Anixa Biosciences, Inc.

 
 
 
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, 2025
 
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 30, 2025 (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 ($2.79): $85,116,394.
 
On January 12, 2026, the registrant had outstanding 33,376,690 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
 
 
 
Page
 
PART I
 
 
 
 
Item 1.
Business
2
Item 1A.
Risk Factors
9
Item 1B.
Unresolved Staff Comments
26
Item 1C.
Cybersecurity
26
Item 2.
Properties
27
Item 3.
Legal Proceedings
27
Item 4.
Mine Safety Disclosures
27
 
 
 
 
PART II
 
 
 
 
Item 5.
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
28
Item 6.
[Reserved]
28
Item 7.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
28
Item 7A.
Quantitative and Qualitative Disclosures about Market Risk
32
Item 8.
Financial Statements and Supplementary Data
32
Item 9.
Changes in and Disagreements With Accountants on Accounting and Financial Disclosure
32
Item 9A.
Controls and Procedures
32
Item 9B.
Other Information
33
 
 
 
 
PART III
 
 
 
 
Item 10.
Directors, Executive Officers and Corporate Governance
33
Item 11.
Executive Compensation
33
Item 12.
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
34
Item 13.
Certain Relationships and Related Transactions, and Director Independence
34
Item 14.
Principal Accountant Fees and Services
34
 
 
 
 
PART IV
 
 
 
 
Item 15.
Exhibits and Financial Statement Schedules
34
Item 16.
Form 10-K Summary
35
 
i

 
 
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.
 
1

 
  
PART I
 
Item 1. Business
 
Overview
 
Anixa Biosciences, Inc. is a biotechnology company developing therapies and vaccines that are focused on critical unmet needs in oncology. Our therapeutics program
consists of the development of liraltagene autoleucel (“lira-cel”), a chimeric endocrine receptor-T cell therapy, which is a novel form of chimeric antigen receptor-T cell
(“CAR-T”) technology, initially focused on treating ovarian cancer, that is being developed at our subsidiary, Certainty Therapeutics, Inc. (“Certainty”). Our vaccine programs
include (i) the development of a vaccine against breast cancer, (ii) the development of a vaccine against ovarian cancer, and (iii) a vaccine discovery program utilizing the same
mechanism as our breast and ovarian cancer vaccines to develop additional cancer vaccines to address many intractable cancers, including high incidence malignancies in lung,
colon and prostate.
 
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 National Cancer Institute
(“NCI”) designated cancer research center, relating to Wistar’s chimeric endocrine receptor targeted therapy technology. We have initially focused on the development of a
treatment for ovarian cancer, but we also may pursue applications of the technology for the development of treatments for additional solid tumors. The license agreement
requires Certainty to make certain cash and equity payments to Wistar upon achievement of specific development 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 is subject to dilution by further
funding of Certainty’s activities by the Company. Due to such Company funding, Wistar’s equity stake in Certainty was 4.1% as of October 31, 2025.
 
Certainty, in collaboration with the H. Lee Moffitt Cancer Center and Research Institute, Inc. (“Moffitt”), has begun human clinical testing of lira-cel, the CAR-T
technology licensed by Certainty from Wistar aimed initially at treating ovarian cancer. After receiving authorization from the U.S. Food and Drug Administration (“FDA”), we
commenced enrollment of patients in a Phase 1 clinical trial and treated the first patient in August 2022. Further, in May 2023 and August 2023, we treated the second and third
patients in the trial, respectively, at the same dose level as the first patient, and the treatment was well-tolerated by the patients. Between February and June 2024, we treated the
three patients of the second dose cohort, where the patients were administered a three-times higher dose of cells than the patients in the first cohort. The treatment at this dose
level was also well-tolerated by the patients. From November 2024 to February 2025, we treated three patients in the third dose cohort, where they were administered a ten-
times higher dose of cells than the patients in the first dose cohort. Consistent with the lower dose cohorts, the treatment was well-tolerated by the patients. Subsequently, we
treated the patients in the fourth dose cohort, administering a 30-times higher dose of cells than the patients in the first dose cohort, and again the treatment appears to have
been well-tolerated.
 
While the dose levels in the first three cohorts were expected to be sub-therapeutic, multiple patients have exhibited anecdotal signs of efficacy, including possible
signs of T cell infiltration and tumor necrosis. For example, many patients have survived beyond expectations, including one patient that survived over two years past initial
treatment and three other patients that survived over one year past treatment. In the case of the patient that survived over two years past initial treatment, due to the encouraging
results with her initial treatment, we sought single patient Investigational New Drug (“IND”) application permission from the FDA to re-dose her. This re-dosing was approved
by the FDA, and we administered her second treatment in October 2024. This second treatment was well-tolerated by the patient.
 
This study is a dose-escalation trial with two arms based on route of delivery—intraperitoneal or intravenous—to determine the maximum tolerated dose in patients
with recurrent epithelial ovarian cancer and to assess persistence, expansion and efficacy of the modified T cells. The study is being conducted at Moffitt and will consist of up
to 24 to 48 patients who have received at least two prior lines of chemotherapy. The study is estimated to be completed in two to three years depending on multiple factors
including when the maximum tolerated dose is reached, the rate of patient enrollment, the significance of efficacy data and how long we maintain the two different delivery
methods.
 
We hold an exclusive worldwide, royalty-bearing license to use certain intellectual property owned or controlled by The Cleveland Clinic Foundation (“Cleveland
Clinic”) relating to certain breast cancer vaccine technology developed at Cleveland Clinic. The license agreement requires us to make certain cash payments to Cleveland
Clinic upon achievement of specific development milestones. Utilizing this technology, we are working in collaboration with Cleveland Clinic to develop a method to vaccinate
women against breast cancer, focused initially on triple-negative breast cancer (“TNBC”), the most lethal form of the disease. The focus of this vaccine is a specific protein, α-
lactalbumin, that is only expressed during lactation in a healthy woman’s mammary tissue. This protein disappears when the woman is no longer lactating, but reappears in
many forms of breast cancer, especially TNBC. Studies have shown that vaccinating against this protein prevents breast cancer in mice.
 
2

 
 
In October 2021, following the FDA’s authorization to proceed, we commenced dosing patients in a Phase 1 clinical trial of our breast cancer vaccine. This study,
which has been fully funded by a U.S. Department of Defense grant to Cleveland Clinic, is a multiple-ascending dose Phase 1 trial to determine the maximum tolerated dose
(“MTD”) of the vaccine in patients with early-stage, triple-negative breast cancer as well as monitor immune response. The study has been conducted at Cleveland Clinic.
During the course of the Phase 1 study, participants received three vaccinations, each two weeks apart, and have been closely monitored for side effects and immune response.
The first patient cohort in the study, Cohort Ia, consisted of patients who had completed treatment for early-stage, triple-negative breast cancer within the past three years and
were currently tumor-free but at high risk for recurrence. Studies show that 42% of TNBC patients will have a recurrence of their cancer, with most of the recurrences occurring
in the first two to three years after standard of care treatment. In January 2023, the number of participants in each dose cohort was expanded, and as of August 2023, we had
completed vaccinating all patients in these expanded cohorts. Subsequently, we began vaccinating participants in additional dose cohorts at varying dose levels of the different
key components of the vaccine. Further, in November 2023, we commenced vaccination of participants in the second patient cohort in the trial, Cohort Ib, that included
participants who have never had cancer, but carry certain mutations in genes such as BRCA1, BRCA2 or PALB2, that indicate a greater risk of developing TNBC in the future,
and had elected to have a prophylactic mastectomy. Finally, in January 2024, we commenced vaccination of participants in the third patient cohort in the trial, Cohort Ic, that
includes post-operative TNBC patients that have residual disease following treatment and are currently undergoing treatment with pembrolizumab (Keytruda®). In June 2025,
we completed enrollment in the Phase 1 trial and in October 2025, we completed all patient clinical visits.
 
On December 11, 2025, we presented the final data from the Phase 1 clinical trial of our investigational breast cancer vaccine at the San Antonio Breast Cancer
Symposium. The key results presented were that i) all primary study endpoints were met, ii) protocol defined immune responses were observed in 74% of the study subjects, iii)
the vaccine was safe and well-tolerated by study participants at the MTD, with adverse events primarily injection-site irritation and iv) preliminary immunohistochemistry
(IHC) of the subjects’ primary tumors for alpha-lactalbumin protein revealed a range of expression from absent to strong—analysis and correlation to immune response and
clinical outcomes is ongoing. Consenting participants will be followed for five years after completing the study. Combination of Keytruda and the vaccine also generated
antigen-specific T cell responses and showed no major additional side effect. The data from the Phase 1 trial will inform planned Phase 2 study design, including a potential
Phase 2 combination study with Keytruda in the neoadjuvant setting among newly diagnosed breast cancer patients.
 
The Phase 1 study evaluated safety and monitored immune response to an investigational vaccine targeting α-lactalbumin. The trial enrolled 35 participants across
three cohorts: Cohort Ia (n=26), women who completed standard-of-care treatment, including surgery, for early-stage TNBC within three years and were tumor-free but at
elevated risk of recurrence; Cohort Ib (n=4), cancer-free women with BRCA1, BRCA2, or PALB2 mutations who elected preventive mastectomy and were vaccinated prior to
surgery; and Cohort Ic (n=5), women with TNBC receiving pembrolizumab (Keytruda) in the adjuvant (post-surgery) setting, with evaluation of safety of combination
administration and immune responses. In Cohort Ia, at the MTD, the vaccine was reported as safe, with no flu-like symptoms (fever and myalgias), no abnormal clinical
laboratory tests, and no other observed adverse side effects in this cohort; the primary notable adverse event was injection-site irritation. Participants demonstrated α-
lactalbumin-specific T cell responses, including production of interferon gamma and interleukin-17. In Cohort Ib, safety and tolerability were similar to Cohort Ia.
Immunohistochemistry analyses of resected breast tissue are ongoing and will be presented in a future scientific presentation. In Cohort Ic, a key objective was to assess
whether administration of the investigational vaccine in combination with pembrolizumab could create intolerable side effects. No major adverse side effects were reported; as
in other cohorts, the primary adverse event was injection-site irritation. Two participants in Cohort Ic experienced Grade 3 adverse events consisting of greater irritation at an
injection site.
 
We hold an exclusive worldwide, royalty-bearing license to use certain intellectual property owned or controlled by Cleveland Clinic relating to certain ovarian cancer
vaccine technology. The license agreement requires us to make certain cash payments to Cleveland Clinic upon achievement of specific development 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 NCI’s 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 IND enabling studies. This work is being performed at
NCI facilities, by NCI scientific staff and with NCI financial resources and will require no material financial expenditures by the Company, nor the payment of any future
consideration by the Company to NCI.
 
In May 2024, based on the positive clinical results to date in the development of our breast cancer vaccine, we entered into a Joint Development and Option
Agreement with Cleveland Clinic to collaborate in efforts to develop additional vaccines for the prevention or treatment of cancers. Working with Cleveland Clinic researchers,
we are focusing on the same novel scientific mechanism as in our breast and ovarian cancer vaccines, and working to discover additional retired proteins that may be associated
with other forms of cancer, specifically high incidence malignancies in the lung, colon and prostate.
 
Over the next several quarters, we expect the development of our therapeutics and vaccines to be the primary focus of the Company. As part of our legacy operations,
the Company remains engaged in limited patent licensing activities of its various patent portfolios. We do not expect these activities to be a significant part of the Company’s
ongoing operations nor do we expect these activities to require material financial resources or attention of senior management.
 
3

 
 
Over the past several years, our revenue was derived from technology licensing and the sale of patented technologies, including revenue from the settlement of
litigation. We have not generated any revenue to date from our therapeutics or vaccine programs. In addition, while we pursue our therapeutics and vaccine programs, we may
also make investments in and form new companies to develop additional emerging technologies. We do not expect to begin generating revenue with respect to any of our
current therapeutics or vaccine programs in the near term. We hope to achieve a profitable outcome by eventually licensing our technologies to large pharmaceutical companies
that have the resources and infrastructure in place to manufacture, market and sell our technologies as therapeutics or vaccines. The eventual licensing of any of our
technologies may take several years, if it is to occur at all, and may depend on positive results from human clinical trials.
 
CAR-T therapeutics
 
Certainty was formed to develop immuno-therapy drugs against cancer, and in November 2017, we entered into a license with Wistar whereby we obtained rights to
certain intellectual property surrounding Wistar’s chimeric endocrine receptor targeted therapy technology.
 
CAR-T therapeutics have demonstrated positive results in B cell cancers, but very little progress has been made on solid tumors. Our CAR-T technology, lira-cel, is
initially focused on ovarian cancer and is based on engineering killer T cells with the Follicle Stimulating Hormone (“FSH”) to target cells that express the FSH-Receptor. Data
on this technology, including the animal studies showing efficacy, was published in January 2017 in the journal, Clinical Cancer Research. The FSH-Receptor has been shown
to be a very exclusive protein found on a large percentage of ovarian cancer cells, but not on a significant number of non-ovarian healthy tissues in adult 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 lira-cel 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 lira-cel. Moffitt is one of the top cancer centers in the country with pre-clinical and clinical expertise with
CAR-T technology. Moffitt has conducted many of the highest profile CAR-T trials in the world.
 
In August 2022, Moffitt began treating patients in a Phase 1 clinical trial of lira-cel. While the results to date have been positive, there are many uncertainties in drug
development, and most drugs fail to reach commercialization. In the future, we hope to achieve a profitable outcome by eventually licensing lira-cel to a large pharmaceutical
company that has the resources and infrastructure in place to manufacture, market and sell lira-cel as a cancer treatment.
 
The Market
 
We believe that lira-cel may be used as an effective treatment against multiple solid tumor types, however, we have initially focused on ovarian cancer. According to
American Cancer Society statistics, in the U.S., ovarian cancer accounts for just 2% of all female cancer cases, but over 4% of cancer deaths in women due to the disease’s low
survival rate. It has been estimated that in 2025, approximately 21,000 new cases of ovarian cancer would be diagnosed in the U.S. and approximately 13,000 women would die
from this disease. Despite continuous advances made in the field of cancer research every year, there remains a significant unmet medical need, as the overall five-year relative
survival rate for ovarian cancer patients is 51%, but ranges from 43% among Black women to 61% among Asian American/Pacific Islander women, and ranges from 92% to
31% based on whether it is first diagnosed at a local stage or a distant stage, respectively.
 
4

 
 
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. In addition, we have entered into a Joint
Development and Option Agreement with Cleveland Clinic to collaborate in efforts to develop additional vaccines for the prevention or treatment of cancers. Working with
Cleveland Clinic researchers, we are focusing on the same novel scientific mechanism as in our breast and ovarian cancer vaccines, and working to discover additional retired
proteins that may be associated with other forms of cancer, specifically high incidence malignancies in the lung, colon and prostate.
 
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 July 2016 in the journal, Nature Medicine.
 
The ovarian cancer vaccine technology licensed from Cleveland Clinic has identified the AMHR2-ED protein, the expression of which is involved in egg production in
the ovaries and is no longer expressed after menopause. AMHR2-ED is not meaningfully present on any other cell in the body. However, it does appear in many cases of
epithelial ovarian cancers, the most common type of ovarian cancer. By developing a vaccine that targets AMHR2-ED, we feel the immune system can destroy these ovarian
cancer cells as they arise and ultimately prevent tumors from forming. Data on this technology, including animal studies showing efficacy, was published in November 2017 in
the journal, Cancer Prevention Research.
 
In December 2025, the final data from the recently completed Phase 1 clinical trial of our breast cancer vaccine was presented at the San Antonio Breast Cancer
Symposium. While the reported results have been positive, there are many uncertainties in drug development, and most drugs fail to reach commercialization. In addition, we
and our partners at Cleveland Clinic continue working with the NCI who are or will be performing pre-clinical research and development, manufacturing and IND-enabling
studies to advance our ovarian cancer vaccine technology toward human clinical testing. Further, the vaccine discovery program focused on discovering vaccine targets for
lung, colon and prostate cancer is in its early stages, and there can be no assurance that appropriate vaccine targets may be identified or developed.
 
5

 
 
The Breast Cancer Market
 
According to American Cancer Society statistics, in the U.S., breast cancer accounts for over 30% of all female cancer cases, and nearly 15% of cancer deaths in
women. It has been estimated that in 2025, approximately 317,000 new cases of breast cancer would be diagnosed in the U.S. and approximately 42,000 women would die
from this disease. Despite continuous advances made in the field of cancer research every year, invasive female breast cancer incidence rates have been increasing by 1% per
year since the mid-2000s.
 
The market for prophylactic cancer vaccines is sizable—bigger in fact than the market for any type of cancer therapeutic. Cancer therapies are only administered after
a patient has been diagnosed, while a prophylactic vaccine may be administered to all people who have a possibility of developing the disease.
 
While in the U.S., approximately 317,000 women were estimated to be diagnosed with breast cancer in 2025, there are approximately 84 million women age 40 and
over—the time in life when women face an increased risk of developing breast cancer. Worldwide, the number is dramatically larger.
 
The Ovarian Cancer Market
 
According to American Cancer Society statistics, in the U.S., ovarian cancer accounts for just 2% of all female cancer cases, but over 4% of cancer deaths in women
due to the disease’s low survival rate. It has been estimated that in 2025, approximately 21,000 new cases of ovarian cancer would be diagnosed in the U.S. and approximately
13,000 women would die from this disease. Despite continuous advances made in the field of cancer research every year, there remains a significant unmet medical need, as the
overall five-year relative survival rate for ovarian cancer patients is 51%, but ranges from 43% among Black women to 61% among Asian American/Pacific Islander women,
and ranges from 92% to 31% based on whether it is first diagnosed at a local stage or a distant stage, respectively.
 
The market for prophylactic cancer vaccines is sizable—bigger in fact than the market for any type of cancer therapeutic. While in the U.S., approximately 21,000
women were estimated to be diagnosed with ovarian cancer in 2024, there are approximately 42 million women age 60 and over—the time in life when women face an
increased risk of developing ovarian cancer. Worldwide, the number is dramatically larger.
 
The Lung Cancer Market
 
According to American Cancer Society statistics, lung cancer accounts for 11% of all cancer cases, and 20% of cancer deaths. It is the third most common form of
cancer, after breast and prostate cancers, but it accounts for more deaths than any other form of cancer. It has been estimated that in 2025, approximately 227,000 new cases of
lung cancer would be diagnosed in the U.S. and approximately 125,000 people would die from this disease. Despite declining incidence and mortality rates, largely due to
reductions in smoking, the 5-year relative survival rate for lung cancer is only 27%.
 
The Colon Cancer Market
 
According to American Cancer Society statistics, colon cancer, including rectal cancer, accounts for 8% of all cancer cases, and 9% of cancer deaths. It is the fourth
most common form of cancer, after breast, prostate and lung cancers, but it is second only to lung cancer in terms of deaths. It has been estimated that in 2025, approximately
154,000 new cases of colon cancer would be diagnosed in the U.S. and approximately 53,000 people would die from this disease. While incidence rates have been declining,
primarily due to improved screening, these reduced incidence rates have been confined to individuals 65 and older. Incidence rates have been increasing in individuals younger
than 50, and have been stable for those between 50 and 64. Similar trends have been seen in mortality rates.
 
6

 
 
The Prostate Cancer Market
 
According to American Cancer Society statistics, prostate cancer accounts for nearly 30% of all male cancer cases, and 11% of cancer deaths in men. It has been
estimated that in 2025, approximately 314,000 new cases of prostate cancer would be diagnosed in the U.S. and approximately 36,000 men would die from this disease. While
overall incidence rates have been increasing by 3% per year over the last 10 years, mortality rates are relatively unchanged. The 5-year relative survival rate is nearly 100% for
men diagnosed with localized- or regional-stage prostate cancer, but drops to 37% for those diagnosed with distant-stage disease.
 
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, our proprietary cancer vaccine technologies and our scientific expertise in the field
of cell therapy provide us with competitive advantages, we face potential competition from various sources, including larger and better-funded pharmaceutical and
biotechnology companies, as well as from academic institutions, governmental agencies and public and private research institutions.
 
Many of our competitors, either alone or with their strategic partners, have substantially greater financial, technical and human resources than we do and significantly
greater experience in the discovery and development of product candidates, obtaining FDA and other regulatory approvals of therapies and vaccines and commercializing those
therapies and vaccines. Accordingly, our competitors may be more successful than us in obtaining approval for therapies and vaccines and achieving widespread market
acceptance. Our competitors’ therapies and vaccines may be more effective, or more effectively marketed and sold, than any therapy or vaccine we may commercialize and may
render our therapies and vaccines obsolete or non-competitive before we can recover the expenses of developing and commercializing any of our therapies and vaccines.
 
Mergers and acquisitions in the biotechnology and pharmaceutical industries may result in even more resources being concentrated among a smaller number of our
competitors. These competitors also compete with us in recruiting and retaining qualified scientific and management personnel and establishing clinical study sites and subject
registration for clinical studies, as well as in acquiring technologies complementary to, or necessary for, our 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 therapies and vaccines that we develop and commercialize to compete on the basis of, among other things, efficacy, safety, convenience of administration and delivery,
price and the availability of reimbursement from government and other third-party payers.
 
Our commercial opportunities could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective, have fewer or less
severe side effects, are more convenient or are less expensive than any products that we may develop. Our competitors also may obtain FDA or other regulatory approvals for
their products more rapidly than we may obtain approvals for ours, which could result in our competitors establishing a strong market position before we are able to enter the
market.
 
Employees
 
As of October 31, 2025, we had four full-time employees working for our Company and subsidiaries. In addition, we work with research teams at Moffitt and
Cleveland Clinic, as well as their and our subcontractors, to develop each of our projects.
 
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.
 
7

 
 
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.
 
8

 
 
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, 2025, our accumulated
deficit was approximately $251,677,000, and we had approximately $15,174,000 in cash, cash equivalents and short-term investments, and working capital of approximately
$13,920,000. In fiscal year 2025, we incurred losses of approximately $11,028,000 and we experienced negative cash flows from operations of approximately $7,173,000. 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 12, 2026, we believe that our existing cash, cash equivalents and short-term investments 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. During the year ended
October 31, 2025, we raised approximately $2,378,000, net of expenses, through an at-the-market equity offering of 772,001 shares of common stock. 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, 2025, we may sell up to an additional $100 million of
common stock. We may seek to obtain working capital during our fiscal year 2026 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 could 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, 2025, the Company
had approximately $15,174,000 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 lira-cel and our 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.
 
9

 
 
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 cancer vaccines are in
their early stages of development, and we still must establish and implement many important functions necessary to commercialize the technologies.
 
10

 
 
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;
 
11

 
 
 
●
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 early discovery stage of developing vaccines against high-incidence malignancies such as lung, colon and prostate cancers, 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.
 
12

 
 
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.
 
13

 
 
We have limited human clinical data from our CAR-T ovarian cancer therapeutic and our breast cancer vaccine, 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. Further, our vaccine research programs in high-incidence cancers of the lung,
colon and prostate are in the early discovery stage, and have generated no data to date. As our pre-clinical 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 lira-cel and Cleveland Clinic for our 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 non-clinical 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.
 
14

 
 
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 clinical trial of lira-cel is enrolling patients with late-stage ovarian cancer who have failed conventional treatment, and are willing and able to
undergo treatment at Moffitt.
 
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 lira-cel 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.
 
15

 
 
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. While we
have not observed any adverse side effects in our clinical trial of lira-cel to date, as we continue dose escalation, future trial participants may experience adverse side effects.
 
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. In the Phase 1 clinical trial of our breast cancer vaccine, the side effects observed were limited to injection site reactions.
 
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.
 
Vaccine hesitancy, misinformation about vaccine safety, and evolving positions of public health authorities on vaccines could adversely affect the development and
commercial success of our cancer vaccine product candidates.
 
Our cancer vaccines depend on the willingness of patients, caregivers, physicians, payors and regulators to accept vaccination as a safe and effective approach to
preventing or treating cancer. Public confidence in vaccines has been challenged in recent years by highly publicized debates about vaccine safety, the spread of misinformation
and disinformation on traditional and social media, and increasing skepticism toward public health institutions. These trends, often described collectively as “vaccine
hesitancy,” could materially and adversely impact our ability to successfully develop, obtain regulatory approval for, and commercialize our cancer vaccines.
 
U.S. public health authorities, including the Department of Health and Human Services (“HHS”), the FDA, and the Centers for Disease Control and Prevention
(“CDC”), have consistently stated that vaccines that meet regulatory standards are safe and effective, that vaccination is one of the most important tools to prevent serious
disease, and that for licensed vaccines the benefits are expected to outweigh the risks. At the same time, these authorities acknowledge that vaccines, like all medical products,
can have side effects, that rare but serious adverse events may occur, and that vaccine safety is continuously monitored before and after licensure. Regulatory agencies may
update product labeling, add warnings or contraindications, restrict indications or age groups, or modify recommended dosing schedules as new data emerge. Any such actions
with respect to vaccines generally, or to products that use similar technologies or delivery platforms to ours, even if not directly related to our product candidates, could
negatively affect public perception of vaccine safety and reduce willingness to receive our cancer vaccines.
 
Negative publicity about vaccine safety, whether accurate or inaccurate, could also reduce enrollment and retention in our clinical trials, particularly if patients or
investigators are reluctant to participate in studies labeled as “vaccine” trials, or if competing cancer therapies are perceived as safer or more familiar. Even if our cancer
vaccines demonstrate an acceptable safety profile in clinical trials and receive regulatory approval, vaccine hesitancy could limit physician prescribing, patient acceptance, and
payor coverage. This risk may be heightened if our products are used in earlier-stage disease, in adjuvant or prophylactic settings, or in combination with other therapies, where
both patients and clinicians may have lower tolerance for perceived safety concerns relative to expected benefit.
 
16

 
 
Furthermore, evolving recommendations, public statements, or guidance from HHS, FDA, CDC, or other health authorities regarding vaccine safety, benefit-risk
assessment, or target populations may lead to changes in standard-of-care vaccination practices, reimbursement policies, or clinical trial design expectations that are difficult to
anticipate. If public health authorities adopt more conservative positions toward vaccines or certain vaccine technologies, impose more stringent evidentiary requirements, or
prioritize alternative modalities for cancer prevention or treatment, our development strategy could become less attractive or more costly to pursue. Any of the foregoing could
materially and adversely affect our ability to obtain and maintain regulatory approvals for our cancer vaccine candidates, the size of the addressable market for our products,
and, ultimately, our business, financial condition, and results of operations.
 
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 lira-cel is
based on relatively new technology and engineered on a patient-by-patient basis, we expect that it will 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 future clinical trials of our breast cancer vaccine 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 than a trial designed to assess therapeutic effect.
 
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.
 
17

 
 
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.
 
18

 
 
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.
 
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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 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.
 
20

 
 
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.
 
21

 
 
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 i) non-U.S. patents and patent applications owned by us, and ii) 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.
 
22

 
 
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 lira-cel, to pay for the development of our cancer vaccines and for acquisitions of companies. We
have an at-the-market equity offering under which, as of January 12, 2026 we may issue up to approximately $98.6 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.
 
23

 
 
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 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 lira-cel;
 
●
clinical trial results relating to our breast cancer vaccine;
 
●
results of pre-clinical studies relating to our ovarian cancer vaccine;
 
●
results of our new vaccine discovery efforts;
 
●
progress with regulatory authorities towards the certification/approval of lira-cell, 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;
 
●
announcements of our or our competitors’ clinical trial results;
 
●
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.
 
24

 
 
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 13,897,094 shares of our common stock with a weighted average exercise price of
$3.53. Further, as of the date of this Report, our Board of Directors and Compensation Committee have the authority to issue awards totaling an additional 1,295,000 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.
 
25

 
 
Item 1B. Unresolved Staff Comments
 
None.
 
Item 1C. Cybersecurity
 
Overview
 
Our IT and related systems are critical to the efficient operation of our business and essential to our ability to perform day-to-day processes. We face persistent security
threats, including threats to our IT infrastructure and unlawful attempts to gain access to our confidential or otherwise proprietary information, or that of our employees, via
phishing/malware campaigns and other cyberattack methods.
 
Our security policies and processes are based on industry best practices and are revisited regularly to ensure their appropriateness based on risk, threats and current
technological capabilities. We regularly assess our threat landscape and monitor our systems and other technical security controls, maintain information security practices and
ensure maintenance of backup and protective systems. We review System and Organization Controls 1 (SOC 1 Type II) certifications where relevant from key third party
partners and other service providers with access to information assets at least annually.
 
Our internal controls and procedures address cybersecurity and include processes intended to ensure that security breaches are reported to appropriate personnel and, if
warranted, analyzed for potential disclosure. We also maintain insurance coverage that is intended to address certain aspects of cybersecurity risks. To date, there have not been
any cybersecurity threats that have materially affected the Company.
 
Governance
 
Board Oversight of Cybersecurity Matters
 
Assessing and managing information security matters is the responsibility of our Audit Committee. The Audit Committee meets with the senior executives, specifically
the Chief Executive Officer and Chief Financial Officer on at least an annual basis to discuss cybersecurity posture. The Audit Committee may also periodically receive
targeted briefings related to cybersecurity and reviews our incident response capabilities.
 
Management of Cybersecurity Risks
 
The senior executives work to protect our information systems from cybersecurity threats and to promptly assist in coordinating a response to any cybersecurity
incidents in accordance with our cybersecurity incident response and recovery plans. We have engaged an IT Managed Service Provider who assists in the oversight of our
corporate-wide data security, including developing, implementing and enforcing security policies to manage our overall cybersecurity risks. The senior executives regularly
meet with our IT Managed Service Provider during the course of the year to review and discuss cybersecurity issues.
 
Strategy
 
Our Security Culture
 
We protect our information assets and manage risk by promoting a culture that communicates security risks, designs secure IT systems and operates according to
approved processes to reduce the likelihood and impact of security incidents. We achieve this objective by:
 
 
●
designing, implementing and maintaining solutions with appropriate security controls;
 
●
sustaining solutions with required patching and vulnerability remediation;
 
●
creating and executing controls in support of policy as well as regulatory compliance;
 
●
ensuring that our policies, processes, practices and technologies proactively protect, shield, defend and remediate cyber threats; and
 
●
delivering quality communications and training to stakeholders on cyber awareness and computing hygiene.
 
26

 
 
We believe that the conduct of our employees is critical to the success of our information security. We keep our employees apprised of threats, risks and the part that
they play in protecting both themselves and the Company.
 
We assess our service providers prior to allowing our information to be processed, stored or transmitted by third parties, and we include standardized contractual
requirements in each contract where appropriate. We validate our service providers’ security via open-source intelligence and, where appropriate, SOC 1 Type II reports on
financially significant third-party service providers. Our process also includes regular monitoring of risk related to third parties on a periodic basis or when services or product
purchases expand beyond their original scope or intended use.
 
Item 2. Properties
 
We lease approximately 2,000 square feet of office space at 3150 Almaden Expressway, San Jose, California 95118 (our principal executive offices) from an unrelated
party pursuant to a lease that expires September 30, 2027, 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.
 
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.
 
27

 
  
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 under the symbol “ANIX” on the NASDAQ Capital Market.
 
Holders
 
As of January 9, 2026, the approximate number of record holders of our common stock was 280 and the closing price of our common stock was $3.38 per share.
 
Securities Authorized for Issuance Under Equity Compensation Plans
 
The following is information as of October 31, 2025 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)
 
 
786,283   
$
2.73   
 
- 
Equity compensation plans approved by security holders (2)
 
 
12,411,094   
$
3.60   
 
721,642 
 
 
(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, 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
 
The Company did not issue any unregistered securities during the three months ended October 31, 2025.
 
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.
 
28

 
 
Results of Operations
 
Fiscal Year ended October 31, 2025 compared with Fiscal Year ended October 31, 2024
 
Revenue
 
We did not have any revenue in fiscal years 2025 and 2024. 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. Our plan is 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.
 
Research and Development Expenses
 
Our research and development expenses are related to the development of our cancer vaccines and CAR-T therapeutics programs and in fiscal year 2025, the expenses
incurred consisted of approximately $3,121,000 and $1,950,000 for cancer vaccines and CAR-T therapeutics, respectively. In fiscal year 2024, research and development
expenses for our cancer vaccines and CAR-T therapeutics were approximately $3,748,000 and $2,648,000, respectively.
 
Research and development expenses decreased by approximately $1,325,000 to approximately $5,071,000 in fiscal year 2025, from approximately $6,396,000 in fiscal
year 2024. The decrease in research and development expenses was primarily due to a decrease in research and development expenses related to our breast cancer vaccine
development program as a result of fluctuations in the timing of certain materials manufacturing activities of approximately $674,000, a decrease in research and development
expenses related to our CAR-T development program as a result of fluctuations in the timing of certain materials manufacturing activities of approximately $406,000, a
decrease in employee stock option expense as a result of decreases in the calculated fair market value of stock options granted during the year and allocations of headcount to
research and development activities of approximately $274,000, and a decrease in employee compensation expense other than stock-based compensation as a result of changes
in allocations of headcount to research and development activities of approximately $61,000, offset by an increase in research and development expenses related to our new
vaccine discovery program due to a full year of activity compared to the prior year of approximately $113,000.
 
General and Administrative Expenses
 
General and administrative expenses decreased by approximately $805,000 to approximately $6,630,000 in fiscal year 2025, from approximately $7,435,000 in fiscal
year 2024. The decrease in general and administrative expenses was principally due to a decrease in investor and public relations firm expenses as a result of changes in firms
used during the year of approximately $454,000, a decrease in director stock option compensation expense as a result of decreases in the calculated fair market value of stock
options granted during the year of approximately $359,000, a decrease in stock compensation for investor and public relations firms as a result of changes in firms used during
the year of approximately $219,000, a decrease in employee stock option compensation expense as a result of decreases in the calculated fair market value of stock options
granted during the year of approximately $106,000, and a decrease in employee compensation expense other than stock-based compensation as a result of changes in
allocations of headcount between research and development and general and administrative activities as well as changes in employee compensation of approximately $54,000,
offset by an increase in expenses related to a change in clinical materials manufacturing vendors of approximately $244,000, an increase in shareholder relations expenses of
approximately $74,000, and an increase in patent prosecution expenses of approximately $73,000.
 
Interest Income
 
Interest income decreased to approximately $673,000 in fiscal year 2025 compared to approximately $1,133,000 in fiscal year 2024, due to a decrease in the amount of
short-term investments held and a decrease in interest rates.
 
29

 
 
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 $43,000 to
approximately $101,000 in fiscal year 2025, from approximately $144,000 in fiscal year 2024, 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 12, 2026, 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. During the
year ended October 31, 2025, we raised approximately $2,378,000, net of expenses, through an at-the-market equity offering of 772,001 shares of common stock. 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, 2025, we may sell up to $100 million of common
stock. We may seek to obtain working capital during our fiscal year 2026 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 could significantly harm the business and development of operations.
 
During the fiscal year ended October 31, 2025, cash used in operating activities was approximately $7,173,000. Cash provided by investing activities was
approximately $4,866,000, resulting from the proceeds on maturities of short-term investments of approximately $49,226,000, which was offset by the purchase of short-term
investments of approximately $44,360,000. Cash provided by financing activities was approximately $2,280,000, resulting from the sale of 772,001 shares of common stock in
an at-the-market equity offering of approximately $2,378,000 net of expenses and proceeds from the sale of common stock pursuant to an employee stock purchase plan of
approximately $7,000, offset by net costs from the exercise of stock options of approximately $105,000. As a result, our cash, cash equivalents, and short-term investments at
October 31, 2025 decreased approximately $4,750,000 to approximately $15,174,000 from approximately $19,924,000 at the end of fiscal year 2024.
 
We have expected future cash obligations related to the lease of our offices through 2029, inclusive of extension periods, estimated at approximately $256,000.
 
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.
 
30

 
 
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 restricted 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).
 
31

 
 
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 we have sufficient historical exercise data on which to base our own estimate. 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 potential expected impacts 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 October 31, 2025.
 
32

 
 
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, 2025. 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, 2025.
 
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, 2025 has not been audited by our independent
registered public accounting firm, 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 2025 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 2026 Annual Meeting of Stockholders scheduled for March 10, 2026 which such
Proxy Statement will be filed with the SEC within 120 days of October 31, 2025, 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 2026 Annual Meeting of Stockholders scheduled for March 10, 2026 which such
Proxy Statement will be filed with the SEC within 120 days of October 31, 2025, and will be incorporated into this Annual Report on Form 10-K by reference.
 
33

 
 
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 2026 Annual Meeting of Stockholders scheduled for March 10, 2026 which such
Proxy Statement will be filed with the SEC within 120 days of October 31, 2025, 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 2026 Annual Meeting of Stockholders scheduled for March 10, 2026 which such
Proxy Statement will be filed with the SEC within 120 days of October 31, 2025, and will be incorporated into this Annual Report on Form 10-K by reference.
 
Item 14. Principal Accountant Fees and Services
 
The information required by this Item will be set forth in our Proxy Statement for the 2026 Annual Meeting of Stockholders scheduled for March 10, 2026 which such
Proxy Statement will be filed with the SEC within 120 days of October 31, 2025, and will be incorporated into this Annual Report on Form 10-K by reference.
 
PART IV
 
Item 15. Exhibits and Financial Statement Schedules
 
(a)(1)(2) Financial Statement Schedules
 
See accompanying “Index to Consolidated Financial Statements.”
 
(b)
Exhibits
 
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.)
 
34

 
 
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 10, 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. (Incorporated by reference to Exhibit 10.10 to our
Form 10-K, for the fiscal year ended October 31, 2023.)
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
Joint Development and Option Agreement, dated May 3, 2024, 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 April 30, 2024.) (Certain information has been redacted in the marked portions of the exhibit.)
10.14
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, 2024.)
19
Insider Trading Policy (Incorporated by reference to Exhibit 19 to our Form 10-K, for the fiscal year ended October 31, 2023.)
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 12, 2026. (Filed herewith.)
31.2
Certification of Chief Financial Officer, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, dated January 12, 2026. (Filed herewith.)
32.1
Statement of Chief Executive Officer, pursuant to Section 1350 of Title 18 of the United States Code, dated January 12, 2026. (Filed herewith.)
32.2
Statement of Chief Financial Officer, pursuant to Section 1350 of Title 18 of the United States Code, dated January 12, 2026. (Filed herewith.)
99.1
Clawback Policy (Incorporated by reference to Exhibit 99.1 to our Form 10-K, for the fiscal year ended October 31, 2023.)
 
Item 16. Form 10-K Summary
 
The Company has elected not to include a summary pursuant to this Item 16.
 
35

 
 
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 12, 2026
 
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 12, 2026
 
(Principal Executive Officer)
 
 
 
 
By: /s/ Michael J. Catelani
 
 
Michael J. Catelani
 
 
President, Chief Operating Officer and
 
 
Chief Financial Officer
January 12, 2026
 
(Principal Financial and Accounting Officer)
 
 
 
 
By: /s/ Lewis H. Titterton, Jr.
 
 
Lewis H. Titterton, Jr.
January 12, 2026
 
Director
 
 
 
 
By: /s/ Arnold Baskies
 
 
Dr. Arnold Baskies
January 12, 2026
 
Director
 
 
 
 
By: /s/ Emily Gottschalk
 
 
Emily Gottschalk
January 12, 2026
 
Director
 
36

 
 
ANIXA BIOSCIENCES, INC. AND SUBSIDIARIES
 
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
OCTOBER 31, 2025
 
 
Page
 
 
Report of Independent Registered Public Accounting Firm (PCAOB ID: 200)
F-2
 
 
Consolidated Balance Sheets as of October 31, 2025 and 2024
F-3
 
 
Consolidated Statements of Operations for the years ended October 31, 2025 and 2024
F-4
 
 
Consolidated Statements of Equity for the years ended October 31, 2025 and 2024
F-5
 
 
Consolidated Statements of Cash Flows for the years ended October 31, 2025 and 2024
F-6
 
 
Notes to Consolidated Financial Statements
F-7
 
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.
 
F-1

 
 
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, 2025 and 2024, and the related consolidated
statements of operations, equity, and cash flows for each of the two years in the period ended October 31, 2025, 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,
2025 and 2024, and the consolidated results of its operations and its cash flows for each of the years in the two year period ended October 31, 2025, 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 and
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
 
Critical audit matters are matters arising from the current period audit of the financial statements that were communicated or required to be communicated to the audit
committee and that: (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex
judgments. We determined that there are no critical audit matters.
 
 
/s/ Haskell & White LLP
 
HASKELL & WHITE LLP
 
We have served as the Company’s auditor since 2013.
 
Irvine, California
January 12, 2026
 
F-2

 
 
ANIXA BIOSCIENCES, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)
 
 
 
October 31,
   
October 31,
 
 
 
2025
   
2024
 
ASSETS
 
 
    
 
  
Current assets:
 
 
    
 
  
Cash and cash equivalents
 
$
1,244   
$
1,271 
Short–term investments
 
 
13,930   
 
18,653 
Receivables
 
 
-   
 
173 
Prepaid expenses and other current assets
 
 
713   
 
1,265 
Total current assets
 
 
15,887   
 
21,362 
 
 
 
    
 
  
Operating lease right-of-use asset
 
 
193   
 
229 
 
 
 
    
 
  
Total assets
 
$
16,080   
$
21,591 
 
 
 
    
 
  
LIABILITIES AND EQUITY
 
 
    
 
  
Current liabilities:
 
 
    
 
  
Accounts payable
 
$
165   
$
525 
Accrued expenses
 
 
1,761   
 
1,946 
Operating lease liability
 
 
41   
 
29 
Total current liabilities
 
 
1,967   
 
2,500 
 
 
 
    
 
  
Operating lease liability, non-current
 
 
163   
 
203 
Total liabilities
 
 
2,130   
 
2,703 
 
 
 
    
 
  
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
 
 
-   
 
- 
Common stock, par value $.01 per share; 100,000,000 shares authorized; 33,013,829 and 32,196,862
shares issued and outstanding as of October 31, 2025 and 2024, respectively
 
 
330   
 
322 
Additional paid-in capital
 
 
266,508   
 
260,432 
Accumulated deficit
 
 
(251,677)  
 
(240,750)
Treasury stock, 2,000 shares at cost as of October 31, 2024
 
 
-   
 
(6)
Total shareholders’ equity
 
 
15,161   
 
19,998 
Noncontrolling interest (Note 2)
 
 
(1,211)  
 
(1,110)
Total equity
 
 
13,950   
 
18,888 
 
 
 
    
 
  
Total liabilities and equity
 
$
16,080   
$
21,591 
 
The accompanying notes are an integral part of these statements.
 
F-3

 
 
ANIXA BIOSCIENCES, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
 
 
 
For the years ended October 31,
 
 
 
2025
   
2024
 
 
 
 
   
  
Revenue
 
$
-   
$
- 
 
 
 
    
 
  
Operating costs and expenses:
 
 
    
 
  
Research and development expenses (including non-cash stock-based compensation expenses of
$1,560 and $1,859, respectively)
 
 
5,071   
 
6,396 
General and administrative expenses (including non-cash stock-based compensation expenses of
$2,250 and $2,923, respectively)
 
 
6,630   
 
7,435 
 
 
 
    
 
  
Total operating costs and expenses
 
 
11,701   
 
13,831 
 
 
 
    
 
  
Loss from operations
 
 
(11,701)  
 
(13,831)
 
 
 
    
 
  
Interest income
 
 
673   
 
1,133 
 
 
 
    
 
  
Net loss
 
 
(11,028)  
 
(12,698)
 
 
 
    
 
  
Less: Net loss attributable to noncontrolling interest
 
 
(101)  
 
(144)
 
 
 
    
 
  
Net loss attributable to common shareholders
 
$
(10,927)  
$
(12,554)
 
 
 
    
 
  
Net loss per share:
 
 
    
 
  
Basic and diluted
 
$
(0.34)  
$
(0.39)
 
 
 
    
 
  
Weighted average common shares outstanding:
 
 
    
 
  
Basic and diluted
 
 
32,454   
 
31,898 
 
The accompanying notes are an integral part of these statements.
 
F-4

 
 \
ANIXA BIOSCIENCES, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF EQUITY
FOR THE YEARS ENDED OCTOBER 31, 2025 AND 2024
(in thousands, except share data)
 
 
 
Common Stock
    Additional    
 
   
 
   
Total
   
Non-
   
 
 
 
 
Shares
    Par Value    
Paid-in
Capital
   
Accumulated
Deficit
   
Treasury
Stock
   
Shareholders’
Equity
   
controlling
Interest
   
Total
Equity
 
 
 
    
 
   
    
    
 
   
    
    
  
BALANCE, October 31, 2023
 
  31,145,219   
$
311   
$ 252,222   
$
(228,196)  
$
-   
$
24,337   
$
(966)  
$
23,371 
 
 
 
    
 
    
 
    
 
    
 
    
 
    
 
    
 
  
Stock option compensation to employees
and directors
 
 
-   
 
-   
 
4,420   
 
-   
 
-   
 
4,420   
 
-   
 
4,420 
Stock options issued to consultants
 
 
-   
 
-   
 
125   
 
-   
 
-   
 
125   
 
-   
 
125 
Common stock issued upon exercise of
stock options
 
 
173,031   
 
2   
 
454   
 
-   
 
-   
 
456   
 
-   
 
456 
Common stock issued to consultants
 
 
89,336   
 
1   
 
254   
 
-   
 
-   
 
255   
 
-   
 
255 
Common stock issued in an at-the-market
offering, net of offering expenses of $168
 
 
785,290   
 
8   
 
2,947   
 
-   
 
-   
 
2,955   
 
-   
 
2,955 
Common stock issued pursuant to employee
stock purchase plan
 
 
3,986   
 
-   
 
10   
 
-   
 
-   
 
10   
 
-   
 
10 
Purchase of treasury stock
 
 
-   
 
-   
 
-   
 
-   
 
(6)  
 
(6)  
 
-   
 
(6)
Net loss
 
 
-   
 
-   
 
-   
 
(12,554)  
 
-   
 
(12,554)  
 
(144)  
 
(12,698)
 
 
 
    
 
    
 
    
 
    
 
    
 
    
 
    
 
  
BALANCE, October 31, 2024
 
  32,196,862   
$
322   
$ 260,432   
$
(240,750)  
$
(6)  
$
19,998   
$
(1,110)  
$
18,888 
 
 
 
    
 
    
 
    
 
    
 
    
 
    
 
    
 
  
Stock option compensation to employees
and directors
 
 
-   
 
-   
 
3,681   
 
-   
 
-   
 
3,681   
 
-   
 
3,681 
Stock options issued to consultants
 
 
-   
 
-   
 
129   
 
-   
 
-   
 
129   
 
-   
 
129 
Common stock issued upon exercise of
stock options
 
 
43,930   
 
-   
 
(105)  
 
-   
 
-   
 
(105)  
 
-   
 
(105)
Common stock issued in an at-the-market
offering, net of offering expenses of $183
 
 
772,001   
 
8   
 
2,370   
 
-   
 
-   
 
2,378   
 
-   
 
2,378 
Common stock issued pursuant to employee
stock purchase plan
 
 
3,036   
 
-   
 
7   
 
-   
 
-   
 
7   
 
-   
 
7 
Cancelation of treasury shares
 
 
(2,000)  
 
-   
 
(6)  
 
-   
 
6   
 
-   
 
-   
 
- 
Net loss
 
 
-   
 
-   
 
-   
 
(10,927)  
 
-   
 
(10,927)  
 
(101)  
 
(11,028)
BALANCE, October 31, 2025
 
  33,013,829   
$
330   
$ 266,508   
$
(251,677)  
$
-   
$
15,161   
$
(1,211)  
$
13,950 
 
The accompanying notes are an integral part of these statements.
 
F-5

 
 
ANIXA BIOSCIENCES, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
 
 
 
For the years ended October 31,
 
 
 
2025
   
2024
 
Cash flows from operating activities:
 
 
    
 
  
Reconciliation of net loss to net cash used in operating activities:
 
 
    
 
  
Net loss
 
$
(11,028)  
$
(12,698)
Stock option compensation to employees and directors
 
 
3,681   
 
4,420 
Stock options issued to consultants
 
 
129   
 
125 
Common stock issued to consultants
 
 
-   
 
255 
Amortization of operating lease right-of-use asset
 
 
36   
 
37 
Amortization of discount on held-to-maturity securities
 
 
(143)  
 
- 
Change in operating assets and liabilities:
 
 
    
 
  
Receivables
 
 
173   
 
97 
Prepaid expenses and other current assets
 
 
552   
 
(23)
Accounts payable
 
 
(360)  
 
319 
Accrued expenses
 
 
(185)  
 
176 
Operating lease liability
 
 
(28)  
 
(43)
Net cash used in operating activities
 
 
(7,173)  
 
(7,335)
 
 
 
    
 
  
Cash flows from investing activities:
 
 
    
 
  
Disbursements to acquire short-term investments
 
 
(44,360)  
 
(63,770)
Proceeds from maturities of short-term investments
 
 
49,226   
 
68,046 
Net cash provided by investing activities
 
 
4,866   
 
4,276 
 
 
 
    
 
  
Cash flows from financing activities:
 
 
    
 
  
Proceeds from sale of common stock in an at-the-market offering, net of offering expenses of $183 and
$168, for the years ended October 31, 2025 and 2024, respectively
 
 
2,378   
 
2,955 
Proceeds from sale of common stock pursuant to employee stock purchase plan
 
 
7   
 
10 
Net (costs) proceeds from exercise of stock options
 
 
(105)  
 
456 
Disbursements for purchases of treasury stock
 
 
-   
 
(6)
Net cash provided by financing activities
 
 
2,280   
 
3,415 
 
 
 
    
 
  
Net (decrease) increase in cash and cash equivalents
 
 
(27)  
 
356 
Cash and cash equivalents at beginning of year
 
 
1,271   
 
915 
Cash and cash equivalents at end of year
 
$
1,244   
$
1,271 
 
 
 
    
 
  
Supplemental cash flow information:
 
 
    
 
  
Cash proceeds from interest income
 
$
686   
$
1,230 
 
 
 
    
 
  
Supplemental disclosure of non-cash investing activity:
 
 
    
 
  
Modification to operating lease right-of-use asset
 
$
-   
$
(100)
 
 
 
    
 
  
Supplemental disclosure of non-cash financing activity:
 
 
    
 
  
Modification to operating lease liability
 
$
-   
$
100 
 
The accompanying notes are an integral part of these statements.
 
F-6

 
 
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 therapies and vaccines that are focused on critical unmet needs in oncology. Our therapeutics program
consists of the development of liraltagene autoleucel (“lira-cel”), a chimeric endocrine receptor-T cell therapy, which is a novel form of chimeric antigen receptor-T cell
(“CAR-T”) technology, initially focused on treating ovarian cancer, that is being developed at our subsidiary, Certainty Therapeutics, Inc. (“Certainty”). Our vaccine programs
include (i) the development of a vaccine against breast cancer, (ii) the development of a vaccine against ovarian cancer, and (iii) a vaccine discovery program utilizing the same
mechanism as our breast and ovarian cancer vaccines to develop additional cancer vaccines to address many intractable cancers, including high incidence malignancies in lung,
colon and prostate.
 
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 National Cancer Institute
(“NCI”) designated cancer research center, relating to Wistar’s chimeric endocrine receptor targeted therapy technology. We have initially focused on the development of a
treatment for ovarian cancer, but we also may pursue applications of the technology for the development of treatments for additional solid tumors. The license agreement
requires Certainty to make certain cash and equity payments to Wistar upon achievement of specific development 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 is subject to dilution by further
funding of Certainty’s activities by the Company. Due to such Company funding, Wistar’s equity stake in Certainty was 4.1% as of October 31, 2025.
 
Certainty, in collaboration with the H. Lee Moffitt Cancer Center and Research Institute, Inc. (“Moffitt”), has begun human clinical testing of lira-cel, the CAR-T
technology licensed by Certainty from Wistar aimed initially at treating ovarian cancer. After receiving authorization from the U.S. Food and Drug Administration (“FDA”), we
commenced enrollment of patients in a Phase 1 clinical trial and treated the first patient in August 2022. Further, in May 2023 and August 2023, we treated the second and third
patients in the trial, respectively, at the same dose level as the first patient, and the treatment was well-tolerated by the patients. Between February and June 2024, we treated the
three patients of the second dose cohort, where the patients were administered a three-times higher dose of cells than the patients in the first cohort. The treatment at this dose
level was also well-tolerated by the patients. From November 2024 to February 2025, we treated three patients in the third dose cohort, where they were administered a ten-
times higher dose of cells than the patients in the first dose cohort. Consistent with the lower dose cohorts, the treatment was well-tolerated by the patients. Subsequently, we
treated the patients in the fourth dose cohort, administering a 30-times higher dose of cells than the patients in the first dose cohort, and again the treatment appears to have
been well-tolerated.
 
While the dose levels in the first three cohorts were expected to be sub-therapeutic, multiple patients have exhibited anecdotal signs of efficacy, including possible
signs of T cell infiltration and tumor necrosis. For example, many patients have survived beyond expectations, including one patient that survived over two years past initial
treatment and three other patients that survived over one year past treatment. In the case of the patient that survived over two years past initial treatment, due to the encouraging
results with her initial treatment, we sought single patient Investigational New Drug (“IND”) application permission from the FDA to re-dose her. This re-dosing was approved
by the FDA, and we administered her second treatment in October 2024. This second treatment was well-tolerated by the patient.
 
F-7

 
 
This study is a dose-escalation trial with two arms based on route of delivery—intraperitoneal or intravenous—to determine the maximum tolerated dose in patients
with recurrent epithelial ovarian cancer and to assess persistence, expansion and efficacy of the modified T cells. The study is being conducted at Moffitt and will consist of up
to 24 to 48 patients who have received at least two prior lines of chemotherapy. The study is estimated to be completed in two to three years depending on multiple factors
including when the maximum tolerated dose is reached, the rate of patient enrollment, the significance of efficacy data and how long we maintain the two different delivery
methods.
 
We hold an exclusive worldwide, royalty-bearing license to use certain intellectual property owned or controlled by The Cleveland Clinic Foundation (“Cleveland
Clinic”) relating to certain breast cancer vaccine technology developed at Cleveland Clinic. The license agreement requires us to make certain cash payments to Cleveland
Clinic upon achievement of specific development milestones. Utilizing this technology, we are working in collaboration with Cleveland Clinic to develop a method to vaccinate
women against breast cancer, focused initially on triple-negative breast cancer (“TNBC”), the most lethal form of the disease. The focus of this vaccine is a specific protein, α-
lactalbumin, that is only expressed during lactation in a healthy woman’s mammary tissue. This protein disappears when the woman is no longer lactating, but reappears in
many forms of breast cancer, especially TNBC. Studies have shown that vaccinating against this protein prevents breast cancer in mice.
 
In October 2021, following the FDA’s authorization to proceed, we commenced dosing patients in a Phase 1 clinical trial of our breast cancer vaccine. This study,
which has been fully funded by a U.S. Department of Defense grant to Cleveland Clinic, is a multiple-ascending dose Phase 1 trial to determine the maximum tolerated dose
(“MTD”) of the vaccine in patients with early-stage, triple-negative breast cancer as well as monitor immune response. The study has been conducted at Cleveland Clinic.
During the course of the Phase 1 study, participants received three vaccinations, each two weeks apart, and have been closely monitored for side effects and immune response.
The first segment of the study, Phase 1a, consisted of approximately 24 patients who had completed treatment for early-stage, triple-negative breast cancer within the past three
years and were currently tumor-free but at high risk for recurrence. Studies show that 42% of TNBC patients will have a recurrence of their cancer, with most of the recurrences
occurring in the first two to three years after standard of care treatment. In January 2023, the number of participants in each dose cohort was expanded, and as of August 2023,
we had completed vaccinating all patients in these expanded cohorts. Subsequently, we began vaccinating participants in additional dose cohorts at varying dose levels of the
different key components of the vaccine. Further, in November 2023, we commenced vaccination of participants in the second segment of the trial, Phase 1b, that included
participants who have never had cancer, but carry certain mutations in genes such as BRCA1, BRCA2 or PALB2, that indicate a greater risk of developing TNBC in the future,
and had elected to have a prophylactic mastectomy. Finally, in January 2024, we commenced vaccination of participants in the third segment of the trial, Phase 1c, that includes
post-operative TNBC patients that have residual disease following treatment and are currently undergoing treatment with pembrolizumab (Keytruda®). In June 2025, we
completed enrollment in the Phase 1 trial and in October 2025, we completed all patient clinical visits. In December 2025, we presented the final data from the Phase 1 trial at
the San Antonio Breast Cancer Symposium. The key results presented were that i) all primary study endpoints were met, ii) protocol defined immune responses were observed
in 74% of the study subjects, iii) the vaccine was safe and well-tolerated by study participants at the maximum tolerated dose, and iv) immunohistochemistry (IHC) of the
subjects’ primary tumors for alpha-lactalbumin protein revealed a range of expression from absent to strong—analysis and correlation to immune response and clinical
outcomes is ongoing. The Phase 1 findings are promising, and we are preparing to initiate a Phase 2 clinical trial in the neo-adjuvant setting (pre-surgery) to determine possible
therapeutic effect of the vaccine. The Phase 2 trial will commence following FDA consultations, protocol development, manufacturing and clinical site selection.
 
We hold an exclusive worldwide, royalty-bearing license to use certain intellectual property owned or controlled by Cleveland Clinic relating to certain ovarian cancer
vaccine technology. The license agreement requires us to make certain cash payments to Cleveland Clinic upon achievement of specific development 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.
 
F-8

 
 
In May 2021, Cleveland Clinic was granted acceptance for our ovarian cancer vaccine technology into the NCI’s 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 IND enabling studies. This work is being performed at
NCI facilities, by NCI scientific staff and with NCI financial resources and will require no material financial expenditures by the Company, nor the payment of any future
consideration by the Company to NCI.
 
In May 2024, based on the positive clinical results to date in the development of our breast cancer vaccine, we entered into a Joint Development and Option
Agreement with Cleveland Clinic to collaborate in efforts to develop additional vaccines for the prevention or treatment of cancers. Working with Cleveland Clinic researchers,
we are focusing on the same novel scientific mechanism as in our breast and ovarian cancer vaccines, and working to discover additional retired proteins that may be associated
with other forms of cancer, specifically high incidence malignancies in the lung, colon and prostate.
 
Over the next several quarters, we expect the development of our therapeutics and vaccines to be the primary focus of the Company. As part of our legacy operations,
the Company remains engaged in limited patent licensing activities of its various patent portfolios. We do not expect these activities to be a significant part of the Company’s
ongoing operations nor do we expect these activities to require material financial resources or attention of senior management.
 
Over the past several years, our revenue was derived from technology licensing and the sale of patented technologies, including revenue from the settlement of
litigation. We have not generated any revenue to date from our therapeutics or vaccine programs. In addition, while we pursue our therapeutics and vaccine programs, we may
also make investments in and form new companies to develop additional emerging technologies. We do not expect to begin generating revenue with respect to any of our
current therapeutics or vaccine programs in the 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.
 
Funding and Management’s Plans
 
Based on currently available information as of January 12, 2026, 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. During the
year ended October 31, 2025, we raised approximately $2,378,000, net of expenses, through an at-the-market equity offering of 772,001 shares of common stock. 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, 2025, we may sell up to an additional $100
million of common stock. We may seek to obtain working capital during our fiscal year 2026 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 could significantly harm the business and development of
operations.
 
F-9

 
 
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, 2025 (in thousands):
   
Balance October 31, 2023
 
$
(966)
Net loss attributable to noncontrolling interest
 
 
(144)
Balance October 31, 2024
 
 
(1,110)
Net loss attributable to noncontrolling interest
 
 
(101)
Balance October 31, 2025
 
$
(1,211)
 
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.
 
Cost of Revenues
 
Cost of revenues includes 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.
 
F-10

 
 
Research and Development Expenses
 
Research and development expenses consist primarily of employee compensation, payments to third parties for research and development activities 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.
 
Investment Policy
 
The Company’s investment policy is designed to optimize returns while managing risk and liquidity. The policy allows for investments in a diversified range of
financial instruments, including U.S. government debt securities with fixed maturities and contractual cash flows, as well as alternative investments such as Bitcoin and
Bitcoin-based exchange traded funds (collectively, the “Bitcoin Assets”).
 
The Company acquires U.S. government debt securities that it has the positive intent and ability to hold to maturity. These securities are recorded at amortized cost, net
of any applicable discount which is amortized to interest income, and are accounted for as held-to-maturity securities. The Company’s Bitcoin Assets are measured at fair value
based on quoted prices on active exchanges. The Company recognizes changes in the fair value of Bitcoin Assets as gains or losses in the statement of operations during the
period in which they occur.
 
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.
 
F-11

 
 
The following table presents the hierarchy for our financial assets measured at fair value as of October 31, 2025 (in thousands):
 
 
 
Level 1
   
Level 2
   
Level 3
   
Total
 
Money market funds:
 
 
    
 
    
 
    
 
  
Cash equivalents
 
$
1,197   
$
-   
$
-   
$
1,197 
Bitcoin exchange traded funds:
 
 
    
 
    
 
    
 
  
Short term investments
 
 
-   
 
11   
 
-   
 
11 
U.S. treasury bills:
 
 
    
 
    
 
    
 
  
Short term investments
 
 
-   
 
13,887   
 
-   
 
13,887 
Total financial assets
 
$
1,197   
$
13,898   
$
-   
$
15,095 
 
The following table presents the hierarchy for our financial assets measured at fair value as of October 31, 2024 (in thousands):
 
 
 
Level 1
   
Level 2
   
Level 3
   
Total
 
Money market funds:
 
 
    
 
    
 
    
 
  
Cash equivalents
 
$
1,170   
$
-   
$
-   
$
1,170 
U.S. treasury bills:
 
 
    
 
    
 
    
 
  
Short term investments
 
 
-   
 
18,792   
 
-   
 
18,792 
Total financial assets
 
$
1,170   
$
18,792   
$
-   
$
19,962 
 
As noted above, the Company classifies its investments in U.S. treasury bills as short-term investments that are held-to-maturity, and accordingly, are presented on the
accompanying consolidated balance sheets at amortized cost.
 
Our non-financial assets that are measured at fair value 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 maturities of three months or less when purchased.
 
Short-term Investments
 
At October 31, 2025 and 2024, we held United States treasury bills with maturities greater than 90 days and less than 12 months when acquired with amortized costs
of approximately $13,930,000 and $18,653,000, respectively, that were classified as short-term investments. Furthermore, at October 31, 2025, we held Bitcoin Assets with fair
value of approximately $11,000 that were classified as short-term investments.
 
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. We have provided a full valuation allowance against out deferred tax asset due to our historical pre-tax losses and the uncertainty regarding the
realizability of these deferred tax assets.
 
F-12

 
 
Stock-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 $3,681,000 and
$4,420,000, during the years ended October 31, 2025 and 2024, respectively. Included in stock-based compensation cost for service-based options granted to employees and
directors during the years ended October 31, 2025 and 2024 was approximately $3,023,000 and $3,187,000, respectively, related to the amortization of compensation cost for
stock options granted in prior periods but not yet vested. As of October 31, 2025, there was unrecognized compensation cost related to non-vested service-based stock options
granted to employees and directors of approximately $3,166,000, which will be recognized over a weighted-average period of 1.6 years.
 
We recorded consulting expense, related to service-based stock options granted to consultants, during the years ended October 31, 2025 and 2024 of approximately
$129,000 and $125,000, respectively. Included in stock-based consulting expense for the years ended October 31, 2025 and 2024 was approximately $94,000 and $120,000,
respectively, related to compensation cost for stock options granted in prior periods but not yet vested. As of October 31, 2025, there was unrecognized consulting expense
related to non-vested service-based stock options granted to consultants of approximately $108,000, which will be recognized over a weighted-average period of 1.2 years.
 
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, 2025 and 2024 consisted of awards with 5-year and 10-year terms that vest over 3 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, 2025 and 2024:
 
 
 
For the Year Ended October 31,
 
 
 
2025
   
2024
 
Weighted average fair value at grant date
 
$
1.62   
$
2.94 
Valuation assumptions:
 
 
    
 
  
Expected life (years)
 
 
5.8   
 
5.7 
Expected volatility
 
 
75.7% 
 
76.5%
Risk-free interest rate
 
 
4.4% 
 
3.9%
Expected dividend yield
 
 
0.0% 
 
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.
 
F-13

 
 
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.
 
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, 2025 and
2024 were options to purchase 13,197,377, shares and 12,158,062 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, research and development expense accruals, the allowance for expected credit losses, depreciation
lives and other contingencies. Actual results could differ from those estimates.
 
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 U.S. treasury bills and Bitcoin Assets. Where applicable, management reviews our accounts
receivable and other receivables for potential expected credit losses 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.
 
Effect of Recently Issued Pronouncements
 
In November 2023, the FASB issued Accounting Standards Update 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, to
provide more disaggregated expense information about a public entity’s reportable segments. The amendments in this update should be applied retrospectively and are effective
for fiscal years beginning after December 15, 2023, and interim periods beginning after December 15, 2024. The adoption of this standard did not have a material impact on our
consolidated financial statements and related disclosures (Note 8).
 
In December 2023, the FASB issued Accounting Standards Update 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, to require
disaggregated information about a reporting entity’s effective tax rate reconciliation as well as information on income taxes paid. The amendments in this update should be
applied prospectively, with an option to apply them retrospectively, and are effective for fiscal years beginning after December 15, 2024 for public entities. We are currently
evaluating the impact of this guidance on our consolidated financial statements and related disclosures.
 
In March 2024, the FASB issued Accounting Standards Update 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation
Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, to improve the disclosures about a public business entity’s expenses and to provide more
detailed information about the types of expenses in commonly presented expense captions. The amendments in this update should be applied either prospectively or
retrospectively, and are effective for fiscal years beginning after December 15, 2026, and interim periods beginning after December 15, 2027. We are currently evaluating the
impact of this guidance on our consolidated financial statements and related disclosures.
 
F-14

 
 
3. ACCRUED EXPENSES
 
Accrued liabilities consist of the following as of (in thousands):
 
 
 
October 31,
 
 
 
2025
   
2024
 
Payroll and related expenses
 
$
839   
$
1,126 
Accrued royalty and contingent legal fees
 
 
626   
 
626 
Accrued other
 
 
296   
 
194 
Accrued expenses
 
$
1,761   
$
1,946 
 
4. SHAREHOLDERS’ EQUITY
 
Stock Option Plans
 
During the year ended October 31, 2025, 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, 2025 and 2024, stock options to purchase 235,685 and 173,031 shares of common stock, respectively, were exercised in aggregate.
Of those exercised options, during the years ended October 31, 2025 and 2024, 685 and 173,031, respectively, were exercised on a cash basis, with aggregate proceeds of
approximately $2,000 and $456,000, respectively. During the year ended October 31, 2025, stock options to purchase 235,000 shares of common stock, of which 191,755
shares were withheld, were exercised on a cashless basis. The withheld shares covered the aggregate exercise price of the options, as well as approximately $107,000 in
applicable taxes resulting from the exercise. During the year ended October 31, 2024, no stock options were exercised on a cashless basis.
 
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. 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, 2025 is as follows:
 
 
Shares
   
Weighted
|Average
Exercise Price
Per Share
   
Aggregate Intrinsic
Value
 
Options outstanding at October 31, 2023
 
 
1,189,000   
$
2.94   
 
  
Exercised
 
 
(112,032)  
$
2.58   
 
  
Expired
 
 
(90,000)  
$
5.29   
 
  
Options outstanding at October 31, 2024
 
 
986,968   
$
2.77   
 
  
Exercised
 
 
(200,685)  
$
2.92   
 
  
Options outstanding and exercisable at October 31, 2025
 
 
786,283   
$
2.73   
$
1,215,353 
 
F-15

 
 
The following table summarizes information about stock options outstanding under the 2010 Share Plan as of October 31, 2025:
 
  
Range of Exercise Prices
   
Number
Outstanding
and
Exercisable
   
Weighted
Average
Remaining
Contractual
Life
(in years)
   
Weighted
Average
Exercise
Price
 
$
0.67 - $0.96   
 
266,000   
 
1.7   
$
0.89 
$
2.27 - $3.46   
 
401,283   
 
2.3   
$
3.25 
$
4.85 - $5.30   
 
119,000   
 
1.7   
$
5.11 
 
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, 2025, the 2018 Share Plan had 721,642 shares available for future grants. Information regarding the 2018
Share Plan for the two years ended October 31, 2025 is as follows:
 
 
Shares
   
Weighted Average
Exercise Price
Per Share
   
Aggregate Intrinsic
Value
 
Options outstanding at October 31, 2023
 
 
10,241,000   
$
3.67   
 
  
Granted
 
 
1,415,000   
$
4.33   
 
  
Exercised
 
 
(60,999)  
$
2.73   
 
  
Forfeited/expired
 
 
(423,907)  
$
4.12   
 
  
Options outstanding at October 31, 2024
 
 
11,171,094   
$
3.74   
 
  
Granted
 
 
1,440,000   
$
2.41   
 
  
Exercised
 
 
(35,000)  
$
2.09   
 
  
Forfeited/expired
 
 
(165,000)  
$
3.33   
 
  
Options outstanding at October 31, 2025
 
 
12,411,094   
$
3.60   
$
7,374,152 
Options exercisable at October 31, 2025
 
 
9,295,268   
$
3.60   
$
5,510,841 
 
The following table summarizes information about stock options outstanding under the 2018 Share Plan as of October 31, 2025:
 
   
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
 
$
2.37 - $3.87   
 
6,573,879   
 
5.5   
$
3.06   
 
5,586,187   
 
4.9   
$
3.17 
$
4.02 - $5.30   
 
5,837,215   
 
6.4   
$
4.20   
 
3,709,081   
 
6.6   
$
4.26 
 
F-16

 
 
Employee Stock Purchase Plan
 
The Company maintains the Anixa Biosciences, Inc. Employee Stock Purchase Plan (the “ESPP”) 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 ESPP 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, 2025 and 2024,
employees purchased 3,036 and 3,986 shares, respectively, with aggregate proceeds of approximately $7,000 and $10,000, respectively.
 
Common Stock Purchase Warrants
 
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, 2025 is as follows:
 
 
 
Shares
   
Weighted
Average
Exercise Price
Per Share
   
Aggregate
Intrinsic
Value
 
Warrants outstanding and exercisable at October 31, 2025 and 2024
 
 
300,000   
$
6.56   
$
0 
 
The following table summarizes information about the Company’s outstanding and exercisable warrants as of October 31, 2025:
 
Exercise Price
   
Number
Outstanding and
Exercisable
   
Weighted Average
Remaining
Contractual Life
(in years)
   
Weighted
Average
Exercise Price
 
$
6.56   
 
300,000   
 
0.4   
$
6.56 
 
Stock Awards
 
During the year ended October 31, 2025, we did not issue any stock awards. During the year ended October 31, 2024, we issued 89,336 shares of common stock to
consultants providing investor relations services and recorded expense of approximately $237,000. As of October 31, 2024, approximately $18,000 was recorded as a prepaid
expense which was expensed during the year ended October 31, 2025.
 
Treasury stock
 
As of October 31, 2024, the Company held 2,000 shares of its common stock as treasury stock. These shares were repurchased at an average cost of $3.17 per share for
a total cost of approximately $6,000. The repurchases were made as part of a stock buyback program approved by our Board of Directors on July 11, 2024. The treasury shares
were accounted for under the cost method and were recorded as a reduction in shareholders’ equity in the consolidated balance sheet. In March 2025, the Company cancelled
the treasury shares resulting in a reduction in shares outstanding and paid-in capital.
 
5. LEASES
 
We lease approximately 2,000 square feet of office space at 3150 Almaden Expressway, San Jose, California 95118 (our principal executive offices) from an unrelated
party pursuant to an operating lease that, as amended, will expire on September 30, 2027, with an option to extend the lease an additional two years. The 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 $250,000 with a discount rate of 12%. Rent expense was approximately $63,000 and $61,000 for
the years ended October 31, 2025 and 2024, respectively.
 
F-17

 
 
For operating leases, the lease liability is initially and subsequently measured at the present value of the unpaid lease payments. The remaining 47-month lease term as
of October 31, 2025 for the Company’s lease includes the noncancelable period of the lease and the additional two-year option period that the Company is reasonably certain to
exercise. All right-of-use assets are reviewed for impairment when indications of impairment are present.
 
As of October 31, 2025, the annual minimum lease payments of our operating lease liability were as follows (in thousands):
 
For Years Ending October 31,
 
Operating Leases
 
2026
 
$
63 
2027
 
 
64 
2028
 
 
66 
2029
 
 
63 
Total future minimum lease payments, undiscounted
 
 
256 
Less: Imputed interest
 
 
(52)
Present value of future minimum lease payments
 
$
204 
 
 
 
  
Balance as of October 31, 2025
 
 
  
Operating lease liability
 
$
41 
Operating lease liability, non-current
 
 
163 
Total
 
$
204 
 
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, 2025, our commitments under certain technology license agreements related to our therapeutic and vaccine development programs for the next
twelve months, were approximately $150,000.
 
Research & Development Agreements
 
We have entered into certain research and development agreements with various collaboration partners and third-party vendors related to i) the manufacturing of
materials necessary for the expected Phase 2 clinical trial of our breast cancer vaccine, ii) the discovery of new vaccine targets in high incidence malignancies in prostate, lung
and colon and iii) the further development of our CAR-T technology. As of October 31, 2025, future payments the Company may make under these agreements, dependent
upon, among other things, development of analytical methods, formulation feasibility studies, stability testing and results of manufacturing processes, may be approximately
$1.8 million and such payments may be made over up to a four-year period.
 
F-18

 
 
7. INCOME TAXES
 
Income tax provision (benefit) consists of the following (in thousands):
 
 
 
Year Ended October 31,
 
 
 
2025
   
2024
 
Federal:
 
 
    
 
  
Current
 
$
-   
$
- 
Deferred
 
 
(1,237)  
 
(2,284)
State:
 
 
    
 
  
Current
 
 
-   
 
- 
Deferred
 
 
(574)  
 
(754)
Adjustment to valuation allowance related to net deferred tax assets
 
 
1,811   
 
3,038 
Total
 
$
-   
$
- 
 
The tax effects of temporary differences that give rise to significant portions of the deferred tax asset, net, at October 31, 2025 and 2024, are as follows (in thousands):
 
 
 
October 31,
 
 
 
2025
   
2024
 
Long-term deferred tax assets:
 
 
    
 
  
Federal and state NOL and tax credit carryforwards
 
$
30,582   
$
29,198 
Deferred compensation
 
 
8,763   
 
8,394 
Intangibles
 
 
104   
 
161 
Subtotal
 
 
39,449   
 
37,753 
Less: valuation allowance
 
 
(39,449)  
 
(37,753)
Deferred tax asset, net
 
$
-   
$
- 
 
As of October 31, 2025, we had Federal tax net operating loss and tax credit carryforwards of approximately $106,253,000 and $2,413,000, respectively. At the federal
level, businesses can carry forward their net operating losses indefinitely, but the deductions are limited to 80% 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, 2025, management has not determined the extent of any such limitations, if any.
 
We had California tax net operating loss carryforwards of approximately $68,597,000 as of October 31, 2025, available within statutory limits (expiring at various
dates between 2026 and 2045), 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 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) (in thousands):
 
 
Year Ended October 31,
 
 
 
2025
 
 
2024
 
Income tax benefit at U.S. Federal statutory
income tax rate
 
$
(2,316,000)  
 
(21.00)% 
$
(2,667,000)  
 
(21.00)%
State income taxes
 
 
(770,000)  
 
(6.98)% 
 
(887,000)  
 
(6.99)%
Permanent differences
 
 
31,000   
 
0.28%  
 
21,000   
 
0.17%
Expiring net operating losses, credits and other  
 
1,244,000   
 
11.28%  
 
495,000   
 
3.90%
Change in valuation allowance
 
 
1,811,000   
 
16.42%  
 
3,038,000   
 
23.92%
Income tax provision
 
$
-   
 
0.00%  
$
-   
 
0.00%
 
During the two fiscal years ended October 31, 2025, we incurred no Federal and no State income taxes. We have no unrecognized tax benefits as of October 31, 2025
and 2024 and we account for interest and penalties related to income tax matters, if any, 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.
 
F-19

 
 
8. SEGMENT INFORMATION
 
In November 2023, the FASB issued Accounting Standard Update 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which
was intended to improve reportable segment disclosures by public companies. The update amended and significantly expanded what is required to be disclosed under FASB
Accounting Standard Codification Topic 280 by requiring companies to disclose segment expense information based on what the chief operating decision maker deems to be
material and introduces a disclosure principle based on the significant segment expense categories regularly provided to the CODM and included in the reported measure or
measures of segment profit or loss.
 
We manage our operations in three reportable segments: (i) Cancer Vaccines, (ii) CAR-T Therapies, and (iii) Other. The Cancer Vaccines segment consists of the
development of vaccines to treat and prevent breast cancer and ovarian cancer, as well as additional cancer vaccines to address many intractable cancers, including high-
incidence malignancies in lung, colon, and prostate. The CAR-T Therapies segment consists of the development of an ovarian cancer immunotherapy using a novel type of
CAR-T, known as chimeric endocrine receptor-T cell technology. The Other segment consists of our legacy operations, including limited patent licensing activities of our
various patent portfolios.
 
The Company’s chief operating decision-maker (“CODM”) is our Chief Executive Officer. The CODM reviews our operating results and operating plans and makes
resource allocation decisions on a Company-wide, as well as reportable segment, basis. The CODM uses segment information to evaluate cash flow, identify risks and
opportunities, allocate resources, and set strategic priorities. As stock-based compensation expense does not impact cash, segment operating expenses excluding non-cash stock-
based compensation is the measurement the CODM uses in managing the enterprise. Segment operating expenses excluding non-cash stock-based compensation is a non-
GAAP measure.
 
The following represents selected financial information for our segments for the years ended October 31, 2025 and 2024, and as of October 31, 2025 and 2024 (in
thousands):
 
 
 
For the Years Ended October 31,
 
 
 
2025
   
2024
 
 
 
Cancer
Vaccines    
CAR-T
Therapies   
Other
   
Total
   
Cancer
Vaccines    
CAR-T
Therapies   
Other
   
Total
 
 
 
    
    
    
    
    
    
    
  
Revenues
 
$
-   
$
-   
$
-   
$
-   
$
-   
$
-   
$
-   
$
- 
 
 
 
    
 
    
 
    
 
    
 
    
 
    
 
    
 
  
Research & development expenses
 
 
3,121   
 
1,950   
 
-   
 
5,071   
 
3,748   
 
2,648   
 
-   
 
6,396 
General & administrative expenses
 
 
4,137   
 
2,439   
 
54   
 
6,630   
 
4,291   
 
3,084   
 
60   
 
7,435 
Total operating expenses
 
 
7,258   
 
4,389   
 
54   
 
11,701   
 
8,039   
 
5,732   
 
60   
 
13,831 
 
 
 
    
 
    
 
    
 
    
 
    
 
    
 
    
 
  
Loss from operations
 
 
(7,394)  
 
(4,453)  
 
(54)  
 
(11,701)  
 
(8,039)  
 
(5,732)  
 
(60)  
 
(13,831)
 
 
 
    
 
    
 
    
 
    
 
    
 
    
 
    
 
  
Interest income
 
 
417   
 
252   
 
4   
 
673   
 
651   
 
476   
 
6   
 
1,133 
 
 
 
    
 
    
 
    
 
    
 
    
 
    
 
    
 
  
Net loss
 
$
(6,841)  
$
(4,137)  
$
(50)  
$ (11,028)  
$
(7,388)  
$
(5,256)  
$
(54)  
$ (12,698)
 
 
 
    
 
    
 
    
 
    
 
    
 
    
 
    
 
  
Total operating expenses
 
$
7,258   
$
4,389   
$
54   
$
11,701   
$
8,039   
$
5,732   
$
60   
$
13,831 
Less non-cash stock-based compensation
 
 
(2,365)  
 
(1,435)  
 
(10)  
 
(3,810)  
 
(2,804)  
 
(1,966)  
 
(12)  
 
(4,782)
Operating expenses excluding non-cash stock-
based compensation (a non-GAAP measure)
 
$
4,893   
$
2,954   
$
44   
$
7,891   
$
5,235   
$
3,766   
$
48   
$
9,049 
 
 
 
October 31,
 
 
 
2025
   
2024
 
Total assets:
 
 
    
 
  
Cancer Vaccines
 
$
9,604   
$
12,917 
CAR-T Therapeutics
 
 
6,347   
 
8,535 
Other
 
 
129   
 
139 
Total
 
$
16,080   
$
21,591 
 
F-20
 

 
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, 333-232067 and 333-290178) and the Registration Statement on Form S-8 (No. 333-284239) of Anixa Biosciences,
Inc. (the “Company”) of our report dated January 12, 2026, relating to our audits of the Company’s consolidated financial statements as of October 31, 2025 and 2024, and for
each of the years in the two year period ended October 31, 2025, included in the Company’s Annual Report on Form 10-K for the fiscal year ended October 31, 2025.
 
 
/s/ Haskell & White LLP
 
HASKELL & WHITE LLP
 
Irvine, California
January 12, 2026
 
 
 

 
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 12, 2026
/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 12, 2026
/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, 2025 (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 12, 2026
/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, 2025 (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 12, 2026
/s/ Michael J. Catelani
 
Michael J. Catelani
 
President, Chief Operating Officer and
 
Chief Financial Officer