Item 9A. Controls and Procedures
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 Offering SM 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
-
-
Preferred stock, value
-
-
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):
SCHEDULE
OF CHANGES IN NONCONTROLLING INTEREST
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):
SCHEDULE
OF FAIR VALUE MEASUREMENTS
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:
SCHEDULE
OF WEIGHTED AVERAGE ASSUMPTIONS USED IN ESTIMATING FAIR VALUE OF STOCK OPTIONS
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):
SCHEDULE OF ACCRUED EXPENSES
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:
SCHEDULE
OF OPTION ACTIVITY
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:
SCHEDULE OF OPTIONS OUTSTANDING AND EXERCISABLE
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:
SCHEDULE
OF OPTION ACTIVITY
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:
SCHEDULE OF OPTIONS OUTSTANDING AND EXERCISABLE
Options Outstanding
Options Exercisable
Range of
Exercise Prices
Number
Outstanding
Weighted
Average
Remaining
Contractual Life
(in years)
Weighted
Average
Exercise Price
Number
Exercisable
Weighted
Average
Remaining
Contractual Life
(in years)
Weighted
Average
Exercise Price
$ 2.37 - $ 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:
SCHEDULE
OF WARRANTS ACTIVITY
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:
SCHEDULE
OF WARRANTS OUTSTANDING AND EXERCISABLE
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):
SCHEDULE OF MINIMUM LEASE PAYMENTS
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 4 four-year period.
F- 18
7.
INCOME TAXES
Income
tax provision (benefit) consists of the following (in thousands):
SCHEDULE
OF INCOME TAX PROVISION (BENEFIT)
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):
SCHEDULE
OF DEFERRED TAX ASSETS AND LIABILITIES
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):
SCHEDULE
OF RECONCILIATION OF INCOME TAXES
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):
SCHEDULE OF SEGMENT INFORMATION
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
Total assets
$ 16,080
$ 21,591
F- 20
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.