UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
☒
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended July 31, 2025
or
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from ______ to ______
Commission
file number 001-37492
ANIXA
BIOSCIENCES, INC.
(Exact
name of registrant as specified in its charter)
Delaware
11-2622630
(State
or other jurisdiction of
(I.R.S.
Employer
incorporation
or organization)
Identification
No.)
3150
Almaden Expressway , Suite 250
San
Jose , CA
95118
(Address
of principal executive offices)
(Zip
Code)
(408)
708-9808
(Registrant’s
telephone number, including area code)
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class
Trading
symbol
Name
of exchange on which registered
Common
Stock, par value $.01 per share
ANIX
NASDAQ
Capital Market
Indicate
by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days.
Yes
☒
No
☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files).
Yes
☒
No
☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company,
or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller
reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer ☐
Accelerated
filer ☐
Non-accelerated
filer ☒
Smaller
reporting company ☒
Emerging
growth company ☐
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes
☐
No
☒
Indicate
the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.
On
September 10, 2025, the registrant had outstanding 32,916,915 shares of Common Stock, par value $ .01 per share, which is the
registrant’s only class of common stock.
TABLE
OF CONTENTS
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements.
1
Condensed Consolidated Balance Sheets (Unaudited) as of July 31, 2025 and October 31, 2024
1
Condensed Consolidated Statements of Operations (Unaudited) for the three and nine months ended July 31, 2025 and 2024
2
Condensed Consolidated Statements of Equity (Unaudited) for the three months ended July 31, 2025 and 2024
3
Condensed Consolidated Statements of Equity (Unaudited) for the nine months ended July 31, 2025 and 2024
4
Condensed Consolidated Statements of Cash Flows (Unaudited) for the nine months ended July 31, 2025 and 2024
5
Notes to Condensed Consolidated Financial Statements (Unaudited)
6
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
17
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
21
Item 4. Controls and Procedures.
21
PART II. OTHER INFORMATION
22
Item 1. Legal Proceedings.
22
Item 1A. Risk Factors.
22
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
22
Item 3. Defaults Upon Senior Securities.
22
Item 4. Mine Safety Disclosures.
22
Item 5. Other Information.
22
Item 6. Exhibits.
22
SIGNATURES
23
i
PART
I. FINANCIAL INFORMATION
Item
1. Financial Statements.
ANIXA
BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED BALANCE SHEETS (UNAUDITED)
(in
thousands, except share and per share data)
July
31, 2025
October
31, 2024
ASSETS
Current
assets:
Cash
and cash equivalents
$ 1,495
$ 1,271
Short-term
investments
14,534
18,653
Receivables
-
173
Prepaid
expenses and other current assets
1,420
1,265
Total
current assets
17,449
21,362
Operating
lease right-of-use asset
202
229
Total
assets
$ 17,651
$ 21,591
LIABILITIES
AND EQUITY
Current
liabilities:
Accounts
payable
$ 276
$ 525
Accrued
expenses
1,751
1,946
Operating
lease liability, current
39
29
Total
current liabilities
2,066
2,500
Operating
lease liability, non-current
174
203
Total
liabilities
2,240
2,703
Commitments
and contingencies (Note 10)
-
-
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; 32,822,109 and 32,196,862 shares issued and outstanding as of July
31, 2025 and October 31, 2024, respectively
328
322
Additional
paid-in capital
265,249
260,432
Accumulated
deficit
( 248,982 )
( 240,750 )
Treasury
stock, 2,000 shares at cost as of October 31, 2024
-
( 6 )
Total
shareholders’ equity
16,595
19,998
Noncontrolling
interest (Note 2)
( 1,184 )
( 1,110 )
Total
equity
15,411
18,888
Total
liabilities and equity
$ 17,651
$ 21,591
The
accompanying notes are an integral part of these condensed consolidated financial statements.
1
ANIXA
BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
(in
thousands, except per share data)
2025
2024
2025
2024
For
the three months ended
For
the nine months ended
July
31,
July
31,
2025
2024
2025
2024
Revenue
$ -
$ -
$ -
$ -
Operating
expenses:
Research
and development expenses (including non-cash stock-based compensation expenses of $ 358 , $ 462 , $ 1,172 and $ 1,471 , respectively)
1,055
1,925
3,929
4,920
General
and administrative expenses (including non-cash stock-based compensation expenses of $ 497 , $ 717 , $ 1,727 and $ 2,228 , respectively)
1,381
1,667
4,896
5,748
Total
operating expenses
2,436
3,592
8,825
10,668
Loss
from operations
( 2,436 )
( 3,592 )
( 8,825 )
( 10,668 )
Interest
income
156
277
519
883
Net
loss
( 2,280 )
( 3,315 )
( 8,306 )
( 9,785 )
Less:
Net loss attributable to noncontrolling interest
( 22 )
( 38 )
( 74 )
( 114 )
Net
loss attributable to common shareholders
$ ( 2,258 )
$ ( 3,277 )
$ ( 8,232 )
$ ( 9,671 )
Net
loss per common share attributable to common shareholders:
Basic
and diluted
$ ( 0.07 )
$ ( 0.10 )
$ ( 0.25 )
$ ( 0.30 )
Weighted
average common shares outstanding:
Basic
and diluted
32,476
32,054
32,293
31,804
The
accompanying notes are an integral part of these condensed consolidated financial statements.
2
ANIXA
BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF EQUITY
(in
thousands, except share data)
FOR
THE THREE MONTHS ENDED JULY 31, 2025 (UNAUDITED )
Shares
Par
Value
Paid-in
Capital
Accumulated
Deficit
Treasury
Stock
Shareholders’
Equity
controlling
Interest
Total
Equity
Common
Stock
Additional
Total
Non-
Shares
Par
Value
Paid-in
Capital
Accumulated
Deficit
Treasury
Stock
Shareholders’
Equity
controlling
Interest
Total
Equity
Balance,
April 30, 2025
32,211,092
$ 322
$ 262,470
$ ( 246,724 )
$ -
$ 16,068
$ ( 1,162 )
$ 14,906
Stock
option compensation to employees and directors
-
-
829
-
-
829
-
829
Stock
options issued to consultants
-
-
26
-
-
26
-
26
Offering
expenses related to an at-the-market offering
Common
stock issued in an at-the-market offering, net of offering expenses of $ 73
596,974
6
1,922
-
-
1,928
-
1,928
Common
stock issued upon exercise of stock options
14,043
-
2
-
-
2
-
2
Common
stock issued to consultants
Common
stock issued to consultants , shares
Common
stock issued pursuant to an employee stock purchase plan
Common
stock issued pursuant to an employee stock purchase plan , shares
Cancelation of treasury
shares
Cancelation of treasury
shares , shares
Net
loss
-
-
-
( 2,258 )
-
( 2,258 )
( 22 )
( 2,280 )
Balance,
July 31, 2025
32,822,109
$ 328
$ 265,249
$ ( 248,982 )
$ -
$ 16,595
$ ( 1,184 )
$ 15,411
FOR
THE THREE MONTHS ENDED JULY 31, 2024 (UNAUDITED )
Common
Stock
Additional
Total
Non-
Shares
Par
Value
Paid-in
Capital
Accumulated
Deficit
Treasury
Stock
Shareholders’
Equity
controlling
Interest
Total
Equity
Balance,
April 30, 2024
32,006,460
$ 320
$ 257,893
$ ( 234,590 )
$ -
$ 23,623
$ ( 1,042 )
$ 22,581
Stock
option compensation to employees and directors
-
-
1,094
-
-
1,094
-
1,094
Stock
options issued to consultants
-
-
23
-
-
23
-
23
Offering
expenses related to an at-the-market offering
-
-
( 45 )
-
-
( 45 )
-
( 45 )
Common
stock issued upon exercise of stock options
80,000
1
193
-
-
194
-
194
Common
stock issued to consultants
60,000
-
159
-
-
159
-
159
Net
loss
-
-
-
( 3,277 )
-
( 3,277 )
( 38 )
( 3,315 )
Balance,
July 31, 2024
32,146,460
$ 321
$ 259,317
$ ( 237,867 )
$ -
$ 21,771
$ ( 1,080 )
$ 20,691
The
accompanying notes are an integral part of these condensed consolidated financial statements.
3
ANIXA
BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF EQUITY
(in
thousands, except share data)
FOR
THE NINE MONTHS ENDED JULY 31, 2025 (UNAUDITED)
Common
Stock
Additional
Total
Non-
Shares
Par
Value
Paid-in
Capital
Accumulated
Deficit
Treasury
Stock
Shareholders’
Equity
controlling
Interest
Total
Equity
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
-
-
2,822
-
-
2,822
-
2,822
Stock
options issued to consultants
-
-
77
-
-
77
-
77
Common
stock issued in an at-the-market offering, net of offering expenses of $ 123
611,686
6
1,918
-
-
1,924
-
1,924
Common
stock issued upon exercise of stock options
14,043
-
2
-
-
2
-
2
Common
stock issued pursuant to an employee stock purchase plan
1,518
-
4
-
-
4
-
4
Cancelation of treasury
shares
( 2,000 )
-
( 6 )
-
6
-
-
-
Net
loss
-
-
-
( 8,232 )
-
( 8,232 )
( 74 )
( 8,306 )
Balance,
July 31, 2025
32,822,109
$ 328
$ 265,249
$ ( 248,982 )
$ -
$ 16,595
$ ( 1,184 )
$ 15,411
FOR
THE NINE MONTHS ENDED JULY 31, 2024 (UNAUDITED)
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
Balance
31,145,219
$ 311
$ 252,222
$ ( 228,196 )
$ -
$ 24,337
$ ( 966 )
$ 23,371
Stock
option compensation to employees and directors
-
-
3,440
-
-
3,440
-
3,440
Stock
options issued to consultants
-
-
101
-
-
101
-
101
Common
stock issued in an at-the-market offering, net of offering expenses of $ 139
785,290
8
2,976
-
-
2,984
-
2,984
Common
stock issued in an at-the-market offering, net of offering expenses
785,290
8
2,976
-
-
2,984
-
2,984
Common
stock issued upon exercise of stock options
123,999
1
317
-
-
318
-
318
Common
stock issued to consultants
89,336
1
254
-
-
255
-
255
Common
stock issued pursuant to an employee stock purchase plan
2,616
-
7
-
-
7
-
7
Net
loss
-
-
-
( 9,671 )
-
( 9,671 )
( 114 )
( 9,785 )
Balance,
July 31, 2024
32,146,460
$ 321
$ 259,317
$ ( 237,867 )
$ -
$ 21,771
$ ( 1,080 )
$ 20,691
Balance
32,146,460
$ 321
$ 259,317
$ ( 237,867 )
$ -
$ 21,771
$ ( 1,080 )
$ 20,691
The
accompanying notes are an integral part of these condensed consolidated financial statements.
4
ANIXA
BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
(in
thousands)
2025
2024
For
the nine months ended
July 31,
2025
2024
Cash
flows from operating activities:
Reconciliation
of net loss to net cash used in operating activities:
Net
loss
$ ( 8,306 )
$ ( 9,785 )
Stock
option compensation to employees and directors
2,822
3,440
Stock
options issued to consultants
77
101
Common
stock issued to consultants
-
255
Amortization
of operating lease right-of-use asset
27
28
Amortization
of discount on held-to-maturity securities
( 93 )
-
Change
in operating assets and liabilities:
Receivables
173
( 140 )
Prepaid
expenses and other current assets
( 155 )
( 273 )
Accounts
payable
( 249 )
96
Accrued
expenses
( 195 )
( 92 )
Operating
lease liability
( 19 )
( 38 )
Net
cash used in operating activities
( 5,918 )
( 6,408 )
Cash
flows from investing activities:
Disbursements
to acquire short-term investments
( 36,700 )
( 47,307 )
Proceeds
from maturities of short-term investments
40,912
50,716
Net
cash provided by investing activities
4,212
3,409
Cash
flows from financing activities:
Proceeds
from sale of common stock in an at-the-market offering, net of offering expenses of $ 123 and $ 139 , respectively
1,924
2,984
Proceeds
from sale of common stock pursuant to an employee stock purchase plan
4
7
Proceeds
from exercise of stock options
2
318
Net
cash provided by financing activities
1,930
3,309
Net
increase in cash and cash equivalents
224
310
Cash
and cash equivalents at beginning of period
1,271
915
Cash
and cash equivalents at end of period
$ 1,495
$ 1,225
Supplemental
disclosure of non-cash investing activity:
Operating
lease right-of-use asset from lease extension
$ -
$ ( 100 )
Supplemental
disclosure of non-cash financing activity:
Operating
lease liability from lease extension
$ -
$ 100
The
accompanying notes are an integral part of these condensed consolidated financial statements.
5
ANIXA
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
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 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”). 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 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 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 July 31, 2025.
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 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 appears to have been well-tolerated by the patients.
From June 2025 through September 10, 2025, we treated three 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. While many patients have survived beyond expectations, one is still
alive two years past initial treatment and another survived over one year past treatment. In the case of the patient that is 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 appears to have been well-tolerated by the patient.
6
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 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. 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 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 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. We have completed enrollment and treatment in the trial, and have completed all patient follow up visits. We anticipate
reporting final Phase 1 data at the San Antonio Breast Cancer Symposium in December 2025. The Phase 1 findings to date 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 final Phase 1 data release, FDA consultations, protocol development,
manufacturing and clinical site selection.
7
We
hold an exclusive worldwide, royalty-bearing license to use certain intellectual property owned or controlled by Cleveland Clinic relating
to certain ovarian cancer vaccine technology. The license agreement requires us to make certain cash payments to Cleveland Clinic upon
achievement of specific development milestones. This technology pertains to among other things, the use of vaccines for the treatment
or prevention of ovarian cancers which express the anti-Mullerian hormone receptor 2 protein containing an extracellular domain (“AMHR2-ED”).
In healthy tissue, this protein regulates growth and development of egg-containing follicles in the ovary. While expression of AMHR2-ED
naturally and markedly declines during menopause, this protein is expressed at high levels in the ovaries of postmenopausal women with
ovarian cancer. Researchers at Cleveland Clinic believe that a vaccine targeting AMHR2-ED could prevent the occurrence of ovarian cancer.
In
May 2021, Cleveland Clinic was granted acceptance for our ovarian cancer vaccine technology into the NCI’s PREVENT program. The
NCI is a part of the National Institutes of Health (“NIH”). The PREVENT program is a peer-reviewed agent development program
designed to support pre-clinical development of innovative interventions and biomarkers for cancer prevention and interception towards
clinical trials. The scientific and financial resources of the PREVENT program are being used for our ovarian cancer vaccine technology
to perform virtually all pre-clinical research and development, manufacturing and IND enabling studies. This work is being performed
at NCI facilities, by NCI scientific staff and with NCI financial resources and will require no material financial expenditures by the
Company, nor the payment of any future consideration by the Company to NCI.
In
May 2024, based on the positive clinical results to date in the development of our breast cancer vaccine, we entered into a Joint Development
and Option Agreement with Cleveland Clinic to collaborate in efforts to develop additional vaccines for the prevention or treatment of
cancers. Working with Cleveland Clinic researchers, we are focusing on the same novel scientific mechanism as in our breast and ovarian
cancer vaccines, and working to discover additional retired proteins that may be associated with other forms of cancer, specifically
high incidence malignancies in the lung, colon and prostate.
Over
the next several quarters, we expect the development of our therapeutics and vaccines to be the primary focus of the Company. As part
of our legacy operations, the Company remains engaged in limited patent licensing activities of its various patent portfolios. We do
not expect these activities to be a significant part of the Company’s ongoing operations nor do we expect these activities to require
material financial resources or attention of senior management.
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 September 10, 2025, we believe that our existing cash, cash equivalents and short-term investments
will be sufficient to fund our activities for at least the next twelve months. The Company had approximately $ 16,029,000 of cash, cash
equivalents and short-term investments at July 31, 2025 compared to approximately $ 19,924,000 at October 31, 2024 which is a reduction
of approximately $ 3,895,000 for the nine months ended July 31, 2025. Therefore, the Company believes that it has sufficient cash, cash
equivalents and short-term investments to operate its business, as currently contemplated, for significantly longer than 12 months from
the date of this Report. We have implemented a business model that conserves funds by collaborating with third parties to develop our
technologies. During the nine months ended July 31, 2025, we raised approximately $ 1,924,000 , net of expenses, through an at-the-market
equity offering of 611,686 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 July 31, 2025, we may sell approximately $ 95 million of common stock.
8
2.
SIGNIFICANT ACCOUNTING POLICIES
Basis
of Presentation
The
accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting
principles in the United States of America (“US GAAP”) for interim financial information and with the instructions to Form
10-Q and Rule 8-03 of Regulation S-X. Accordingly, certain information and disclosures required by US GAAP in annual financial statements
have been omitted or condensed. These interim condensed consolidated financial statements should be read in conjunction with the audited
consolidated financial statements and related disclosures included in our Annual Report on Form 10-K for the fiscal year ended October
31, 2024. The accompanying October 31, 2024 condensed consolidated balance sheet data was derived from the audited financial statements
but does not include all disclosures required by US GAAP. The condensed consolidated financial statements include all adjustments of
a normal recurring nature which, in the opinion of management, are necessary for a fair statement of our financial position as of July
31, 2025, and results of operations and cash flows for the interim periods represented. The results of operations for the three and nine
months ended July 31, 2025 are not necessarily indicative of the results to be expected for the year.
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 nine months ended July 31, 2025 (in thousands):
SCHEDULE OF CHANGES IN NONCONTROLLING INTEREST
Balance,
October 31, 2024
$ ( 1,110 )
Net
loss attributable to noncontrolling interest
( 74 )
Balance,
July 31, 2025
$ ( 1,184 )
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 condensed consolidated statements of operations.
9
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.
3.
STOCK-BASED COMPENSATION
The
Company maintains stock equity incentive plans under which the Company 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.
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 $ 829,000 and $ 1,094,000 during the three months ended July 31, 2025
and 2024, respectively, and approximately $ 2,822,000 and $ 3,440,000 during the nine months ended July 31, 2025 and 2024, respectively.
The
compensation cost for service-based stock options granted to consultants is measured at the grant date, based on the fair value of the
award using the Black-Scholes pricing model, and is expensed on a straight-line basis over the requisite service period (the vesting
period of the stock option) which is one to three years. We recorded stock-based consulting expense related to stock options granted
to consultants of approximately $ 26,000 and $ 23,000 during the three months ended July 31, 2025 and 2024, respectively, and approximately
$ 77,000 , and $ 101,000 , during the nine months ended July 31, 2025 and 2024, respectively.
10
Stock
Option Activity
During
the three months ended July 31, 2025 and 2024, we granted options to purchase 75,000 shares and 0 shares of common stock, respectively,
and during the nine months ended July 31, 2025 and 2024, we granted options to purchase 1,430,000 shares and 1,350,000 shares of common
stock, respectively, to employees and consultants, with exercise prices ranging from $ 2.37 to $ 3.07 per share, pursuant to the Anixa
Biosciences, Inc. 2018 Share Incentive Plan (the “2018 Share Plan”).
During
the three and nine months ended July 31, 2025, stock options to purchase 685 shares of common stock were exercised on a cash basis, with
aggregate proceeds of approximately $ 2,000 . During the three and nine months ended July 31, 2025, stock options to purchase 35,000 shares
of common stock, of which 21,642 shares of common stock were withheld, were exercised on a cashless basis. During the three months ended
July 31, 2024, stock options to purchase 80,000 shares of common stock were exercised on a cash basis, with aggregate proceeds of approximately
$ 194,000 . During the nine months ended July 31, 2024, stock options to purchase 123,999 shares of common stock were exercised on a cash
basis, with aggregate proceeds of approximately $ 318,000 .
Stock
Option Plans
During
the three and nine months ended July 31, 2025, we had two stock option plans: the Anixa Biosciences, Inc. 2010 Share Incentive Plan (the
“2010 Share Plan”) and 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.
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. In accordance with the provisions of the 2010 Share Plan, the plan terminated with
respect to the ability to grant future awards on July 14, 2020. Information regarding the 2010 Share Plan for the nine months ended July
31, 2025 is as follows:
SCHEDULE OF OPTION ACTIVITY
Shares
Weighted
Average Exercise
Price Per Share
Aggregate
Intrinsic Value
(in thousands)
Options
outstanding at October 31, 2024
986,968
$ 2.77
Granted
1,430,000
2.41
Exercised
( 685 )
2.92
Forfeited/expired
( 90,000 )
3.54
Options
outstanding and exercisable at July 31, 2025
986,283
$ 2.77
$ 650
The
following table summarizes information about stock options outstanding and exercisable under the 2010 Share Plan as of July 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
- $ 2.27
316,000
2.0
$ 1.11
$
2.58
- $ 3.13
251,283
0.6
$ 2.93
$
3.46
- $ 5.30
419,000
2.7
$ 3.93
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. As of July 31, 2025, the 2018 Share Plan had 656,642 shares
available for future grants. Information regarding the 2018 Share Plan for the nine months ended July 31, 2025 is as follows:
SCHEDULE OF OPTION ACTIVITY
Shares
Weighted
Average Exercise
Price Per Share
Aggregate
Intrinsic Value
(in thousands)
Options
outstanding at October 31, 2024
11,171,094
$ 3.74
Granted
1,430,000
2.41
Exercised
( 35,000 )
2.09
Forfeited/expired
( 90,000 )
3.54
Options
outstanding at July 31, 2025
12,476,094
$ 3.59
$ 1,707
Options
exercisable at July 31, 2025
8,943,235
$ 3.61
$ 972
The
following table summarizes information about stock options outstanding and exercisable under the 2018 Share Plan as of July 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
$
2.09
- $ 3.87
6,638,879
5.7
$ 3.06
5,439,960
5.0
$ 3.19
$
4.02
- $ 5.30
5,837,215
6.7
$ 4.20
3,503,275
6.6
$ 4.25
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 semi-annual 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 nine months ended July 31, 2025 and 2024, employees purchased
1,518 shares and 2,616 shares, respectively, under the ESPP with aggregate proceeds of approximately $ 4,000 and $ 7,000 , respectively
.
Warrants
As
of July 31, 2025, we had warrants outstanding to purchase 300,000 shares of common stock at $ 6.56 per share, issued during fiscal year
2021 and expiring on March 22, 2026 .
Information
regarding the Company’s warrants for the nine months ended July 31, 2025 is as follows:
SCHEDULE OF WARRANTS ACTIVITY
Shares
Weighted
Average
Exercise
Price Per Share
Aggregate
Intrinsic
Value
Warrants
outstanding at October 31, 2024
300,000
$ 6.56
Warrants
outstanding and exercisable at July 31, 2025
300,000
$ 6.56
$ 0
12
The
following table summarizes information about the Company’s outstanding and exercisable warrants as of July 31, 2025:
SCHEDULE OF OUTSTANDING AND EXERCISABLE WARRANTS
Range
of
Exercise Prices
Number
Outstanding and
Exercisable
Weighted
Average
Remaining
Contractual Life
(in years)
Weighted
Average
Exercise Price
$ 6.56
300,000
0.6
$ 6.56
Stock
Awards
During
the three and nine months ended July 31, 2025, we did not issue any stock awards. During the three and nine months ended July 31, 2024,
we issued 60,000 shares and 89,336 shares of common stock, respectively, to consultants providing investor relations services, and recorded
expense of approximately $ 62,000 and $ 158,000 , respectively.
Treasury
stock
During
the fiscal year ended October 31, 2024, the Company purchased 2,000 shares of its common stock as treasury stock. The shares were purchased
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, that has subsequently expired. The treasury shares were accounted for under
the cost method and were recorded as a reduction in shareholders’ equity in the condensed consolidated balance sheet. In March
2025, the Company cancelled the treasury shares resulting in a reduction in shares outstanding and paid-in capital.
4.
FAIR VALUE MEASUREMENTS
US
GAAP defines fair value and establishes a framework for measuring fair value. 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 condensed 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.
The
following table presents the hierarchy for our financial assets measured at fair value on a recurring basis as of July 31, 2025 (in thousands):
SCHEDULE OF FINANCIAL ASSETS MEASURED AT FAIR VALUE ON A RECURRING BASIS
Level
1
Level
2
Level
3
Total
Money
market funds:
Cash
equivalents
$ 1,448
$ -
$ -
$ 1,448
Bitcoin
exchange traded funds:
Short-term
investments
-
12
-
12
U.S.
treasury bills:
Short-term
investments
-
14,522
-
14,522
Total
financial assets
$ 1,448
$ 14,534
$ -
$ 15,982
13
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):
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
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.
5.
ACCRUED EXPENSES
Accrued
expenses consist of the following as of:
SCHEDULE OF ACCRUED EXPENSES
July
31,
October
31,
2025
2024
(in
thousands)
Payroll
and related expenses
$ 865
$ 1,126
Accrued
royalty and contingent legal fees
626
626
Accrued
other
260
194
Accrued
expenses
$ 1,751
$ 1,946
6.
NET LOSS PER SHARE OF COMMON STOCK
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 periods 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 nine months ended July 31, 2025 and 2024, were stock options to purchase
13,462,377 shares and 12,342,094 shares, respectively, and warrants to purchase 300,000 shares and 300,000 shares, respectively.
7.
EFFECT OF RECENTLY ADOPTED AND 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. We are currently evaluating the impact of this guidance on our consolidated financial statements and related
disclosures.
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.
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 are currently evaluating the impact of this guidance
on our consolidated financial statements and related disclosures.
8.
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 our deferred tax asset due to our historical pre-tax losses and the uncertainty
regarding the realizability of these deferred tax assets.
We
have substantial net operating loss carryforwards for Federal and California income tax returns. These net operating loss carryforwards
could be subject to limitations under Internal Revenue Code section 382, the effects of which have not been determined by the Company.
We have no unrecognized income tax benefits as of July 31, 2025 and October 31, 2024 and we account for interest and penalties related
to income tax matters, if any, in general and administrative expenses.
9.
LEASES
We
lease approximately 2,000 square feet of office space at 3150 Almaden Expressway, San Jose, California (our principal executive offices)
from an unrelated party pursuant to an operating lease that, as amended, will expire on September 30, 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 $ 16,000 and $ 16,000 , respectively, for
the three months ended July 31, 2025 and 2024, and approximately $ 47,000 and $ 49,000 , respectively, for the nine months ended July 31,
2025 and 2024.
For
operating leases, the lease liability is initially and subsequently measured at the present value of the unpaid lease payments. The remaining
50 -month lease term as of July 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 July 31, 2025, the annual minimum future lease payments of our operating lease liability were as follows (in thousands):
SCHEDULE OF MINIMUM LEASE PAYMENTS
For
Years Ended October 31,
Operating
Leases
2025
(remaining)
$ 15
2026
63
2027
64
2028
66
2029
63
Total
future minimum lease payments, undiscounted
271
Less:
Imputed interest
58
Present
value of future minimum lease payments
$ 213
Balance as of July
31, 2025:
Operating
lease liability, current
$ 39
Operating
lease liability, non-current
174
Total
$ 213
15
10.
COMMITMENTS AND CONTINGENCES
Litigation
Matters
Other
than lawsuits related to the enforcement of our patent rights, we are not a party to any material pending legal proceedings, nor are
we aware of any pending litigation or legal proceeding against us that would have a material adverse effect upon our results of operations
or financial condition.
License
Commitments
As
of July 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 July 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 three-year
period.
11.
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 three and nine months ended July 31,
2025 and 2024 and as of July 31, 2025 and October 31, 2024 (in thousands):
SCHEDULE OF SEGMENT INFORMATION
2025
2024
2025
2024
For
the Three Months Ended
July 31,
For
the Nine Months Ended
July 31,
2025
2024
2025
2024
Net
loss:
Cancer
Vaccines
$ ( 1,298 )
$ ( 2,160 )
$ ( 5,195 )
$ ( 5,628 )
CAR-T
Therapeutics
( 973 )
( 1,145 )
( 3,074 )
( 4,115 )
Other
( 9 )
( 10 )
( 37 )
( 42 )
Total
$ ( 2,280 )
$ ( 3,315 )
$ ( 8,306 )
$ ( 9,785 )
Net
loss
$ ( 2,280 )
$ ( 3,315 )
$ ( 8,306 )
$ ( 9,785 )
Total
operating costs and expenses
$ 2,436
$ 3,592
$ 8,825
$ 10,668
Less
non-cash stock-based compensation
( 855 )
( 1,179 )
( 2,899 )
( 3,699 )
Operating
costs and expenses excluding non-cash stock-based compensation
$ 1,581
$ 2,413
$ 5,926
$ 6,969
Operating
costs and expenses excluding non-cash stock-based compensation:
Cancer
Vaccines
$ 884
$ 1,614
$ 3,714
$ 3,988
CAR-T
Therapeutics
689
789
2,180
2,943
Other
8
10
32
38
Total
$ 1,581
$ 2,413
$ 5,926
$ 6,969
Operating costs and expenses excluding non-cash stock-based compensation
$ 1,581
$ 2,413
$ 5,926
$ 6,969
July
31,
2025
October
31,
2024
Total
assets:
Cancer
Vaccines
$ 9,842
$ 12,917
CAR-T
Therapeutics
7,691
8,535
Other
118
139
Total
$ 17,651
$ 21,591
Total assets
$ 17,651
$ 21,591
Operating
costs and expenses excluding non-cash stock-based compensation is the measurement the chief operating decision-maker uses in managing
the enterprise.
16
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
Information
included in this Quarterly Report on Form 10-Q (this “Report”) contains forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange
Act”). Forward-looking statements are not statements of historical facts, but rather reflect our current expectations concerning
future events and results. We generally use the words “believes,” “expects,” “intends,” “plans,”
“anticipates,” “likely,” “will” and similar expressions to identify forward-looking statements. Such
forward-looking statements, including those concerning our expectations, involve risks, uncertainties and other factors, some of which
are beyond our control, which may cause our actual results, performance or achievements, or industry results, to be materially different
from any future results, performance or achievements expressed or implied by such forward-looking statements. These risks, uncertainties
and factors include, but are not limited to, those factors set forth in our Annual Report on Form 10-K for the fiscal year ended October
31, 2024. Except as required by applicable law, including the securities laws of the United States, we undertake no obligation to publicly
update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. You are cautioned
not to unduly rely on such forward-looking statements when evaluating the information presented in this Report.
GENERAL
We
discuss the description of our business in the Notes to our Condensed Consolidated Financial Statements.
RESULTS
OF OPERATIONS
Three
months ended July 31, 2025 compared with three months ended July 31, 2024
Revenue
We
had no revenue during the three-month periods ended July 31, 2025 and 2024.
We
have not generated any revenue to date from our therapeutics or vaccine programs. In addition, while we pursue our therapeutics and vaccine
programs, we may also make investments in and form new companies to develop additional emerging technologies. We do not expect to begin
generating revenue with respect to any of our current therapy or vaccine programs in the near term. We hope to achieve a profitable outcome
by eventually licensing our technologies to large pharmaceutical companies that have the resources and infrastructure in place to manufacture,
market and sell our technologies as therapeutics or vaccines. The eventual licensing of any of our technologies may take several years,
if it is to occur at all, and may depend on positive results from human clinical trials.
Research
and Development Expenses
During
the three months ended July 31, 2025, research and development expenses related to the development of our cancer vaccines and CAR-T therapeutics
consisted of approximately $615,000 and $440,000, respectively. During the three months ended July 31, 2024 research and development
expenses related to the development of our cancer vaccines and CAR-T therapeutics consisted of approximately $1,259,000 and $666,000,
respectively.
17
Research
and development expenses decreased by approximately $870,000 to approximately $1,055,000 in the three months ended July 31, 2025, from
approximately $1,925,000 in the three months ended July 31, 2024. The decrease in research and development expenses was primarily due
to a decrease in outside research and development expenses related to our breast cancer vaccine of approximately $631,000, a decrease in outside research and development expenses related to our ovarian cancer CAR-T therapeutic of approximately
$170,000, a decrease
in employee stock-based compensation expense of approximately $106,000, and a decrease in clinical consulting services of approximately $52,000,
offset by an increase in employee compensation and related costs, other than stock-based compensation expense, of approximately $96,000.
General
and Administrative Expenses
General
and administrative expenses decreased by approximately $286,000 to approximately $1,381,000 in the three months ended July 31, 2025,
from approximately $1,667,000 in the three months ended July 31, 2024. The decrease in general and administrative expenses was primarily
due to a decrease in director stock-based compensation of approximately $98,000, a decrease in investor and public relations expense
of approximately $94,000, a decrease in employee compensation and related costs, other than stock-based compensation expense, of approximately
$77,000 and a decrease in employee stock-based compensation of approximately $61,000.
Interest
Income
Interest
income decreased by approximately $121,000 to approximately $156,000 in the three months ended July 31, 2025, from approximately $277,000
in the three months ended July 31, 2024, primarily due to a decrease in the amount of short-term investments held and a decrease in interest
rates.
Net
Loss Attributable to Noncontrolling Interest
The
net loss attributable to noncontrolling interest, representing Wistar’s ownership interest in Certainty’s net loss, decreased
by approximately $16,000 to approximately $22,000 in the three months ended July 31, 2025 from approximately $38,000 in the three months
ended July 31, 2024, as Certainty’s net loss decreased.
Nine
months ended July 31, 2025 compared with nine months ended July 31, 2024
Revenue
We
had no revenue during the nine-month periods ended July 31, 2025 and 2024.
We
have not generated any revenue to date from our therapeutics or vaccine programs. In addition, while we pursue our therapeutics and vaccine
programs, we may also make investments in and form new companies to develop additional emerging technologies. We do not expect to begin
generating revenue with respect to any of our current therapy or vaccine programs in the near term. We hope to achieve a profitable outcome
by eventually licensing our technologies to large pharmaceutical companies that have the resources and infrastructure in place to manufacture,
market and sell our technologies as therapeutics or vaccines. The eventual licensing of any of our technologies may take several years,
if it is to occur at all, and may depend on positive results from human clinical trials.
Research
and Development Expenses
During
the nine months ended July 31, 2025, research and development expenses related to the development of our cancer vaccines and CAR-T therapeutics
consisted of approximately $2,489,000 and $1,440,000, respectively. During the nine months ended July 31, 2024 research and development
expenses related to the development of our cancer vaccines and CAR-T therapeutics consisted of approximately $2,827,000 and $2,093,000,
respectively.
18
Research
and development expenses decreased by approximately $991,000 to approximately $3,929,000 in the nine months ended July 31, 2025,
from approximately $4,920,000 in the nine months ended July 31, 2024. The decrease in research and development expenses was
primarily due to a decrease in outside research and development expenses related to our breast cancer vaccine of approximately
$524,000, a decrease in outside research and development expenses related to our ovarian cancer CAR-T therapeutic of approximately
$402,000, a
decrease in employee stock-based compensation expense of approximately $271,000, offset by an increase in outside research and
development expenses related to our new vaccine discovery program of approximately $113,000, and an increase in technology licensing
fees of approximately $56,000.
General
and Administrative Expenses
General
and administrative expenses decreased by approximately $852,000 to approximately $4,896,000 in the nine months ended July 31, 2025, from
approximately $5,748,000 in the nine months ended July 31, 2024. The decrease in general and administrative expenses was primarily due
to a decrease in investor and public relations expense of approximately $478,000, a decrease in director stock-based compensation of
approximately $280,000, a decrease in employee stock-based compensation of approximately $68,000, and a decrease in consulting fees of
approximately $58,000, offset by an increase in patent-related costs of approximately $67,000.
Interest
Income
Interest
income decreased by approximately $364,000 to approximately $519,000 in the nine months ended July 31, 2025, from approximately $883,000
in the nine months ended July 31, 2024, primarily due to a decrease in the amount of short-term investments held and a decrease in interest
rates.
Net
Loss Attributable to Noncontrolling Interest
The
net loss attributable to noncontrolling interest, representing Wistar’s ownership interest in Certainty’s net loss, decreased
by approximately $40,000 to approximately $74,000 in the nine months ended July 31, 2025 from approximately $114,000 in the nine months
ended July 31, 2024, as Certainty’s net loss decreased.
LIQUIDITY
AND CAPITAL RESOURCES
Our
primary sources of liquidity are cash, cash equivalents and short-term investments.
Based
on currently available information as of September 10, 2025, we believe that our existing cash, cash equivalents and short-term investments
will be sufficient to fund our activities for at least the next twelve months. The Company had approximately $16,029,000 of cash, cash
equivalents and short-term investments at July 31, 2025 compared to approximately $19,924,000 at October 31, 2024 which is a reduction
of approximately $3,895,000 for the nine months ended July 31, 2025. Therefore, the Company believes that it has sufficient cash, cash
equivalents and short-term investments to operate its business, as currently contemplated, for significantly longer than 12 months from
the date of this Report. We have implemented a business model that conserves funds by collaborating with third parties to develop our
technologies. During the nine months ended July 31, 2025, we raised approximately $1,924,000, net of expenses, through an at-the-market
equity offering of 611,686 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 July 31, 2025, we may sell approximately $95 million of common stock.
During
the nine months ended July 31, 2025, cash used in operating activities was approximately $5,918,000. Cash provided by investing
activities was approximately $4,212,000, resulting from the maturities of short-term investments of approximately $40,912,000,
offset by purchases of short-term investments of approximately $36,700,000. Cash provided by financing activities was approximately
$1,930,000, resulting from the sale of 611,686 shares of common stock in an at-the-market equity offering of approximately
$1,924,000, net of expenses, proceeds from the sale of common stock pursuant to an employee stock purchase plan of approximately
$4,000 and proceeds from stock option exercises of approximately $2,000. As a result, our cash, cash equivalents, and short-term
investments at July 31, 2025 decreased approximately $3,895,000 to approximately $16,029,000 from approximately $19,924,000 at the
end of fiscal year 2024.
19
CRITICAL
ACCOUNTING POLICIES
The
Company’s condensed consolidated financial statements are prepared in conformity with accounting principles generally accepted
in the United States of America. In preparing these financial statements, we make assumptions, judgments and estimates that can have
a significant impact on amounts reported in our condensed consolidated financial statements. We base our assumptions, judgments and estimates
on historical experience and various other factors that we believe to be reasonable under the circumstances. Actual results could differ
materially from these estimates under different assumptions or conditions. On a regular basis, we evaluate our assumptions, judgments
and estimates and make changes accordingly.
We
believe that, of the significant accounting policies discussed in Note 2 to our consolidated financial statements in our Annual Report
on Form 10-K for the fiscal year ended October 31, 2024, the following accounting policies require our most difficult, subjective or
complex judgments:
●
Revenue
Recognition,
●
Stock-Based
Compensation, and
●
Research
and Development Expenses.
Revenue
Recognition
Our
revenue has been derived solely from technology licensing and the sale of patented technologies. Revenue is recognized upon transfer
of control of intellectual property rights and satisfaction of other contractual performance obligations to licensees in an amount that
reflects the consideration we expect to receive.
Our
revenue recognition policy requires us to make certain judgments and estimates in connection with the accounting for revenue. Such areas
may include determining the existence of a contract and identifying each party’s rights and obligations to transfer goods and services,
identifying the performance obligations in the contract, determining the transaction price and allocating the transaction price to separate
performance obligations, estimating the timing of satisfaction of performance obligations, determining whether a promise to grant a license
is distinct from other promised goods or services and evaluating whether a license transfers to a customer at a point in time or over
time.
Our
revenue arrangements provide for the payment, within 30 days of execution of the agreement, of contractually determined, one-time, paid-up
license fees in settlement of litigation and in consideration for the grant of certain intellectual property rights for patented technologies
owned or controlled by the Company. These arrangements typically include some combination of the following: (i) the grant of a non-exclusive,
retroactive and future license to manufacture and/or sell products covered by patented technologies owned or controlled by the Company,
(ii) a covenant-not-to-sue, (iii) the release of the licensee from certain claims, and (iv) the dismissal of any pending litigation.
In such instances, the intellectual property rights granted have been perpetual in nature, extending until the expiration of the related
patents. Pursuant to the terms of these agreements, we have no further obligations with respect to the granted intellectual property
rights, including no obligation to maintain or upgrade the technology, or provide future support or services. Licensees obtained control
of the intellectual property rights they have acquired upon execution of the agreement. Accordingly, the performance obligations from
these agreements were satisfied and 100% of the revenue was recognized upon the execution of the agreements.
Stock-Based
Compensation
The
compensation cost for service-based stock options granted to employees, directors and consultants is measured at the grant date, based
on the fair value of the award using the Black-Scholes pricing model, and is recognized as an expense on a straight-line basis over the
requisite service period (the vesting period of the stock option) which is one to four years. For employee options vesting if the trading
price of the Company’s common stock exceeds certain price targets, we use a Monte Carlo Simulation in estimating the fair value
at grant date and recognize compensation cost over the implied service period.
For
stock awards granted to employees and directors that vest at date of grant we recognize expense based on the grant date market price
of the underlying common stock. For restricted stock awards vesting upon achievement of a price target of our common stock, we use a
Monte Carlo Simulation in estimating the fair value at grant date and recognize compensation cost over the implied service period (median
time to vest).
20
The
Black-Scholes pricing model and the Monte Carlo Simulation we use to estimate fair value requires valuation assumptions of expected term,
expected volatility, risk-free interest rates and expected dividend yield. The expected term of stock options represents the weighted
average period the stock options are expected to remain outstanding. For employees we use the simplified method, which is a weighted
average of the vesting term and contractual term, to determine expected term. The simplified method was adopted since we do not believe
that historical experience is representative of future performance because of the impact of the changes in our operations and the change
in terms from historical options. For consultants we use the contract term for expected term. Under the Black-Scholes pricing model,
we estimated the expected volatility of our shares of common stock based upon the historical volatility of our share price over a period
of time equal to the expected term of the grants. We estimated the risk-free interest rate based on the implied yield available on the
applicable grant date of a U.S. Treasury note with a term equal to the expected term of the underlying grants. We made the dividend yield
assumption based on our history of not paying dividends and our expectation not to pay dividends in the future.
We
will reconsider use of the Black-Scholes pricing model and the Monte Carlo Simulation if additional information becomes available in
the future that indicates another model would be more appropriate. If factors change and we employ different assumptions in future periods,
the compensation expense that we record may differ significantly from what we have recorded in the current period.
Research
and Development Expenses
We
recognize research and development expenses as incurred. Advance payments for future research and development activities are deferred
and expensed as the services are performed. We recognize our preclinical studies and clinical trial expenses based on the services performed
pursuant to contracts with research institutions, clinical research organizations (“CROs”), clinical manufacturing organizations
(“CMOs”), and other parties that conduct and manage various stages of research and development activities on our behalf.
Fees for such services are recognized based on management’s estimates after considering the activities and tasks completed by each
service provider in a given period, the time period over which services are expected to be performed, and the level of effort expended
in each reporting period.
At
each balance sheet date, management estimates prepaid and accrued research and development costs by discussing progress or stage of completion
of activities with internal personnel and external service providers, and comparing this information to payments made, invoices received,
and the agreed-upon contractual fee to be paid for such services in the applicable contract or statements of work.
In
addition, we allocate certain internal compensation costs to research and development expenses based on management’s estimates
of each employee’s time and effort expended.
EFFECT
OF RECENTLY ISSUED PRONOUNCEMENTS
We
discuss the effect of recently issued pronouncements in Note 7 of the condensed consolidated financial statements, included elsewhere
in this Report.
Item
3. Quantitative and Qualitative Disclosures About Market Risk. Not applicable.
Item
4. Controls and Procedures.
We
carried out an evaluation, under the supervision and with the participation of our management including our Chief Executive Officer and
our Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures pursuant to Rule
13(a)-15(b) of the Exchange Act. Based upon that evaluation, our Chief Executive Officer and our Chief Financial Officer concluded that
our disclosure controls and procedures are effective as of the end of the period covered by this Report.
There
was no change in our internal control over financial reporting during the three months ended July 31, 2025, that has materially affected,
or is reasonably likely to materially affect, our internal control over financial reporting.
21
PART
II. OTHER INFORMATION
Item
1. Legal Proceedings.
Other
than lawsuits related to the enforcement of our patent rights, we are not a party to any material pending legal proceedings, nor are
we aware of any pending litigation or legal proceeding against us that would have a material adverse effect upon our results of operations
or financial condition.
Item
1A. Risk Factors.
There
have been no material changes in our risk factors from those disclosed in our Annual Report on Form 10-K for the fiscal year ended October
31, 2024.
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds. None.
Item
3. Defaults Upon Senior Securities. None.
Item
4 . Mine Safety Disclosures. Not Applicable.
Item
5. Other Information. None.
Item
6. Exhibits.
31.1
Certification
of Chief Executive Officer, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, dated September 10, 2025.
31.2
Certification
of Chief Financial Officer, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, dated September 10, 2025.
32.1
Statement
of Chief Executive Officer, pursuant to Section 1350 of Title 18 of the United States Code, dated September 10, 2025.
32.2
Statement
of Chief Financial Officer, pursuant to Section 1350 of Title 18 of the United States Code, dated September 10, 2025.
101.INS
Inline
XBRL Instance Document
101.SCH
Inline
XBRL Taxonomy Extension Schema
101.CAL
Inline
XBRL Taxonomy Extension Calculation Linkbase
101.DEF
Inline
XBRL Taxonomy Extension Definition Linkbase
101.LAB
Inline
XBRL Taxonomy Extension Label Linkbase
101.PRE
Inline
XBRL Taxonomy Extension Presentation Linkbase
104
Cover
Page Interactive Data File (formatted in Inline XBRL and contained in Exhibit 101)
22
SIGNATURES
Pursuant
to the requirements 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/
Dr. Amit Kumar
Dr.
Amit Kumar
Chairman
and Chief Executive Officer
September
10, 2025
(Principal
Executive Officer)
By:
/s/
Michael J. Catelani
Michael
J. Catelani
President,
Chief Operating Officer and
Chief
Financial Officer
(Principal
Financial and
September
10, 2025
Accounting
Officer)
23
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.