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
the end of fiscal year 2024.
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, 2024. 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, 2024.
33
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, 2024 has not been audited by our auditors, Haskell & White LLP.
Changes in Internal Control Over Financial Reporting
There were no changes in our internal
control over financial reporting during the fourth quarter of fiscal year 2024 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 2025 Annual Meeting of Stockholders scheduled for March 20, 2025 which such Proxy
Statement will be filed with the SEC within 120 days of October 31, 2024, 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 2025 Annual Meeting of Stockholders scheduled for March 20, 2025 which such Proxy
Statement will be filed with the SEC within 120 days of October 31, 2024, and will be incorporated into this Annual Report on Form 10-K
by reference.
Item 12. Security Ownership of Certain Beneficial
Owners and Management and Related Stockholder Matters
The information required by this
Item will be set forth in our Proxy Statement for the 2025 Annual Meeting of Stockholders scheduled for March 20, 2025 which such Proxy
Statement will be filed with the SEC within 120 days of October 31, 2024, 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 2025 Annual Meeting of Stockholders scheduled for March 20, 2025 which such Proxy
Statement will be filed with the SEC within 120 days of October 31, 2024, and will be incorporated into this Annual Report on Form 10-K
by reference.
Item 14. Principal Accounting Fees and Services
The information required by this
Item will be set forth in our Proxy Statement for the 2025 Annual Meeting of Stockholders scheduled for March 20, 2025 which such Proxy
Statement will be filed with the SEC within 120 days of October 31, 2024, and will be incorporated into this Annual Report on Form 10-K
by reference.
34
PART IV
Item 15. Exhibits, 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.)
10.3
Amendment No. 2 to the 2010 Share Incentive Plan. (Incorporated by reference to Exhibit 10.1 to our Form 8-K, dated September 5, 2012.)
10.4
Amendment No. 3 to the 2010 Share Incentive Plan. (Incorporated by reference to Exhibit 10.1 to our Form 10-Q for the fiscal quarter ended January 31, 2014.)
10.5
2018 Share Incentive Plan. (Incorporated by reference to Exhibit 4.13 to our Form S-8 dated October 1, 2018.)
10.6
License Agreement, dated November 13, 2017, between Certainty Therapeutics, Inc. and The Wistar Institute of Anatomy and Biology. (Incorporated by reference to Exhibit 10.14 to our Form 10-K, dated January 9, 2018.) (Portions of this exhibit have been redacted pursuant to a request for confidential treatment. The redacted portions have been separately filed with the Securities and Exchange Commission.)
10.7
Amendment to License Agreement between Certainty Therapeutics, Inc. and The Wistar Institute of Anatomy and Biology. (Incorporated by reference to Exhibit 10.1 to our Form 10-Q for the fiscal quarter ended January 31, 2021.) (Certain information has been redacted in the marked portions of the exhibit.)
10.8
Amended and Restated Master Collaboration Agreement, dated November 1, 2021, between Certainty Therapeutics, Inc. and H. Lee Moffitt Cancer Center and Research Institute, Inc. (Incorporated by reference to Exhibit 10.8 to our Form 10-K for the fiscal year ended October 31, 2021.)
10.9
Exclusive License Agreement, dated July 8, 2019, between the Company and The Cleveland Clinic Foundation. (Incorporated by reference to Exhibit 10.1 to our Form 10-Q for the fiscal quarter ended July 31, 2019.) (Certain information has been redacted in the marked portions of the exhibit.)
35
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 (Filed herewith.)
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 10, 2025. (Filed herewith.)
31.2
Certification of Chief Financial Officer, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, dated January 10, 2025. (Filed herewith.)
32.1
Statement of Chief Executive Officer, pursuant to Section 1350 of Title 18 of the United States Code, dated January 10, 2025. (Filed herewith.)
32.2
Statement of Chief Financial Officer, pursuant to Section 1350 of Title 18 of the United States Code, dated January 10, 2025. (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.
36
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 10, 2025
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 10, 2025
(Principal Executive Officer)
By:
/s/ Michael J. Catelani
Michael J. Catelani
President, Chief Operating Officer and
Chief Financial Officer
January 10, 2025
(Principal Financial and Accounting Officer)
By:
/s/ Lewis H. Titterton, Jr.
Lewis H. Titterton, Jr.
January 10, 2025
Director
By:
/s/ Arnold Baskies
Dr. Arnold Baskies
January 10, 2025
Director
By:
/s/ Emily Gottschalk
Emily Gottschalk
January 10, 2025
Director
37
ANIXA BIOSCIENCES, INC. AND SUBSIDIARIES
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
OCTOBER 31, 2024
Page
Report of Independent Registered Public Accounting Firm (PCAOB ID: 200 )
F-1
Consolidated Balance Sheets as of October 31, 2024 and 2023
F-3
Consolidated Statements of Operations for the years ended October 31, 2024 and 2023
F-4
Consolidated Statements of Equity for the years ended October 31, 2024 and 2023
F-5
Consolidated Statements of Cash Flows for the years ended October 31, 2024 and 2023
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.
38
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, 2024 and 2023, and the related consolidated statements of operations, equity, and cash
flows for each of the two years in the period ended October 31, 2024, 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, 2024 and 2023, and the consolidated results of its operations and its cash flows for each of
the years in the two year period ended October 31, 2024, 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 Matter
The critical audit matter communicated below is a matter arising from the
current period audit of the consolidated financial statements that was communicated or required to be communicated to the audit committee
and that: (1) relate to accounts or disclosures that are material to the consolidated financial statements, and (2) involved our especially
challenging, subjective, or complex judgments. The communication of the critical audit matter does not alter in any way our opinion on
the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing separate
opinions on the critical audit matter or on the accounts or disclosures to which it relates.
Research and Development Expenses – Refer to Note 2 of the consolidated
financial statements
Critical Audit Matter Description:
The Company recognizes research and development expenses as incurred. Advance
payments for future research and development activities are deferred and expensed as the services are performed. The Company recognizes
its preclinical studies and clinical trial expenses based on the services performed pursuant to contracts with research institutions,
clinical research organizations (“CROs”), clinical manufacturing organizations (“CMOs”), and other parties that
conduct and manage various stages of research and development activities on the Company’s behalf. Fees for such services are recognized
based on management’s estimates after considering the activities and tasks completed by each service provider in a given period,
the time period over which services are expected to be performed, and the level of effort expended in each reporting period.
F- 1
At each balance sheet date, management estimates prepaid and accrued research
and development costs by discussing progress or stage of completion of activities with internal personnel and external service providers,
and comparing this information to payments made, invoices received, and the agreed-upon contractual fee to be paid for such services in
the applicable contract or statements of work.
In addition, the Company allocates certain internal compensation costs
to research and development expenses based on management’s estimates of each employee’s time and effort expended.
How
the Critical Matter was Addressed in the Audit:
The primary procedures we performed to address this critical audit matter
included the following:
§
We obtained an understanding, and evaluated the design and implementation, of controls relating to research and development costs, including controls over the review of third-party contracts, the process of gathering information from external and internal sources and management’s review thereof, and the determination of prepaid positions, period-end accruals, and expense allocations.
§
For the Company’s significant third-party contracts, we performed the following procedures:
○
We obtained and read related master service agreements, statements of work, or other supporting agreements with the research institution, CRO, or CMO.
○
We performed corroborating inquiries with management personnel responsible for the oversight of the activities regarding the nature and status of work performed.
○
We evaluated evidence of services provided by third parties including invoices regarding activities completed, and we inspected evidence supporting payments made by the Company.
○
We compared the data and evidence obtained from internal and external sources to the amounts recorded by management and recalculated the related research and development expense and prepaid research and development expense.
§
For the Company’s internal compensation allocations, we performed the following procedures:
○
We performed corroborating inquiries with management personnel responsible for the oversight of the activities regarding the nature of employee services performed.
○
We evaluated the reasonableness of allocations estimated by management by comparisons with prior periods, evaluating the reasonableness of significant changes made by management, and performing sensitivity analysis.
○
We obtained written representations from management regarding the appropriateness of allocation estimates.
/s/
Haskell & White LLP
HASKELL
& WHITE LLP
We have served as the Company’s auditor since
2013.
Irvine, California
January 10, 2025
F- 2
ANIXA BIOSCIENCES, INC.
AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(in thousands, except share
and per share data)
October 31,
October 31,
2024
2023
ASSETS
Current assets:
Cash and cash equivalents
$ 1,271
$ 915
Short–term investments
18,653
22,929
Receivables
173
270
Prepaid expenses and other current assets
1,265
1,242
Total current assets
21,362
25,356
Operating lease right-of-use asset
229
166
Total assets
$ 21,591
$ 25,522
LIABILITIES AND EQUITY
Current liabilities:
Accounts payable
$ 525
$ 206
Accrued expenses
1,946
1,770
Operating lease liability
29
52
Total current liabilities
2,500
2,028
Operating lease liability, non-current
203
123
Total liabilities
2,703
2,151
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; 32,196,862 and 31,145,219 shares issued and outstanding as of October 31, 2024 and 2023, respectively
322
311
Additional paid-in capital
260,432
252,222
Accumulated deficit
( 240,750 )
( 228,196 )
Treasury stock, 2,000 shares at cost
( 6 )
-
Total shareholders’ equity
19,998
24,337
Noncontrolling interest (Note 2)
( 1,110 )
( 966 )
Total equity
18,888
23,371
Total liabilities and equity
$ 21,591
$ 25,522
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,
2024
2023
Revenue
$ -
$ 210
Operating costs and expenses:
Inventor royalties, contingent legal fees, litigation and licensing expenses
-
161
Research and development expenses (including non-cash stock-based compensation expenses of $ 1,859 and $ 2,037 , respectively)
6,396
4,769
General and administrative expenses (including non-cash stock-based compensation expenses of $ 2,923 and $ 2,698 , respectively)
7,435
6,291
Total operating costs and expenses
13,831
11,221
Loss from operations
( 13,831 )
( 11,011 )
Interest income
1,133
1,081
Net loss
( 12,698 )
( 9,930 )
Less: Net loss attributable to noncontrolling interest
( 144 )
( 119 )
Net loss attributable to common shareholders
$ ( 12,554 )
$ ( 9,811 )
Net loss per share:
Basic and diluted
$ ( 0.39 )
$ ( 0.32 )
Weighted average common shares outstanding:
Basic and diluted
31,898
30,980
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, 2024 AND 2023
(in thousands, except share data)
Common Stock
Additional Paid-in
Accumulated
Treasury
Total Shareholders’
Non-
controlling
Total
Shares
Par Value
Capital
Deficit
Stock
Equity
Interest
Equity
BALANCE, October 31, 2022
30,913,902
$ 309
$ 247,123
$ ( 218,385 )
$ -
$ 29,047
$ ( 847 )
$ 28,200
Stock option compensation to employees and directors
-
-
4,422
-
-
4,422
-
4,422
Stock options issued to consultants
-
-
221
-
-
221
-
221
Common stock issued upon exercise of stock options
202,647
2
351
-
-
353
-
353
Common stock issued to consultants
24,310
-
92
-
-
92
-
92
Common stock issued pursuant to employee stock purchase plan
4,360
-
13
-
-
13
-
13
Net loss
-
-
-
( 9,811 )
-
( 9,811 )
( 119 )
( 9,930 )
BALANCE, October 31, 2023
31,145,219
$ 311
$ 252,222
$ ( 228,196 )
$ -
$ 24,337
$ ( 966 )
$ 23,371
Balance
31,145,219
$ 311
$ 252,222
$ ( 228,196 )
$ -
$ 24,337
$ ( 966 )
$ 23,371
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
Balance
32,196,862
$ 322
$ 260,432
$ ( 240,750 )
$ ( 6 )
$ 19,998
$ ( 1,110 )
$ 18,888
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,
2024
2023
Cash flows from operating activities:
Reconciliation of net loss to net cash used in operating activities:
Net loss
$ ( 12,698 )
$ ( 9,930 )
Stock option compensation to employees and directors
4,420
4,422
Stock options issued to consultants
125
221
Common stock issued to consultants
255
92
Amortization of operating lease right-of-use asset
37
46
Change in operating assets and liabilities:
Receivables
97
( 224 )
Prepaid expenses and other current assets
( 23 )
( 775 )
Accounts payable
319
( 59 )
Accrued expenses
176
44
Operating lease liability
( 43 )
( 46 )
Net cash used in operating activities
( 7,335 )
( 6,209 )
Cash flows from investing activities:
Disbursements to acquire short-term investments
( 63,770 )
( 44,411 )
Proceeds from maturities of short-term investments
68,046
38,809
Net cash provided by (used in) investing activities
4,276
( 5,602 )
Cash flows from financing activities:
Proceeds from sale of common stock in an at-the-market offering, net of offering expenses of $168
2,955
-
Proceeds from sale of common stock pursuant to employee stock purchase plan
10
13
Proceeds from exercise of stock options
456
353
Disbursements for purchases of treasury stock
( 6 )
-
Net cash provided by financing activities
3,415
366
Net increase (decrease) in cash and cash equivalents
356
( 11,445 )
Cash and cash equivalents at beginning of year
915
12,360
Cash and cash equivalents at end of year
$ 1,271
$ 915
Supplemental cash flow information:
Cash proceeds from interest income
$ 1,230
$ 838
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 programs include (i)
the development of a chimeric endocrine receptor-T cell therapy, a novel form of chimeric antigen receptor-T cell (“CAR-T”)
technology, initially focused on treating ovarian cancer, which is being developed at our subsidiary, Certainty Therapeutics, Inc. (“Certainty”),
and (ii) until March 2023, the development of anti-viral drug candidates for the treatment of COVID-19. Our vaccine programs include (i)
the development of a vaccine against breast cancer, initially focused on triple negative breast cancer (“TNBC”), the most
lethal form of 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 NCI designated cancer research center, relating to Wistar’s chimeric endocrine receptor targeted therapy
technology. We have initially focused on the development of a treatment for ovarian cancer, but we also may pursue applications of the
technology for the development of treatments for additional solid tumors. The license agreement requires Certainty to make certain cash
and equity payments to Wistar upon achievement of specific development milestones. With respect to Certainty’s equity obligations
to Wistar, Certainty issued to Wistar shares of its common stock equal to five percent ( 5 %) of the common stock of Certainty, such equity
stake subject to dilution by further funding of Certainty’s activities by the Company. Due to such Company funding, Wistar’s
equity stake in Certainty was 4.4 % as of October 31, 2024.
Certainty, in collaboration with
the H. Lee Moffitt Cancer Center and Research Institute, Inc. (“Moffitt”), has begun human clinical testing of the CAR-T technology
licensed by Certainty from Wistar aimed initially at treating ovarian cancer. After receiving authorization from the FDA, we commenced
enrollment of patients in a Phase 1 clinical trial and treated the first patient in August 2022. Further, in May 2023 and August 2023,
we treated the second and third patients in the trial, respectively, at the same dose level as the first patient, and the treatment was
well-tolerated by the patients. In February 2024, May 2024 and June 2024, we treated the three patients, respectively, 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 has also been well-tolerated by the patients. While the dose levels in the first two cohorts were expected to be sub-therapeutic,
two of the six patients exhibited some anecdotal signs of efficacy. Both have shown possible signs of tumor necrosis, and one is 20 months
past initial treatment. In the case of this patient, 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 appears to have been well-tolerated by the patient. In
November 2024, we treated the first patient in the third dose cohort, where patients are administered a ten-times higher dose of cells
than the patients in the first dose cohort. As of January 10, 2025, we have treated two patients in this dose cohort and the treatment
at this dose level appears to be well-tolerated by the patients. We anticipate completing treatment of patients in the third dose cohort
in February 2025, and commencing treatment of the fourth dose cohort—at a three-times higher dose than the third dose cohort—shortly
thereafter.
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 TNBC.
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
U.S. Food and Drug Administration’s (“FDA”) authorization to proceed, we commenced dosing patients in a Phase 1 clinical
trial of our breast cancer vaccine. This study, which is being 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 is being conducted at Cleveland Clinic. During
the course of the Phase 1 study, participants will receive three vaccinations, each two weeks apart, and will be closely monitored for
side effects and immune response. The first segment of the study, Phase 1a, will consist of approximately 24 patients who have completed
treatment for early-stage, triple-negative breast cancer within the past three years and are currently tumor-free but at high risk for
recurrence. Studies show that 42% of TNBC patients will have a recurrence of their cancer, with most of the recurrences occurring in the
first two to three years after standard of care treatment. In January 2023, the number of participants in each dose cohort was expanded,
and as of August 2023, we had completed vaccinating all patients in these expanded cohorts. In December 2023, we presented the immunological
data collected to date at the San Antonio Breast Cancer Symposium. The data presented show that in the vaccinated women who had been tested
to date, various levels of antigen-specific T cell responses were observed at all dose levels. 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 includes 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 have 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 November 2024, we presented the most recent data from each of the three arms of the trial at the
Society for Immunotherapy of Cancer (SITC) Annual Meeting. Key findings presented include i) patients exhibited antigen-specific immune
responses at all dose levels and in all three patient groups (Phase 1a, 1b and 1c), ii) patients receiving our vaccine in combination
with Keytruda are not showing any additional or more severe adverse side effects, and iii) no adverse side effects were seen other than
varying degrees of injection site irritation. These findings are promising, and as we continue the Phase 1 trial, 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. We
anticipate commencing the Phase 2 trial in 2025.
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 National Cancer Institute’s (“NCI”) PREVENT
program. The NCI is a part of the National Institutes of Health (“NIH”). The PREVENT program is a peer-reviewed agent development
program designed to support pre-clinical development of innovative interventions and biomarkers for cancer prevention and interception
towards clinical trials. The scientific and financial resources of the PREVENT program are being used for our ovarian cancer vaccine technology
to perform virtually all pre-clinical research and development, manufacturing and 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 vaccine or therapeutics programs. In addition, while we pursue our vaccine and therapeutics
programs, we may also make investments in and form new companies to develop additional emerging technologies. We do not expect to begin
generating revenue with respect to any of our current vaccine or therapy programs in the near term. We hope to achieve a profitable outcome
by eventually licensing our technologies to large pharmaceutical companies that have the resources and infrastructure in place to manufacture,
market and sell our technologies as vaccines or therapeutics. The eventual licensing of any of our technologies may take several years,
if it is to occur at all, and may depend on positive results from human clinical trials.
Funding and Management’s Plans
Based on currently available information
as of January 10, 2025, 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, 2024, we raised approximately $ 2,955,000 , net of expenses, through an at-the-market equity offering of 785,290 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, 2024, we may sell up to $ 97 million of common stock. We may seek to obtain working capital during our fiscal year 2025 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, 2024 (in thousands):
SCHEDULE
OF CHANGES IN NONCONTROLLING INTEREST
Balance October 31, 2022
$ ( 847 )
Net loss attributable to noncontrolling interest
( 119 )
Balance October 31, 2023
( 966 )
Net loss attributable to noncontrolling interest
( 144 )
Balance October 31, 2024
$ ( 1,110 )
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 include the costs
and expenses incurred in connection with our patent licensing and enforcement activities, including inventor royalties paid to original
patent owners, contingent legal fees paid to external counsel, other patent-related legal expenses paid to external counsel, licensing
and enforcement related research and consulting and other expenses paid to third-parties. These costs are included under the caption “Operating
costs and expenses” in the accompanying consolidated statements of operations.
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. The Company has no Bitcoin Assets as of October 31, 2024 and 2023.
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 on a recurring basis as of October 31, 2024 (in thousands):
SCHEDULE
OF FAIR VALUE MEASUREMENTS
Level 1
Level 2
Level 3
Total
Money market funds:
Cash equivalents
$ 1,170
$ -
$ -
$ 1,170
U.S. treasury bills:
Short term investments
-
18,653
-
18,653
Total financial assets
$ 1,170
$ 18,653
$ -
$ 19,823
The following table presents the
hierarchy for our financial assets measured at fair value on a recurring basis as of October 31, 2023 (in thousands):
Level 1
Level 2
Level 3
Total
Money market funds:
Cash equivalents
$ 778
$ -
$ -
$ 778
Certificates of deposit:
Short term investments
-
720
-
720
U.S. treasury bills:
Short term investments
-
22,209
-
22,209
Total financial assets
$ 778
$ 22,929
$ -
$ 23,707
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, 2024 and 2023,
we had certificates of deposit and United States treasury bills with maturities greater than 90 days and less than 12 months when acquired
of approximately $ 18,653,000 and $ 22,929,000 , respectively, 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.
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.
F- 12
Stock Option Compensation Expense
We account for stock options granted
to employees, directors and consultants using the accounting guidance in ASC 718, Stock Compensation (“ASC 718”). We estimate
the fair value of service-based stock options on the date of grant, using the Black-Scholes pricing model, and recognize compensation
expense over the requisite service period of the grant.
We recorded stock-based compensation
expense, related to service-based stock options granted to employees and directors, of approximately $ 4,420,000 and $ 4,422,000 , during
the years ended October 31, 2024 and 2023, respectively. Included in stock-based compensation cost for service-based options granted to
employees and directors during the years ended October 31, 2024 and 2023 was approximately $ 3,187,000 and $ 3,023,000 , respectively, related
to the amortization of compensation cost for stock options granted in prior periods but not yet vested. As of October 31, 2024, there
was unrecognized compensation cost related to non-vested service-based stock options granted to employees and directors of approximately
$ 4,843,000 , which will be recognized over a weighted-average period of 1.7 years.
We recorded consulting expense,
related to service-based stock options granted to consultants, during the years ended October 31, 2024 and 2023 of approximately $ 125,000
and $ 221,000 , respectively. Included in stock-based consulting expense for the years ended October 31, 2024 and 2023 was approximately
$ 120,000 and $ 209,000 , respectively, related to compensation cost for stock options granted in prior periods but not yet vested. As of
October 31, 2024, there was unrecognized consulting expense related to non-vested service-based stock options granted to consultants of
approximately $ 180,000 , which will be recognized over a weighted-average period of 1.9 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, 2024 and 2023 consisted of awards with 5 -year and 10 -year
terms that vest over 12 to 36 months.
The following weighted average
assumptions were used in estimating the fair value of stock options granted during the years ended October 31, 2024 and 2023:
SCHEDULE
OF WEIGHTED AVERAGE ASSUMPTIONS USED IN ESTIMATING FAIR VALUE OF STOCK OPTIONS
For the Year Ended October 31,
2024
2023
Weighted average fair value at grant date
$ 2.94
$ 3.29
Valuation assumptions:
Expected life (years)
5.71
5.47
Expected volatility
76.48 %
100.27 %
Risk-free interest rate
3.87 %
3.87 %
Expected dividend yield
0 %
0 %
The expected term of stock options
represents the weighted average period the stock options are expected to remain outstanding. For employees and directors, we use the simplified
method, which is a weighted average of the vesting term and contractual term, to determine expected term. The simplified method was adopted
since we do not believe that historical experience is representative of future performance because of the impact of the changes in our
operations and the change in terms from historical operations. For consultants, we use the contract term for expected term. Under the
Black-Scholes pricing model, we estimated the expected volatility of our shares of common stock based upon the historical volatility of
our share price over a period of time equal to the expected term of the options. We estimated the risk-free interest rate based on the
implied yield available on the applicable grant date of a U.S. Treasury note with a term equal to the expected term of the underlying
grants. We made the dividend yield assumption based on our history of not paying cash dividends and our expectation not to pay dividends
in the future.
Under ASC 718, the amount of stock-based
compensation expense recognized is based on the portion of the awards that are ultimately expected to vest. Accordingly, if deemed necessary,
we reduce the fair value of the stock option awards for expected forfeitures, which are forfeitures of the unvested portion of surrendered
options. Based on our historical experience and future expectations, we have not reduced the amount of stock-based compensation expenses
for anticipated forfeitures.
F- 13
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, 2024 and 2023 were options to purchase 12,158,062
shares and 11,430,000 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 doubtful
accounts, depreciation lives and other contingencies. Actual results could differ from those estimates.
Effect of Recently Issued Pronouncements
In October 2021, the FASB issued
Accounting Standards Update 2021-08, Business Combinations (Topic 805): Accounting for Contract Assets and
Contract Liabilities from Contracts with Customers, to require that an acquirer recognize and measure contract assets and contract liabilities
acquired in a business combination in accordance with Topic 606, Revenue from Contracts with Customers. At the acquisition date, an acquirer
should account for the related revenue contracts in accordance with Topic 606 as if it had originated the contracts. The amendments in
this update should be applied prospectively and are effective for fiscal years beginning after December 15, 2022, including interim periods
within those fiscal years. The adoption of this standard did not have a material impact on our consolidated financial statements and related
disclosures.
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. We began
a detailed assessment of the impact that this guidance will have on our consolidated financial statements and related disclosures, and
our analysis is currently ongoing.
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 began a detailed assessment of the impact that this guidance will have on our consolidated financial
statements and related disclosures, and our analysis is currently ongoing.
F- 14
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 began a detailed assessment of the impact that this guidance will have on our consolidated
financial statements and related disclosures, and our analysis is currently ongoing.
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. Where applicable,
management reviews our accounts receivable and other receivables for potential doubtful accounts and maintains an allowance for estimated
uncollectible amounts. Our policy is to write-off uncollectable amounts at the time it is determined that collection will not occur. One
licensee accounted for 100 % of revenues from patent licensing activities during fiscal year 2023. We recorded no revenue in fiscal year
2024.
3. ACCRUED EXPENSES
Accrued liabilities consist of
the following as of:
SCHEDULE OF ACCRUED EXPENSES
2024
2023
October 31,
2024
2023
Payroll and related expenses
$ 1,126
$ 1,114
Accrued royalty and contingent legal fees
626
626
Accrued other
194
30
Accrued expenses
$ 1,946
$ 1,770
4. SHAREHOLDERS’ EQUITY
Stock Option Plans
During the year ended October
31, 2024, 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, 2024 and 2023, stock options to purchase 173,031 and 157,761 shares of common stock, respectively, were exercised on a cash basis,
with aggregate proceeds of approximately $ 456,000 and $ 353,000 , respectively. During the year ended October 31, 2023, stock options to
purchase 161,111 shares of common stock, of which 116,225 shares were withheld, were exercised on a cashless basis, respectively. During
the year ended October 31, 2024, no stock options were exercised on a cashless basis.
F- 15
2010 Share Plan
The 2010 Share Plan provided for
the grant of nonqualified stock options, stock appreciation rights, stock awards, performance awards and stock units to employees, directors
and consultants. On the first business day of each calendar year the aggregate number of shares available for future issuance was replenished
such that 800,000 shares were available. The exercise price with respect to all of the options granted under the 2010 Share Plan was equal
to the fair market value of the underlying common stock at the grant date. Information regarding the 2010 Share Plan for the two years
ended October 31, 2024 is as follows:
SCHEDULE
OF OPTION ACTIVITY
Shares
Weighted Average
Exercise Price
Per Share
Aggregate Intrinsic Value
Options Outstanding at October 31, 2022
1,501,500
$ 2.83
Exercised
( 312,500 )
$ 2.41
Options Outstanding at October 31, 2023
1,189,000
$ 2.94
Exercised
( 112,032 )
$ 2.58
Expired
( 90,000 )
$ 5.29
Options Outstanding and Exercisable at October 31, 2024
986,968
$ 2.77
$ 911,362
The following table summarizes
information about stock options outstanding under the 2010 Share Plan as of October 31, 2024:
SCHEDULE
OF OUTSTANDING AND EXERCISABLE
Range of Exercise Prices
Number
Outstanding and
Exercisable
Weighted Average
Remaining
Contractual Life
(in years)
Weighted
Average
Exercise Price
$ 0.67 - $ 2.27
316,000
2.75
$ 1.11
$ 2.58 - $ 3.13
251,968
1.32
$ 2.93
$ 3.46 - $ 5.30
419,000
3.45
$ 3.93
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,
2024, the 2018 Share Plan had 983,907 shares available for future grants. Information regarding the 2018 Share Plan for the two years
ended October 31, 2024 is as follows:
SCHEDULE
OF OPTION ACTIVITY
Shares
Weighted Average
Exercise Price
Per Share
Aggregate Intrinsic Value
Options Outstanding at October 31, 2022
8,817,372
$ 3.60
Granted
1,640,000
$ 3.97
Exercised
( 6,372 )
$ 2.89
Forfeited/Expired
( 210,000 )
$ 5.10
Options Outstanding at October 31, 2023
10,241,000
$ 3.67
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
$ 2,016,259
Options Exercisable at October 31, 2024
7,921,567
$ 3.56
$ 1,904,173
F- 16
The following table summarizes
information about stock options outstanding under the 2018 Share Plan as of October 31, 2024:
SCHEDULE
OF OUTSTANDING AND EXERCISABLE
Options Outstanding
Options Exercisable
Range of
Exercise Prices
Number
Outstanding
Weighted
Average
Remaining
Contractual Life
(in years)
Weighted
Average
Exercise Price
Number
Exercisable
Weighted
Average
Remaining
Contractual Life
(in years)
Weighted
Average
Exercise Price
$ 2.09 - $ 3.87
5,308,879
5.60
$ 3.23
5,023,213
5.44
$ 3.24
$ 3.96 - $ 5.30
5,862,215
7.41
$ 4.20
2,898,354
6.98
$ 4.11
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, 2024 and 2023, employees purchased 3,986 and 4,360 shares, respectively, with aggregate proceeds
of approximately $ 10,000 and $ 13,000 , 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, 2024 is as follows:
SCHEDULE
OF WARRANTS ACTIVITY
Shares
Weighted Average
Exercise Price
Per Share
Aggregate
Intrinsic
Value
Warrants Outstanding and Exercisable at October 31, 2023 and October 31, 2024
300,000
$ 6.56
$ 0
The following table summarizes
information about the Company’s outstanding and exercisable warrants as of October 31 , 2024:
SCHEDULE
OF OUTSTANDING AND EXERCISABLE
Exercise Price
Number
Outstanding and
Exercisable
Weighted Average
Remaining
Contractual Life
(in years)
Weighted
Average
Exercise Price
$ 6.56
300,000
1.39
$ 6.56
Stock Awards
During the years ended October
31, 2024 and 2023, we issued 89,336 shares and 24,310 shares of common stock, respectively, to consultants providing investor relations
services and recorded expense of approximately $ 237,000 and $ 92,000 , respectively. As of October 31, 2024 and 2023, approximately $ 18,000
and $ 0 , respectively, was recorded as a prepaid expense.
F- 17
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 are accounted for under the cost method and are recorded as a reduction in shareholders’ equity in
the consolidated balance sheet. The Company may reissue treasury shares for stock option exercises, acquisitions, or other corporate purposes.
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 $ 61,000 and $ 66,000 for the years ended October 31, 2024 and 2023,
respectively.
For operating leases, the lease
liability is initially and subsequently measured at the present value of the unpaid lease payments. The remaining 59 -month lease term
as of October 31, 2024 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, 2024, 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
2025
$ 56
2026
63
2027
64
2028
66
2029
63
Total future minimum lease payments, undiscounted
312
Less: Imputed interest
80
Present value of future minimum lease payments
$ 232
Balance as of October 31, 2024
Operating lease liability
$
29
Operating lease liability, non-current
203
Total
$ 232
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, 2024, 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, 2024, 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 $ 4.2 million and such payments may be made over up to a
five-year period.
F- 18
7. INCOME TAXES
Income tax provision (benefit)
consists of the following:
SCHEDULE
OF INCOME TAX PROVISION (BENEFIT)
2024
2023
Year Ended October 31,
2024
2023
Federal:
Current
$ -
$ -
Deferred
( 2,284,000 )
( 739,000 )
State:
Current
-
-
Deferred
( 754,000 )
( 583,000 )
Adjustment to valuation allowance related to net deferred tax assets
3,038,000
1,322,000
Total
$ -
$ -
The tax effects of temporary differences
that give rise to significant portions of the deferred tax asset, net, at October 31, 2024 and 2023, are as follows:
SCHEDULE
OF DEFERRED TAX ASSETS AND LIABILITIES
2024
2023
October 31,
2024
2023
Long-term deferred tax assets:
Federal and state NOL and tax credit carryforwards
$ 29,198,000
$ 26,532,000
Deferred compensation
8,394,000
7,752,000
Intangibles
161,000
218,000
Subtotal
37,753,000
34,502,000
Less: valuation allowance
( 37,753,000 )
( 34,502,000 )
Deferred tax asset, net
$ -
$ -
As of October 31, 2024, we had
Federal tax net operating loss and tax credit carryforwards of approximately $ 99,868,000 and $ 1,946,000 , respectively. At the federal
level, businesses can carry forward their net operating losses indefinitely, but the deductions are limited to 80 percent of taxable income.
Prior to the Tax Cuts and Jobs Act (TCJA) of 2017, businesses could carry losses forward for 20 years (without a deductibility limit).
If the tax benefits relating to deductions of option holders’ income are ultimately realized, those benefits will be credited directly
to additional paid-in capital. Certain changes in stock ownership can result in a limitation on the amount of net operating loss and tax
credit carryovers that can be utilized each year. As of October 31, 2024, management has not determined the extent of any such limitations,
if any.
We had California tax net operating
loss carryforwards of approximately $ 60,618,000 as of October 31, 2024, available within statutory limits ( expiring at various dates between
2025 and 2044 ), 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):
SCHEDULE
OF RECONCILIATION OF INCOME TAXES
Year Ended October 31,
2024
2023
Income tax benefit at U.S. Federal statutory income tax rate
$ ( 2,667,000 )
( 21.00 )%
$ ( 2,085,000 )
( 21.00 )%
State income taxes
( 887,000 )
( 6.99 )%
( 693,000 )
( 6.98 )%
Permanent differences
21,000
0.17 %
20,000
0.20 %
Expiring net operating losses, credits and other
495,000
3.90 %
1,436,000
14.46 %
Change in valuation allowance
3,038,000
23.92 %
1,322,000
13.32 %
Income tax provision
$ -
0.00 %
$ -
0.00 %
F- 19
During the two fiscal years ended
October 31, 2024, we incurred no Federal and no State income taxes. We have no unrecognized tax benefits as of October 31, 2024 and 2023
and we account for interest and penalties related to income tax matters in general and administrative expenses. Tax years to which our
net operating losses relate remain open to examination by Federal and California authorities to the extent which the net operating losses
have yet to be utilized.
8. SEGMENT INFORMATION
We follow the accounting guidance
of ASC 280, Segment Reporting (“ASC 280”). Reportable operating segments are determined based on the management approach.
The management approach, as defined by ASC 280, is based on the way that the chief operating decision-maker organizes the segments within
an enterprise for making operating decisions and assessing performance. While our results of operations are primarily reviewed on a consolidated
basis, the chief operating decision-maker manages the enterprise in three reportable segments, each with different operating and potential
revenue generating characteristics: (i) Cancer Vaccines, (ii) CAR-T Therapeutics, and (iii) Other. The following represents selected financial
information for our segments for the years ended October 31, 2024 and 2023, in thousands:
SCHEDULE
OF SEGMENT INFORMATION
2024
2023
Year Ended October 31,
2024
2023
Net loss:
Cancer Vaccines
$ ( 7,388 )
$ ( 5,111 )
CAR-T Therapeutics
( 5,256 )
$ ( 3,879 )
Other
( 54 )
( 940 )
Total
$ ( 12,698 )
$ ( 9,930 )
Net income (loss)
$ ( 12,698 )
$ ( 9,930 )
Total operating costs and expenses
$ 13,831
$ 11,221
Less non-cash stock-based compensation
( 4,782 )
( 4,735 )
Operating costs and expenses excluding non-cash stock-based compensation
$ 9,049
$ 6,486
Operating costs and expenses excluding non-cash stock-based compensation:
Cancer Vaccines
$ 5,235
$ 3,265
CAR-T Therapeutics
3,766
2,467
Other
48
754
Total
$ 9,049
$ 6,486
Operating
costs and expenses excluding non-cash share based compensation
$ 9,049
$ 6,486
2024
2023
October 31,
2024
2023
Total assets:
Cancer Vaccines
$ 12,917
$ 17,215
CAR-T Therapeutics
8,535
7,523
Other
139
784
Total
$ 21,591
$ 25,522
Total assets
$ 21,591
$ 25,522
Operating costs and expenses excluding
non-cash stock-based compensation is the measurement the chief operating decision-maker uses in managing the enterprise.
The Company had no revenue during
the year ended October 31, 2024. The Company’s consolidated revenue of $ 210,000 and inventor royalties, contingent legal fees, litigation
and licensing expense of $ 161,000 , for the year ended October 31, 2023 were solely related to our other segment. All our revenue is generated
domestically (United States) based on the country in which the licensee is located.
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.