and future license, and covenant not to sue. Pursuant to the terms of the agreement, we have no further obligations with respect to the
granted intellectual property rights, including no obligation to maintain or upgrade the technology, or provide future support or services.
Accordingly, the performance obligations from the license were satisfied and 100% of the revenue was recognized upon execution of the
license agreement. We did not have any revenue in fiscal year 2022.
Over
the past several years, our revenue, if any, was derived from technology licensing and the sale of patented technologies, including revenue
from the settlement of litigation. As part of our legacy operations, the Company remains engaged in limited patent licensing activities
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.
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.
Inventor
Royalties, Contingent Legal Fees, Litigation and Licensing Expenses Related to Patent Assertion
In
fiscal year 2023, inventor royalties, contingent legal fees, litigation and licensing expenses related to patent assertion activities
were approximately $161,000. Inventor royalties and contingent legal fees are expensed in the period that the related revenues are recognized.
Litigation and licensing expenses related to patent assertion, other than contingent legal fees, are expensed in the period incurred.
We
did not have any inventor royalties, contingent legal fees, litigation and licensing expenses related to patent assertion activities
in fiscal year 2022.
Research
and Development Expenses
Research
and development expenses incurred in fiscal year 2023 associated with each of our development programs consisted of approximately $1,839,000
for CAR-T therapeutics, approximately $2,682,000 for cancer vaccines, and approximately $248,000 for anti-viral therapeutics.
Research
and development expenses are related to the development of our cancer therapeutic and vaccine programs, and our anti-viral drug program,
and decreased by approximately $1,934,000 to approximately $4,769,000 in fiscal year 2023, from approximately $6,703,000 in fiscal year
2022. The decrease in research and development expenses was primarily due to a decrease in employee stock option compensation expense
of approximately $1,386,000, a decrease in research and development expenses related to our COVID-19 development program of approximately
$485,000 as a result of the suspension of that program in March 2023, a decrease in license fees of approximately $225,000, a decrease
in consultant stock option expense of approximately $213,000, a decrease in research and development expenses related to our CAR-T development
program of approximately $156,000, and a decrease in research and development expenses related to our ovarian cancer vaccine development
program of approximately $130,000, offset by an increase in research and development expenses related to our breast cancer vaccine development
program of approximately $563,000 and an increase in employee compensation and related costs, other than stock option compensation expense,
of approximately $147,000.
General
and Administrative Expenses
General
and administrative expenses decreased by approximately $881,000 to approximately $6,291,000 in fiscal year 2023, from approximately $7,172,000
in fiscal year 2022. The decrease in general and administrative expenses was principally due to a decrease in employee stock option compensation
expense of approximately $309,000, a decrease in professional fees of approximately $239,000, a decrease in consultant warrant expense
of approximately $221,000, a decrease in employee compensation and related costs, other than stock option compensation expense, of approximately
$214,000, and a decrease in patent expenses of approximately $152,000, offset by an increase in director compensation expense, other
than stock option compensation expense, of approximately $121,000 and an increase in director stock option compensation expense of approximately
$116,000.
Interest
Income
Interest
income increased to approximately $1,081,000 in fiscal year 2023 compared to approximately $104,000 in fiscal year 2022, due to an increase
in interest rates and the increased dollar amount held in short-term investments.
Net
Loss Attributable to Noncontrolling Interest
The
net loss attributable to noncontrolling interest, representing Wistar’s ownership interest in Certainty’s net loss, decreased
by approximately $57,000 to approximately $119,000 in fiscal year 2023, from approximately $176,000 in fiscal year 2022, as Certainty’s
net loss decreased.
Liquidity
and Capital Resources
Our
primary sources of liquidity are cash, cash equivalents and short-term investments.
Based
on currently available information as of January 16, 2024, we believe that our existing cash, cash equivalents, short-term investments
and expected cash flows will be sufficient to fund our activities for at least the next twelve months. We have implemented a business
model that conserves funds by collaborating with third parties to develop our technologies. However, our projections of future cash needs
and cash flows may differ from actual results. If current cash on hand, cash equivalents, short-term investments and cash that may be
generated from our business operations are insufficient to continue to operate our business, or if we elect to invest in or acquire a
company or companies or new technology or technologies that are synergistic with or complementary to our technologies, we may be required
to obtain more working capital. Under our at-the-market equity program, which is currently effective and may remain available for us
to use in the future, as of October 31, 2023, we may sell up to $100 million of common stock. We did not sell any shares under our at-the-market
equity program during the fiscal year ended October 31, 2023. We may seek to obtain working capital during our fiscal year 2024 or thereafter
through sales of our equity securities or through bank credit facilities or public or private debt from various financial institutions
where possible. We cannot be certain that additional funding will be available on acceptable terms, or at all. If we do identify sources
for additional funding, the sale of additional equity securities or convertible debt will result in dilution to our stockholders. We
can give no assurance that we will generate sufficient cash flows in the future to satisfy our liquidity requirements or sustain future
operations, or that other sources of funding, such as sales of equity or debt, would be available or would be approved by our security
holders, if needed, on favorable terms or at all. If we fail to obtain additional working capital as and when needed, such failure could
have a material adverse impact on our business, results of operations and financial condition. Furthermore, such lack of funds may inhibit
our ability to respond to competitive pressures or unanticipated capital needs, or may force us to reduce operating expenses, which would
significantly harm the business and development of operations.
During
the fiscal year ended October 31, 2023, cash used in operating activities was approximately $6,209,000. Cash used in investing activities
was approximately $5,602,000, resulting from the purchase of short-term investments of approximately $44,411,000, which was offset by
the proceeds on maturities of short-term investments of approximately $38,809,000. Cash provided by financing activities was approximately
$366,000, resulting from proceeds from the exercise of stock options of approximately $353,000 and proceeds from the sale of common stock
pursuant to an employee stock purchase plan of approximately $13,000. As a result, our cash, cash equivalents, and short-term investments
at October 31, 2023 decreased approximately $5,843,000 to approximately $23,844,000 from approximately $29,687,000 at the end of fiscal
year 2022.
We
have expected future cash obligations related to the lease of our offices through 2026, estimated at approximately $202,000.
Off-Balance
Sheet Arrangements
We
have no variable interest entities or other significant off-balance sheet obligation arrangements.
Critical
Accounting Policies
The
Company’s consolidated financial statements are prepared in conformity with accounting principles generally accepted in the United
States of America. In preparing these financial statements, we make assumptions, judgments and estimates that can have a significant
impact on amounts reported in our consolidated financial statements. We base our assumptions, judgments and estimates on historical experience
and various other factors that we believe to be reasonable under the circumstances. Actual results could differ materially from these
estimates under different assumptions or conditions. On a regular basis, we evaluate our assumptions, judgments and estimates and make
changes accordingly.
We
believe that, of the significant accounting policies discussed in Note 2 to our Consolidated Financial Statements, the following accounting
policies require our most difficult, subjective, or complex judgments:
|
● |
Revenue
Recognition; |
|
● |
Stock-Based
Compensation; and |
|
● |
Research
and Development Expense. |
Revenue
Recognition
Our
revenue has been derived solely from technology licensing and the sale of patented technologies. Revenue is recognized upon transfer
of control of intellectual property rights and satisfaction of other contractual performance obligations to licensees in an amount that
reflects the consideration we expect to receive.
Our
revenue recognition policy requires us to make certain judgments and estimates in connection with the accounting for revenue. Such areas
may include determining the existence of a contract and identifying each party’s rights and obligations to transfer goods and services,
identifying the performance obligations in the contract, determining the transaction price and allocating the transaction price to separate
performance obligations, estimating the timing of satisfaction of performance obligations, determining whether a promise to grant a license
is distinct from other promised goods or services and evaluating whether a license transfers to a customer at a point in time or over
time.
Our
revenue arrangements provide for the payment, within 30 days of execution of the agreement, of contractually determined, one-time, paid-up
license fees in settlement of litigation and in consideration for the grant of certain intellectual property rights for patented technologies
owned or controlled by the Company. These arrangements typically include some combination of the following: (i) the grant of a non-exclusive,
retroactive and future license to manufacture and/or sell products covered by patented technologies owned or controlled by the Company,
(ii) a covenant-not-to-sue, (iii) the release of the licensee from certain claims, and (iv) the dismissal of any pending litigation.
In such instances, the intellectual property rights granted have been perpetual in nature, extending until the expiration of the related
patents. Pursuant to the terms of these agreements, we have no further obligations with respect to the granted intellectual property
rights, including no obligation to maintain or upgrade the technology, or provide future support or services. Licensees obtained control
of the intellectual property rights they have acquired upon execution of the agreement. Accordingly, the performance obligations from
these agreements were satisfied and 100% of the revenue was recognized upon the execution of the agreements.
Stock-Based
Compensation
The
compensation cost for service-based stock options granted to employees, directors and consultants is measured at the grant date, based
on the fair value of the award using the Black-Scholes pricing model, and is recognized as an expense on a straight-line basis over the
requisite service period (the vesting period of the stock option) which is one to four years. For employee options vesting if the trading
price of the Company’s common stock exceeds certain price targets, we use a Monte Carlo Simulation in estimating the fair value
at grant date and recognize compensation cost over the implied service period. For stock-based awards that vest upon the achievement
of a performance metric, the Company recognizes the estimated fair value of the award when achievement becomes probable.
For
stock awards granted to employees and directors that vest at date of grant, we recognize expense based on the grant date market price
of the underlying common stock. For restricted stock awards vesting upon achievement of a price target of our common stock, we use a
Monte Carlo Simulation in estimating the fair value at grant date and recognize compensation cost over the implied service period (median
time to vest).
The
Black-Scholes pricing model and the Monte Carlo Simulation we use to estimate fair value requires valuation assumptions of expected term,
expected volatility, risk-free interest rates and expected dividend yield. The expected term of stock options represents the weighted
average period the stock options are expected to remain outstanding. For employees, we use the simplified method, which is a weighted
average of the vesting term and contractual term, to determine expected term. The simplified method was adopted since we do not believe
that historical experience is representative of future performance because of the impact of the changes in our operations and the change
in terms from historical options. For consultants we use the contract term for expected term. Under the Black-Scholes pricing model,
we estimated the expected volatility of our shares of common stock based upon the historical volatility of our share price over a period
of time equal to the expected term of the grants. We estimated the risk-free interest rate based on the implied yield available on the
applicable grant date of a U.S. Treasury note with a term equal to the expected term of the underlying grants. We made the dividend yield
assumption based on our history of not paying dividends and our expectation not to pay dividends in the future.
We
will reconsider use of the Black-Scholes pricing model and the Monte Carlo Simulation if additional information becomes available in
the future that indicates another model would be more appropriate. If factors change and we employ different assumptions in future periods,
the compensation expense that we record may differ significantly from what we have recorded in the current period.
Research
and Development Expense
We
recognize research and development expenses as incurred. Advance payments for future research and development activities are deferred
and expensed as the services are performed. We recognize our preclinical studies and clinical trial expenses based on the services performed
pursuant to contracts with research institutions, clinical research organizations (“CROs”), clinical manufacturing organizations
(“CMOs”), and other parties that conduct and manage various stages of research and development activities on our behalf.
Fees for such services are recognized based on management’s estimates after considering the activities and tasks completed by each
service provider in a given period, the time period over which services are expected to be performed, and the level of effort expended
in each reporting period.
At
each balance sheet date, management estimates prepaid and accrued research and development costs by discussing progress or stage of completion
of activities with internal personnel and external service providers, and comparing this information to payments made, invoices received,
and the agreed-upon contractual fee to be paid for such services in the applicable contract or statements of work.
In
addition, we allocate certain internal compensation costs to research and development expenses based on management’s estimates
of each employee’s time and effort expended.
Effect
of Recent Accounting Pronouncements
We
discuss the effect of recently issued pronouncements in Note 2 to the Consolidated Financial Statements.
Item
7A. Quantitative and Qualitative Disclosures About Market Risk.
Not
required for a smaller reporting company.
Item
8. Financial Statements and Supplementary Data.
See
accompanying “Index to Consolidated Financial Statements.”
Item
9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure.
None.
Item
9A. Controls and Procedures.
Disclosure
Controls and Procedures
We
maintain disclosure controls and procedures, as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act. Under the
supervision and with the participation of our management, including our Chief Executive Officer and our Chief Financial Officer, we evaluated
the effectiveness of the design and operation of our disclosure controls and procedures pursuant to Rule 13a-15 and 15d-15 of the Exchange
Act. Based upon that evaluation, our Chief Executive Officer and our Chief Financial Officer concluded that our disclosure controls and
procedures were effective as of the end of fiscal year 2023.
Management’s
Report on Internal Control Over Financial Reporting
Our
management is responsible for establishing and maintaining adequate internal control over financial reporting as such term is defined
in Rules 13a-15(f) and 15d-15(f) of the Exchange Act. Our management, including the principal executive officer and principal financial
officer, does not expect that our internal controls over financial reporting will prevent all errors and all fraud. A control system,
no matter how well designed and operated, cannot provide full assurance that the objectives of the control system are met, and no evaluation
of controls can provide absolute assurance that all control issues and instances of fraud, if any, within a company have been detected.
Our internal control over financial reporting is designed to provide reasonable assurance regarding the reliability of financial reporting
and the preparation of consolidated financial statements for external purposes in accordance with generally accepted accounting principles.
Under
the supervision and with the participation of our management, including the principal executive officer and principal financial officer,
we conducted an evaluation as to the effectiveness of our internal control over financial reporting as of October 31, 2023. In making
this assessment, our management used the criteria for effective internal control set forth by the Committee of Sponsoring Organizations
of the Treadway Commission in the 2013 Internal Control – Integrated Framework. Based on this assessment, our management
concluded that our internal control over financial reporting was effective as of October 31, 2023.
This
Annual Report on Form 10-K does not include an attestation report of our independent registered public accounting firm regarding internal
control over financial reporting. Management’s report was not subject to attestation by the Company’s independent registered
public accounting firm pursuant to an exemption of the Commission that permits smaller reporting companies and non-accelerated filers,
such as the Company, to provide only management’s report in this Annual Report on Form 10-K. Accordingly, our management’s
assessment of the effectiveness of our internal control over financial reporting as of October 31, 2023 has not been audited by our auditors,
Haskell & White LLP.
Changes
in Internal Control Over Financial Reporting
There
were no changes in our internal control over financial reporting during the fourth quarter of fiscal year 2023 that has materially affected,
or is reasonably likely to materially affect, the Company’s internal control over financial reporting.
Item
9B. Other Information.
None.
PART
III
Item
10. Directors, Executive Officers and Corporate Governance.
The
information required by this Item will be set forth in our Proxy Statement for the 2024 Annual Meeting of Stockholders scheduled for
March 21, 2024 which such Proxy Statement will be filed with the SEC within 120 days of October 31, 2023, and will be incorporated into
this Annual Report on Form 10-K by reference.
Item
11. Executive Compensation.
The
information required by this Item will be set forth in our Proxy Statement for the 2024 Annual Meeting of Stockholders scheduled for
March 21, 2024 which such Proxy Statement will be filed with the SEC within 120 days of October 31, 2023, and will be incorporated into
this Annual Report on Form 10-K by reference.
Item
12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
The
information required by this Item will be set forth in our Proxy Statement for the 2024 Annual Meeting of Stockholders scheduled for
March 21, 2024 which such Proxy Statement will be filed with the SEC within 120 days of October 31, 2023, and will be incorporated into
this Annual Report on Form 10-K by reference.
Item
13. Certain Relationships and Related Transactions, and Director Independence.
The
information required by this Item will be set forth in our Proxy Statement for the 2024 Annual Meeting of Stockholders scheduled for
March 21, 2024 which such Proxy Statement will be filed with the SEC within 120 days of October 31, 2023, and will be incorporated into
this Annual Report on Form 10-K by reference.
Item
14. Principal Accounting Fees and Services.
The
information required by this Item will be set forth in our Proxy Statement for the 2024 Annual Meeting of Stockholders scheduled for
March 21, 2024 which such Proxy Statement will be filed with the SEC within 120 days of October 31, 2023, and will be incorporated into
this Annual Report on Form 10-K by reference.
PART
IV
Item
15. Exhibits, Financial Statement Schedules.
(a)(1)(2)
Financial Statement Schedules
See
accompanying “Index to Consolidated Financial Statements.”
3.1 |
Certificate
of Incorporation, as amended. (Incorporated by reference to Form 10-Q for the fiscal quarter ended July 31, 1992 and Form S-3, dated
February 11, 2014.) |
3.2 |
Amendment
to the Certificate of Incorporation. (Incorporated by reference to Exhibit 3.2 to our Form 10-K for the fiscal year ended October
31, 2013.) |
3.3 |
Certificate
of Amendment to the Certificate of Incorporation. (Incorporated by reference to Exhibit 3.1 to our Form 8-K, dated September 4, 2014.) |
3.4 |
Certificate
of Designations, Preferences and Rights of Series A Convertible Preferred Stock. (Incorporated by reference to Exhibit 3.1 to our
Form 8-K, dated September 10, 2014.) |
3.5 |
Certificate
of Amendment to the Certificate of Incorporation. (Incorporated by reference to Exhibit 3.1 to our Form 8-K, dated June 25, 2015.) |
3.6 |
Certificate
of Amendment to the Certificate of Incorporation. (Incorporated by reference to Exhibit 3.1 to our Form 10-Q for the fiscal quarter
ended April 30, 2018.) |
3.7 |
Certificate
of Amendment to the Certificate of Incorporation. (Incorporated by reference to Exhibit 3.1 to our Form 8-K, dated October 1, 2018.) |
3.8 |
Certificate
of Amendment to the Certificate of Incorporation. (Incorporated by reference to Exhibit 3.1 to our Form 8-K, dated August 13, 2020.) |
3.9 |
Amended
and Restated By-laws. (Incorporated by reference to Exhibit 3.8 to our Form 10-K for the fiscal year ended October 31, 2019.) |
3.10 |
Amendment
to the Amended and Restated Bylaws of the Company. (Incorporated by reference to our Form 8-K, dated April 2, 2021.) |
4.1 |
Form
of Underwriter Warrants. (Incorporated by reference to Exhibit 4.1 to our Form 8-K, dated March 24, 2021.) |
4.2 |
Description
of the Company’s Securities Registered under Section 12 of the Exchange Act (Incorporated by reference to the description of
our common stock contained in our Current Report on Form 8-K filed on March 31, 2014.) |
10.1 |
2010
Share Incentive Plan. (Incorporated by reference to Exhibit 10.1 to our Form 8-K, dated July 20, 2010.) |
10.2 |
Amendment
No. 1 to the 2010 Share Incentive Plan. (Incorporated by reference to Exhibit 10.1 to our Form 8-K, dated July 7, 2011.) |
10.3 |
Amendment
No. 2 to the 2010 Share Incentive Plan. (Incorporated by reference to Exhibit 10.1 to our Form 8-K, dated September 5, 2012.) |
10.4 |
Amendment
No. 3 to the 2010 Share Incentive Plan. (Incorporated by reference to Exhibit 10.1 to our Form 10-Q for the fiscal quarter ended
January 31, 2014.) |
10.5 |
2018
Share Incentive Plan. (Incorporated by reference to Exhibit 4.13 to our Form S-8 dated October 1, 2018.) |
10.6 |
License
Agreement, dated November 13, 2017, between Certainty Therapeutics, Inc. and The Wistar Institute of Anatomy and Biology. (Incorporated
by reference to Exhibit 10.14 to our Form 10-K, dated January 9, 2018.) (Portions of this exhibit have been redacted pursuant to
a request for confidential treatment. The redacted portions have been separately filed with the Securities and Exchange Commission.) |
10.7 |
Amendment
to License Agreement between Certainty Therapeutics, Inc. and The Wistar Institute of Anatomy and Biology. (Incorporated by reference
to Exhibit 10.1 to our Form 10-Q for the fiscal quarter ended January 31, 2021.) (Certain information has been redacted in the marked
portions of the exhibit.) |
10.8 |
Amended
and Restated Master Collaboration Agreement, dated November 1, 2021, between Certainty Therapeutics, Inc. and H. Lee Moffitt Cancer
Center and Research Institute, Inc. (Incorporated by reference to Exhibit 10.8 to our Form 10-K for the fiscal year ended October
31, 2021.) |
10.9 |
Exclusive
License Agreement, dated July 8, 2019, between the Company and The Cleveland Clinic Foundation. (Incorporated by reference to Exhibit
10.1 to our Form 10-Q for the fiscal quarter ended July 31, 2019.) (Certain information has been redacted in the marked portions
of the exhibit.) |
10.10 |
Amendment
to Exclusive License Agreement between the Company and The Cleveland Clinic Foundation. (Filed herewith.) |
10.11 |
Exclusive
License Agreement, dated October 20, 2020, between the Company and The Cleveland Clinic Foundation. (Incorporated by reference to
Exhibit 10.14 to our Form 10-K, for the fiscal year ended October 31, 2020.) (Certain information has been redacted in the marked
portions of the exhibit.) |
10.12 |
Amendment
No. 1 to Exclusive License Agreement between the Company and The Cleveland Clinic Foundation. (Incorporated by reference to Exhibit
10.1 to our Form 10-Q for the fiscal quarter ended July 31, 2022.) (Certain information has been redacted in the marked portions
of the exhibit.) |
10.13 |
Form
of Controlled Equity OfferingSM Sales Agreement (Incorporated by reference to Exhibit 10.1 to our Form S-3 dated September
9, 2022) |
14 |
Code
of Conduct (Incorporated by reference to Exhibit 14 to our Form 10-K, for the fiscal year ended October 31, 2020.) |
19 |
Insider
Trading Policy (Filed herewith.) |
21 |
Subsidiaries
of Anixa Biosciences, Inc. (Incorporated by reference to Exhibit 21 to our Form 10-K, for the fiscal year ended October 31, 2020.) |
23.1 |
Consent
of Haskell & White LLP. (Filed herewith.) |
31.1 |
Certification
of Chief Executive Officer, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, dated January 16, 2024. (Filed herewith.) |
31.2 |
Certification
of Chief Financial Officer, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, dated January 16, 2024. (Filed herewith.) |
32.1 |
Statement
of Chief Executive Officer, pursuant to Section 1350 of Title 18 of the United States Code, dated January 16, 2024. (Filed herewith.) |
32.2 |
Statement
of Chief Financial Officer, pursuant to Section 1350 of Title 18 of the United States Code, dated January 16, 2024. (Filed herewith.) |
99.1 |
Clawback
Policy (Filed herewith.) |
Item
16. Form 10-K Summary.
The
Company has elected not to include a summary pursuant to this Item 16.
SIGNATURES
Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed
on its behalf by the undersigned, thereunto duly authorized.
|
Anixa
Biosciences, Inc. |
|
|
|
|
By:
|
/s/
Amit Kumar |
|
|
Dr.
Amit Kumar |
|
|
Chairman
of the Board and |
January
16, 2024 |
|
Chief
Executive Officer |
Pursuant
to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the
registrant and in the capacities and on the date indicated.
|
By: |
/s/
Amit Kumar |
|
|
Dr.
Amit Kumar |
|
|
Chairman
of the Board and |
|
|
Chief
Executive Officer |
January
16, 2024 |
|
(Principal
Executive Officer) |
|
|
|
|
By: |
/s/
Michael J. Catelani |
|
|
Michael
J. Catelani |
|
|
President,
Chief Operating Officer and |
|
|
Chief
Financial Officer |
January
16, 2024 |
|
(Principal
Financial and Accounting Officer) |
|
|
|
|
By: |
/s/
Lewis H. Titterton, Jr. |
|
|
Lewis
H. Titterton, Jr. |
January
16, 2024 |
|
Director |
|
|
|
|
By: |
/s/
Arnold Baskies |
|
|
Dr.
Arnold Baskies |
January
16, 2024 |
|
Director |
|
|
|
|
By: |
/s/
Emily Gottschalk |
|
|
Emily
Gottschalk |
January
16, 2024 |
|
Director |
ANIXA
BIOSCIENCES, INC. AND SUBSIDIARIES
INDEX
TO CONSOLIDATED FINANCIAL STATEMENTS
OCTOBER
31, 2023
Additional
information required by schedules called for under Regulation S-X is either not applicable or is included in the consolidated financial
statements or notes thereto.
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To
the Board of Directors and Shareholders
Anixa
Biosciences, Inc.
Opinion
on the Consolidated Financial Statements
We
have audited the accompanying consolidated balance sheets of Anixa Biosciences, Inc. (the “Company”) as of October 31, 2023
and 2022, and the related consolidated statements of operations, equity, and cash flows for each of the two years in the period ended
October 31, 2023, and the related notes (collectively, the “consolidated financial statements”). In our opinion, the consolidated
financial statements present fairly, in all material respects, the consolidated financial position of the Company as of October 31, 2023
and 2022, and the consolidated results of its operations and its cash flows for each of the years in the two year period ended October
31, 2023, in conformity with accounting principles generally accepted in the United States of America.
Basis
for Opinion
These
consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion
on the Company’s consolidated financial statements based on our audits. We are a public accounting firm registered with the Public
Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company
in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities Exchange Commission and
the PCAOB.
We
conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtain
reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud.
The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part
of our audits, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing
an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our
audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether
due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence
supporting the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles
used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements.
We believe that our audits provide a reasonable basis for our opinion.
Critical
Audit Matters
The
critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial statements
that was communicated or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are
material to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex
judgments. The communication of critical audit matters does not alter in any way our opinion on the consolidated financial
statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing separate opinions on the critical
audit matter or on the accounts or disclosures to which it relates.
Research
and Development Expenses – Refer to Note 2 of the Consolidated Financial Statements
Critical
Audit Matter Description:
The
Company recognizes research and development expenses as incurred. Advance payments for future research and development activities are
deferred and expensed as the services are performed. The Company recognizes its preclinical studies and clinical trial expenses based
on the services performed pursuant to contracts with research institutions, clinical research organizations (“CROs”), clinical
manufacturing organizations (“CMOs”), and other parties that conduct and manage various stages of research and development
activities on the Company’s behalf. Fees for such services are recognized based on management’s estimates after considering
the activities and tasks completed by each service provider in a given period, the time period over which services are expected to be
performed, and the level of effort expended in each reporting period.
At
each balance sheet date, management estimates prepaid and accrued research and development costs by discussing progress or stage of completion
of activities with internal personnel and external service providers, and comparing this information to payments made, invoices received,
and the agreed-upon contractual fee to be paid for such services in the applicable contract or statements of work.
In
addition, the Company allocates certain internal compensation costs to research and development expenses based on management’s
estimates of each employee’s time and effort expended.
How
the Critical Matter was Addressed in the Audit:
The
primary procedures we performed to address this critical audit matter included the following:
| ● | We
obtained an understanding, and evaluated the design and implementation, of controls relating
to research and development costs, including controls over the review of third-party contracts,
the process of gathering information from external and internal sources and management’s
review thereof, and the determination of prepaid positions, period-end accruals, and expense
allocations. |
| ● | For
the Company’s significant third-party contracts, we performed the following procedures: |
| ○ | We
obtained and read related master service agreements, statements of work, or other supporting
agreements with the research institution, CRO, or CMO. |
| ○ | We
performed corroborating inquiries with management personnel responsible for the oversight
of the activities regarding the nature and status of work performed. |
| ○ | We
evaluated evidence of services provided by third parties including invoices regarding activities
completed, and we inspected evidence supporting payments made by the Company. |
| ○ | We
compared the data and evidence obtained from internal and external sources to the amounts
recorded by management and recalculated the related research and development expense and
prepaid research and development expense. |
| ● | For
the Company’s internal compensation allocations, we performed the following procedures: |
| ○ | We
performed corroborating inquiries with management personnel responsible for the oversight
of the activities regarding the nature of employee services performed. |
| ○ | We
evaluated the reasonableness of allocations estimated by management by comparisons with prior
periods and evaluating the reasonableness of significant changes made by management. |
| ○ | We
obtained written representations from management regarding the appropriateness of allocation
estimates. |
HASKELL
& WHITE LLP
We
have served as the Company’s auditor since 2013
Irvine,
California
January
16, 2024
ANIXA
BIOSCIENCES, INC. AND SUBSIDIARIES
CONSOLIDATED
BALANCE SHEETS
(in
thousands, except share and per share data)
| |
October
31, | | |
October
31, | |
| |
2023 | | |
2022 | |
ASSETS | |
| | | |
| | |
Current assets: | |
| | | |
| | |
Cash and cash
equivalents | |
$ | 915 | | |
$ | 12,360 | |
Short–term investments | |
| 22,929 | | |
| 17,327 | |
Receivables | |
| 270 | | |
| 46 | |
Prepaid
expenses and other current assets | |
| 1,242 | | |
| 467 | |
Total current assets | |
| 25,356 | | |
| 30,200 | |
| |
| | | |
| | |
Operating lease right-of-use
asset | |
| 166 | | |
| 212 | |
| |
| | | |
| | |
Total
assets | |
$ | 25,522 | | |
$ | 30,412 | |
| |
| | | |
| | |
LIABILITIES AND
EQUITY | |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 206 | | |
$ | 265 | |
Accrued expenses | |
| 1,770 | | |
| 1,726 | |
Operating
lease liability | |
| 52 | | |
| 46 | |
Total current liabilities | |
| 2,028 | | |
| 2,037 | |
| |
| | | |
| | |
Operating lease liability,
non-current | |
| 123 | | |
| 175 | |
Total
liabilities | |
| 2,151 | | |
| 2,212 | |
| |
| | | |
| | |
Commitments and contingencies (Note 6) | |
| | | |
| | |
| |
| | | |
| | |
Equity: | |
| | | |
| | |
Shareholders’ equity: | |
| | | |
| | |
Preferred stock, par value
$100 per
share; 19,860 shares
authorized; no shares
issued or outstanding | |
| - | | |
| - | |
Series A convertible preferred
stock, par value $100
per share; 140
shares authorized; no
shares issued or outstanding | |
| - | | |
| - | |
Preferred stock, value | |
| - | | |
| - | |
Common stock, par value
$.01 per
share; 100,000,000 shares
authorized; 31,145,219 and
30,913,902 shares
issued and outstanding as of October 31, 2023 and 2022, respectively | |
| 311 | | |
| 309 | |
Additional paid-in capital | |
| 252,222 | | |
| 247,123 | |
Accumulated
deficit | |
| (228,196 | ) | |
| (218,385 | ) |
Total shareholders’
equity | |
| 24,337 | | |
| 29,047 | |
Noncontrolling
interest (Note 2) | |
| (966 | ) | |
| (847 | ) |
Total
equity | |
| 23,371 | | |
| 28,200 | |
| |
| | | |
| | |
Total
liabilities and equity | |
$ | 25,522 | | |
$ | 30,412 | |
The
accompanying notes are an integral part of these statements.
ANIXA
BIOSCIENCES, INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF OPERATIONS
(in
thousands, except per share data)
| |
2023 | | |
2022 | |
| |
For
the years ended October 31, | |
| |
2023 | | |
2022 | |
| |
| | |
| |
Revenue | |
$ | 210 | | |
$ | - | |
| |
| | | |
| | |
Operating costs and expenses: | |
| | | |
| | |
Inventor royalties, contingent
legal fees, litigation and licensing expenses | |
| 161 | | |
| - | |
Research and development
expenses (including non-cash share based compensation expenses of $2,037
and $3,635,
respectively) | |
| 4,769 | | |
| 6,703 | |
General
and administrative expenses (including non-cash share based compensation expenses of $2,698
and $3,117,
respectively) | |
| 6,291 | | |
| 7,172 | |
| |
| | | |
| | |
Total operating costs
and expenses | |
| 11,221 | | |
| 13,875 | |
| |
| | | |
| | |
Loss from operations | |
| (11,011 | ) | |
| (13,875 | ) |
| |
| | | |
| | |
Interest income | |
| 1,081 | | |
| 104 | |
| |
| | | |
| | |
Net loss | |
| (9,930 | ) | |
| (13,771 | ) |
| |
| | | |
| | |
Less: Net loss attributable
to noncontrolling interest | |
| (119 | ) | |
| (176 | ) |
| |
| | | |
| | |
Net loss attributable
to common stockholders | |
$ | (9,811 | ) | |
$ | (13,595 | ) |
| |
| | | |
| | |
Net loss per share: | |
| | | |
| | |
Basic
and diluted | |
$ | (0.32 | ) | |
$ | (0.45 | ) |
| |
| | | |
| | |
Weighted average common shares outstanding: | |
| | | |
| | |
Basic
and diluted | |
| 30,980 | | |
| 30,374 | |
The
accompanying notes are an integral part of these statements.
ANIXA
BIOSCIENCES, INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF EQUITY
FOR
THE YEARS ENDED OCTOBER 31, 2023 AND 2022
(in
thousands, except share data)
| |
| | |
| | |
Additional | | |
| | |
Total | | |
Non- | | |
| |
| |
Common
Stock | | |
Paid-in | | |
Accumulated | | |
Shareholders’ | | |
controlling | | |
Total | |
| |
Shares | | |
Par
Value | | |
Capital | | |
Deficit | | |
Equity | | |
Interest | | |
Equity | |
| |
| | |
| | |
| | |
| | |
| | |
| | |
| |
BALANCE,
October 31, 2021 | |
| 30,050,894 | | |
$ | 301 | | |
$ | 239,927 | | |
$ | (204,790 | ) | |
$ | 35,438 | | |
$ | (671 | ) | |
$ | 34,767 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Stock
option compensation to employees and directors | |
| - | | |
| - | | |
| 6,000 | | |
| - | | |
| 6,000 | | |
| - | | |
| 6,000 | |
Stock
options and warrants issued to consultants | |
| - | | |
| - | | |
| 655 | | |
| - | | |
| 655 | | |
| - | | |
| 655 | |
Common
stock issued upon exercise of stock options and warrants | |
| 827,619 | | |
| 8 | | |
| 431 | | |
| - | | |
| 439 | | |
| - | | |
| 439 | |
Common
stock issued to consultants | |
| 30,648 | | |
| - | | |
| 97 | | |
| - | | |
| 97 | | |
| - | | |
| 97 | |
Common
stock issued pursuant to employee stock purchase plan | |
| 4,741 | | |
| - | | |
| 13 | | |
| - | | |
| 13 | | |
| - | | |
| 13 | |
Net
loss | |
| - | | |
| - | | |
| - | | |
| (13,595 | ) | |
| (13,595 | ) | |
| (176 | ) | |
| (13,771 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
BALANCE,
October 31, 2022 | |
| 30,913,902 | | |
$ | 309 | | |
$ | 247,123 | | |
$ | (218,385 | ) | |
$ | 29,047 | | |
$ | (847 | ) | |
$ | 28,200 | |
Balance | |
| 30,913,902 | | |
$ | 309 | | |
$ | 247,123 | | |
$ | (218,385 | ) | |
$ | 29,047 | | |
$ | (847 | ) | |
$ | 28,200 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Stock
option compensation to employees and directors | |
| - | | |
| - | | |
| 4,422 | | |
| - | | |
| 4,422 | | |
| - | | |
| 4,422 | |
Stock
options issued to consultants | |
| - | | |
| - | | |
| 221 | | |
| - | | |
| 221 | | |
| - | | |
| 221 | |
Common
stock issued upon exercise of stock options | |
| 202,647 | | |
| 2 | | |
| 351 | | |
| - | | |
| 353 | | |
| - | | |
| 353 | |
Common
stock issued to consultants | |
| 24,310 | | |
| - | | |
| 92 | | |
| - | | |
| 92 | | |
| - | | |
| 92 | |
Common
stock issued pursuant to employee stock purchase plan | |
| 4,360 | | |
| - | | |
| 13 | | |
| - | | |
| 13 | | |
| - | | |
| 13 | |
Net
loss | |
| - | | |
| - | | |
| - | | |
| (9,811 | ) | |
| (9,811 | ) | |
| (119 | ) | |
| (9,930 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
BALANCE,
October 31, 2023 | |
| 31,145,219 | | |
$ | 311 | | |
$ | 252,222 | | |
$ | (228,196 | ) | |
$ | 24,337 | | |
$ | (966 | ) | |
$ | 23,371 | |
Balance | |
| 31,145,219 | | |
$ | 311 | | |
$ | 252,222 | | |
$ | (228,196 | ) | |
$ | 24,337 | | |
$ | (966 | ) | |
$ | 23,371 | |
The
accompanying notes are an integral part of these statements.
ANIXA
BIOSCIENCES, INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF CASH FLOWS
(in
thousands)
| |
2023 | | |
2022 | |
| |
For
the years ended October 31, | |
| |
2023 | | |
2022 | |
Cash flows from operating activities: | |
| | | |
| | |
Reconciliation of net loss to net cash used
in operating activities: | |
| | | |
| | |
Net loss | |
$ | (9,930 | ) | |
$ | (13,771 | ) |
Stock option compensation
to employees and directors | |
| 4,422 | | |
| 6,000 | |
Stock options and warrants
issued to consultants | |
| 221 | | |
| 655 | |
Common stock issued to
consultants | |
| 92 | | |
| 97 | |
Amortization of operating
lease right-of-use asset | |
| 46 | | |
| 42 | |
Change in operating assets
and liabilities: | |
| | | |
| | |
Receivables | |
| (224 | ) | |
| (29 | ) |
Prepaid expenses and other
current assets | |
| (775 | ) | |
| (208 | ) |
Accounts payable | |
| (59 | ) | |
| 129 | |
Accrued expenses | |
| 44 | | |
| 631 | |
Operating
lease liability | |
| (46 | ) | |
| (38 | ) |
Net
cash used in operating activities | |
| (6,209 | ) | |
| (6,492 | ) |
| |
| | | |
| | |
Cash flows from investing activities: | |
| | | |
| | |
Disbursements to acquire
short-term investments | |
| (44,411 | ) | |
| (22,486 | ) |
Proceeds
from maturities of short-term investments | |
| 38,809 | | |
| 11,758 | |
Net
cash used in investing activities | |
| (5,602 | ) | |
| (10,728 | ) |
| |
| | | |
| | |
Cash flows from financing activities: | |
| | | |
| | |
Proceeds from sale of common
stock pursuant to employee stock purchase plan | |
| 13 | | |
| 13 | |
Proceeds
from exercise of stock options and warrants | |
| 353 | | |
| 439 | |
Net
cash provided by financing activities | |
| 366 | | |
| 452 | |
| |
| | | |
| | |
Net decrease in cash and cash equivalents | |
| (11,445 | ) | |
| (16,768 | ) |
Cash and cash equivalents
at beginning of year | |
| 12,360 | | |
| 29,128 | |
Cash and cash equivalents
at end of year | |
$ | 915 | | |
$ | 12,360 | |
| |
| | | |
| | |
Supplemental cash flow information: | |
| | | |
| | |
Cash
proceeds from interest income | |
$ | 838 | | |
$ | 23 | |
The
accompanying notes are an integral part of these statements.
ANIXA
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
1.
BUSINESS AND FUNDING
Description
of Business
As
used herein, “we,” “us,” “our,” the “Company” or “Anixa” means Anixa Biosciences,
Inc. and its consolidated subsidiaries.
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®).
ANIXA
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
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.
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.
ANIXA
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
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.
Funding
and Management’s Plans
Based
on currently available information as of January 16, 2024, we believe that our existing cash, cash equivalents, short-term investments
and expected cash flows will be sufficient to fund our activities for at least the next twelve months. We have implemented a business
model that conserves funds by collaborating with third parties to develop our technologies. However, our projections of future cash needs
and cash flows may differ from actual results. If current cash on hand, cash equivalents, short-term investments and cash that may be
generated from our business operations are insufficient to continue to operate our business, or if we elect to invest in or acquire a
company or companies or new technology or technologies that are synergistic with or complementary to our technologies, we may be required
to obtain more working capital. Under our at-the-market equity program which is currently effective and may remain available for us to
use in the future, as of October 31, 2023, we may sell up to $100
million of common stock. We did not sell any
shares under our at-the-market equity program during the fiscal year ended October 31, 2023. We may seek to obtain working capital during
our fiscal year 2024 or thereafter through sales of our equity securities or through bank credit facilities or public or private debt
from various financial institutions where possible. We cannot be certain that additional funding will be available on acceptable terms,
or at all. If we do identify sources for additional funding, the sale of additional equity securities or convertible debt will result
in dilution to our stockholders. We can give no assurance that we will generate sufficient cash flows in the future to satisfy our liquidity
requirements or sustain future operations, or that other sources of funding, such as sales of equity or debt, would be available or would
be approved by our security holders, if needed, on favorable terms or at all. If we fail to obtain additional working capital as and
when needed, such failure could have a material adverse impact on our business, results of operations and financial condition. Furthermore,
such lack of funds may inhibit our ability to respond to competitive pressures or unanticipated capital needs, or may force us to reduce
operating expenses, which would significantly harm the business and development of operations.
ANIXA
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
2.
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis
of Presentation
The
consolidated financial statements include the accounts of Anixa Biosciences, Inc. and its wholly and majority owned subsidiaries. All
intercompany transactions have been eliminated.
Noncontrolling
Interest
Noncontrolling
interest represents Wistar’s equity ownership in Certainty and is presented as a component of equity. The following table sets
forth the changes in noncontrolling interest for the two years ended October 31, 2023 (in thousands):
SCHEDULE
OF CHANGES IN NONCONTROLLING INTEREST
Balance October 31, 2021 | |
$ | (671 | ) |
Net loss attributable
to noncontrolling interest | |
| (176 | ) |
Balance October 31, 2022 | |
| (847 | ) |
Net loss attributable
to noncontrolling interest | |
| (119 | ) |
Balance October 31,
2023 | |
$ | (966 | ) |
Revenue
Recognition
Our
revenue has been derived solely from technology licensing and the sale of patented technologies. Revenue is recognized upon transfer
of control of intellectual property rights and satisfaction of other contractual performance obligations to licensees in an amount that
reflects the consideration we expect to receive.
Our
revenue recognition policy requires us to make certain judgments and estimates in connection with the accounting for revenue. Such areas
may include determining the existence of a contract and identifying each party’s rights and obligations to transfer goods and services,
identifying the performance obligations in the contract, determining the transaction price and allocating the transaction price to separate
performance obligations, estimating the timing of satisfaction of performance obligations, determining whether a promise to grant a license
is distinct from other promised goods or services and evaluating whether a license transfers to a customer at a point in time or over
time.
Our
revenue arrangements provide for the payment, within 30 days of execution of the agreement, of contractually determined, one-time, paid-up
license fees in settlement of litigation and in consideration for the grant of certain intellectual property rights for patented technologies
owned or controlled by the Company. These arrangements typically include some combination of the following: (i) the grant of a non-exclusive,
retroactive and future license to manufacture and/or sell products covered by patented technologies owned or controlled by the Company,
(ii) a covenant-not-to-sue, (iii) the release of the licensee from certain claims, and (iv) the dismissal of any pending litigation.
In such instances, the intellectual property rights granted have been perpetual in nature, extending until the expiration of the related
patents. Pursuant to the terms of these agreements, we have no further obligations with respect to the granted intellectual property
rights, including no obligation to maintain or upgrade the technology, or provide future support or services. Licensees obtained control
of the intellectual property rights they have acquired upon execution of the agreement. Accordingly, the performance obligations from
these agreements were satisfied and 100%
of the revenue was recognized upon the execution of the agreements.
ANIXA
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
Cost
of Revenues
Cost
of revenues include the costs and expenses incurred in connection with our patent licensing and enforcement activities, including inventor
royalties paid to original patent owners, contingent legal fees paid to external counsel, other patent-related legal expenses paid to
external counsel, licensing and enforcement related research and consulting and other expenses paid to third-parties. These costs are
included under the caption “Operating costs and expenses” in the accompanying consolidated statements of operations.
Research
and Development Expenses
Research
and development expenses consist primarily of payments to third parties for research and development activities, including expenses related
to clinical trials, employee compensation, and other direct costs associated with developing our therapeutics and vaccines.
We
recognize research and development expenses as incurred. Advance payments for future research and development activities are deferred
and expensed as the services are performed. We recognize our preclinical studies and clinical trial expenses based on the services performed
pursuant to contracts with research institutions, clinical research organizations (“CROs”), clinical manufacturing organizations
(“CMOs”), and other parties that conduct and manage various stages of research and development activities on our behalf.
Fees for such services are recognized based on management’s estimates after considering the activities and tasks completed by each
service provider in a given period, the time period over which services are expected to be performed, and the level of effort expended
in each reporting period.
At
each balance sheet date, management estimates prepaid and accrued research and development costs by discussing progress or stage of completion
of activities with internal personnel and external service providers, and comparing this information to payments made, invoices received,
and the agreed-upon contractual fee to be paid for such services in the applicable contract or statements of work.
In addition, we allocate certain internal compensation
costs to research and development expenses based on management’s estimates of each employee’s time and effort expended.
Fair
Value Measurements
Accounting
Standards Codification (“ASC”) 820, Fair Value Measurements and Disclosures (“ASC 820”), defines fair value,
establishes a framework for measuring fair value under U.S. generally accepted accounting principles (GAAP), and expands disclosures
about fair value measurements. In accordance with ASC 820, we have categorized our financial assets and liabilities, based on the priority
of the inputs to the valuation technique, into a three-level fair value hierarchy as set forth below. If the inputs used to measure the
financial instruments fall within different levels of the hierarchy, the categorization is based on the lowest level input that is significant
to the fair value measurement of the instrument.
Financial
assets and liabilities recorded in the accompanying consolidated balance sheets are categorized based on the inputs to the valuation
techniques as follows:
Level
1 – Financial instruments whose values are based on unadjusted quoted prices for identical assets or liabilities in an active market
which we have the ability to access at the measurement date.
Level
2 – Financial instruments whose values are based on quoted market prices in markets where trading occurs infrequently or whose
values are based on quoted prices of instruments with similar attributes in active markets.
Level
3 – Financial instruments whose values are based on prices or valuation techniques that require inputs that are both unobservable
and significant to the overall fair value measurement. These inputs reflect management’s own assumptions about the assumptions
a market participant would use in pricing the instrument.
ANIXA
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
The
following table presents the hierarchy for our financial assets measured at fair value on a recurring basis as of October 31, 2023 (in
thousands):
SCHEDULE
OF FAIR VALUE MEASUREMENTS
| |
Level
1 | | |
Level
2 | | |
Level
3 | | |
Total | |
Money market funds: | |
| | | |
| | | |
| | | |
| | |
Cash equivalents | |
$ | 778 | | |
$ | - | | |
$ | - | | |
$ | 778 | |
Certificates of deposit: | |
| | | |
| | | |
| | | |
| | |
Short term investments | |
| - | | |
| 720 | | |
| - | | |
| 720 | |
U. S. treasury bills: | |
| | | |
| | | |
| | | |
| | |
Short
term investments | |
| - | | |
| 22,209 | | |
| - | | |
| 22,209 | |
Total financial assets | |
$ | 778 | | |
$ | 22,929 | | |
$ | - | | |
$ | 23,707 | |
The
following table presents the hierarchy for our financial assets measured at fair value on a recurring basis as of October 31, 2022 (in
thousands):
| |
Level
1 | | |
Level
2 | | |
Level
3 | | |
Total | |
Money market funds: | |
| | | |
| | | |
| | | |
| | |
Cash equivalents | |
$ | 11,175 | | |
$ | - | | |
$ | - | | |
$ | 11,175 | |
Certificates of deposit: | |
| | | |
| | | |
| | | |
| | |
Cash equivalents | |
| | | |
| 1,000 | | |
| | | |
| 1,000 | |
Short term investments | |
| - | | |
| 13,700 | | |
| - | | |
| 13,700 | |
U. S. treasury bills: | |
| | | |
| | | |
| | | |
| | |
Short
term investments | |
| - | | |
| 3,627 | | |
| - | | |
| 3,627 | |
Total financial assets | |
$ | 11,175 | | |
$ | 18,327 | | |
$ | - | | |
$ | 29,502 | |
Our
non-financial assets that are measured on a non-recurring basis are property and equipment and other assets which are measured using
fair value techniques whenever events or changes in circumstances indicate a condition of impairment exists. The estimated fair value
of prepaid expenses and other current assets, accounts payable and accrued expenses approximates their individual carrying amounts due
to the short-term nature of these measurements. Cash equivalents are stated at carrying value which approximates fair value.
Cash
Equivalents
Cash
equivalents consist of highly liquid, short-term investments with original maturities of three months or less when purchased.
Short-term
Investments
At
October 31, 2023 and 2022, we had certificates of deposit and United States treasury bills with maturities greater than 90 days and less
than 12 months when acquired of approximately $22,929,000
and $17,327,000,
respectively, that were classified as short-term investments and reported at fair value.
Income
Taxes
We
recognize deferred tax assets and liabilities for the estimated future tax effects of events that have been recognized in our financial
statements or tax returns. Under this method, deferred tax assets and liabilities are determined based on the difference between the
financial statement and tax bases of assets and liabilities using enacted tax rates in effect in the years in which the differences are
expected to reverse. A valuation allowance is established, when necessary, to reduce deferred tax assets to the amount expected to be
realized.
ANIXA
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
Share-Based
Compensation
We
maintain equity incentive plans under which we may grant incentive stock options, non-qualified stock options, stock appreciation rights,
stock awards, performance awards, or stock units to employees, directors and consultants.
Stock
Option Compensation Expense
We
account for stock options granted to employees, directors and consultants using the accounting guidance in ASC 718, Stock Compensation
(“ASC 718”). We estimate the fair value of service-based stock options on the date of grant, using the Black-Scholes pricing
model, and recognize compensation expense over the requisite service period of the grant.
We
recorded stock-based compensation expense, related to service-based stock options granted to employees and directors, of approximately
$4,422,000
and $3,463,000,
during the years ended October 31, 2023 and 2022, respectively. Included in stock-based compensation cost for service-based options granted
to employees and directors during the years ended October 31, 2023 and 2022 was approximately $3,023,000
and $2,788,000,
respectively, related to the amortization of compensation cost for stock options granted in prior periods but not yet vested. As of October
31, 2023, there was unrecognized compensation cost related to non-vested service-based stock options granted to employees and directors
of approximately $5,194,000,
which will be recognized over a weighted-average period of 1.7
years.
For
stock options that vest based on market conditions, such as the trading price of the Company’s common stock exceeding certain price
targets, we use a Monte Carlo Simulation in estimating the fair value at grant date and recognize compensation expense over the implied
service period (median time to vest). On June 1, 2021, our Chairman, then-President and Chief Executive Officer and our Chief Operating
Officer and Chief Financial Officer were awarded market condition stock options for 2,000,000
shares and 100,000
shares of common stock, respectively, that vest
in four equal installments upon the Company’s share price achieving targets ranging from $5.00
to $8.00
per share, with implied service periods of three
to fifteen months. The assumptions used in the Monte Carlo Simulation for the June 1, 2021 grants were stock price on date of grant and
exercise price of $4.02,
contract term of 10
years, expected volatility of 75%
and risk-free interest rate of 1.62%.
As of October 31, 2023, 500,000
options and 25,000
options granted to our Chairman, then-President
and Chief Executive Officer and our Chief Operating Officer and Chief Financial Officer, respectively, have vested.
During
the year ended October 31, 2023, we recorded no
stock-based compensation expense related to market
condition stock options granted to employees. We recorded stock-based compensation expense related to market condition stock options
granted to employees of approximately $2,537,000
during the year ended October 31, 2022, which
amount represented expense related to the amortization of compensation cost for stock options granted during the year ended October 31,
2021. As of October 31, 2023, there was no
unrecognized compensation cost related to market
condition stock options granted to employees.
We
recorded consulting expense, related to service-based stock options granted to consultants, during the years ended October 31, 2023 and
2022 of approximately $221,000
and $434,000,
respectively. Included in stock-based consulting expense for the years ended October 31, 2023 and 2022 was approximately $209,000
and $434,000,
respectively, related to compensation cost for stock options granted in prior periods but not yet vested. As of October 31, 2023, there
was unrecognized consulting expense related to non-vested service-based stock options granted to consultants of approximately $281,000,
which will be recognized over a weighted-average period of 2.5
years.
ANIXA
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
Fair
Value Determination
We
use the Black-Scholes pricing model in estimating the fair value of stock options granted to employees, directors and consultants which
vest over a specific period of time. The stock options we granted during each of the years ended October 31, 2023 and 2022 consisted
of awards with 5-year
and 10-year
terms that vest over 12
to 36
months.
The
following weighted average assumptions were used in estimating the fair value of stock options granted during the years ended October
31, 2023 and 2022:
SCHEDULE
OF WEIGHTED AVERAGE ASSUMPTIONS USED IN ESTIMATING FAIR VALUE OF STOCK OPTIONS
| |
For
the Year Ended October 31, | |
| |
2023 | | |
2022 | |
Weighted average fair value at
grant date | |
$ | 3.29 | | |
$ | 2.18 | |
Valuation assumptions: | |
| | | |
| | |
Expected life (years) | |
| 5.47 | | |
| 5.76 | |
Expected volatility | |
| 100.27 | % | |
| 102.72 | % |
Risk-free interest rate | |
| 3.87 | % | |
| 1.99 | % |
Expected dividend yield | |
| 0 | % | |
| 0 | % |
The
expected term of stock options represents the weighted average period the stock options are expected to remain outstanding. For employees
and directors, we use the simplified method, which is a weighted average of the vesting term and contractual term, to determine expected
term. The simplified method was adopted since we do not believe that historical experience is representative of future performance because
of the impact of the changes in our operations and the change in terms from historical operations. For consultants, we use the contract
term for expected term. Under the Black-Scholes pricing model, we estimated the expected volatility of our shares of common stock based
upon the historical volatility of our share price over a period of time equal to the expected term of the options. We estimated the risk-free
interest rate based on the implied yield available on the applicable grant date of a U.S. Treasury note with a term equal to the expected
term of the underlying grants. We made the dividend yield assumption based on our history of not paying cash dividends and our expectation
not to pay dividends in the future.
Under
ASC 718, the amount of stock-based compensation expense recognized is based on the portion of the awards that are ultimately expected
to vest. Accordingly, if deemed necessary, we reduce the fair value of the stock option awards for expected forfeitures, which are forfeitures
of the unvested portion of surrendered options. Based on our historical experience and future expectations, we have not reduced the amount
of stock-based compensation expenses for anticipated forfeitures.
We
will reconsider use of the Black-Scholes pricing model if additional information becomes available in the future that indicates another
model would be more appropriate. If factors change and we employ different assumptions in the application of ASC 718 in future periods,
the compensation expense that we record under ASC 718 may differ significantly from what we have recorded in the current period.
ANIXA
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
Warrants
For
warrants granted to consultants for services rendered, we estimate the fair value using the Black-Scholes pricing model on the date of
grant. During the years ended October 31, 2023 and 2022 we recorded consulting expense, based on the fair value, of $0
and approximately $221,000,
respectively, for warrants granted to consultants.
Net
Loss Per Share of Common Stock
In
accordance with ASC 260, Earnings Per Share, basic net loss per common share (“Basic EPS”) is computed by dividing net loss
by the weighted average number of common shares outstanding. Diluted net loss per common share (“Diluted EPS”) is computed
by dividing net loss by the weighted average number of common shares and dilutive common share equivalents and convertible securities
then outstanding. Diluted EPS for all years presented is the same as Basic EPS, as the inclusion of the effect of common share equivalents
then outstanding would be anti-dilutive. For this reason, excluded from the calculation of Diluted EPS for the years ended October 31,
2023 and 2022 were options to purchase 11,430,000
shares and 10,318,872
shares, respectively, and warrants to purchase
300,000
shares and 300,000
shares, respectively.
Use
of Estimates
The
preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires
management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent
assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting
period. Estimates and assumptions are used for, but not limited to, determining stock-based compensation, asset impairment evaluations,
tax assets and liabilities, license fee revenue, the allowance for doubtful accounts, depreciation lives and other contingencies. Actual
results could differ from those estimates.
ANIXA
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
Effect
of Recently Issued Pronouncements
In
August 2020, the FASB issued Accounting Standards Update 2020-06 (“ASU 2020-06”), Accounting for Convertible Instruments
and Contracts in an Entity’s Own Equity. The amendments in ASU 2020-06 include guidance on convertible instruments and the derivative
scope exception for contracts in an entity’s own equity and simplifies the accounting for convertible instruments which include
beneficial conversion features or cash conversion features by removing certain separation models in Subtopic 470-20. Additionally, ASU
2020-06 will require entities to use the “if-converted” method when calculating diluted earnings per share for convertible
instruments. The amendments in this update are effective for fiscal years beginning after December 15, 2021, including interim periods
within those fiscal years. The adoption of this standard did not have a material impact on our consolidated financial statements and
related disclosures.
In
May 2021, the FASB issued Accounting Standards Update 2021-04 (“ASU 2021-04”), Issuer’s Accounting for Certain Modifications
or Exchanges of Freestanding Equity-Classified Written Call Options. The guidance in ASU 2021-04 requires the issuer to treat a modification
of an equity-classified written call option (the “option”) that does not cause the option to become liability-classified
as an exchange of the original option for a new option. This guidance applies whether the modification is structured as an amendment
to the terms and conditions of the option or as termination of the original option and issuance of a new option. The amendments in this
update are effective for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. The adoption
of this standard did not have a material impact on our consolidated financial statements and related disclosures.
In
October 2021, the FASB issued Accounting Standards Update 2021-08 (“ASU 2021-08”), Business Combinations (Topic 805): Accounting
for Contract Assets and Contract Liabilities from Contracts with Customers, to require that an acquirer recognize and measure contract
assets and contract liabilities acquired in a business combination in accordance with Topic 606, Revenue from Contracts with Customers.
At the acquisition date, an acquirer should account for the related revenue contracts in accordance with Topic 606 as if it had originated
the contracts. The amendments in this update should be applied prospectively and are effective for fiscal years beginning after December
15, 2022, including interim periods within those fiscal years. We do not expect the adoption of this standard to have a material impact
on our consolidated financial statements and related disclosures.
Concentration
of Credit Risks
Financial
instruments that potentially subject us to concentrations of credit risk are cash equivalents, short-term investments and accounts receivable.
Cash equivalents are primarily highly rated money market funds. Short-term investments are certificates of deposit within federally insured
limits as well as U.S. treasury bills. Where applicable, management reviews our accounts receivable and other receivables for potential
doubtful accounts and maintains an allowance for estimated uncollectible amounts. Our policy is to write-off uncollectable amounts at
the time it is determined that collection will not occur. One licensee accounted for 100% of revenues from patent licensing activities
during fiscal year 2023.
3.
ACCRUED EXPENSES
Accrued
liabilities consist of the following as of:
SCHEDULE
OF ACCRUED EXPENSES
| |
2023 | | |
2022 | |
| |
October
31, | |
| |
2023 | | |
2022 | |
Payroll and related expenses | |
$ | 1,114 | | |
$ | 1,144 | |
Accrued royalty and contingent legal fees | |
| 626 | | |
| 577 | |
Accrued other | |
| 30 | | |
| 5 | |
Accrued
expenses | |
$ | 1,770 | | |
$ | 1,726 | |
ANIXA
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
4.
SHAREHOLDERS’ EQUITY
Stock
Option Plans
During
the year ended October 31, 2023, we had two stock option plans: the Anixa Biosciences, Inc. 2010 Share Incentive Plan (the “2010
Share Plan”) and the Anixa Biosciences, Inc. 2018 Share Incentive Plan (the “2018 Share Plan”) which were adopted by
our Board of Directors on July 14, 2010 and January 25, 2018, respectively. The 2018 Share Plan was approved by our shareholders on March
29, 2018. In accordance with the provisions of the 2010 Share Plan, the plan terminated with respect to the grant of future securities
on July 14, 2020.
During
the years ended October 31, 2023 and 2022, stock options to purchase 157,761
and 387,739
shares of common stock, respectively, were exercised
on a cash basis, with aggregate proceeds of approximately $353,000
and $439,000,
respectively. During the years ended October 31, 2023 and 2022, stock options to purchase 161,111
shares of common stock, of which 116,225
shares were withheld, and 1,488,881
shares of common stock, of which 1,083,517
shares were withheld, were exercised on a cashless
basis, respectively.
2010
Share Plan
The
2010 Share Plan provided for the grant of nonqualified stock options, stock appreciation rights, stock awards, performance awards and
stock units to employees, directors and consultants. On the first business day of each calendar year the aggregate number of shares available
for future issuance was replenished such that 800,000
shares were available. The exercise price with
respect to all of the options granted under the 2010 Share Plan was equal to the fair market value of the underlying common stock at
the grant date. Information regarding the 2010 Share Plan for the two years ended October 31, 2023 is as follows:
SCHEDULE
OF OPTION ACTIVITY
| |
Shares | | |
Weighted
Average
Exercise Price
Per Share | | |
Aggregate
Intrinsic Value | |
Options Outstanding at October
31, 2021 | |
| 1,718,634 | | |
$ | 2.82 | | |
| | |
Exercised | |
| (212,000 | ) | |
$ | 2.68 | | |
| | |
Expired | |
| (5,134 | ) | |
$ | 3.63 | | |
| | |
Options Outstanding at October 31, 2022 | |
| 1,501,500 | | |
$ | 2.83 | | |
| | |
Exercised | |
| (312,500 | ) | |
$ | 2.41 | | |
| | |
Options Outstanding
and Exercisable at October 31, 2023 | |
| 1,189,000 | | |
$ | 2.94 | | |
$ | 770,800 | |
The
following table summarizes information about stock options outstanding under the 2010 Share Plan as of October 31, 2023:
SCHEDULE
OF OUTSTANDING AND EXERCISABLE
Range
of Exercise Prices | |
Number Outstanding
and Exercisable | | |
Weighted
Average Remaining Contractual
Life (in
years) | | |
Weighted Average Exercise
Price | |
$0.67
- $2.27 | |
| 366,000 | | |
| 3.59 | | |
$ | 1.27 | |
$2.58
- $3.13 | |
| 314,000 | | |
| 2.21 | | |
$ | 2.91 | |
$3.46
- $5.30 | |
| 509,000 | | |
| 4.54 | | |
$ | 4.17 | |
ANIXA
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
2018
Share Plan
The
2018 Share Plan provides for the grant of incentive stock options, nonqualified stock options, stock appreciation rights, stock awards,
performance awards and stock units to employees, directors and consultants. On the first business day of each calendar year the maximum
aggregate number of shares available for future issuance is replenished such that 2,000,000
shares are available. The exercise price with
respect to all of the options granted under the 2018 Share Plan was equal to the fair market value of the underlying common stock at
the grant date. As of October 31, 2023, the 2018 Share Plan had 750,000
shares available for future grants. Information
regarding the 2018 Share Plan for the two years ended October 31, 2023 is as follows:
SCHEDULE
OF OPTION ACTIVITY
| |
Shares | | |
Weighted
Average
Exercise Price
Per Share | | |
Aggregate
Intrinsic Value | |
Options Outstanding at October
31, 2021 | |
| 7,409,992 | | |
$ | 3.76 | | |
| | |
Granted | |
| 1,430,000 | | |
$ | 2.74 | | |
| | |
Exercised | |
| (22,620 | ) | |
$ | 3.15 | | |
| | |
Options Outstanding at October 31, 2022 | |
| 8,817,372 | | |
$ | 3.60 | | |
| | |
Granted | |
| 1,640,000 | | |
$ | 3.97 | | |
| | |
Exercised | |
| (6,372 | ) | |
$ | 2.89 | | |
| | |
Forfeited/Expired | |
| (210,000 | ) | |
$ | 5.10 | | |
| | |
Options Outstanding
at October 31, 2023 | |
| 10,241,000 | | |
$ | 3.67 | | |
$ | 1,112,030 | |
Options Exercisable
at October 31, 2023 | |
| 6,721,970 | | |
$ | 3.50 | | |
$ | 884,783 | |
The
following table summarizes information about stock options outstanding under the 2018 Share Plan as of October 31, 2023:
SCHEDULE
OF OUTSTANDING AND EXERCISABLE
| |
Options
Outstanding | | |
Options
Exercisable | |
Range
of Exercise
Prices | |
Number Outstanding | | |
Weighted Average Remaining Contractual
Life (in
years) | | |
Weighted Average Exercise
Price | | |
Number Exercisable | | |
Weighted Average Remaining Contractual
Life (in
years) | | |
Weighted Average Exercise
Price | |
$ 2.09
- $3.87 | |
| 5,476,000 | | |
| 6.50 | | |
$ | 3.24 | | |
| 4,828,361 | | |
| 6.22 | | |
$ | 3.29 | |
$ 3.96
- $5.30 | |
| 4,765,000 | | |
| 7.70 | | |
$ | 4.16 | | |
| 1,893,609 | | |
| 7.20 | | |
$ | 4.02 | |
Non-Plan
Options
In
addition to options granted under stock option plans, during the years ended October 31, 2012 and 2013, the Board of Directors approved
the grant of stock options to certain employees and directors (the “Non-Plan Options”).
ANIXA
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
Information
regarding the Non-Plan Options for the two years ended October 31, 2023 is as follows:
SCHEDULE
OF OPTION ACTIVITY
| |
Shares | | |
Weighted
Average
Exercise Price
Per Share | |
Options Outstanding October 31,
2021 | |
| 1,642,000 | | |
$ | 2.58 | |
Exercised | |
| (1,642,000 | ) | |
$ | 2.58 | |
Options Outstanding
and Exercisable at October 31, 2022 | |
| - | | |
| | |
Employee
Stock Purchase Plan
The
Company maintains the Anixa Biosciences, Inc. Employee Stock Purchase Plan which permits eligible employees to purchase shares at not
less than 85%
of the market value of the Company’s common stock on the offering date or the purchase date of the applicable offering period,
whichever is lower. The plan was adopted by our Board of Directors on August 13, 2018 and approved by our shareholders on September 27,
2018. During the years ended October 31, 2023 and 2022, employees purchased 4,360
and 4,741
shares, respectively, with aggregate proceeds
of approximately $13,000
and $13,000,
respectively.
Common
Stock Purchase Warrants
On
November 1, 2021 we issued a warrant, expiring on October
30, 2026, to purchase 60,000
shares of common stock at $4.77
per share, vesting over five
months, to a consultant for investor relations
services. We recorded consulting expense of approximately $221,000
during the year ended October 31, 2022, based
on the fair value of the warrant recognized on a straight-line basis over the vesting period. The warrant terminated in May 2022 upon
termination of the consulting agreement.
In
connection with a public offering in March 2021, we issued to certain designees of the underwriter, as compensation, warrants to purchase
300,000
shares of common stock at $6.5625
per share, expiring on March
22, 2026.
Information
regarding the Company’s warrants for the two years ended October 31, 2023 is as follows:
SCHEDULE
OF WARRANTS ACTIVITY
| |
Shares | | |
Weighted
Average
Exercise Price
Per Share | | |
Aggregate
Intrinsic Value | |
Warrants Outstanding at October
31, 2021 | |
| 860,000 | | |
$ | 5.36 | | |
| | |
Issued | |
| 60,000 | | |
$ | 4.77 | | |
| | |
Exercised | |
| (60,000 | ) | |
$ | 2.06 | | |
| | |
Expired | |
| (560,000 | ) | |
$ | 4.71 | | |
| | |
Warrants Outstanding
and Exercisable at October 31, 2022 and October 31, 2023 | |
| 300,000 | | |
$ | 6.56 | | |
$ | 0 | |
The
following table summarizes information about the Company’s outstanding and exercisable warrants as of October 31, 2023:
SCHEDULE
OF OUTSTANDING AND EXERCISABLE
Exercise
Price | | |
Number Outstanding
and Exercisable | | |
Weighted
Average Remaining Contractual
Life (in
years) | | |
Weighted Average Exercise
Price | |
$ | 6.56 | | |
| 300,000 | | |
| 2.39 | | |
$ | 6.56 | |
ANIXA
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
5.
LEASES
We
lease approximately 2,000
square feet of office space at 3150 Almaden Expressway,
San Jose, California (our principal executive offices) from an unrelated party pursuant to an operating lease that, as amended, will
expire on September
30, 2024, with an
option to extend the lease an additional two years. Our
base rent is approximately $5,000
per month and the lease provides for annual increases
of approximately 3%
and an escalation clause for increases in certain operating costs. The lease, as amended, resulted in a right-of-use asset and lease
liability of approximately $260,000
with a discount rate of 10%.
Rent expense was approximately $66,000 for
each of the years ended October 31, 2023 and 2022.
For
operating leases, the lease liability is initially and subsequently measured at the present value of the unpaid lease payments. The remaining
35-month
lease term as of October 31, 2023 for the Company’s lease includes the noncancelable period of the lease and the additional two-year
option period that the Company believes it is reasonably certain to exercise. All right-of-use assets are reviewed for impairment when
indications of impairment are present.
As
of October 31, 2023, the annual minimum lease payments of our operating lease liability were as follows (in thousands):
SCHEDULE
OF MINIMUM LEASE PAYMENTS
For Years Ending October 31, | |
Operating
Leases | |
2024 | |
$ | 67 | |
2025 | |
| 70 | |
2026 | |
| 65 | |
Total future minimum lease
payments, undiscounted | |
| 202 | |
Less: Imputed interest | |
| 27 | |
Present
value of future minimum lease payments | |
$ | 175 | |
6.
COMMITMENTS AND CONTINGENCIES
Litigation
Matters
Other
than lawsuits we bring to enforce our patent rights, we are not involved in any litigation or other legal proceedings and management
is not aware of any pending litigation or legal proceeding against us that would have a material adverse effect upon our results of operations
or financial condition.
License
Commitments
As
of October 31, 2023, our commitments under the license agreements with Wistar and Cleveland Clinic for the year ending October 31, 2024
were approximately $70,000.
Research
& Development Agreements
We
have entered into certain research and development agreements with various third-party vendors related to the manufacturing of materials
necessary for the expected Phase 2 clinical trial of our breast cancer vaccine. As of October 31, 2023, future payments the Company may
make under these agreements may be approximately $3.5 million and such payments may be made over up to a five-year period.
7.
INCOME TAXES
Income
tax provision (benefit) consists of the following:
SCHEDULE
OF INCOME TAX PROVISION (BENEFIT)
| |
| | |
| |
| |
Year
Ended October 31, | |
| |
2023 | | |
2022 | |
Federal: | |
| | | |
| | |
Current | |
$ | - | | |
$ | - | |
Deferred | |
| (1,739,000 | ) | |
| (1,021,000 | ) |
State: | |
| | | |
| | |
Current | |
| - | | |
| - | |
Deferred | |
| (583,000 | ) | |
| (350,000 | ) |
Adjustment to valuation
allowance related to net deferred tax assets | |
| 1,322,000 | | |
| 1,371,000 | |
Total | |
$ | - | | |
$ | - | |
ANIXA
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
The
tax effects of temporary differences that give rise to significant portions of the deferred tax asset, net, at October 31, 2023 and 2022,
are as follows:
SCHEDULE
OF DEFERRED TAX ASSETS AND LIABILITIES
| |
| | |
| |
| |
October
31, | |
| |
2023 | | |
2022 | |
Long-term deferred tax assets: | |
| | | |
| | |
Federal and
state NOL and tax credit carryforwards | |
$ | 26,532,000 | | |
$ | 22,196,000 | |
Deferred compensation | |
| 7,752,000 | | |
| 6,851,000 | |
Intangibles | |
| 218,000 | | |
| 274,000 | |
Other | |
| - | | |
| 281,000 | |
Subtotal | |
| 34,502,000 | | |
| 29,602,000 | |
Less: valuation allowance | |
| (34,502,000 | ) | |
| (29,602,000 | ) |
Deferred
tax asset, net | |
$ | - | | |
$ | - | |
As
of October 31, 2023, we had Federal tax net operating loss and tax credit carryforwards of approximately $95,752,000
and $1,870,000,
respectively. At the federal level, businesses can carry forward their net operating losses indefinitely, but the deductions are limited
to 80 percent of taxable income. Prior to the Tax Cuts and Jobs Act (TCJA) of 2017, businesses could carry losses forward for 20 years
(without a deductibility limit). If the tax benefits relating to deductions of option holders’ income are ultimately realized,
those benefits will be credited directly to additional paid-in capital. Certain changes in stock ownership can result in a limitation
on the amount of net operating loss and tax credit carryovers that can be utilized each year. As of October 31, 2023, management has
not determined the extent of any such limitations, if any.
We
had California tax net operating loss carryforwards of approximately $51,065,000
as of October 31, 2023, available within statutory
limits (expiring
at various dates between 2024 and 2043), to offset
future corporate taxable income and taxes payable, if any, under certain computations of such taxes.
We
have provided a 100%
valuation allowance against our deferred tax
asset due to our current and historical pre-tax losses and the uncertainty regarding their realizability. The primary differences from
the Federal statutory rate of 21%
and the effective rate of 0%
is attributable to expiring net operating losses and a change in the valuation allowance. The following is a reconciliation of income
taxes at the Federal statutory tax rate to income tax expense (benefit):
SCHEDULE
OF RECONCILIATION OF INCOME TAXES
| |
Year
Ended October 31, | |
| |
2023 | | |
2022 | |
Income tax benefit at U.S. Federal
statutory income tax rate | |
| (2,085,000 | ) | |
| (21.00 | )% | |
$ | (2,892,000 | ) | |
| (21.00 | )% |
State income taxes | |
| (693,000 | ) | |
| (6.98 | )% | |
| (962,000 | ) | |
| (6.98 | )% |
Permanent differences | |
| 20,000 | | |
| 0.20 | % | |
| 14,000 | | |
| 0.10 | % |
Expiring net operating losses, credits and
other | |
| 1,436,000 | | |
| 14.46 | % | |
| 2,469,000 | | |
| 17.93 | % |
Change in valuation
allowance | |
| 1,322,000 | | |
| 13.32 | % | |
| 1,371,000 | | |
| 9.95 | % |
Income
tax provision | |
$ | - | | |
| 0.00 | % | |
$ | - | | |
| 0.00 | % |
ANIXA
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
During
the two fiscal years ended October 31, 2023, we incurred no Federal and no State income taxes. We have no
unrecognized tax benefits as of October 31, 2023
and 2022 and we account for interest and penalties related to income tax matters in general and administrative expenses. Tax years to
which our net operating losses relate remain open to examination by Federal and California authorities to the extent which the net operating
losses have yet to be utilized.
8.
SEGMENT INFORMATION
We
follow the accounting guidance of ASC 280, Segment Reporting (“ASC 280”). Reportable operating segments are determined based
on the management approach. The management approach, as defined by ASC 280, is based on the way that the chief operating decision-maker
organizes the segments within an enterprise for making operating decisions and assessing performance. While our results of operations
are primarily reviewed on a consolidated basis, the chief operating decision-maker manages the enterprise in four
reportable segments, each with different operating
and potential revenue generating characteristics: (i) CAR-T Therapeutics, (ii) Cancer Vaccines, (iii) Anti-Viral Therapeutics and (iv)
Other. The following represents selected financial information for our segments for the years ended October 31, 2023 and 2022:
SCHEDULE
OF SEGMENT INFORMATION
| |
| | |
| |
| |
Year
Ended October 31, | |
| |
2023 | | |
2022 | |
Net income (loss): | |
| | | |
| | |
CAR-T Therapeutics | |
$ | (3,879 | ) | |
$ | (5,776 | ) |
Cancer Vaccines | |
| (5,111 | ) | |
| (4,889 | ) |
Anti-Viral Therapeutics | |
| (945 | ) | |
| (3,075 | ) |
Other | |
| 5 | | |
| (31 | ) |
Total | |
$ | (9,930 | ) | |
$ | (13,771 | ) |
| |
| | | |
| | |
Net
income (loss) | |
$ | (9,930 | ) | |
$ | (13,771 | ) |
Total operating costs and expenses | |
$ | 11,221 | | |
$ | 13,875 | |
Less non-cash share-based
compensation | |
| (4,735 | ) | |
| (6,655 | ) |
Operating
costs and expenses excluding non-cash share-based compensation | |
$ | 6,486 | | |
$ | 7,220 | |
| |
| | | |
| | |
Operating costs and expenses excluding non-cash
share based compensation: | |
| | | |
| | |
CAR-T Therapeutics | |
$ | 2,467 | | |
$ | 3,206 | |
Cancer Vaccines | |
| 3,265 | | |
| 2,355 | |
Anti-Viral Therapeutics | |
| 553 | | |
| 1,634 | |
Other | |
| 201 | | |
| 25 | |
Total | |
$ | 6,486 | | |
$ | 7,220 | |
Operating
costs and expenses excluding non-cash share based compensation | |
$ | 6,486 | | |
$ | 7,220 | |
| |
| | | |
| | |
| |
| October
31, | |
| |
| 2023 | | |
| 2022 | |
Total assets: | |
| | | |
| | |
CAR-T Therapeutics | |
$ | 7,523 | | |
$ | 16,921 | |
Cancer Vaccines | |
| 17,215 | | |
| 9,442 | |
Anti-Viral Therapeutics | |
| 700 | | |
| 3,811 | |
Other | |
| 84 | | |
| 238 | |
Total | |
$ | 25,522 | | |
$ | 30,412 | |
Total assets | |
$ | 25,522 | | |
$ | 30,412 | |
Operating
costs and expenses excluding non-cash share-based compensation is the measurement the chief operating decision-maker uses in managing
the enterprise.
The
Company’s consolidated revenue of $210,000
and inventor royalties, contingent legal fees, litigation and
licensing expense of $161,000,
for the year ended October 31, 2023 were solely related to our other segment. All our revenue is generated domestically (United States)
based on the country in which the licensee is located.
Exhibit 10.10
Exhibit
19
Anixa
Biosciences, Inc.
POLICY ON INSIDER TRADING
Anixa
Biosciences, Inc., a Delaware corporation (the “Company”), is committed to the highest standards of ethical business
conduct. This Insider Trading Policy provides the standards of the Company on trading and causing the trading of the Company’s
securities or securities of other publicly-traded companies while in possession of confidential information of the Company. This policy
is divided into two parts: the first part prohibits trading in certain circumstances and applies to all directors, officers and employees
of the Company and its wholly-owned subsidiaries, and the second part imposes special additional trading restrictions and applies to
all (i) directors of the Company, (ii) executive officers of the Company and its wholly-owned subsidiaries and (iii) all employees that
are designated as Vice Presidents or whose main function is accounting or financial reporting (collectively, “Covered Persons”
or “Insiders”). To the extent applicable, any reference hereinafter to the Company applies with equal force and effect to
the Company’s wholly-owned subsidiaries.
One
of the principal purposes of the federal securities laws is to prohibit so-called “insider trading.” Simply stated, insider
trading occurs when a person uses material non-public information obtained through involvement with the Company to make decisions to
purchase, sell, give away or otherwise trade the Company’s securities or the securities of any other publicly-traded companies
or to provide that information to others outside the Company. The prohibitions against insider trading apply to trades, tips and recommendations
by virtually any person, including all persons associated with the Company, if the information involved is “material” and
“non-public.” These terms are defined in this Policy under Part I, Section 3 below. The prohibitions would apply to any director,
officer or employee who buys or sells securities of the Company or the securities of any other publicly-traded companies in a related
business (collectively, “Company securities”) on the basis of material non-public information that he or she obtained about
the Company, its customers, suppliers, or other companies with which the Company has contractual relationships or may be negotiating
transactions.
Revised
March 2023
PART
I
1. Applicability
This
Policy applies to all transactions in the Company’s securities, including common stock, stock options and any other securities
that the Company may issue, such as preferred stock, notes, bonds and convertible securities, as well as to derivative securities relating
to any of the Company’s securities, whether or not issued by the Company.
This
Policy applies to all directors, officers and employees of the Company and its wholly-owned subsidiaries, as applicable.
Post-Termination
Transactions. This Policy continues to apply to transactions in Company securities even after an employee, officer or director
has resigned or terminated employment. If the person who resigns or separates from the Company is in possession of material non-public
information at that time, he or she may not trade in Company securities until that information has become public or is no longer material.
2. General
Policy: No Trading or Causing Trading While in Possession of Material Non-public Information
(a)
No director, officer or employee may purchase or sell any Company security, whether or not issued by the Company, while in possession
of material non-public information about the Company. (The terms “material” and “non-public” are defined in Part
I, Section 3(a) and (b) below.)
(b)
No director, officer or employee who knows of any material non-public information about the Company may communicate that information
to any other person, including family and friends, except when such communication is part of their regular duties and is needed to further
the business of the Company.
(c)
In addition, no director, officer or employee may purchase or sell any security of any other company, whether or not issued by the Company,
while in possession of material non-public information about that company that was obtained in the course of his or her involvement with
the Company. No director, officer or employee who knows of any such material non-public information may communicate that information
to any other person, including family and friends, except when such communication is part of their regular duties and is needed to further
the business of the Company.
(d)
For compliance purposes, you should never trade, tip or recommend securities (or otherwise cause the purchase or sale of securities)
while in possession of information that you have reason to believe is material and non-public unless you first consult with, and obtain
the advance approval of the Compliance Officer (defined in Part I, Section 3(c) below).
(e)
Covered Persons must “pre-clear” all trading in securities of the Company in accordance with the procedures set forth in
Part II, Section 3 below.
APPLICABILITY
OF POLICY TO INSIDER INFORMATION
REGARDING
OTHER COMPANIES
This
Policy and the guidelines described herein also apply to material non-public information relating to other companies, including the Company’s
customers, vendors or suppliers (“business partners”), when that information is obtained in the course of employment
with, or other services performed on behalf of the Company. Civil and criminal penalties, as well as termination of employment, may result
from trading on material non-public information regarding the Company’s business partners. All Insiders should treat material non-public
information about the Company’s business partners with the same care as is required with respect to information relating directly
to the Company.
3. Definitions
(a)
Materiality. Insider trading restrictions come into play only if the information you possess is “material.” Materiality,
however, involves a relatively low threshold. The U.S. Supreme Court and other federal courts have ruled that information should be regarded
as “material” if there is a substantial likelihood that
a reasonable investor:
|
(1) |
would
consider the information important in making an investment decision; and |
|
|
|
|
(2) |
would
view the information as having significantly altered the “total mix” of available information about the Company.
|
Information
dealing with the following subjects is reasonably likely to be found material in particular situations:
(i)
significant changes in the Company’s prospects;
(ii)
significant write-downs in assets or increases in reserves;
(iii)
developments regarding significant litigation or government agency investigations;
(iv)
liquidity problems;
(v)
changes in earnings estimates or unusual gains or losses in major operations;
(vi)
major changes in management;
(vii)
changes in dividends;
(viii)
extraordinary borrowings;
(ix)
award or loss of a significant contract;
(x)
changes in debt ratings;
(xi)
proposals, plans or agreements, even if preliminary in nature, involving mergers, acquisitions, divestitures, recapitalizations, strategic
alliances, licensing arrangements, or purchases or sales of substantial assets;
(xii)
public offerings;
(xiii)
pending statistical reports;
(xiv)
results of studies; and
(xv)
potential licenses and joint ventures.
Material
information is not limited to historical facts but may also include projections and forecasts. With respect to a future event, such as
a merger, acquisition, licenses or introduction of a new business line, the point at which negotiations or business line development
are determined to be material is determined by balancing the probability that the event will occur against the magnitude of the effect
the event would have on the Company’s operations or the market price of the Company’s securities should it occur. Thus, information
concerning an event that would have a large effect on the price of the Company’s common stock, such as a merger, may be material
even if the possibility that the event will occur is relatively small. When in doubt about whether particular non-public information
is material, presume it is material. If you are unsure whether information is material, you should consult with the Compliance Officer
before making any decision to disclose such or to trade in or recommend securities to which that information relates.
(b)
Non-public Information. Insider trading prohibitions come into play only when you possess information that is material and “non-public.”
The fact that information has been disclosed to a few members of the public does not make it public for insider trading purposes. To
be “public” the information must have been disseminated in a manner designed to reach investors generally, and sufficient
time must have elapsed to permit the investors to absorb and evaluate the information. Even after public disclosure of information about
the Company, you must wait until the close of business on the second trading day after the information was publicly disclosed before
you can treat the information as public.
Non-public
information may include:
(i)
information available to a select group of analysts or brokers or institutional investors;
(ii)
undisclosed facts that are the subject of rumors, even if the rumors are widely circulated; and
(iii)
information that has been entrusted to the Company on a confidential basis until a public announcement of the information has been made
and enough time has elapsed for the market to respond to a public announcement of the information (normally two or three days).
As
with questions of materiality, if you are not sure whether information is considered public, you should either consult with the Compliance
Officer or assume that the information is “non-public” and treat it as confidential.
(c)
Compliance Officer. The Company has appointed its Chief Financial Officer as the Compliance Officer for this Policy. The duties
of the Compliance Officer include, but are not limited to, the following:
(i)
assisting with implementation of this Policy;
(ii)
circulating this Policy to all employees and ensuring that this Policy is amended as necessary to remain up-to-date with insider trading
laws;
(iii)
pre-clearing all trading in securities of the Company by Covered Persons in accordance with the procedures set forth in Part II, Section
3 below; and
(iv)
providing approval of any transactions under Part II, Section 4 below.
4. Violations
of Insider Trading Laws
Penalties
for trading on or communicating material non-public information can be severe, both for individuals involved in such unlawful conduct
and their employers and supervisors, and may include jail terms, criminal fines, civil penalties and civil enforcement injunctions. Given
the severity of the potential penalties, compliance with this Policy is absolutely mandatory.
(a)
Legal Penalties. A person who violates insider trading laws by engaging in transactions in a company’s securities when he
or she has material non-public information can be sentenced to a substantial jail term and required to pay a penalty of several times
the amount of profits gained or losses avoided.
In
addition, a person who tips others may also be liable for transactions by the tippees to whom he or she has disclosed material non-public
information. Tippers can be subject to the same penalties and sanctions as the tippees, and the SEC has imposed large penalties even
when the tipper did not profit from the transaction.
Insiders
may be subject to penalties of up to $5,000,000 for individuals (and $25,000,000 for a business entity) and up to twenty (20) years in
prison for engaging in transactions in the Company’s securities at a time when they possess material non-public information regarding
the Company. In addition, the SEC has the authority to seek a civil monetary penalty of up to three times the amount of profit gained
or loss avoided by illegal insider trading. “Profit gained” or “loss avoided” generally means the difference
between the purchase or sale price of the Company’s stock and its value as measured by the trading price of the stock a reasonable
period after public dissemination of the material non-public information.
(b)
Company-imposed Penalties. Employees who violate this Policy may be subject to disciplinary action by the Company, including dismissal
for cause. Any exceptions to the Policy, if permitted, may only be granted by the Compliance Officer and must be provided before any
activity contrary to the above requirements takes place.
PART
II
1. Blackout
Periods
All
Covered Persons are prohibited from trading in the Company’s securities during blackout periods.
(a)
Quarterly Blackout Periods. Trading in the Company’s securities is prohibited during the period beginning at the close of
the market on the last day of each fiscal quarter and ending at the close of business on the second business day following the earlier
of the Company’s (i) issuance of a full earnings release for such quarter (containing substantially the material information that
would be included in the subsequent report) or (ii) filing of the Form 10-Q or Form 10-K (the “Standard Blackout Period”).
During these periods, Covered Persons generally possess or are presumed to possess material non-public information about the Company’s
financial results.
(b)
Other Blackout Periods. From time to time, other types of material non-public information regarding the Company (such as negotiation
of mergers, acquisitions, licenses or dispositions or new business line developments or study results) may be pending and not be publicly
disclosed. While such material non-public information is pending, the Company may impose special blackout periods during which Covered
Persons are prohibited from trading in the Company’s securities. If the Company imposes a special blackout period, it will notify
the Covered Persons affected.
(c)
Exception. Trading According to a Pre-established Plan (10b5-1) or by Delegation. The SEC has adopted Rule 10b5-1 (which
was amended in December 2022) under which insider trading liability can be avoided if Insiders follow very specific procedures. In general,
such procedures involve trading according to pre-established instructions, plans or programs (a “10b5-1 Plan”) after
a required “cooling off” period described below. 10b5-1 Plans must:
(i)
Be documented by a contract, written plan, or formal instruction which provides that the trade take place in the future. For example,
an Insider can contract to sell his or her shares on a specific date, or simply delegate such decisions to an investment manager, 401(k)
plan administrator or similar third party. This documentation must be provided to the Company’s Insider Trading Compliance Officer;
(ii)
Include in its documentation the specific amount, price and timing of the trade, or the formula for determining the amount, price
and timing. For example, the Insider can buy or sell shares in a specific amount and on a specific date each month, or according
to a pre-established percentage (of the Insider’s salary, for example) each time that the share price falls or rises to pre-established
levels. In the case where trading decisions have been delegated (i.e., to a third party broker or money manager), the specific amount,
price and timing need not be provided;
(iii)
Be implemented at a time when the Insider does not possess material non-public information. As a practical matter, this
means that the Insider may set up 10b5-1 Plans, or delegate trading discretion, only outside a Blackout Period (discussed in Part
II, Section 1, above), assuming the Insider is not in possession of material non-public information;
(iv)
Remain beyond the scope of the Insider’s influence after implementation. In general, the Insider must allow the 10b5-1 Plan
to be executed without changes to the accompanying instructions, and the Insider cannot later execute a hedge transaction that modifies
the effect of the 10b5-1 Plan. Insiders should be aware that the termination or modification of a 10b5-1 Plan after trades have
been undertaken under such plan could negate the 10b5-1 affirmative defense afforded by such program for all such prior trades. As such,
termination or modification of a 10b-5 Plan should only be undertaken in consultation with your legal counsel. If the Insider has delegated
decision-making authority to a third party, the Insider cannot subsequently influence the third party in any way and such third party
must not possess material non-public information at the time of any of the trades;
(v)
Be subject to a “cooling off” period. Effective February 27, 2023, Rule 10b5-1 contains a “cooling-off period”
for directors and officers that prohibit such insiders from trading in a 10b5-1 Plan until the later of (i) 90 days following the plan’s
adoption or modification or (ii) two business days following the Company’s disclosure (via a report filed with the SEC) of its
financial results for the fiscal quarter in which the plan was adopted or modified; and
(vi)
Contain Insider certifications. Effective February 27, 2023, directors and officers are required to include a certification in
their 10b5-1 Plans to certify that at the time the plan is adopted or modified: (i) they are not aware of material non-public information
about the Company or its securities and (ii) they are adopting the 10b5-1 Plan in good faith and not as part of a plan or scheme to evade
the anti-fraud provisions of the Exchange Act.
Important:
In addition, effective February 27, 2023: (i) Insiders are prohibited from having multiple overlapping 10b5-1 Plans or more than one
plan in any given year, (ii) a modification relating to amount, price and timing of trades under a 10b5-1 Plan is deemed a plan termination
and the adoption of a new 10b5-1 Plan which requires a new cooling off period, and (iii) whether a particular trade is undertaken pursuant
to a 10b5-1 Plan will need to be disclosed (by checkoff box) on the applicable Forms 4 or 5 of the Insider.
Pre-Approval
Required: Prior to implementing a 10b5-1 Plan, all officers and directors must receive the approval for such plan from (and provide
the details of the plan to) the Company’s Insider Trading Compliance Officer in accordance with the procedures set forth in Part
II, Section 3.
2. Trading
Window
Covered
Persons are permitted to trade in the Company’s securities when no blackout period is in effect. Generally, this means that Covered
Persons can trade at any time outside of the Standard Blackout Period. However, even during this trading window, a Covered Person who
is in possession of any material non-public information should not trade in the Company’s securities until the information has
been made publicly available or is no longer material. In addition, the Company may close this trading window if a special blackout period
under Part II, Section 1(b) above is imposed and will re-open the trading window once the special blackout period has ended.
3. Pre-clearance
of Securities Transactions
(a)
Because Covered Persons are likely to obtain material non-public information on a regular basis, the Company requires all such persons
to refrain from trading, even during a trading window under Part II, Section 2 above, without first pre-clearing all transactions in
the Company’s securities.
(b)
Subject to the exemption in subsection (d) below, no Covered Person may, directly or indirectly, purchase or sell (or otherwise make
any transfer, gift, pledge or loan of) any Company security at any time without first obtaining prior approval from the Compliance Officer.
These procedures also apply to transactions by such person’s spouse, other persons living in such person’s household and
minor children and to transactions by entities over which such person exercises control.
(c)
The Compliance Officer shall record the date each request is received and the date and time each request is approved or disapproved.
Unless revoked, a grant of permission will normally remain valid until the close of trading two business days following the day on which
it was granted. If the transaction does not occur during the two-day period, pre-clearance of the transaction must be re-requested.
(d)
Pre-clearance of trades after an Approved 10b5-1 Plan is properly entered into and followed is not required for purchases and sales of
securities under an Approved 10b5-1 Plan. With respect to any purchase or sale under an Approved 10b5-1 Plan, the third party effecting
transactions on behalf of the Covered Person should be instructed to send duplicate confirmations of all such transactions to the Compliance
Officer.
4. Prohibited
Transactions
(a)
Directors and executive officers are prohibited from trading in the Company’s equity securities during a blackout period imposed
under an “individual account” retirement or pension plan of the Company, during which at least 50% of the plan participants
are unable to purchase, sell or otherwise acquire or transfer an interest in equity securities of the Company, due to a temporary suspension
of trading by the Company or the plan fiduciary.
(b)
A Covered Person, including such person’s spouse, other persons living in such person’s household and minor children and
entities over which such person exercises control, is prohibited from engaging in the following transactions in the Company’s securities
unless advance approval is obtained from the Compliance Officer:
(i)
Short-term trading. Covered Persons who purchase Company securities may not sell any Company securities of the same class for
at least six months after the purchase and a Covered Person who sells Company securities may not purchase any Company securities of the
same class for at least six months after the sale (in each case, other than purchases of securities from the Company pursuant to the
exercise of options that are exempt from Section 16(b) of the Securities Exchange Act of 1934 by reason of Rule 16b-3);
(ii)
Short sales. Covered Persons may not sell the Company’s securities short;
(iii)
Options trading. Covered Persons may not buy or sell puts or calls or other derivative securities on the Company’s securities;
and
(iv)
Hedging. Covered Persons may not enter into hedging or monetization transactions or similar arrangements with respect to Company
securities.
5. Acknowledgment
and Certification
All
Covered Persons are required to sign the attached acknowledgment and certification.
ACKNOWLEDGMENT
AND CERTIFICATION
The
undersigned does hereby acknowledge receipt of the Company’s Insider Trading Policy. The undersigned has read and understands (or
has had explained) such Policy and agrees to be governed by such Policy at all times in connection with the purchase and sale of securities
and the confidentiality of non-public information.
|
______________________________
(Signature)
|
|
______________________________
(Please
print name) |
Date:
________________________ |
|
Exhibit
23.1
CONSENT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We
consent to the incorporation by reference in Post-Effective Amendment No. 2 to the Registration Statement on Form S-1 on Form S-3
(No. 333-193869), Registration Statements on Form S-3 (Nos. 333-267369, 333-217060 and 333-232067) and the Registration Statement on
Form S-8 (No. 333-269118) of Anixa Biosciences, Inc. (the “Company”) of our report dated January 16,
2024, relating to our audits of the Company’s consolidated financial statements as of October 31, 2023 and 2022, and for each
of the years in the two year period ended October 31, 2023, included in the Company’s Annual Report on Form 10-K for the
fiscal year ended October 31, 2023.
Irvine,
California
January
16, 2024
Exhibit
31.1
CERTIFICATION
OF PRINCIPAL EXECUTIVE OFFICER
PURSUANT
TO SECURITIES EXCHANGE ACT RULES 13A-14(A) AND 15D-14(A)
AS
ADOPTED PURSUANT TO
SECTION
302 OF THE SARBANES-OXLEY ACT OF 2002
I,
Dr. Amit Kumar, Chairman of the Board and Chief Executive Officer of Anixa Biosciences, Inc., certify that:
1. |
I
have reviewed this Annual Report on Form 10-K of Anixa Biosciences, Inc.; |
|
|
2. |
Based
on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to
the period covered by this report; |
|
|
3. |
Based
on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in
this report; |
|
|
4. |
The
registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange
Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
|
(a) |
Designed
such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared; |
|
|
|
|
(b) |
Designed
such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles; |
|
|
|
|
(c) |
Evaluated
the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about
the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and |
|
|
|
|
(d) |
Disclosed
in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. |
The
registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial
reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing
the equivalent functions): |
|
(a) |
All
significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and |
|
|
|
|
(b) |
Any
fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting. |
Date:
January 16, 2024 |
/s/
Amit Kumar |
|
Dr.
Amit Kumar |
|
Chairman
of the Board and
|
|
Chief
Executive Officer |
Exhibit
31.2
CERTIFICATION
OF PRINCIPAL FINANCIAL OFFICER
PURSUANT
TO SECURITIES EXCHANGE ACT RULES 13A-14(A) AND 15D-14(A)
AS
ADOPTED PURSUANT TO
SECTION
302 OF THE SARBANES-OXLEY ACT OF 2002
I,
Michael J. Catelani, President, Chief Operating Officer and Chief Financial Officer of Anixa Biosciences, Inc., certify that:
1. |
I
have reviewed this Annual Report on Form 10-K of Anixa Biosciences, Inc.; |
|
|
2. |
Based
on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to
the period covered by this report; |
|
|
3. |
Based
on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in
this report; |
|
|
4. |
The
registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange
Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
|
(a) |
Designed
such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared; |
|
|
|
|
(b) |
Designed
such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles; |
|
|
|
|
(c) |
Evaluated
the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about
the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and |
|
|
|
|
(d) |
Disclosed
in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. |
The
registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial
reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing
the equivalent functions): |
|
(a) |
All
significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and |
|
|
|
|
(b) |
Any
fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting. |
Date:
January 16, 2024 |
/s/
Michael J. Catelani |
|
Michael
J. Catelani |
|
President,
Chief Operating Officer and
|
|
Chief
Financial Officer |
Exhibit
32.1
CERTIFICATION
PURSUANT TO
18
U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION
906 OF THE SARBANES-OXLEY ACT OF 2002
Pursuant
to Section 1350 of Title 18 of the United States Code, the undersigned, Dr. Amit Kumar, Chairman of the Board and Chief Executive Officer
of Anixa Biosciences, Inc. (the “Company”),
hereby certifies that:
1. |
The
Company’s Form 10-K Annual Report for the fiscal year ended October 31, 2023 (the “Report”) fully complies with
the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
|
|
2. |
The
information contained in the Report fairly presents, in all material respects, the financial condition and results of operations
of the Company. |
Date:
January 16, 2024 |
/s/
Amit Kumar |
|
Dr.
Amit Kumar |
|
Chairman
of the Board and
|
|
Chief
Executive Officer |
Exhibit
32.2
CERTIFICATION
PURSUANT TO
18
U.S.C. SECTION 1350,
AS
ADOPTED PURSUANT TO
SECTION
906 OF THE SARBANES-OXLEY ACT OF 2002
Pursuant
to Section 1350 of Title 18 of the United States Code, the undersigned, Michael J. Catelani, President, Chief Operating Officer and Chief
Financial Officer of Anixa Biosciences, Inc. (the “Company”),
hereby certifies that:
1. |
The
Company’s Form 10-K Annual Report for the fiscal year ended October 31, 2023 (the “Report”) fully complies with
the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
|
|
2. |
The
information contained in the Report fairly presents, in all material respects, the financial condition and results of operations
of the Company. |
Date:
January 16, 2024 |
/s/
Michael J. Catelani |
|
Michael
J. Catelani |
|
President,
Chief Operating Officer and
|
|
Chief
Financial Officer |
Exhibit
99.1
ANIXA
BIOSCIENCES, INC.
EXECUTIVE
COMPENSATION CLAWBACK POLICY
Adopted
as of November 17, 2023
The
Board of Directors (the “Board”) of Anixa Biosciences, Inc. (the “Company”) has adopted the following
executive compensation clawback policy (this “Policy”). This Policy shall supplement any other clawback or compensation
recovery policy or policies adopted by the Company or included in any agreement between the Company, or any subsidiary of the Company,
and a person covered by this Policy. If any such other policy or agreement provides that a greater amount of compensation shall be subject
to clawback, such other policy or agreement shall apply to the amount in excess of the amount subject to clawback under this Policy.
This
Policy shall be interpreted to comply with Securities and Exchange Commission (“SEC”) Rule 10D-1 and Listing Rule
5608 (the “Listing Rule”) of The Nasdaq Stock Market, LLC (“Nasdaq”), as may be amended or supplemented
and interpreted from time to time by Nasdaq. To the extent this Policy is in any manner deemed inconsistent with the Listing Rule, this
Policy shall be treated as having been amended to be compliant with the Listing Rule.
1.
Definitions. Unless the context indicates otherwise the following definitions apply for purposes of this Policy:
(a)
Executive Officer. An executive officer is the Company’s chief
executive officer and/or president, principal financial officer, principal accounting officer (or if there is no such accounting officer,
the controller), any vice-president of the Company in charge of a principal business unit, division, or function (such as sales, administration,
or finance), any other officer who performs a policy-making function, or any other person who performs similar policy-making functions
for the Company. Executive officers
of the Company’s parent(s) or subsidiaries are deemed executive officers of the Company if they perform such policy making functions
for the Company. Policy-making function is not intended to include policy-making functions that are not significant. Identification of
an executive officer for purposes of the Listing Rule would include at a minimum executive officers identified in the Listing Rule.
(b)
Financial Reporting Measures. Financial reporting measures are measures that are determined and presented in accordance
with the accounting principles used in preparing the Company’s financial statements, and any measures that are derived wholly or
in part from such measures. Stock price and total shareholder return are also financial reporting measures. A financial reporting measure
need not be presented within the financial statements or included in a filing with the SEC and may be such financial measures as may
be determined by the Board or the Compensation Committee thereof (the “Compensation Committee”).
(c)
Incentive-Based Compensation. Incentive-based compensation is any compensation that is granted, earned or vested based
wholly or in part upon the attainment of a financial reporting measure.
(d)
Received. Incentive-based compensation is deemed “received” in the Company’s fiscal period during which
the financial reporting measure specified in the incentive-based compensation award is attained, even if the payment or grant of the
incentive-based compensation occurs after the end of that period.
2.
Application of this Policy. This recovery of Incentive-Based Compensation from an Executive Officer as provided for
in this Policy shall apply only in the event that the Company is required to prepare an accounting restatement due to the material noncompliance
of Company with any financial reporting requirement under the United States securities laws, including any required accounting restatement
to correct an error in previously issued financial statements that is material to the previously issued financial statements, or that
would result in a material misstatement if the error were corrected in the current period or left uncorrected in the current period.
Questions as to “materiality” will be made by the Compensation Committee in coordination with the Audit Committee
3.
Recovery Period.
(a)
The Incentive-Based Compensation subject to recovery is the Incentive-Based Compensation Received during the three (3) completed fiscal
years immediately preceding the date that the Company is required to prepare an accounting restatement as described in Section 2 above,
provided that the person served as an Executive Officer at any time during the performance period applicable to the Incentive-Based Compensation
in question. The date that the Company is required to prepare an accounting restatement shall be determined pursuant to the Listing Rule.
(b)
Notwithstanding the foregoing, this Policy shall only apply if the Incentive-Based Compensation is Received (i) while the Company has
a class of securities listed on Nasdaq and (ii) on or after October 2, 2023.
(c)
The provisions of the Listing Rule shall apply with respect to Incentive-Based Compensation received during a transition period arising
due to a change in the Company’s fiscal year.
4.
Erroneously Awarded Compensation. The amount of Incentive-Based Compensation subject to recovery from the applicable Executive
Officers under this Policy (“Erroneously Awarded Compensation”) shall be equal to the amount of Incentive-Based Compensation
Received that exceeds the amount of Incentive Based-Compensation that otherwise would have been Received had it been determined based
on the restated amounts and shall be computed without regard to any taxes paid. For Incentive-Based Compensation based on stock price
or total shareholder return, where the amount of Erroneously Awarded Compensation is not subject to mathematical recalculation directly
from the information in an accounting restatement: (a) the amount shall be based on a reasonable estimate by the Company’s Chief
Financial Officer (or principal accounting officer, if the office of Chief Financial Officer is not then filled) of the effect of the
accounting restatement on the stock price or total shareholder return upon which the Incentive-Based Compensation was received, which
estimate shall be subject to the review and approval of the Compensation Committee; and (b) the Company must maintain reasonable documentation
of the determination of that reasonable estimate and provide such documentation to Nasdaq if requested. Notwithstanding the foregoing,
if the proposed Incentive-Based Compensation recovery would affect compensation paid to the Company’s Chief Financial Officer,
the determination shall be made by the Compensation Committee.
5.
Timing of Recovery. The Company shall recover any Erroneously Awarded Compensation reasonably promptly except to the extent
that the conditions of paragraphs (a), (b), or (c) below apply. The Compensation Committee shall determine the repayment schedule for
each amount of Erroneously Awarded Compensation in a manner that complies with this “reasonably promptly” requirement. Such
determination shall be consistent with any applicable legal guidance by the SEC, Nasdaq, judicial opinion, or otherwise. The determination
of “reasonably promptly” may vary from case to case and the Compensation Committee is authorized to adopt additional rules
or policies to further describe what repayment schedules satisfy this requirement.
(a)
Erroneously Awarded Compensation need not be recovered if the direct expense paid to a third party to assist in enforcing (or making
determinations in connection with the enforcement of) this Policy would exceed the amount to be recovered and the Compensation Committee
has made a determination that recovery would be impracticable. Before concluding that it would be impracticable to recover any amount
of Erroneously Awarded Compensation based on expense of enforcement, the Company shall (i) make a reasonable attempt to recover such
Erroneously Awarded Compensation, (ii) document such reasonable attempt or attempts to recover, and (iii) provide appropriate documentation
to the Compensation Committee or Nasdaq, if requested.
(b)
Erroneously Awarded Compensation need not be recovered if recovery would violate home country law where that law was adopted prior to
November 28, 2022. Before concluding that it would be impracticable to recover any amount of Erroneously Awarded Compensation based on
a violation of home country law, the Company shall obtain an opinion of home country counsel, in form and substance that would be reasonably
acceptable to Nasdaq, that recovery would result in such a violation and shall provide such opinion to Nasdaq, if requested.
(c)
Erroneously Awarded Compensation need not be recovered if recovery would likely cause an otherwise tax-qualified retirement plan, under
which benefits are broadly available to employees of the Company, to fail to meet the requirements of 26 U.S.C. 401(a)(13) or 26 U.S.C.
411(a) and the regulations thereunder (as such provision may be amended, modified or supplemented).
6.
Compensation Committee Decisions. Decisions of the Compensation Committee with respect to this Policy shall be final, conclusive
and binding on all Executive Officers subject to this Policy.
7.
No Indemnification. Notwithstanding anything to the contrary in any other policy of the Company or any agreement between the
Company and an Executive Officer, no Executive Officer shall be indemnified by the Company against the loss arising from the recovery
of any Erroneously Awarded Compensation.
8.
Agreement to Policy by Executive Officers. The Company shall take reasonable steps to inform Executive Officers of this Policy
and obtain their express agreement to this Policy, which steps may constitute the inclusion of this Policy as an attachment to any award
that is accepted by an Executive Officer. This Policy shall be deemed to apply to each employment or grant agreement between the Company
or any of its subsidiaries and any Executive Officer subject to this Policy.
#
# #
v3.23.4
Cover - USD ($)
|
12 Months Ended |
|
|
Oct. 31, 2023 |
Jan. 16, 2024 |
Apr. 28, 2023 |
Cover [Abstract] |
|
|
|
Document Type |
10-K
|
|
|
Amendment Flag |
false
|
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|
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FY
|
|
|
Document Fiscal Year Focus |
2023
|
|
|
Current Fiscal Year End Date |
--10-31
|
|
|
Entity File Number |
001-37492
|
|
|
Entity Registrant Name |
ANIXA
BIOSCIENCES, INC.
|
|
|
Entity Central Index Key |
0000715446
|
|
|
Entity Tax Identification Number |
11-2622630
|
|
|
Entity Incorporation, State or Country Code |
DE
|
|
|
Entity Address, Address Line One |
3150
Almaden Expressway
|
|
|
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Suite
250
|
|
|
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San
Jose
|
|
|
Entity Address, State or Province |
CA
|
|
|
Entity Address, Postal Zip Code |
95118
|
|
|
City Area Code |
(408)
|
|
|
Local Phone Number |
708-9808
|
|
|
Title of 12(b) Security |
Common
Stock, $0.01 par value
|
|
|
Trading Symbol |
ANIX
|
|
|
Security Exchange Name |
NASDAQ
|
|
|
Entity Well-known Seasoned Issuer |
No
|
|
|
Entity Voluntary Filers |
No
|
|
|
Entity Current Reporting Status |
Yes
|
|
|
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Yes
|
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Entity Filer Category |
Non-accelerated Filer
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Entity Small Business |
true
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Entity Emerging Growth Company |
false
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Entity Public Float |
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$ 120,568,574
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Entity Common Stock, Shares Outstanding |
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31,699,701
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Documents Incorporated by Reference [Text Block] |
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ICFR Auditor Attestation Flag |
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Auditor Firm ID |
200
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HASKELL
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v3.23.4
Consolidated Balance Sheets - USD ($) $ in Thousands |
Oct. 31, 2023 |
Oct. 31, 2022 |
Current assets: |
|
|
Cash and cash equivalents |
$ 915
|
$ 12,360
|
Short–term investments |
22,929
|
17,327
|
Receivables |
270
|
46
|
Prepaid expenses and other current assets |
1,242
|
467
|
Total current assets |
25,356
|
30,200
|
Operating lease right-of-use asset |
166
|
212
|
Total assets |
25,522
|
30,412
|
Current liabilities: |
|
|
Accounts payable |
206
|
265
|
Accrued expenses |
1,770
|
1,726
|
Operating lease liability |
52
|
46
|
Total current liabilities |
2,028
|
2,037
|
Operating lease liability, non-current |
123
|
175
|
Total liabilities |
2,151
|
2,212
|
Equity: |
|
|
Preferred stock, value |
|
|
Common stock, par value $.01 per share; 100,000,000 shares authorized; 31,145,219 and 30,913,902 shares issued and outstanding as of October 31, 2023 and 2022, respectively |
311
|
309
|
Additional paid-in capital |
252,222
|
247,123
|
Accumulated deficit |
(228,196)
|
(218,385)
|
Total shareholders’ equity |
24,337
|
29,047
|
Noncontrolling interest (Note 2) |
(966)
|
(847)
|
Total equity |
23,371
|
28,200
|
Total liabilities and equity |
25,522
|
30,412
|
Series A Convertible Preferred Stock [Member] |
|
|
Equity: |
|
|
Preferred stock, value |
|
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v3.23.4
Consolidated Balance Sheets (Parenthetical) - $ / shares
|
Oct. 31, 2023 |
Oct. 31, 2022 |
Preferred stock, par value |
$ 100
|
$ 100
|
Preferred stock, shares authorized |
19,860
|
19,860
|
Preferred stock, shares issued |
0
|
0
|
Preferred stock, shares outstanding |
0
|
0
|
Common stock, par value |
$ 0.01
|
$ 0.01
|
Common stock, shares authorized |
100,000,000
|
100,000,000
|
Common Stock, Shares, Issued |
31,145,219
|
30,913,902
|
Common stock, shares outstanding |
31,145,219
|
30,913,902
|
Series A Convertible Preferred Stock [Member] |
|
|
Preferred stock, par value |
$ 100
|
$ 100
|
Preferred stock, shares authorized |
140
|
140
|
Preferred stock, shares issued |
0
|
0
|
Preferred stock, shares outstanding |
0
|
0
|
X |
- DefinitionFace amount or stated value per share of common stock.
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v3.23.4
Consolidated Statements of Operations - USD ($) $ in Thousands |
12 Months Ended |
Oct. 31, 2023 |
Oct. 31, 2022 |
Income Statement [Abstract] |
|
|
Revenue |
$ 210
|
|
Operating costs and expenses: |
|
|
Inventor royalties, contingent legal fees, litigation and licensing expenses |
161
|
|
Research and development expenses (including non-cash share based compensation expenses of $2,037 and $3,635, respectively) |
4,769
|
6,703
|
General and administrative expenses (including non-cash share based compensation expenses of $2,698 and $3,117, respectively) |
6,291
|
7,172
|
Total operating costs and expenses |
11,221
|
13,875
|
Loss from operations |
(11,011)
|
(13,875)
|
Interest income |
1,081
|
104
|
Net loss |
(9,930)
|
(13,771)
|
Less: Net loss attributable to noncontrolling interest |
(119)
|
(176)
|
Net loss attributable to common stockholders |
$ (9,811)
|
$ (13,595)
|
Net loss per share: |
|
|
Basic |
$ 0.32
|
$ 0.45
|
Diluted |
$ 0.32
|
$ 0.45
|
Weighted average common shares outstanding: |
|
|
Basic |
30,980
|
30,374
|
Diluted |
30,980
|
30,374
|
X |
- DefinitionTotal costs of sales and operating expenses for the period.
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Consolidated Statements of Equity - USD ($) $ in Thousands |
Total |
Common Stock [Member] |
Additional Paid-in Capital [Member] |
Retained Earnings [Member] |
Parent [Member] |
Noncontrolling Interest [Member] |
Balance at Oct. 31, 2021 |
$ 34,767
|
$ 301
|
$ 239,927
|
$ (204,790)
|
$ 35,438
|
$ (671)
|
Balance, shares at Oct. 31, 2021 |
|
30,050,894
|
|
|
|
|
Stock option compensation to employees and directors |
6,000
|
|
6,000
|
|
6,000
|
|
Stock options issued to consultants |
655
|
|
655
|
|
655
|
|
Common stock issued upon exercise of stock options |
$ 439
|
$ 8
|
431
|
|
439
|
|
Common stock issued upon exercise of stock options, shares |
1,642,000
|
827,619
|
|
|
|
|
Common stock issued to consultants |
$ 97
|
|
97
|
|
97
|
|
Common stock issued to consultants, shares |
|
30,648
|
|
|
|
|
Common stock issued pursuant to employee stock purchase plan |
13
|
|
13
|
|
13
|
|
Common stock issued pursuant to employee stock purchase plan, shares |
|
4,741
|
|
|
|
|
Net loss |
(13,771)
|
|
|
(13,595)
|
(13,595)
|
(176)
|
Balance at Oct. 31, 2022 |
28,200
|
$ 309
|
247,123
|
(218,385)
|
29,047
|
(847)
|
Balance, shares at Oct. 31, 2022 |
|
30,913,902
|
|
|
|
|
Stock option compensation to employees and directors |
4,422
|
|
4,422
|
|
4,422
|
|
Stock options issued to consultants |
221
|
|
221
|
|
221
|
|
Common stock issued upon exercise of stock options |
353
|
$ 2
|
351
|
|
353
|
|
Common stock issued upon exercise of stock options, shares |
|
202,647
|
|
|
|
|
Common stock issued to consultants |
92
|
|
92
|
|
92
|
|
Common stock issued to consultants, shares |
|
24,310
|
|
|
|
|
Common stock issued pursuant to employee stock purchase plan |
13
|
|
13
|
|
13
|
|
Common stock issued pursuant to employee stock purchase plan, shares |
|
4,360
|
|
|
|
|
Net loss |
(9,930)
|
|
|
(9,811)
|
(9,811)
|
(119)
|
Balance at Oct. 31, 2023 |
$ 23,371
|
$ 311
|
$ 252,222
|
$ (228,196)
|
$ 24,337
|
$ (966)
|
Balance, shares at Oct. 31, 2023 |
|
31,145,219
|
|
|
|
|
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v3.23.4
Consolidated Statements of Cash Flows - USD ($) $ in Thousands |
12 Months Ended |
Oct. 31, 2023 |
Oct. 31, 2022 |
Reconciliation of net loss to net cash used in operating activities: |
|
|
Net loss |
$ (9,930)
|
$ (13,771)
|
Stock option compensation to employees and directors |
4,422
|
6,000
|
Stock options and warrants issued to consultants |
221
|
655
|
Common stock issued to consultants |
92
|
97
|
Amortization of operating lease right-of-use asset |
46
|
42
|
Change in operating assets and liabilities: |
|
|
Receivables |
(224)
|
(29)
|
Prepaid expenses and other current assets |
(775)
|
(208)
|
Accounts payable |
(59)
|
129
|
Accrued expenses |
44
|
631
|
Operating lease liability |
(46)
|
(38)
|
Net cash used in operating activities |
(6,209)
|
(6,492)
|
Cash flows from investing activities: |
|
|
Disbursements to acquire short-term investments |
(44,411)
|
(22,486)
|
Proceeds from maturities of short-term investments |
38,809
|
11,758
|
Net cash used in investing activities |
(5,602)
|
(10,728)
|
Cash flows from financing activities: |
|
|
Proceeds from sale of common stock pursuant to employee stock purchase plan |
13
|
13
|
Proceeds from exercise of stock options and warrants |
353
|
439
|
Net cash provided by financing activities |
366
|
452
|
Net decrease in cash and cash equivalents |
(11,445)
|
(16,768)
|
Cash and cash equivalents at beginning of year |
12,360
|
29,128
|
Cash and cash equivalents at end of year |
915
|
12,360
|
Supplemental cash flow information: |
|
|
Cash proceeds from interest income |
$ 838
|
$ 23
|
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v3.23.4
BUSINESS AND FUNDING
|
12 Months Ended |
Oct. 31, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
BUSINESS AND FUNDING |
1.
BUSINESS AND FUNDING
Description
of Business
As
used herein, “we,” “us,” “our,” the “Company” or “Anixa” means Anixa Biosciences,
Inc. and its consolidated subsidiaries.
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®).
ANIXA
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
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.
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.
ANIXA
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
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.
Funding
and Management’s Plans
Based
on currently available information as of January 16, 2024, we believe that our existing cash, cash equivalents, short-term investments
and expected cash flows will be sufficient to fund our activities for at least the next twelve months. We have implemented a business
model that conserves funds by collaborating with third parties to develop our technologies. However, our projections of future cash needs
and cash flows may differ from actual results. If current cash on hand, cash equivalents, short-term investments and cash that may be
generated from our business operations are insufficient to continue to operate our business, or if we elect to invest in or acquire a
company or companies or new technology or technologies that are synergistic with or complementary to our technologies, we may be required
to obtain more working capital. Under our at-the-market equity program which is currently effective and may remain available for us to
use in the future, as of October 31, 2023, we may sell up to $100
million of common stock. We did not sell any
shares under our at-the-market equity program during the fiscal year ended October 31, 2023. We may seek to obtain working capital during
our fiscal year 2024 or thereafter through sales of our equity securities or through bank credit facilities or public or private debt
from various financial institutions where possible. We cannot be certain that additional funding will be available on acceptable terms,
or at all. If we do identify sources for additional funding, the sale of additional equity securities or convertible debt will result
in dilution to our stockholders. We can give no assurance that we will generate sufficient cash flows in the future to satisfy our liquidity
requirements or sustain future operations, or that other sources of funding, such as sales of equity or debt, would be available or would
be approved by our security holders, if needed, on favorable terms or at all. If we fail to obtain additional working capital as and
when needed, such failure could have a material adverse impact on our business, results of operations and financial condition. Furthermore,
such lack of funds may inhibit our ability to respond to competitive pressures or unanticipated capital needs, or may force us to reduce
operating expenses, which would significantly harm the business and development of operations.
ANIXA
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
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v3.23.4
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
|
12 Months Ended |
Oct. 31, 2023 |
Accounting Policies [Abstract] |
|
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES |
2.
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis
of Presentation
The
consolidated financial statements include the accounts of Anixa Biosciences, Inc. and its wholly and majority owned subsidiaries. All
intercompany transactions have been eliminated.
Noncontrolling
Interest
Noncontrolling
interest represents Wistar’s equity ownership in Certainty and is presented as a component of equity. The following table sets
forth the changes in noncontrolling interest for the two years ended October 31, 2023 (in thousands):
SCHEDULE
OF CHANGES IN NONCONTROLLING INTEREST
Balance October 31, 2021 | |
$ | (671 | ) |
Net loss attributable
to noncontrolling interest | |
| (176 | ) |
Balance October 31, 2022 | |
| (847 | ) |
Net loss attributable
to noncontrolling interest | |
| (119 | ) |
Balance October 31,
2023 | |
$ | (966 | ) |
Revenue
Recognition
Our
revenue has been derived solely from technology licensing and the sale of patented technologies. Revenue is recognized upon transfer
of control of intellectual property rights and satisfaction of other contractual performance obligations to licensees in an amount that
reflects the consideration we expect to receive.
Our
revenue recognition policy requires us to make certain judgments and estimates in connection with the accounting for revenue. Such areas
may include determining the existence of a contract and identifying each party’s rights and obligations to transfer goods and services,
identifying the performance obligations in the contract, determining the transaction price and allocating the transaction price to separate
performance obligations, estimating the timing of satisfaction of performance obligations, determining whether a promise to grant a license
is distinct from other promised goods or services and evaluating whether a license transfers to a customer at a point in time or over
time.
Our
revenue arrangements provide for the payment, within 30 days of execution of the agreement, of contractually determined, one-time, paid-up
license fees in settlement of litigation and in consideration for the grant of certain intellectual property rights for patented technologies
owned or controlled by the Company. These arrangements typically include some combination of the following: (i) the grant of a non-exclusive,
retroactive and future license to manufacture and/or sell products covered by patented technologies owned or controlled by the Company,
(ii) a covenant-not-to-sue, (iii) the release of the licensee from certain claims, and (iv) the dismissal of any pending litigation.
In such instances, the intellectual property rights granted have been perpetual in nature, extending until the expiration of the related
patents. Pursuant to the terms of these agreements, we have no further obligations with respect to the granted intellectual property
rights, including no obligation to maintain or upgrade the technology, or provide future support or services. Licensees obtained control
of the intellectual property rights they have acquired upon execution of the agreement. Accordingly, the performance obligations from
these agreements were satisfied and 100%
of the revenue was recognized upon the execution of the agreements.
ANIXA
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
Cost
of Revenues
Cost
of revenues include the costs and expenses incurred in connection with our patent licensing and enforcement activities, including inventor
royalties paid to original patent owners, contingent legal fees paid to external counsel, other patent-related legal expenses paid to
external counsel, licensing and enforcement related research and consulting and other expenses paid to third-parties. These costs are
included under the caption “Operating costs and expenses” in the accompanying consolidated statements of operations.
Research
and Development Expenses
Research
and development expenses consist primarily of payments to third parties for research and development activities, including expenses related
to clinical trials, employee compensation, and other direct costs associated with developing our therapeutics and vaccines.
We
recognize research and development expenses as incurred. Advance payments for future research and development activities are deferred
and expensed as the services are performed. We recognize our preclinical studies and clinical trial expenses based on the services performed
pursuant to contracts with research institutions, clinical research organizations (“CROs”), clinical manufacturing organizations
(“CMOs”), and other parties that conduct and manage various stages of research and development activities on our behalf.
Fees for such services are recognized based on management’s estimates after considering the activities and tasks completed by each
service provider in a given period, the time period over which services are expected to be performed, and the level of effort expended
in each reporting period.
At
each balance sheet date, management estimates prepaid and accrued research and development costs by discussing progress or stage of completion
of activities with internal personnel and external service providers, and comparing this information to payments made, invoices received,
and the agreed-upon contractual fee to be paid for such services in the applicable contract or statements of work.
In addition, we allocate certain internal compensation
costs to research and development expenses based on management’s estimates of each employee’s time and effort expended.
Fair
Value Measurements
Accounting
Standards Codification (“ASC”) 820, Fair Value Measurements and Disclosures (“ASC 820”), defines fair value,
establishes a framework for measuring fair value under U.S. generally accepted accounting principles (GAAP), and expands disclosures
about fair value measurements. In accordance with ASC 820, we have categorized our financial assets and liabilities, based on the priority
of the inputs to the valuation technique, into a three-level fair value hierarchy as set forth below. If the inputs used to measure the
financial instruments fall within different levels of the hierarchy, the categorization is based on the lowest level input that is significant
to the fair value measurement of the instrument.
Financial
assets and liabilities recorded in the accompanying consolidated balance sheets are categorized based on the inputs to the valuation
techniques as follows:
Level
1 – Financial instruments whose values are based on unadjusted quoted prices for identical assets or liabilities in an active market
which we have the ability to access at the measurement date.
Level
2 – Financial instruments whose values are based on quoted market prices in markets where trading occurs infrequently or whose
values are based on quoted prices of instruments with similar attributes in active markets.
Level
3 – Financial instruments whose values are based on prices or valuation techniques that require inputs that are both unobservable
and significant to the overall fair value measurement. These inputs reflect management’s own assumptions about the assumptions
a market participant would use in pricing the instrument.
ANIXA
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
The
following table presents the hierarchy for our financial assets measured at fair value on a recurring basis as of October 31, 2023 (in
thousands):
SCHEDULE
OF FAIR VALUE MEASUREMENTS
| |
Level
1 | | |
Level
2 | | |
Level
3 | | |
Total | |
Money market funds: | |
| | | |
| | | |
| | | |
| | |
Cash equivalents | |
$ | 778 | | |
$ | - | | |
$ | - | | |
$ | 778 | |
Certificates of deposit: | |
| | | |
| | | |
| | | |
| | |
Short term investments | |
| - | | |
| 720 | | |
| - | | |
| 720 | |
U. S. treasury bills: | |
| | | |
| | | |
| | | |
| | |
Short
term investments | |
| - | | |
| 22,209 | | |
| - | | |
| 22,209 | |
Total financial assets | |
$ | 778 | | |
$ | 22,929 | | |
$ | - | | |
$ | 23,707 | |
The
following table presents the hierarchy for our financial assets measured at fair value on a recurring basis as of October 31, 2022 (in
thousands):
| |
Level
1 | | |
Level
2 | | |
Level
3 | | |
Total | |
Money market funds: | |
| | | |
| | | |
| | | |
| | |
Cash equivalents | |
$ | 11,175 | | |
$ | - | | |
$ | - | | |
$ | 11,175 | |
Certificates of deposit: | |
| | | |
| | | |
| | | |
| | |
Cash equivalents | |
| | | |
| 1,000 | | |
| | | |
| 1,000 | |
Short term investments | |
| - | | |
| 13,700 | | |
| - | | |
| 13,700 | |
U. S. treasury bills: | |
| | | |
| | | |
| | | |
| | |
Short
term investments | |
| - | | |
| 3,627 | | |
| - | | |
| 3,627 | |
Total financial assets | |
$ | 11,175 | | |
$ | 18,327 | | |
$ | - | | |
$ | 29,502 | |
Our
non-financial assets that are measured on a non-recurring basis are property and equipment and other assets which are measured using
fair value techniques whenever events or changes in circumstances indicate a condition of impairment exists. The estimated fair value
of prepaid expenses and other current assets, accounts payable and accrued expenses approximates their individual carrying amounts due
to the short-term nature of these measurements. Cash equivalents are stated at carrying value which approximates fair value.
Cash
Equivalents
Cash
equivalents consist of highly liquid, short-term investments with original maturities of three months or less when purchased.
Short-term
Investments
At
October 31, 2023 and 2022, we had certificates of deposit and United States treasury bills with maturities greater than 90 days and less
than 12 months when acquired of approximately $22,929,000
and $17,327,000,
respectively, that were classified as short-term investments and reported at fair value.
Income
Taxes
We
recognize deferred tax assets and liabilities for the estimated future tax effects of events that have been recognized in our financial
statements or tax returns. Under this method, deferred tax assets and liabilities are determined based on the difference between the
financial statement and tax bases of assets and liabilities using enacted tax rates in effect in the years in which the differences are
expected to reverse. A valuation allowance is established, when necessary, to reduce deferred tax assets to the amount expected to be
realized.
ANIXA
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
Share-Based
Compensation
We
maintain equity incentive plans under which we may grant incentive stock options, non-qualified stock options, stock appreciation rights,
stock awards, performance awards, or stock units to employees, directors and consultants.
Stock
Option Compensation Expense
We
account for stock options granted to employees, directors and consultants using the accounting guidance in ASC 718, Stock Compensation
(“ASC 718”). We estimate the fair value of service-based stock options on the date of grant, using the Black-Scholes pricing
model, and recognize compensation expense over the requisite service period of the grant.
We
recorded stock-based compensation expense, related to service-based stock options granted to employees and directors, of approximately
$4,422,000
and $3,463,000,
during the years ended October 31, 2023 and 2022, respectively. Included in stock-based compensation cost for service-based options granted
to employees and directors during the years ended October 31, 2023 and 2022 was approximately $3,023,000
and $2,788,000,
respectively, related to the amortization of compensation cost for stock options granted in prior periods but not yet vested. As of October
31, 2023, there was unrecognized compensation cost related to non-vested service-based stock options granted to employees and directors
of approximately $5,194,000,
which will be recognized over a weighted-average period of 1.7
years.
For
stock options that vest based on market conditions, such as the trading price of the Company’s common stock exceeding certain price
targets, we use a Monte Carlo Simulation in estimating the fair value at grant date and recognize compensation expense over the implied
service period (median time to vest). On June 1, 2021, our Chairman, then-President and Chief Executive Officer and our Chief Operating
Officer and Chief Financial Officer were awarded market condition stock options for 2,000,000
shares and 100,000
shares of common stock, respectively, that vest
in four equal installments upon the Company’s share price achieving targets ranging from $5.00
to $8.00
per share, with implied service periods of three
to fifteen months. The assumptions used in the Monte Carlo Simulation for the June 1, 2021 grants were stock price on date of grant and
exercise price of $4.02,
contract term of 10
years, expected volatility of 75%
and risk-free interest rate of 1.62%.
As of October 31, 2023, 500,000
options and 25,000
options granted to our Chairman, then-President
and Chief Executive Officer and our Chief Operating Officer and Chief Financial Officer, respectively, have vested.
During
the year ended October 31, 2023, we recorded no
stock-based compensation expense related to market
condition stock options granted to employees. We recorded stock-based compensation expense related to market condition stock options
granted to employees of approximately $2,537,000
during the year ended October 31, 2022, which
amount represented expense related to the amortization of compensation cost for stock options granted during the year ended October 31,
2021. As of October 31, 2023, there was no
unrecognized compensation cost related to market
condition stock options granted to employees.
We
recorded consulting expense, related to service-based stock options granted to consultants, during the years ended October 31, 2023 and
2022 of approximately $221,000
and $434,000,
respectively. Included in stock-based consulting expense for the years ended October 31, 2023 and 2022 was approximately $209,000
and $434,000,
respectively, related to compensation cost for stock options granted in prior periods but not yet vested. As of October 31, 2023, there
was unrecognized consulting expense related to non-vested service-based stock options granted to consultants of approximately $281,000,
which will be recognized over a weighted-average period of 2.5
years.
ANIXA
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
Fair
Value Determination
We
use the Black-Scholes pricing model in estimating the fair value of stock options granted to employees, directors and consultants which
vest over a specific period of time. The stock options we granted during each of the years ended October 31, 2023 and 2022 consisted
of awards with 5-year
and 10-year
terms that vest over 12
to 36
months.
The
following weighted average assumptions were used in estimating the fair value of stock options granted during the years ended October
31, 2023 and 2022:
SCHEDULE
OF WEIGHTED AVERAGE ASSUMPTIONS USED IN ESTIMATING FAIR VALUE OF STOCK OPTIONS
| |
For
the Year Ended October 31, | |
| |
2023 | | |
2022 | |
Weighted average fair value at
grant date | |
$ | 3.29 | | |
$ | 2.18 | |
Valuation assumptions: | |
| | | |
| | |
Expected life (years) | |
| 5.47 | | |
| 5.76 | |
Expected volatility | |
| 100.27 | % | |
| 102.72 | % |
Risk-free interest rate | |
| 3.87 | % | |
| 1.99 | % |
Expected dividend yield | |
| 0 | % | |
| 0 | % |
The
expected term of stock options represents the weighted average period the stock options are expected to remain outstanding. For employees
and directors, we use the simplified method, which is a weighted average of the vesting term and contractual term, to determine expected
term. The simplified method was adopted since we do not believe that historical experience is representative of future performance because
of the impact of the changes in our operations and the change in terms from historical operations. For consultants, we use the contract
term for expected term. Under the Black-Scholes pricing model, we estimated the expected volatility of our shares of common stock based
upon the historical volatility of our share price over a period of time equal to the expected term of the options. We estimated the risk-free
interest rate based on the implied yield available on the applicable grant date of a U.S. Treasury note with a term equal to the expected
term of the underlying grants. We made the dividend yield assumption based on our history of not paying cash dividends and our expectation
not to pay dividends in the future.
Under
ASC 718, the amount of stock-based compensation expense recognized is based on the portion of the awards that are ultimately expected
to vest. Accordingly, if deemed necessary, we reduce the fair value of the stock option awards for expected forfeitures, which are forfeitures
of the unvested portion of surrendered options. Based on our historical experience and future expectations, we have not reduced the amount
of stock-based compensation expenses for anticipated forfeitures.
We
will reconsider use of the Black-Scholes pricing model if additional information becomes available in the future that indicates another
model would be more appropriate. If factors change and we employ different assumptions in the application of ASC 718 in future periods,
the compensation expense that we record under ASC 718 may differ significantly from what we have recorded in the current period.
ANIXA
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
Warrants
For
warrants granted to consultants for services rendered, we estimate the fair value using the Black-Scholes pricing model on the date of
grant. During the years ended October 31, 2023 and 2022 we recorded consulting expense, based on the fair value, of $0
and approximately $221,000,
respectively, for warrants granted to consultants.
Net
Loss Per Share of Common Stock
In
accordance with ASC 260, Earnings Per Share, basic net loss per common share (“Basic EPS”) is computed by dividing net loss
by the weighted average number of common shares outstanding. Diluted net loss per common share (“Diluted EPS”) is computed
by dividing net loss by the weighted average number of common shares and dilutive common share equivalents and convertible securities
then outstanding. Diluted EPS for all years presented is the same as Basic EPS, as the inclusion of the effect of common share equivalents
then outstanding would be anti-dilutive. For this reason, excluded from the calculation of Diluted EPS for the years ended October 31,
2023 and 2022 were options to purchase 11,430,000
shares and 10,318,872
shares, respectively, and warrants to purchase
300,000
shares and 300,000
shares, respectively.
Use
of Estimates
The
preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires
management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent
assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting
period. Estimates and assumptions are used for, but not limited to, determining stock-based compensation, asset impairment evaluations,
tax assets and liabilities, license fee revenue, the allowance for doubtful accounts, depreciation lives and other contingencies. Actual
results could differ from those estimates.
ANIXA
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
Effect
of Recently Issued Pronouncements
In
August 2020, the FASB issued Accounting Standards Update 2020-06 (“ASU 2020-06”), Accounting for Convertible Instruments
and Contracts in an Entity’s Own Equity. The amendments in ASU 2020-06 include guidance on convertible instruments and the derivative
scope exception for contracts in an entity’s own equity and simplifies the accounting for convertible instruments which include
beneficial conversion features or cash conversion features by removing certain separation models in Subtopic 470-20. Additionally, ASU
2020-06 will require entities to use the “if-converted” method when calculating diluted earnings per share for convertible
instruments. The amendments in this update are effective for fiscal years beginning after December 15, 2021, including interim periods
within those fiscal years. The adoption of this standard did not have a material impact on our consolidated financial statements and
related disclosures.
In
May 2021, the FASB issued Accounting Standards Update 2021-04 (“ASU 2021-04”), Issuer’s Accounting for Certain Modifications
or Exchanges of Freestanding Equity-Classified Written Call Options. The guidance in ASU 2021-04 requires the issuer to treat a modification
of an equity-classified written call option (the “option”) that does not cause the option to become liability-classified
as an exchange of the original option for a new option. This guidance applies whether the modification is structured as an amendment
to the terms and conditions of the option or as termination of the original option and issuance of a new option. The amendments in this
update are effective for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. The adoption
of this standard did not have a material impact on our consolidated financial statements and related disclosures.
In
October 2021, the FASB issued Accounting Standards Update 2021-08 (“ASU 2021-08”), Business Combinations (Topic 805): Accounting
for Contract Assets and Contract Liabilities from Contracts with Customers, to require that an acquirer recognize and measure contract
assets and contract liabilities acquired in a business combination in accordance with Topic 606, Revenue from Contracts with Customers.
At the acquisition date, an acquirer should account for the related revenue contracts in accordance with Topic 606 as if it had originated
the contracts. The amendments in this update should be applied prospectively and are effective for fiscal years beginning after December
15, 2022, including interim periods within those fiscal years. We do not expect the adoption of this standard to have a material impact
on our consolidated financial statements and related disclosures.
Concentration
of Credit Risks
Financial
instruments that potentially subject us to concentrations of credit risk are cash equivalents, short-term investments and accounts receivable.
Cash equivalents are primarily highly rated money market funds. Short-term investments are certificates of deposit within federally insured
limits as well as U.S. treasury bills. Where applicable, management reviews our accounts receivable and other receivables for potential
doubtful accounts and maintains an allowance for estimated uncollectible amounts. Our policy is to write-off uncollectable amounts at
the time it is determined that collection will not occur. One licensee accounted for 100% of revenues from patent licensing activities
during fiscal year 2023.
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v3.23.4
ACCRUED EXPENSES
|
12 Months Ended |
Oct. 31, 2023 |
Payables and Accruals [Abstract] |
|
ACCRUED EXPENSES |
3.
ACCRUED EXPENSES
Accrued
liabilities consist of the following as of:
SCHEDULE
OF ACCRUED EXPENSES
| |
2023 | | |
2022 | |
| |
October
31, | |
| |
2023 | | |
2022 | |
Payroll and related expenses | |
$ | 1,114 | | |
$ | 1,144 | |
Accrued royalty and contingent legal fees | |
| 626 | | |
| 577 | |
Accrued other | |
| 30 | | |
| 5 | |
Accrued
expenses | |
$ | 1,770 | | |
$ | 1,726 | |
ANIXA
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
|
X |
- DefinitionThe entire disclosure for accounts payable and accrued liabilities at the end of the reporting period.
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v3.23.4
SHAREHOLDERS’ EQUITY
|
12 Months Ended |
Oct. 31, 2023 |
Equity [Abstract] |
|
SHAREHOLDERS’ EQUITY |
4.
SHAREHOLDERS’ EQUITY
Stock
Option Plans
During
the year ended October 31, 2023, we had two stock option plans: the Anixa Biosciences, Inc. 2010 Share Incentive Plan (the “2010
Share Plan”) and the Anixa Biosciences, Inc. 2018 Share Incentive Plan (the “2018 Share Plan”) which were adopted by
our Board of Directors on July 14, 2010 and January 25, 2018, respectively. The 2018 Share Plan was approved by our shareholders on March
29, 2018. In accordance with the provisions of the 2010 Share Plan, the plan terminated with respect to the grant of future securities
on July 14, 2020.
During
the years ended October 31, 2023 and 2022, stock options to purchase 157,761
and 387,739
shares of common stock, respectively, were exercised
on a cash basis, with aggregate proceeds of approximately $353,000
and $439,000,
respectively. During the years ended October 31, 2023 and 2022, stock options to purchase 161,111
shares of common stock, of which 116,225
shares were withheld, and 1,488,881
shares of common stock, of which 1,083,517
shares were withheld, were exercised on a cashless
basis, respectively.
2010
Share Plan
The
2010 Share Plan provided for the grant of nonqualified stock options, stock appreciation rights, stock awards, performance awards and
stock units to employees, directors and consultants. On the first business day of each calendar year the aggregate number of shares available
for future issuance was replenished such that 800,000
shares were available. The exercise price with
respect to all of the options granted under the 2010 Share Plan was equal to the fair market value of the underlying common stock at
the grant date. Information regarding the 2010 Share Plan for the two years ended October 31, 2023 is as follows:
SCHEDULE
OF OPTION ACTIVITY
| |
Shares | | |
Weighted
Average
Exercise Price
Per Share | | |
Aggregate
Intrinsic Value | |
Options Outstanding at October
31, 2021 | |
| 1,718,634 | | |
$ | 2.82 | | |
| | |
Exercised | |
| (212,000 | ) | |
$ | 2.68 | | |
| | |
Expired | |
| (5,134 | ) | |
$ | 3.63 | | |
| | |
Options Outstanding at October 31, 2022 | |
| 1,501,500 | | |
$ | 2.83 | | |
| | |
Exercised | |
| (312,500 | ) | |
$ | 2.41 | | |
| | |
Options Outstanding
and Exercisable at October 31, 2023 | |
| 1,189,000 | | |
$ | 2.94 | | |
$ | 770,800 | |
The
following table summarizes information about stock options outstanding under the 2010 Share Plan as of October 31, 2023:
SCHEDULE
OF OUTSTANDING AND EXERCISABLE
Range
of Exercise Prices | |
Number Outstanding
and Exercisable | | |
Weighted
Average Remaining Contractual
Life (in
years) | | |
Weighted Average Exercise
Price | |
$0.67
- $2.27 | |
| 366,000 | | |
| 3.59 | | |
$ | 1.27 | |
$2.58
- $3.13 | |
| 314,000 | | |
| 2.21 | | |
$ | 2.91 | |
$3.46
- $5.30 | |
| 509,000 | | |
| 4.54 | | |
$ | 4.17 | |
ANIXA
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
2018
Share Plan
The
2018 Share Plan provides for the grant of incentive stock options, nonqualified stock options, stock appreciation rights, stock awards,
performance awards and stock units to employees, directors and consultants. On the first business day of each calendar year the maximum
aggregate number of shares available for future issuance is replenished such that 2,000,000
shares are available. The exercise price with
respect to all of the options granted under the 2018 Share Plan was equal to the fair market value of the underlying common stock at
the grant date. As of October 31, 2023, the 2018 Share Plan had 750,000
shares available for future grants. Information
regarding the 2018 Share Plan for the two years ended October 31, 2023 is as follows:
SCHEDULE
OF OPTION ACTIVITY
| |
Shares | | |
Weighted
Average
Exercise Price
Per Share | | |
Aggregate
Intrinsic Value | |
Options Outstanding at October
31, 2021 | |
| 7,409,992 | | |
$ | 3.76 | | |
| | |
Granted | |
| 1,430,000 | | |
$ | 2.74 | | |
| | |
Exercised | |
| (22,620 | ) | |
$ | 3.15 | | |
| | |
Options Outstanding at October 31, 2022 | |
| 8,817,372 | | |
$ | 3.60 | | |
| | |
Granted | |
| 1,640,000 | | |
$ | 3.97 | | |
| | |
Exercised | |
| (6,372 | ) | |
$ | 2.89 | | |
| | |
Forfeited/Expired | |
| (210,000 | ) | |
$ | 5.10 | | |
| | |
Options Outstanding
at October 31, 2023 | |
| 10,241,000 | | |
$ | 3.67 | | |
$ | 1,112,030 | |
Options Exercisable
at October 31, 2023 | |
| 6,721,970 | | |
$ | 3.50 | | |
$ | 884,783 | |
The
following table summarizes information about stock options outstanding under the 2018 Share Plan as of October 31, 2023:
SCHEDULE
OF OUTSTANDING AND EXERCISABLE
| |
Options
Outstanding | | |
Options
Exercisable | |
Range
of Exercise
Prices | |
Number Outstanding | | |
Weighted Average Remaining Contractual
Life (in
years) | | |
Weighted Average Exercise
Price | | |
Number Exercisable | | |
Weighted Average Remaining Contractual
Life (in
years) | | |
Weighted Average Exercise
Price | |
$ 2.09
- $3.87 | |
| 5,476,000 | | |
| 6.50 | | |
$ | 3.24 | | |
| 4,828,361 | | |
| 6.22 | | |
$ | 3.29 | |
$ 3.96
- $5.30 | |
| 4,765,000 | | |
| 7.70 | | |
$ | 4.16 | | |
| 1,893,609 | | |
| 7.20 | | |
$ | 4.02 | |
Non-Plan
Options
In
addition to options granted under stock option plans, during the years ended October 31, 2012 and 2013, the Board of Directors approved
the grant of stock options to certain employees and directors (the “Non-Plan Options”).
ANIXA
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
Information
regarding the Non-Plan Options for the two years ended October 31, 2023 is as follows:
SCHEDULE
OF OPTION ACTIVITY
| |
Shares | | |
Weighted
Average
Exercise Price
Per Share | |
Options Outstanding October 31,
2021 | |
| 1,642,000 | | |
$ | 2.58 | |
Exercised | |
| (1,642,000 | ) | |
$ | 2.58 | |
Options Outstanding
and Exercisable at October 31, 2022 | |
| - | | |
| | |
Employee
Stock Purchase Plan
The
Company maintains the Anixa Biosciences, Inc. Employee Stock Purchase Plan which permits eligible employees to purchase shares at not
less than 85%
of the market value of the Company’s common stock on the offering date or the purchase date of the applicable offering period,
whichever is lower. The plan was adopted by our Board of Directors on August 13, 2018 and approved by our shareholders on September 27,
2018. During the years ended October 31, 2023 and 2022, employees purchased 4,360
and 4,741
shares, respectively, with aggregate proceeds
of approximately $13,000
and $13,000,
respectively.
Common
Stock Purchase Warrants
On
November 1, 2021 we issued a warrant, expiring on October
30, 2026, to purchase 60,000
shares of common stock at $4.77
per share, vesting over five
months, to a consultant for investor relations
services. We recorded consulting expense of approximately $221,000
during the year ended October 31, 2022, based
on the fair value of the warrant recognized on a straight-line basis over the vesting period. The warrant terminated in May 2022 upon
termination of the consulting agreement.
In
connection with a public offering in March 2021, we issued to certain designees of the underwriter, as compensation, warrants to purchase
300,000
shares of common stock at $6.5625
per share, expiring on March
22, 2026.
Information
regarding the Company’s warrants for the two years ended October 31, 2023 is as follows:
SCHEDULE
OF WARRANTS ACTIVITY
| |
Shares | | |
Weighted
Average
Exercise Price
Per Share | | |
Aggregate
Intrinsic Value | |
Warrants Outstanding at October
31, 2021 | |
| 860,000 | | |
$ | 5.36 | | |
| | |
Issued | |
| 60,000 | | |
$ | 4.77 | | |
| | |
Exercised | |
| (60,000 | ) | |
$ | 2.06 | | |
| | |
Expired | |
| (560,000 | ) | |
$ | 4.71 | | |
| | |
Warrants Outstanding
and Exercisable at October 31, 2022 and October 31, 2023 | |
| 300,000 | | |
$ | 6.56 | | |
$ | 0 | |
The
following table summarizes information about the Company’s outstanding and exercisable warrants as of October 31, 2023:
SCHEDULE
OF OUTSTANDING AND EXERCISABLE
Exercise
Price | | |
Number Outstanding
and Exercisable | | |
Weighted
Average Remaining Contractual
Life (in
years) | | |
Weighted Average Exercise
Price | |
$ | 6.56 | | |
| 300,000 | | |
| 2.39 | | |
$ | 6.56 | |
ANIXA
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
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v3.23.4
LEASES
|
12 Months Ended |
Oct. 31, 2023 |
Leases |
|
LEASES |
5.
LEASES
We
lease approximately 2,000
square feet of office space at 3150 Almaden Expressway,
San Jose, California (our principal executive offices) from an unrelated party pursuant to an operating lease that, as amended, will
expire on September
30, 2024, with an
option to extend the lease an additional two years. Our
base rent is approximately $5,000
per month and the lease provides for annual increases
of approximately 3%
and an escalation clause for increases in certain operating costs. The lease, as amended, resulted in a right-of-use asset and lease
liability of approximately $260,000
with a discount rate of 10%.
Rent expense was approximately $66,000 for
each of the years ended October 31, 2023 and 2022.
For
operating leases, the lease liability is initially and subsequently measured at the present value of the unpaid lease payments. The remaining
35-month
lease term as of October 31, 2023 for the Company’s lease includes the noncancelable period of the lease and the additional two-year
option period that the Company believes it is reasonably certain to exercise. All right-of-use assets are reviewed for impairment when
indications of impairment are present.
As
of October 31, 2023, the annual minimum lease payments of our operating lease liability were as follows (in thousands):
SCHEDULE
OF MINIMUM LEASE PAYMENTS
For Years Ending October 31, | |
Operating
Leases | |
2024 | |
$ | 67 | |
2025 | |
| 70 | |
2026 | |
| 65 | |
Total future minimum lease
payments, undiscounted | |
| 202 | |
Less: Imputed interest | |
| 27 | |
Present
value of future minimum lease payments | |
$ | 175 | |
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v3.23.4
COMMITMENTS AND CONTINGENCIES
|
12 Months Ended |
Oct. 31, 2023 |
Commitments and Contingencies Disclosure [Abstract] |
|
COMMITMENTS AND CONTINGENCIES |
6.
COMMITMENTS AND CONTINGENCIES
Litigation
Matters
Other
than lawsuits we bring to enforce our patent rights, we are not involved in any litigation or other legal proceedings and management
is not aware of any pending litigation or legal proceeding against us that would have a material adverse effect upon our results of operations
or financial condition.
License
Commitments
As
of October 31, 2023, our commitments under the license agreements with Wistar and Cleveland Clinic for the year ending October 31, 2024
were approximately $70,000.
Research
& Development Agreements
We
have entered into certain research and development agreements with various third-party vendors related to the manufacturing of materials
necessary for the expected Phase 2 clinical trial of our breast cancer vaccine. As of October 31, 2023, future payments the Company may
make under these agreements may be approximately $3.5 million and such payments may be made over up to a five-year period.
|
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- DefinitionThe entire disclosure for commitments and contingencies.
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v3.23.4
INCOME TAXES
|
12 Months Ended |
Oct. 31, 2023 |
Income Tax Disclosure [Abstract] |
|
INCOME TAXES |
7.
INCOME TAXES
Income
tax provision (benefit) consists of the following:
SCHEDULE
OF INCOME TAX PROVISION (BENEFIT)
| |
| | |
| |
| |
Year
Ended October 31, | |
| |
2023 | | |
2022 | |
Federal: | |
| | | |
| | |
Current | |
$ | - | | |
$ | - | |
Deferred | |
| (1,739,000 | ) | |
| (1,021,000 | ) |
State: | |
| | | |
| | |
Current | |
| - | | |
| - | |
Deferred | |
| (583,000 | ) | |
| (350,000 | ) |
Adjustment to valuation
allowance related to net deferred tax assets | |
| 1,322,000 | | |
| 1,371,000 | |
Total | |
$ | - | | |
$ | - | |
ANIXA
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
The
tax effects of temporary differences that give rise to significant portions of the deferred tax asset, net, at October 31, 2023 and 2022,
are as follows:
SCHEDULE
OF DEFERRED TAX ASSETS AND LIABILITIES
| |
| | |
| |
| |
October
31, | |
| |
2023 | | |
2022 | |
Long-term deferred tax assets: | |
| | | |
| | |
Federal and
state NOL and tax credit carryforwards | |
$ | 26,532,000 | | |
$ | 22,196,000 | |
Deferred compensation | |
| 7,752,000 | | |
| 6,851,000 | |
Intangibles | |
| 218,000 | | |
| 274,000 | |
Other | |
| - | | |
| 281,000 | |
Subtotal | |
| 34,502,000 | | |
| 29,602,000 | |
Less: valuation allowance | |
| (34,502,000 | ) | |
| (29,602,000 | ) |
Deferred
tax asset, net | |
$ | - | | |
$ | - | |
As
of October 31, 2023, we had Federal tax net operating loss and tax credit carryforwards of approximately $95,752,000
and $1,870,000,
respectively. At the federal level, businesses can carry forward their net operating losses indefinitely, but the deductions are limited
to 80 percent of taxable income. Prior to the Tax Cuts and Jobs Act (TCJA) of 2017, businesses could carry losses forward for 20 years
(without a deductibility limit). If the tax benefits relating to deductions of option holders’ income are ultimately realized,
those benefits will be credited directly to additional paid-in capital. Certain changes in stock ownership can result in a limitation
on the amount of net operating loss and tax credit carryovers that can be utilized each year. As of October 31, 2023, management has
not determined the extent of any such limitations, if any.
We
had California tax net operating loss carryforwards of approximately $51,065,000
as of October 31, 2023, available within statutory
limits (expiring
at various dates between 2024 and 2043), to offset
future corporate taxable income and taxes payable, if any, under certain computations of such taxes.
We
have provided a 100%
valuation allowance against our deferred tax
asset due to our current and historical pre-tax losses and the uncertainty regarding their realizability. The primary differences from
the Federal statutory rate of 21%
and the effective rate of 0%
is attributable to expiring net operating losses and a change in the valuation allowance. The following is a reconciliation of income
taxes at the Federal statutory tax rate to income tax expense (benefit):
SCHEDULE
OF RECONCILIATION OF INCOME TAXES
| |
Year
Ended October 31, | |
| |
2023 | | |
2022 | |
Income tax benefit at U.S. Federal
statutory income tax rate | |
| (2,085,000 | ) | |
| (21.00 | )% | |
$ | (2,892,000 | ) | |
| (21.00 | )% |
State income taxes | |
| (693,000 | ) | |
| (6.98 | )% | |
| (962,000 | ) | |
| (6.98 | )% |
Permanent differences | |
| 20,000 | | |
| 0.20 | % | |
| 14,000 | | |
| 0.10 | % |
Expiring net operating losses, credits and
other | |
| 1,436,000 | | |
| 14.46 | % | |
| 2,469,000 | | |
| 17.93 | % |
Change in valuation
allowance | |
| 1,322,000 | | |
| 13.32 | % | |
| 1,371,000 | | |
| 9.95 | % |
Income
tax provision | |
$ | - | | |
| 0.00 | % | |
$ | - | | |
| 0.00 | % |
ANIXA
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
During
the two fiscal years ended October 31, 2023, we incurred no Federal and no State income taxes. We have no
unrecognized tax benefits as of October 31, 2023
and 2022 and we account for interest and penalties related to income tax matters in general and administrative expenses. Tax years to
which our net operating losses relate remain open to examination by Federal and California authorities to the extent which the net operating
losses have yet to be utilized.
|
X |
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v3.23.4
SEGMENT INFORMATION
|
12 Months Ended |
Oct. 31, 2023 |
Segment Reporting [Abstract] |
|
SEGMENT INFORMATION |
8.
SEGMENT INFORMATION
We
follow the accounting guidance of ASC 280, Segment Reporting (“ASC 280”). Reportable operating segments are determined based
on the management approach. The management approach, as defined by ASC 280, is based on the way that the chief operating decision-maker
organizes the segments within an enterprise for making operating decisions and assessing performance. While our results of operations
are primarily reviewed on a consolidated basis, the chief operating decision-maker manages the enterprise in four
reportable segments, each with different operating
and potential revenue generating characteristics: (i) CAR-T Therapeutics, (ii) Cancer Vaccines, (iii) Anti-Viral Therapeutics and (iv)
Other. The following represents selected financial information for our segments for the years ended October 31, 2023 and 2022:
SCHEDULE
OF SEGMENT INFORMATION
| |
| | |
| |
| |
Year
Ended October 31, | |
| |
2023 | | |
2022 | |
Net income (loss): | |
| | | |
| | |
CAR-T Therapeutics | |
$ | (3,879 | ) | |
$ | (5,776 | ) |
Cancer Vaccines | |
| (5,111 | ) | |
| (4,889 | ) |
Anti-Viral Therapeutics | |
| (945 | ) | |
| (3,075 | ) |
Other | |
| 5 | | |
| (31 | ) |
Total | |
$ | (9,930 | ) | |
$ | (13,771 | ) |
| |
| | | |
| | |
Net
income (loss) | |
$ | (9,930 | ) | |
$ | (13,771 | ) |
Total operating costs and expenses | |
$ | 11,221 | | |
$ | 13,875 | |
Less non-cash share-based
compensation | |
| (4,735 | ) | |
| (6,655 | ) |
Operating
costs and expenses excluding non-cash share-based compensation | |
$ | 6,486 | | |
$ | 7,220 | |
| |
| | | |
| | |
Operating costs and expenses excluding non-cash
share based compensation: | |
| | | |
| | |
CAR-T Therapeutics | |
$ | 2,467 | | |
$ | 3,206 | |
Cancer Vaccines | |
| 3,265 | | |
| 2,355 | |
Anti-Viral Therapeutics | |
| 553 | | |
| 1,634 | |
Other | |
| 201 | | |
| 25 | |
Total | |
$ | 6,486 | | |
$ | 7,220 | |
Operating
costs and expenses excluding non-cash share based compensation | |
$ | 6,486 | | |
$ | 7,220 | |
| |
| | | |
| | |
| |
| October
31, | |
| |
| 2023 | | |
| 2022 | |
Total assets: | |
| | | |
| | |
CAR-T Therapeutics | |
$ | 7,523 | | |
$ | 16,921 | |
Cancer Vaccines | |
| 17,215 | | |
| 9,442 | |
Anti-Viral Therapeutics | |
| 700 | | |
| 3,811 | |
Other | |
| 84 | | |
| 238 | |
Total | |
$ | 25,522 | | |
$ | 30,412 | |
Total assets | |
$ | 25,522 | | |
$ | 30,412 | |
Operating
costs and expenses excluding non-cash share-based compensation is the measurement the chief operating decision-maker uses in managing
the enterprise.
The
Company’s consolidated revenue of $210,000
and inventor royalties, contingent legal fees, litigation and
licensing expense of $161,000,
for the year ended October 31, 2023 were solely related to our other segment. All our revenue is generated domestically (United States)
based on the country in which the licensee is located.
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v3.23.4
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)
|
12 Months Ended |
Oct. 31, 2023 |
Accounting Policies [Abstract] |
|
Basis of Presentation |
Basis
of Presentation
The
consolidated financial statements include the accounts of Anixa Biosciences, Inc. and its wholly and majority owned subsidiaries. All
intercompany transactions have been eliminated.
|
Noncontrolling Interest |
Noncontrolling
Interest
Noncontrolling
interest represents Wistar’s equity ownership in Certainty and is presented as a component of equity. The following table sets
forth the changes in noncontrolling interest for the two years ended October 31, 2023 (in thousands):
SCHEDULE
OF CHANGES IN NONCONTROLLING INTEREST
Balance October 31, 2021 | |
$ | (671 | ) |
Net loss attributable
to noncontrolling interest | |
| (176 | ) |
Balance October 31, 2022 | |
| (847 | ) |
Net loss attributable
to noncontrolling interest | |
| (119 | ) |
Balance October 31,
2023 | |
$ | (966 | ) |
|
Revenue Recognition |
Revenue
Recognition
Our
revenue has been derived solely from technology licensing and the sale of patented technologies. Revenue is recognized upon transfer
of control of intellectual property rights and satisfaction of other contractual performance obligations to licensees in an amount that
reflects the consideration we expect to receive.
Our
revenue recognition policy requires us to make certain judgments and estimates in connection with the accounting for revenue. Such areas
may include determining the existence of a contract and identifying each party’s rights and obligations to transfer goods and services,
identifying the performance obligations in the contract, determining the transaction price and allocating the transaction price to separate
performance obligations, estimating the timing of satisfaction of performance obligations, determining whether a promise to grant a license
is distinct from other promised goods or services and evaluating whether a license transfers to a customer at a point in time or over
time.
Our
revenue arrangements provide for the payment, within 30 days of execution of the agreement, of contractually determined, one-time, paid-up
license fees in settlement of litigation and in consideration for the grant of certain intellectual property rights for patented technologies
owned or controlled by the Company. These arrangements typically include some combination of the following: (i) the grant of a non-exclusive,
retroactive and future license to manufacture and/or sell products covered by patented technologies owned or controlled by the Company,
(ii) a covenant-not-to-sue, (iii) the release of the licensee from certain claims, and (iv) the dismissal of any pending litigation.
In such instances, the intellectual property rights granted have been perpetual in nature, extending until the expiration of the related
patents. Pursuant to the terms of these agreements, we have no further obligations with respect to the granted intellectual property
rights, including no obligation to maintain or upgrade the technology, or provide future support or services. Licensees obtained control
of the intellectual property rights they have acquired upon execution of the agreement. Accordingly, the performance obligations from
these agreements were satisfied and 100%
of the revenue was recognized upon the execution of the agreements.
ANIXA
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
|
Cost of Revenues |
Cost
of Revenues
Cost
of revenues include the costs and expenses incurred in connection with our patent licensing and enforcement activities, including inventor
royalties paid to original patent owners, contingent legal fees paid to external counsel, other patent-related legal expenses paid to
external counsel, licensing and enforcement related research and consulting and other expenses paid to third-parties. These costs are
included under the caption “Operating costs and expenses” in the accompanying consolidated statements of operations.
|
Research and Development Expenses |
Research
and Development Expenses
Research
and development expenses consist primarily of payments to third parties for research and development activities, including expenses related
to clinical trials, employee compensation, and other direct costs associated with developing our therapeutics and vaccines.
We
recognize research and development expenses as incurred. Advance payments for future research and development activities are deferred
and expensed as the services are performed. We recognize our preclinical studies and clinical trial expenses based on the services performed
pursuant to contracts with research institutions, clinical research organizations (“CROs”), clinical manufacturing organizations
(“CMOs”), and other parties that conduct and manage various stages of research and development activities on our behalf.
Fees for such services are recognized based on management’s estimates after considering the activities and tasks completed by each
service provider in a given period, the time period over which services are expected to be performed, and the level of effort expended
in each reporting period.
At
each balance sheet date, management estimates prepaid and accrued research and development costs by discussing progress or stage of completion
of activities with internal personnel and external service providers, and comparing this information to payments made, invoices received,
and the agreed-upon contractual fee to be paid for such services in the applicable contract or statements of work.
In addition, we allocate certain internal compensation
costs to research and development expenses based on management’s estimates of each employee’s time and effort expended.
|
Fair Value Measurements |
Fair
Value Measurements
Accounting
Standards Codification (“ASC”) 820, Fair Value Measurements and Disclosures (“ASC 820”), defines fair value,
establishes a framework for measuring fair value under U.S. generally accepted accounting principles (GAAP), and expands disclosures
about fair value measurements. In accordance with ASC 820, we have categorized our financial assets and liabilities, based on the priority
of the inputs to the valuation technique, into a three-level fair value hierarchy as set forth below. If the inputs used to measure the
financial instruments fall within different levels of the hierarchy, the categorization is based on the lowest level input that is significant
to the fair value measurement of the instrument.
Financial
assets and liabilities recorded in the accompanying consolidated balance sheets are categorized based on the inputs to the valuation
techniques as follows:
Level
1 – Financial instruments whose values are based on unadjusted quoted prices for identical assets or liabilities in an active market
which we have the ability to access at the measurement date.
Level
2 – Financial instruments whose values are based on quoted market prices in markets where trading occurs infrequently or whose
values are based on quoted prices of instruments with similar attributes in active markets.
Level
3 – Financial instruments whose values are based on prices or valuation techniques that require inputs that are both unobservable
and significant to the overall fair value measurement. These inputs reflect management’s own assumptions about the assumptions
a market participant would use in pricing the instrument.
ANIXA
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
The
following table presents the hierarchy for our financial assets measured at fair value on a recurring basis as of October 31, 2023 (in
thousands):
SCHEDULE
OF FAIR VALUE MEASUREMENTS
| |
Level
1 | | |
Level
2 | | |
Level
3 | | |
Total | |
Money market funds: | |
| | | |
| | | |
| | | |
| | |
Cash equivalents | |
$ | 778 | | |
$ | - | | |
$ | - | | |
$ | 778 | |
Certificates of deposit: | |
| | | |
| | | |
| | | |
| | |
Short term investments | |
| - | | |
| 720 | | |
| - | | |
| 720 | |
U. S. treasury bills: | |
| | | |
| | | |
| | | |
| | |
Short
term investments | |
| - | | |
| 22,209 | | |
| - | | |
| 22,209 | |
Total financial assets | |
$ | 778 | | |
$ | 22,929 | | |
$ | - | | |
$ | 23,707 | |
The
following table presents the hierarchy for our financial assets measured at fair value on a recurring basis as of October 31, 2022 (in
thousands):
| |
Level
1 | | |
Level
2 | | |
Level
3 | | |
Total | |
Money market funds: | |
| | | |
| | | |
| | | |
| | |
Cash equivalents | |
$ | 11,175 | | |
$ | - | | |
$ | - | | |
$ | 11,175 | |
Certificates of deposit: | |
| | | |
| | | |
| | | |
| | |
Cash equivalents | |
| | | |
| 1,000 | | |
| | | |
| 1,000 | |
Short term investments | |
| - | | |
| 13,700 | | |
| - | | |
| 13,700 | |
U. S. treasury bills: | |
| | | |
| | | |
| | | |
| | |
Short
term investments | |
| - | | |
| 3,627 | | |
| - | | |
| 3,627 | |
Total financial assets | |
$ | 11,175 | | |
$ | 18,327 | | |
$ | - | | |
$ | 29,502 | |
Our
non-financial assets that are measured on a non-recurring basis are property and equipment and other assets which are measured using
fair value techniques whenever events or changes in circumstances indicate a condition of impairment exists. The estimated fair value
of prepaid expenses and other current assets, accounts payable and accrued expenses approximates their individual carrying amounts due
to the short-term nature of these measurements. Cash equivalents are stated at carrying value which approximates fair value.
|
Cash Equivalents |
Cash
Equivalents
Cash
equivalents consist of highly liquid, short-term investments with original maturities of three months or less when purchased.
|
Short-term Investments |
Short-term
Investments
At
October 31, 2023 and 2022, we had certificates of deposit and United States treasury bills with maturities greater than 90 days and less
than 12 months when acquired of approximately $22,929,000
and $17,327,000,
respectively, that were classified as short-term investments and reported at fair value.
|
Income Taxes |
Income
Taxes
We
recognize deferred tax assets and liabilities for the estimated future tax effects of events that have been recognized in our financial
statements or tax returns. Under this method, deferred tax assets and liabilities are determined based on the difference between the
financial statement and tax bases of assets and liabilities using enacted tax rates in effect in the years in which the differences are
expected to reverse. A valuation allowance is established, when necessary, to reduce deferred tax assets to the amount expected to be
realized.
ANIXA
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
|
Share-Based Compensation |
Share-Based
Compensation
We
maintain equity incentive plans under which we may grant incentive stock options, non-qualified stock options, stock appreciation rights,
stock awards, performance awards, or stock units to employees, directors and consultants.
|
Stock Option Compensation Expense |
Stock
Option Compensation Expense
We
account for stock options granted to employees, directors and consultants using the accounting guidance in ASC 718, Stock Compensation
(“ASC 718”). We estimate the fair value of service-based stock options on the date of grant, using the Black-Scholes pricing
model, and recognize compensation expense over the requisite service period of the grant.
We
recorded stock-based compensation expense, related to service-based stock options granted to employees and directors, of approximately
$4,422,000
and $3,463,000,
during the years ended October 31, 2023 and 2022, respectively. Included in stock-based compensation cost for service-based options granted
to employees and directors during the years ended October 31, 2023 and 2022 was approximately $3,023,000
and $2,788,000,
respectively, related to the amortization of compensation cost for stock options granted in prior periods but not yet vested. As of October
31, 2023, there was unrecognized compensation cost related to non-vested service-based stock options granted to employees and directors
of approximately $5,194,000,
which will be recognized over a weighted-average period of 1.7
years.
For
stock options that vest based on market conditions, such as the trading price of the Company’s common stock exceeding certain price
targets, we use a Monte Carlo Simulation in estimating the fair value at grant date and recognize compensation expense over the implied
service period (median time to vest). On June 1, 2021, our Chairman, then-President and Chief Executive Officer and our Chief Operating
Officer and Chief Financial Officer were awarded market condition stock options for 2,000,000
shares and 100,000
shares of common stock, respectively, that vest
in four equal installments upon the Company’s share price achieving targets ranging from $5.00
to $8.00
per share, with implied service periods of three
to fifteen months. The assumptions used in the Monte Carlo Simulation for the June 1, 2021 grants were stock price on date of grant and
exercise price of $4.02,
contract term of 10
years, expected volatility of 75%
and risk-free interest rate of 1.62%.
As of October 31, 2023, 500,000
options and 25,000
options granted to our Chairman, then-President
and Chief Executive Officer and our Chief Operating Officer and Chief Financial Officer, respectively, have vested.
During
the year ended October 31, 2023, we recorded no
stock-based compensation expense related to market
condition stock options granted to employees. We recorded stock-based compensation expense related to market condition stock options
granted to employees of approximately $2,537,000
during the year ended October 31, 2022, which
amount represented expense related to the amortization of compensation cost for stock options granted during the year ended October 31,
2021. As of October 31, 2023, there was no
unrecognized compensation cost related to market
condition stock options granted to employees.
We
recorded consulting expense, related to service-based stock options granted to consultants, during the years ended October 31, 2023 and
2022 of approximately $221,000
and $434,000,
respectively. Included in stock-based consulting expense for the years ended October 31, 2023 and 2022 was approximately $209,000
and $434,000,
respectively, related to compensation cost for stock options granted in prior periods but not yet vested. As of October 31, 2023, there
was unrecognized consulting expense related to non-vested service-based stock options granted to consultants of approximately $281,000,
which will be recognized over a weighted-average period of 2.5
years.
ANIXA
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
|
Fair Value Determination |
Fair
Value Determination
We
use the Black-Scholes pricing model in estimating the fair value of stock options granted to employees, directors and consultants which
vest over a specific period of time. The stock options we granted during each of the years ended October 31, 2023 and 2022 consisted
of awards with 5-year
and 10-year
terms that vest over 12
to 36
months.
The
following weighted average assumptions were used in estimating the fair value of stock options granted during the years ended October
31, 2023 and 2022:
SCHEDULE
OF WEIGHTED AVERAGE ASSUMPTIONS USED IN ESTIMATING FAIR VALUE OF STOCK OPTIONS
| |
For
the Year Ended October 31, | |
| |
2023 | | |
2022 | |
Weighted average fair value at
grant date | |
$ | 3.29 | | |
$ | 2.18 | |
Valuation assumptions: | |
| | | |
| | |
Expected life (years) | |
| 5.47 | | |
| 5.76 | |
Expected volatility | |
| 100.27 | % | |
| 102.72 | % |
Risk-free interest rate | |
| 3.87 | % | |
| 1.99 | % |
Expected dividend yield | |
| 0 | % | |
| 0 | % |
The
expected term of stock options represents the weighted average period the stock options are expected to remain outstanding. For employees
and directors, we use the simplified method, which is a weighted average of the vesting term and contractual term, to determine expected
term. The simplified method was adopted since we do not believe that historical experience is representative of future performance because
of the impact of the changes in our operations and the change in terms from historical operations. For consultants, we use the contract
term for expected term. Under the Black-Scholes pricing model, we estimated the expected volatility of our shares of common stock based
upon the historical volatility of our share price over a period of time equal to the expected term of the options. We estimated the risk-free
interest rate based on the implied yield available on the applicable grant date of a U.S. Treasury note with a term equal to the expected
term of the underlying grants. We made the dividend yield assumption based on our history of not paying cash dividends and our expectation
not to pay dividends in the future.
Under
ASC 718, the amount of stock-based compensation expense recognized is based on the portion of the awards that are ultimately expected
to vest. Accordingly, if deemed necessary, we reduce the fair value of the stock option awards for expected forfeitures, which are forfeitures
of the unvested portion of surrendered options. Based on our historical experience and future expectations, we have not reduced the amount
of stock-based compensation expenses for anticipated forfeitures.
We
will reconsider use of the Black-Scholes pricing model if additional information becomes available in the future that indicates another
model would be more appropriate. If factors change and we employ different assumptions in the application of ASC 718 in future periods,
the compensation expense that we record under ASC 718 may differ significantly from what we have recorded in the current period.
ANIXA
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
|
Warrants |
Warrants
For
warrants granted to consultants for services rendered, we estimate the fair value using the Black-Scholes pricing model on the date of
grant. During the years ended October 31, 2023 and 2022 we recorded consulting expense, based on the fair value, of $0
and approximately $221,000,
respectively, for warrants granted to consultants.
|
Net Loss Per Share of Common Stock |
Net
Loss Per Share of Common Stock
In
accordance with ASC 260, Earnings Per Share, basic net loss per common share (“Basic EPS”) is computed by dividing net loss
by the weighted average number of common shares outstanding. Diluted net loss per common share (“Diluted EPS”) is computed
by dividing net loss by the weighted average number of common shares and dilutive common share equivalents and convertible securities
then outstanding. Diluted EPS for all years presented is the same as Basic EPS, as the inclusion of the effect of common share equivalents
then outstanding would be anti-dilutive. For this reason, excluded from the calculation of Diluted EPS for the years ended October 31,
2023 and 2022 were options to purchase 11,430,000
shares and 10,318,872
shares, respectively, and warrants to purchase
300,000
shares and 300,000
shares, respectively.
|
Use of Estimates |
Use
of Estimates
The
preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires
management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent
assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting
period. Estimates and assumptions are used for, but not limited to, determining stock-based compensation, asset impairment evaluations,
tax assets and liabilities, license fee revenue, the allowance for doubtful accounts, depreciation lives and other contingencies. Actual
results could differ from those estimates.
ANIXA
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
|
Effect of Recently Issued Pronouncements |
Effect
of Recently Issued Pronouncements
In
August 2020, the FASB issued Accounting Standards Update 2020-06 (“ASU 2020-06”), Accounting for Convertible Instruments
and Contracts in an Entity’s Own Equity. The amendments in ASU 2020-06 include guidance on convertible instruments and the derivative
scope exception for contracts in an entity’s own equity and simplifies the accounting for convertible instruments which include
beneficial conversion features or cash conversion features by removing certain separation models in Subtopic 470-20. Additionally, ASU
2020-06 will require entities to use the “if-converted” method when calculating diluted earnings per share for convertible
instruments. The amendments in this update are effective for fiscal years beginning after December 15, 2021, including interim periods
within those fiscal years. The adoption of this standard did not have a material impact on our consolidated financial statements and
related disclosures.
In
May 2021, the FASB issued Accounting Standards Update 2021-04 (“ASU 2021-04”), Issuer’s Accounting for Certain Modifications
or Exchanges of Freestanding Equity-Classified Written Call Options. The guidance in ASU 2021-04 requires the issuer to treat a modification
of an equity-classified written call option (the “option”) that does not cause the option to become liability-classified
as an exchange of the original option for a new option. This guidance applies whether the modification is structured as an amendment
to the terms and conditions of the option or as termination of the original option and issuance of a new option. The amendments in this
update are effective for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. The adoption
of this standard did not have a material impact on our consolidated financial statements and related disclosures.
In
October 2021, the FASB issued Accounting Standards Update 2021-08 (“ASU 2021-08”), Business Combinations (Topic 805): Accounting
for Contract Assets and Contract Liabilities from Contracts with Customers, to require that an acquirer recognize and measure contract
assets and contract liabilities acquired in a business combination in accordance with Topic 606, Revenue from Contracts with Customers.
At the acquisition date, an acquirer should account for the related revenue contracts in accordance with Topic 606 as if it had originated
the contracts. The amendments in this update should be applied prospectively and are effective for fiscal years beginning after December
15, 2022, including interim periods within those fiscal years. We do not expect the adoption of this standard to have a material impact
on our consolidated financial statements and related disclosures.
|
Concentration of Credit Risks |
Concentration
of Credit Risks
Financial
instruments that potentially subject us to concentrations of credit risk are cash equivalents, short-term investments and accounts receivable.
Cash equivalents are primarily highly rated money market funds. Short-term investments are certificates of deposit within federally insured
limits as well as U.S. treasury bills. Where applicable, management reviews our accounts receivable and other receivables for potential
doubtful accounts and maintains an allowance for estimated uncollectible amounts. Our policy is to write-off uncollectable amounts at
the time it is determined that collection will not occur. One licensee accounted for 100% of revenues from patent licensing activities
during fiscal year 2023.
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v3.23.4
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables)
|
12 Months Ended |
Oct. 31, 2023 |
Accounting Policies [Abstract] |
|
SCHEDULE OF CHANGES IN NONCONTROLLING INTEREST |
Noncontrolling
interest represents Wistar’s equity ownership in Certainty and is presented as a component of equity. The following table sets
forth the changes in noncontrolling interest for the two years ended October 31, 2023 (in thousands):
SCHEDULE
OF CHANGES IN NONCONTROLLING INTEREST
Balance October 31, 2021 | |
$ | (671 | ) |
Net loss attributable
to noncontrolling interest | |
| (176 | ) |
Balance October 31, 2022 | |
| (847 | ) |
Net loss attributable
to noncontrolling interest | |
| (119 | ) |
Balance October 31,
2023 | |
$ | (966 | ) |
|
SCHEDULE OF FAIR VALUE MEASUREMENTS |
The
following table presents the hierarchy for our financial assets measured at fair value on a recurring basis as of October 31, 2023 (in
thousands):
SCHEDULE
OF FAIR VALUE MEASUREMENTS
| |
Level
1 | | |
Level
2 | | |
Level
3 | | |
Total | |
Money market funds: | |
| | | |
| | | |
| | | |
| | |
Cash equivalents | |
$ | 778 | | |
$ | - | | |
$ | - | | |
$ | 778 | |
Certificates of deposit: | |
| | | |
| | | |
| | | |
| | |
Short term investments | |
| - | | |
| 720 | | |
| - | | |
| 720 | |
U. S. treasury bills: | |
| | | |
| | | |
| | | |
| | |
Short
term investments | |
| - | | |
| 22,209 | | |
| - | | |
| 22,209 | |
Total financial assets | |
$ | 778 | | |
$ | 22,929 | | |
$ | - | | |
$ | 23,707 | |
The
following table presents the hierarchy for our financial assets measured at fair value on a recurring basis as of October 31, 2022 (in
thousands):
| |
Level
1 | | |
Level
2 | | |
Level
3 | | |
Total | |
Money market funds: | |
| | | |
| | | |
| | | |
| | |
Cash equivalents | |
$ | 11,175 | | |
$ | - | | |
$ | - | | |
$ | 11,175 | |
Certificates of deposit: | |
| | | |
| | | |
| | | |
| | |
Cash equivalents | |
| | | |
| 1,000 | | |
| | | |
| 1,000 | |
Short term investments | |
| - | | |
| 13,700 | | |
| - | | |
| 13,700 | |
U. S. treasury bills: | |
| | | |
| | | |
| | | |
| | |
Short
term investments | |
| - | | |
| 3,627 | | |
| - | | |
| 3,627 | |
Total financial assets | |
$ | 11,175 | | |
$ | 18,327 | | |
$ | - | | |
$ | 29,502 | |
|
SCHEDULE OF WEIGHTED AVERAGE ASSUMPTIONS USED IN ESTIMATING FAIR VALUE OF STOCK OPTIONS |
The
following weighted average assumptions were used in estimating the fair value of stock options granted during the years ended October
31, 2023 and 2022:
SCHEDULE
OF WEIGHTED AVERAGE ASSUMPTIONS USED IN ESTIMATING FAIR VALUE OF STOCK OPTIONS
| |
For
the Year Ended October 31, | |
| |
2023 | | |
2022 | |
Weighted average fair value at
grant date | |
$ | 3.29 | | |
$ | 2.18 | |
Valuation assumptions: | |
| | | |
| | |
Expected life (years) | |
| 5.47 | | |
| 5.76 | |
Expected volatility | |
| 100.27 | % | |
| 102.72 | % |
Risk-free interest rate | |
| 3.87 | % | |
| 1.99 | % |
Expected dividend yield | |
| 0 | % | |
| 0 | % |
|
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v3.23.4
ACCRUED EXPENSES (Tables)
|
12 Months Ended |
Oct. 31, 2023 |
Payables and Accruals [Abstract] |
|
SCHEDULE OF ACCRUED EXPENSES |
Accrued
liabilities consist of the following as of:
SCHEDULE
OF ACCRUED EXPENSES
| |
2023 | | |
2022 | |
| |
October
31, | |
| |
2023 | | |
2022 | |
Payroll and related expenses | |
$ | 1,114 | | |
$ | 1,144 | |
Accrued royalty and contingent legal fees | |
| 626 | | |
| 577 | |
Accrued other | |
| 30 | | |
| 5 | |
Accrued
expenses | |
$ | 1,770 | | |
$ | 1,726 | |
|
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v3.23.4
SHAREHOLDERS’ EQUITY (Tables)
|
12 Months Ended |
Oct. 31, 2023 |
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
SCHEDULE OF OPTION ACTIVITY |
Information
regarding the Non-Plan Options for the two years ended October 31, 2023 is as follows:
SCHEDULE
OF OPTION ACTIVITY
| |
Shares | | |
Weighted
Average
Exercise Price
Per Share | |
Options Outstanding October 31,
2021 | |
| 1,642,000 | | |
$ | 2.58 | |
Exercised | |
| (1,642,000 | ) | |
$ | 2.58 | |
Options Outstanding
and Exercisable at October 31, 2022 | |
| - | | |
| | |
|
Warrant [Member] |
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
SCHEDULE OF OUTSTANDING AND EXERCISABLE |
The
following table summarizes information about the Company’s outstanding and exercisable warrants as of October 31, 2023:
SCHEDULE
OF OUTSTANDING AND EXERCISABLE
Exercise
Price | | |
Number Outstanding
and Exercisable | | |
Weighted
Average Remaining Contractual
Life (in
years) | | |
Weighted Average Exercise
Price | |
$ | 6.56 | | |
| 300,000 | | |
| 2.39 | | |
$ | 6.56 | |
|
SCHEDULE OF WARRANTS ACTIVITY |
Information
regarding the Company’s warrants for the two years ended October 31, 2023 is as follows:
SCHEDULE
OF WARRANTS ACTIVITY
| |
Shares | | |
Weighted
Average
Exercise Price
Per Share | | |
Aggregate
Intrinsic Value | |
Warrants Outstanding at October
31, 2021 | |
| 860,000 | | |
$ | 5.36 | | |
| | |
Issued | |
| 60,000 | | |
$ | 4.77 | | |
| | |
Exercised | |
| (60,000 | ) | |
$ | 2.06 | | |
| | |
Expired | |
| (560,000 | ) | |
$ | 4.71 | | |
| | |
Warrants Outstanding
and Exercisable at October 31, 2022 and October 31, 2023 | |
| 300,000 | | |
$ | 6.56 | | |
$ | 0 | |
|
2010 Share Plan [Member] |
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
SCHEDULE OF OPTION ACTIVITY |
SCHEDULE
OF OPTION ACTIVITY
| |
Shares | | |
Weighted
Average
Exercise Price
Per Share | | |
Aggregate
Intrinsic Value | |
Options Outstanding at October
31, 2021 | |
| 1,718,634 | | |
$ | 2.82 | | |
| | |
Exercised | |
| (212,000 | ) | |
$ | 2.68 | | |
| | |
Expired | |
| (5,134 | ) | |
$ | 3.63 | | |
| | |
Options Outstanding at October 31, 2022 | |
| 1,501,500 | | |
$ | 2.83 | | |
| | |
Exercised | |
| (312,500 | ) | |
$ | 2.41 | | |
| | |
Options Outstanding
and Exercisable at October 31, 2023 | |
| 1,189,000 | | |
$ | 2.94 | | |
$ | 770,800 | |
|
SCHEDULE OF OUTSTANDING AND EXERCISABLE |
The
following table summarizes information about stock options outstanding under the 2010 Share Plan as of October 31, 2023:
SCHEDULE
OF OUTSTANDING AND EXERCISABLE
Range
of Exercise Prices | |
Number Outstanding
and Exercisable | | |
Weighted
Average Remaining Contractual
Life (in
years) | | |
Weighted Average Exercise
Price | |
$0.67
- $2.27 | |
| 366,000 | | |
| 3.59 | | |
$ | 1.27 | |
$2.58
- $3.13 | |
| 314,000 | | |
| 2.21 | | |
$ | 2.91 | |
$3.46
- $5.30 | |
| 509,000 | | |
| 4.54 | | |
$ | 4.17 | |
|
2018 Share Plan [Member] |
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
SCHEDULE OF OPTION ACTIVITY |
SCHEDULE
OF OPTION ACTIVITY
| |
Shares | | |
Weighted
Average
Exercise Price
Per Share | | |
Aggregate
Intrinsic Value | |
Options Outstanding at October
31, 2021 | |
| 7,409,992 | | |
$ | 3.76 | | |
| | |
Granted | |
| 1,430,000 | | |
$ | 2.74 | | |
| | |
Exercised | |
| (22,620 | ) | |
$ | 3.15 | | |
| | |
Options Outstanding at October 31, 2022 | |
| 8,817,372 | | |
$ | 3.60 | | |
| | |
Granted | |
| 1,640,000 | | |
$ | 3.97 | | |
| | |
Exercised | |
| (6,372 | ) | |
$ | 2.89 | | |
| | |
Forfeited/Expired | |
| (210,000 | ) | |
$ | 5.10 | | |
| | |
Options Outstanding
at October 31, 2023 | |
| 10,241,000 | | |
$ | 3.67 | | |
$ | 1,112,030 | |
Options Exercisable
at October 31, 2023 | |
| 6,721,970 | | |
$ | 3.50 | | |
$ | 884,783 | |
|
SCHEDULE OF OUTSTANDING AND EXERCISABLE |
The
following table summarizes information about stock options outstanding under the 2018 Share Plan as of October 31, 2023:
SCHEDULE
OF OUTSTANDING AND EXERCISABLE
| |
Options
Outstanding | | |
Options
Exercisable | |
Range
of Exercise
Prices | |
Number Outstanding | | |
Weighted Average Remaining Contractual
Life (in
years) | | |
Weighted Average Exercise
Price | | |
Number Exercisable | | |
Weighted Average Remaining Contractual
Life (in
years) | | |
Weighted Average Exercise
Price | |
$ 2.09
- $3.87 | |
| 5,476,000 | | |
| 6.50 | | |
$ | 3.24 | | |
| 4,828,361 | | |
| 6.22 | | |
$ | 3.29 | |
$ 3.96
- $5.30 | |
| 4,765,000 | | |
| 7.70 | | |
$ | 4.16 | | |
| 1,893,609 | | |
| 7.20 | | |
$ | 4.02 | |
|
X |
- DefinitionLine items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.
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v3.23.4
LEASES (Tables)
|
12 Months Ended |
Oct. 31, 2023 |
Leases |
|
SCHEDULE OF MINIMUM LEASE PAYMENTS |
As
of October 31, 2023, the annual minimum lease payments of our operating lease liability were as follows (in thousands):
SCHEDULE
OF MINIMUM LEASE PAYMENTS
For Years Ending October 31, | |
Operating
Leases | |
2024 | |
$ | 67 | |
2025 | |
| 70 | |
2026 | |
| 65 | |
Total future minimum lease
payments, undiscounted | |
| 202 | |
Less: Imputed interest | |
| 27 | |
Present
value of future minimum lease payments | |
$ | 175 | |
|
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v3.23.4
INCOME TAXES (Tables)
|
12 Months Ended |
Oct. 31, 2023 |
Income Tax Disclosure [Abstract] |
|
SCHEDULE OF INCOME TAX PROVISION (BENEFIT) |
Income
tax provision (benefit) consists of the following:
SCHEDULE
OF INCOME TAX PROVISION (BENEFIT)
| |
| | |
| |
| |
Year
Ended October 31, | |
| |
2023 | | |
2022 | |
Federal: | |
| | | |
| | |
Current | |
$ | - | | |
$ | - | |
Deferred | |
| (1,739,000 | ) | |
| (1,021,000 | ) |
State: | |
| | | |
| | |
Current | |
| - | | |
| - | |
Deferred | |
| (583,000 | ) | |
| (350,000 | ) |
Adjustment to valuation
allowance related to net deferred tax assets | |
| 1,322,000 | | |
| 1,371,000 | |
Total | |
$ | - | | |
$ | - | |
|
SCHEDULE OF DEFERRED TAX ASSETS AND LIABILITIES |
The
tax effects of temporary differences that give rise to significant portions of the deferred tax asset, net, at October 31, 2023 and 2022,
are as follows:
SCHEDULE
OF DEFERRED TAX ASSETS AND LIABILITIES
| |
| | |
| |
| |
October
31, | |
| |
2023 | | |
2022 | |
Long-term deferred tax assets: | |
| | | |
| | |
Federal and
state NOL and tax credit carryforwards | |
$ | 26,532,000 | | |
$ | 22,196,000 | |
Deferred compensation | |
| 7,752,000 | | |
| 6,851,000 | |
Intangibles | |
| 218,000 | | |
| 274,000 | |
Other | |
| - | | |
| 281,000 | |
Subtotal | |
| 34,502,000 | | |
| 29,602,000 | |
Less: valuation allowance | |
| (34,502,000 | ) | |
| (29,602,000 | ) |
Deferred
tax asset, net | |
$ | - | | |
$ | - | |
|
SCHEDULE OF RECONCILIATION OF INCOME TAXES |
SCHEDULE
OF RECONCILIATION OF INCOME TAXES
| |
Year
Ended October 31, | |
| |
2023 | | |
2022 | |
Income tax benefit at U.S. Federal
statutory income tax rate | |
| (2,085,000 | ) | |
| (21.00 | )% | |
$ | (2,892,000 | ) | |
| (21.00 | )% |
State income taxes | |
| (693,000 | ) | |
| (6.98 | )% | |
| (962,000 | ) | |
| (6.98 | )% |
Permanent differences | |
| 20,000 | | |
| 0.20 | % | |
| 14,000 | | |
| 0.10 | % |
Expiring net operating losses, credits and
other | |
| 1,436,000 | | |
| 14.46 | % | |
| 2,469,000 | | |
| 17.93 | % |
Change in valuation
allowance | |
| 1,322,000 | | |
| 13.32 | % | |
| 1,371,000 | | |
| 9.95 | % |
Income
tax provision | |
$ | - | | |
| 0.00 | % | |
$ | - | | |
| 0.00 | % |
|
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v3.23.4
SEGMENT INFORMATION (Tables)
|
12 Months Ended |
Oct. 31, 2023 |
Segment Reporting [Abstract] |
|
SCHEDULE OF SEGMENT INFORMATION |
SCHEDULE
OF SEGMENT INFORMATION
| |
| | |
| |
| |
Year
Ended October 31, | |
| |
2023 | | |
2022 | |
Net income (loss): | |
| | | |
| | |
CAR-T Therapeutics | |
$ | (3,879 | ) | |
$ | (5,776 | ) |
Cancer Vaccines | |
| (5,111 | ) | |
| (4,889 | ) |
Anti-Viral Therapeutics | |
| (945 | ) | |
| (3,075 | ) |
Other | |
| 5 | | |
| (31 | ) |
Total | |
$ | (9,930 | ) | |
$ | (13,771 | ) |
| |
| | | |
| | |
Net
income (loss) | |
$ | (9,930 | ) | |
$ | (13,771 | ) |
Total operating costs and expenses | |
$ | 11,221 | | |
$ | 13,875 | |
Less non-cash share-based
compensation | |
| (4,735 | ) | |
| (6,655 | ) |
Operating
costs and expenses excluding non-cash share-based compensation | |
$ | 6,486 | | |
$ | 7,220 | |
| |
| | | |
| | |
Operating costs and expenses excluding non-cash
share based compensation: | |
| | | |
| | |
CAR-T Therapeutics | |
$ | 2,467 | | |
$ | 3,206 | |
Cancer Vaccines | |
| 3,265 | | |
| 2,355 | |
Anti-Viral Therapeutics | |
| 553 | | |
| 1,634 | |
Other | |
| 201 | | |
| 25 | |
Total | |
$ | 6,486 | | |
$ | 7,220 | |
Operating
costs and expenses excluding non-cash share based compensation | |
$ | 6,486 | | |
$ | 7,220 | |
| |
| | | |
| | |
| |
| October
31, | |
| |
| 2023 | | |
| 2022 | |
Total assets: | |
| | | |
| | |
CAR-T Therapeutics | |
$ | 7,523 | | |
$ | 16,921 | |
Cancer Vaccines | |
| 17,215 | | |
| 9,442 | |
Anti-Viral Therapeutics | |
| 700 | | |
| 3,811 | |
Other | |
| 84 | | |
| 238 | |
Total | |
$ | 25,522 | | |
$ | 30,412 | |
Total assets | |
$ | 25,522 | | |
$ | 30,412 | |
|
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v3.23.4
X |
- DefinitionThe percentage of ownership of common stock or equity participation in the investee accounted for under the equity method of accounting.
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v3.23.4
SCHEDULE OF FAIR VALUE MEASUREMENTS (Details) - USD ($) $ in Thousands |
Oct. 31, 2023 |
Oct. 31, 2022 |
Platform Operator, Crypto-Asset [Line Items] |
|
|
Total financial assets |
$ 23,707
|
$ 29,502
|
Money Market Funds [Member] |
|
|
Platform Operator, Crypto-Asset [Line Items] |
|
|
Cash equivalents |
778
|
11,175
|
Certificates of Deposit [Member] |
|
|
Platform Operator, Crypto-Asset [Line Items] |
|
|
Cash equivalents |
|
1,000
|
Short term investments |
720
|
13,700
|
US Treasury Securities [Member] |
|
|
Platform Operator, Crypto-Asset [Line Items] |
|
|
Short term investments |
22,209
|
3,627
|
Fair Value, Inputs, Level 1 [Member] |
|
|
Platform Operator, Crypto-Asset [Line Items] |
|
|
Total financial assets |
778
|
11,175
|
Fair Value, Inputs, Level 1 [Member] | Money Market Funds [Member] |
|
|
Platform Operator, Crypto-Asset [Line Items] |
|
|
Cash equivalents |
778
|
11,175
|
Fair Value, Inputs, Level 1 [Member] | Certificates of Deposit [Member] |
|
|
Platform Operator, Crypto-Asset [Line Items] |
|
|
Short term investments |
|
|
Fair Value, Inputs, Level 1 [Member] | US Treasury Securities [Member] |
|
|
Platform Operator, Crypto-Asset [Line Items] |
|
|
Short term investments |
|
|
Fair Value, Inputs, Level 2 [Member] |
|
|
Platform Operator, Crypto-Asset [Line Items] |
|
|
Total financial assets |
22,929
|
18,327
|
Fair Value, Inputs, Level 2 [Member] | Money Market Funds [Member] |
|
|
Platform Operator, Crypto-Asset [Line Items] |
|
|
Cash equivalents |
|
|
Fair Value, Inputs, Level 2 [Member] | Certificates of Deposit [Member] |
|
|
Platform Operator, Crypto-Asset [Line Items] |
|
|
Cash equivalents |
|
1,000
|
Short term investments |
720
|
13,700
|
Fair Value, Inputs, Level 2 [Member] | US Treasury Securities [Member] |
|
|
Platform Operator, Crypto-Asset [Line Items] |
|
|
Short term investments |
22,209
|
3,627
|
Fair Value, Inputs, Level 3 [Member] |
|
|
Platform Operator, Crypto-Asset [Line Items] |
|
|
Total financial assets |
|
|
Fair Value, Inputs, Level 3 [Member] | Money Market Funds [Member] |
|
|
Platform Operator, Crypto-Asset [Line Items] |
|
|
Cash equivalents |
|
|
Fair Value, Inputs, Level 3 [Member] | Certificates of Deposit [Member] |
|
|
Platform Operator, Crypto-Asset [Line Items] |
|
|
Short term investments |
|
|
Fair Value, Inputs, Level 3 [Member] | US Treasury Securities [Member] |
|
|
Platform Operator, Crypto-Asset [Line Items] |
|
|
Short term investments |
|
|
X |
- DefinitionFair value portion of probable future economic benefits obtained or controlled by an entity as a result of past transactions or events.
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v3.23.4
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) - USD ($)
|
|
|
12 Months Ended |
Nov. 01, 2021 |
Jun. 01, 2021 |
Oct. 31, 2023 |
Oct. 31, 2022 |
Property, Plant and Equipment [Line Items] |
|
|
|
|
Revenue percentage |
|
|
100.00%
|
|
Certificates of deposit fair value |
|
|
$ 22,929,000
|
$ 17,327,000
|
Unrecognized tax benefits |
|
|
$ 5,194,000
|
|
Net amount at risk by product and guarantee, weighted average period remaining |
|
|
1 year 8 months 12 days
|
|
Exercise price |
|
|
|
$ 2.58
|
Share-based compensation, expected term |
|
|
5 years 5 months 19 days
|
5 years 9 months 3 days
|
Share-based compensation, expected volatility rate |
|
|
100.27%
|
102.72%
|
Share-based compensation, risk free interest rate |
|
|
3.87%
|
1.99%
|
Equity Option [Member] |
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
Stock or unit option plan expense |
|
|
|
$ 2,537,000
|
Share-Based Payment Arrangement, Tranche One [Member] |
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
Common stock issued market condition stock options to purchase, shares |
|
|
500,000
|
|
Warrant [Member] |
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
Vesting period |
5 months
|
|
|
|
Antidilutive securities excluded from the calculation of Diluted EPS |
|
|
300,000
|
300,000
|
2018 Share Plan [Member] |
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
Shares options, granted |
|
|
1,640,000
|
1,430,000
|
Exercise price |
|
|
$ 2.89
|
$ 3.15
|
Equity Option [Member] |
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
Antidilutive securities excluded from the calculation of Diluted EPS |
|
|
11,430,000
|
10,318,872
|
Equity Option [Member] | Minimum [Member] |
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
Expiration period |
|
|
5 years
|
|
Vesting period |
|
|
12 months
|
|
Equity Option [Member] | Maximum [Member] |
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
Expiration period |
|
|
|
10 years
|
Vesting period |
|
|
36 months
|
|
Equity Option [Member] | 2018 Share Plan [Member] |
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
Shares options, granted |
|
2,000,000
|
|
|
Equity Option [Member] | 2018 Share Plan [Member] | Minimum [Member] |
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
Exercise price |
|
$ 5.00
|
|
|
Equity Option [Member] | 2018 Share Plan [Member] | Maximum [Member] |
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
Exercise price |
|
$ 8.00
|
|
|
Equity Option [Member] | 2018 Share Plan [Member] | Common Stock [Member] |
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
Shares options, granted |
|
100,000
|
|
|
Employees and directors [Member] |
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
Stock-based compensation expense |
|
|
$ 4,422,000
|
$ 3,463,000
|
Stock or unit option plan expense |
|
|
$ 3,023,000
|
2,788,000
|
Chairman president and chief executive officer [Member] | Share-Based Payment Arrangement, Tranche One [Member] |
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
Common stock issued market condition stock options to purchase, shares |
|
|
25,000
|
|
Chairman president and chief executive officer [Member] | Market conditions stock option [Member] |
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
Share-based compensation, exercise price |
|
$ 4.02
|
|
|
Share-based compensation, expected term |
|
10 years
|
|
|
Share-based compensation, expected volatility rate |
|
75.00%
|
|
|
Share-based compensation, risk free interest rate |
|
1.62%
|
|
|
Consultants[Member] | Warrant [Member] |
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
Stock or unit option plan expense |
|
|
$ 0
|
221,000
|
Consultants[Member] | Service based and performance based stock options [Member] |
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
Stock or unit option plan expense |
|
|
221,000
|
434,000
|
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount |
|
|
$ 281,000
|
|
Weighted-average period recognition |
|
|
2 years 6 months
|
|
Consultants[Member] | Non vested stock option[Member] |
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
Stock or unit option plan expense |
|
|
$ 209,000
|
$ 434,000
|
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SCHEDULE OF OPTION ACTIVITY (Details) - USD ($) $ / shares in Units, $ in Thousands |
12 Months Ended |
Oct. 31, 2023 |
Oct. 31, 2022 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
Shares, Options outstanding, beginning balance |
|
1,642,000
|
Weighted Average Exercise Price Per Share, Outstanding Beginning balance |
|
$ 2.58
|
Shares, Options, Exercised |
|
(1,642,000)
|
Weighted Average Exercise Price Per Share, Exercised |
|
$ 2.58
|
Shares, Options outstanding and Exercisable |
|
|
2010 Share Plan [Member] |
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
Shares, Options outstanding, beginning balance |
1,501,500
|
1,718,634
|
Weighted Average Exercise Price Per Share, Outstanding Beginning balance |
$ 2.83
|
$ 2.82
|
Shares, Options, Exercised |
(312,500)
|
(212,000)
|
Weighted Average Exercise Price Per Share, Exercised |
$ 2.41
|
$ 2.68
|
Shares, Options, Expired |
|
(5,134)
|
Weighted average price per share, forfeited or expired |
|
$ 3.63
|
Shares, Options outstanding, Ending balance |
1,189,000
|
1,501,500
|
Weighted Average Exercise Price Per Share, Outstanding Ending balance |
$ 2.94
|
$ 2.83
|
Aggregate intrinsic value, outstanding and exercisable |
$ 770,800
|
|
2018 Share Plan [Member] |
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
Shares, Options outstanding, beginning balance |
8,817,372
|
7,409,992
|
Weighted Average Exercise Price Per Share, Outstanding Beginning balance |
$ 3.60
|
$ 3.76
|
Shares, Options, Exercised |
(6,372)
|
(22,620)
|
Weighted Average Exercise Price Per Share, Exercised |
$ 2.89
|
$ 3.15
|
Weighted average price per share, forfeited or expired |
$ 5.10
|
|
Shares, Options outstanding, Ending balance |
10,241,000
|
8,817,372
|
Weighted Average Exercise Price Per Share, Outstanding Ending balance |
$ 3.67
|
$ 3.60
|
Shares, options, granted |
1,640,000
|
1,430,000
|
Weighted Average Exercise Price Per Share, Granted |
$ 3.97
|
$ 2.74
|
Shares, options, forfeited or expired |
(210,000)
|
|
Aggregate Intrinsic Value, Outstanding Ending balance |
$ 1,112,030
|
|
Shares, Options outstanding, Exercisable |
6,721,970
|
|
Weighted Average Exercise Price Per Share, Exercisable |
$ 3.50
|
|
Aggregate Intrinsic Value, Exercisable |
$ 884,783
|
|
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v3.23.4
SCHEDULE OF OUTSTANDING AND EXERCISABLE (Details) - $ / shares
|
12 Months Ended |
|
|
Oct. 31, 2023 |
Oct. 31, 2022 |
Oct. 31, 2021 |
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
Number outstanding and exercisable |
|
|
1,642,000
|
Weighted average exercise price |
|
|
$ 2.58
|
Range One [Member] | Warrant [Member] |
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
Number outstanding and exercisable |
300,000
|
|
|
Weighted average remaining contractual life |
2 years 4 months 20 days
|
|
|
Weighted average exercise price |
$ 6.56
|
|
|
Range of exercise prices |
$ 6.56
|
|
|
2010 Share Plan [Member] |
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
Number outstanding and exercisable |
1,189,000
|
1,501,500
|
1,718,634
|
Weighted average exercise price |
$ 2.94
|
$ 2.83
|
$ 2.82
|
2010 Share Plan [Member] | Range One [Member] |
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
Range of exercise prices, lower limit |
0.67
|
|
|
Range of exercise prices, upper limit |
$ 2.27
|
|
|
Number outstanding and exercisable |
366,000
|
|
|
Weighted average remaining contractual life |
3 years 7 months 2 days
|
|
|
Weighted average exercise price |
$ 1.27
|
|
|
2010 Share Plan [Member] | Range Two [Member] |
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
Range of exercise prices, lower limit |
2.58
|
|
|
Range of exercise prices, upper limit |
$ 3.13
|
|
|
Number outstanding and exercisable |
314,000
|
|
|
Weighted average remaining contractual life |
2 years 2 months 15 days
|
|
|
Weighted average exercise price |
$ 2.91
|
|
|
2010 Share Plan [Member] | Range Three [Member] |
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
Range of exercise prices, lower limit |
3.46
|
|
|
Range of exercise prices, upper limit |
$ 5.30
|
|
|
Number outstanding and exercisable |
509,000
|
|
|
Weighted average remaining contractual life |
4 years 6 months 14 days
|
|
|
Weighted average exercise price |
$ 4.17
|
|
|
2018 Share Plan [Member] |
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
Number outstanding and exercisable |
10,241,000
|
8,817,372
|
7,409,992
|
Weighted average exercise price |
$ 3.67
|
$ 3.60
|
$ 3.76
|
Number exercisable, options exercisable |
6,721,970
|
|
|
Weighted average exercise price, options exercisable |
$ 3.50
|
|
|
2018 Share Plan [Member] | Range One [Member] |
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
Range of exercise prices, lower limit |
2.09
|
|
|
Range of exercise prices, upper limit |
$ 3.87
|
|
|
Number outstanding and exercisable |
5,476,000
|
|
|
Weighted average remaining contractual life |
6 years 6 months
|
|
|
Weighted average exercise price |
$ 3.24
|
|
|
Number exercisable, options exercisable |
4,828,361
|
|
|
Weighted average remaining contractual life (in years), options exercisable |
6 years 2 months 19 days
|
|
|
Weighted average exercise price, options exercisable |
$ 3.29
|
|
|
2018 Share Plan [Member] | Range Two [Member] |
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
Range of exercise prices, lower limit |
3.96
|
|
|
Range of exercise prices, upper limit |
$ 5.30
|
|
|
Number outstanding and exercisable |
4,765,000
|
|
|
Weighted average remaining contractual life |
7 years 8 months 12 days
|
|
|
Weighted average exercise price |
$ 4.16
|
|
|
Number exercisable, options exercisable |
1,893,609
|
|
|
Weighted average remaining contractual life (in years), options exercisable |
7 years 2 months 12 days
|
|
|
Weighted average exercise price, options exercisable |
$ 4.02
|
|
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v3.23.4
SCHEDULE OF WARRANTS ACTIVITY (Details) - Warrant [Member] - USD ($) $ / shares in Units, $ in Thousands |
12 Months Ended |
|
Oct. 31, 2022 |
Oct. 31, 2023 |
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
Warrants outstanding, beginning balance |
860,000
|
|
Weighted average exercise price per share warrants outstanding, beginning balance |
$ 5.36
|
|
Warrants Outstanding, Issued |
60,000
|
|
Weighted Average Exercise Price Per Share, Issued |
$ 4.77
|
|
Warrants Outstanding, Exercised |
(60,000)
|
|
Weighted Average Exercise Price Per Share, Exercised |
$ 2.06
|
|
Warrants Outstanding, Expired |
(560,000)
|
|
Weighted Average Exercise Price Per Share, Expired |
$ 4.71
|
|
Warrants outstanding and exercisable, ending balance |
300,000
|
|
Warrants outstanding and exercisable, ending balance |
300,000
|
300,000
|
Weighted average exercise price per share warrants outstanding and exercisable, ending balance |
$ 6.56
|
|
Weighted average exercise price per share warrants outstanding and exercisable, ending balance |
$ 6.56
|
$ 6.56
|
Aggregate intrinsic value, Warrants outstanding and exercisable, ending balance |
$ 0
|
|
Aggregate intrinsic value, Warrants outstanding and exercisable, ending balance |
$ 0
|
$ 0
|
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- DefinitionNumber of equity instruments other than options exercisable, including both vested and non-vested instruments.
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v3.23.4
SHAREHOLDERS’ EQUITY (Details Narrative) - USD ($)
|
|
12 Months Ended |
Nov. 01, 2021 |
Oct. 31, 2023 |
Oct. 31, 2022 |
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
Stock Issued During Period, Value, Stock Options Exercised |
|
$ 353,000
|
$ 439,000
|
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Exercises in Period |
|
|
1,642,000
|
Stock Issued During Period, Value, Employee Stock Purchase Plan |
|
$ 13,000
|
$ 13,000
|
Warrant [Member] |
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
Class of Warrant or Right, Date from which Warrants or Rights Exercisable |
Oct. 30, 2026
|
|
|
Class of Warrant or Right, Exercise Price of Warrants or Rights |
|
$ 6.5625
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award, Award Vesting Period |
5 months
|
|
|
Consulting expense |
|
|
$ 221,000
|
Class of Warrant or Right, Number of Securities Called by Warrants or Rights |
|
300,000
|
|
Warrants and Rights Outstanding, Maturity Date |
|
Mar. 22, 2026
|
|
Warrant [Member] | Consultants[Member] |
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
Purchase shares of common stock |
60,000
|
|
|
Class of Warrant or Right, Exercise Price of Warrants or Rights |
$ 4.77
|
|
|
2018 Share Plan [Member] |
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Exercises in Period |
|
6,372
|
22,620
|
Common Stock, Capital Shares Reserved for Future Issuance |
|
2,000,000
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Available for Grant |
|
750,000
|
|
Employee Stock Purchase Plan [Member] |
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award, Purchase Price of Common Stock, Percent |
|
85.00%
|
|
Stock Issued During Period, Shares, Employee Stock Purchase Plans |
|
4,360
|
4,741
|
Stock Issued During Period, Value, Employee Stock Purchase Plan |
|
$ 13,000
|
$ 13,000
|
Stock Option Activity [Member] |
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award, Shares Purchased for Award |
|
157,761
|
387,739
|
Stock Issued During Period, Value, Stock Options Exercised |
|
$ 353,000
|
$ 439,000
|
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Exercises in Period |
|
161,111
|
1,488,881
|
Share-Based Payment Arrangement, Shares Withheld for Tax Withholding Obligation |
|
116,225
|
1,083,517
|
2010 Share Plan [Member] |
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
Common Stock, Capital Shares Reserved for Future Issuance |
|
800,000
|
|
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v3.23.4
SCHEDULE OF INCOME TAX PROVISION (BENEFIT) (Details) - USD ($) $ in Thousands |
12 Months Ended |
Oct. 31, 2023 |
Oct. 31, 2022 |
Income Tax Disclosure [Abstract] |
|
|
Current |
|
|
Deferred |
(1,739,000)
|
(1,021,000)
|
Current |
|
|
Deferred |
(583,000)
|
(350,000)
|
Adjustment to valuation allowance related to net deferred tax assets |
1,322,000
|
1,371,000
|
Total |
|
|
X |
- DefinitionAmount of current federal tax expense (benefit) attributable to income (loss) from continuing operations. Includes, but is not limited to, current national tax expense (benefit) for non-US (United States of America) jurisdiction.
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SCHEDULE OF DEFERRED TAX ASSETS AND LIABILITIES (Details) - USD ($) $ in Thousands |
Oct. 31, 2023 |
Oct. 31, 2022 |
Income Tax Disclosure [Abstract] |
|
|
Federal and state NOL and tax credit carryforwards |
$ 26,532,000
|
$ 22,196,000
|
Deferred compensation |
7,752,000
|
6,851,000
|
Intangibles |
218,000
|
274,000
|
Other |
|
281,000
|
Subtotal |
34,502,000
|
29,602,000
|
Less: valuation allowance |
(34,502,000)
|
(29,602,000)
|
Deferred tax asset, net |
|
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SCHEDULE OF RECONCILIATION OF INCOME TAXES (Details) - USD ($)
|
12 Months Ended |
Oct. 31, 2023 |
Oct. 31, 2022 |
Income Tax Disclosure [Abstract] |
|
|
Income tax benefit at U.S. Federal statutory income tax rate |
$ (2,085,000)
|
$ (2,892,000)
|
Income tax benefit at U.S. Federal statutory income tax rate, rate |
(21.00%)
|
(21.00%)
|
State income taxes |
$ (693,000)
|
$ (962,000)
|
State income taxes, rate |
(6.98%)
|
(6.98%)
|
Permanent differences |
$ 20,000
|
$ 14,000
|
Permanent differences, rate |
0.20%
|
0.10%
|
Expiring net operating losses, credits and other |
$ 1,436,000
|
$ 2,469,000
|
Expiring net operating losses, credits and other, rate |
14.46%
|
17.93%
|
Change in valuation allowance |
$ 1,322,000
|
$ 1,371,000
|
Change in valuation allowance, rate |
13.32%
|
9.95%
|
Income tax provision |
|
|
Income tax provision, rate |
0.00%
|
0.00%
|
v3.23.4
INCOME TAXES (Details Narrative) - USD ($)
|
12 Months Ended |
Oct. 31, 2023 |
Oct. 31, 2022 |
Operating Loss Carryforwards [Line Items] |
|
|
Valuation allowance deferred tax asset percentage |
100.00%
|
|
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent |
21.00%
|
21.00%
|
Effective Income Tax Rate Reconciliation, Percent |
0.00%
|
0.00%
|
Unrecognized income tax benefits, penalties |
|
$ 0
|
Federal Corporate Taxable [Member] |
|
|
Operating Loss Carryforwards [Line Items] |
|
|
Net operating loss carryforwards |
$ 95,752,000
|
|
Tax credit carryforward, amount |
1,870,000
|
|
CANADA |
|
|
Operating Loss Carryforwards [Line Items] |
|
|
Net operating loss carryforwards |
$ 51,065,000
|
|
Operating loss carryforwards, limitations on use |
expiring
at various dates between 2024 and 2043
|
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v3.23.4
SCHEDULE OF SEGMENT INFORMATION (Details) - USD ($) $ in Thousands |
12 Months Ended |
Oct. 31, 2023 |
Oct. 31, 2022 |
Segment Reporting Information [Line Items] |
|
|
Net income (loss) |
$ (9,930)
|
$ (13,771)
|
Total operating costs and expenses |
11,221
|
13,875
|
Less non-cash share-based compensation |
(4,735)
|
(6,655)
|
Operating costs and expenses excluding non-cash share based compensation |
6,486
|
7,220
|
Total assets |
25,522
|
30,412
|
CAR-T Therapeutics [Member] |
|
|
Segment Reporting Information [Line Items] |
|
|
Net income (loss) |
(3,879)
|
(5,776)
|
Operating costs and expenses excluding non-cash share based compensation |
2,467
|
3,206
|
Total assets |
7,523
|
16,921
|
Cancer Vaccines [Member] |
|
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|
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|
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|
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|
|
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553
|
1,634
|
Total assets |
700
|
3,811
|
Other [Member] |
|
|
Segment Reporting Information [Line Items] |
|
|
Net income (loss) |
5
|
(31)
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|
25
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Total assets |
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$ 238
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