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, 2021
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 1, 2021 the registrant had outstanding 29,949,905 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.
Condensed Consolidated Balance Sheets as of July 31, 2021 (Unaudited) and October 31, 2020
1
Condensed Consolidated Statements of Operations (Unaudited) for the three and nine months ended July 31, 2021 and 2020
2
Condensed Consolidated Statements of Shareholders’ Equity (Unaudited) for the three months ended July 31, 2021 and 2020
3
Condensed Consolidated Statements of Shareholders’ Equity (Unaudited) for the nine months ended July 31, 2021 and 2020
4
Condensed Consolidated Statements of Cash Flows (Unaudited) for the nine months ended July 31, 2021 and 2020
5
Notes to Condensed Consolidated Financial Statements (Unaudited)
6
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
21
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
26
Item 4. Controls and Procedures.
26
PART II. OTHER INFORMATION
Item 1. Legal Proceedings.
27
Item 1A. Risk Factors.
27
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
27
Item 3. Defaults Upon Senior Securities.
27
Item 4. Mine Safety Disclosures.
27
Item 5. Other Information.
27
Item 6. Exhibits.
27
SIGNATURES
28
ii
PART
I. FINANCIAL INFORMATION
Item
1. Financial Statements.
ANIXA
BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED BALANCE SHEETS
July
31, 2021
October
31, 2020
(Unaudited)
ASSETS
Current
assets:
Cash
and cash equivalents
$ 27,222,190
$ 6,417,061
Short-term
investments
9,399,784
2,640,000
Prepaid
expenses and other current assets
430,006
311,563
Total
current assets
37,051,980
9,368,624
Operating
lease right-of-use asset
10,411
54,340
Other
assets
-
30,000
Total
assets
$ 37,062,391
$ 9,452,964
LIABILITIES
AND EQUITY
Current
liabilities:
Accounts
payable
$ 207,733
$ 232,368
Accrued
expenses
989,724
901,025
Operating
lease liability
10,567
55,198
Total
current liabilities
1,208,024
1,188,591
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
-
-
Common
stock, par value $ .01 per share; 100,000,000 shares authorized; 29,949,905 and 24,248,695 shares issued and outstanding, respectively
299,499
242,486
Additional
paid-in capital
236,944,345
200,354,488
Accumulated
deficit
( 200,776,749 )
( 191,835,618 )
Total
shareholders’ equity
36,467,095
8,761,356
Noncontrolling
interest (Note 1)
( 612,728 )
( 496,983 )
Total
equity
35,854,367
8,264,373
Total
liabilities and equity
$ 37,062,391
$ 9,452,964
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)
2021
2020
2021
2020
For the Three Months Ended
For the Nine Months Ended
July 31,
July 31,
2021
2020
2021
2020
Revenue
$ -
$ -
$ 512,500
$ -
Operating costs and expenses:
Inventor royalties, contingent legal fees, litigation and licensing expenses
-
-
385,002
-
Research and development expenses (including non-cash share-based compensation expenses
of $ 1,687,754 ,
$ 394,842 ,
$ 2,425,136
and $ 1,250,497 ,
respectively)
2,166,622
1,254,131
4,016,449
3,973,509
General and administrative expenses (including non-cash share-based compensation
expenses of $ 1,499,572 ,
$ 646,957 ,
$ 2,799,561
and $ 1,922,722 ,
respectively)
2,221,614
1,181,838
5,169,698
3,762,466
Total operating costs and expenses
4,388,236
2,435,969
9,571,149
7,735,975
Loss from operations
( 4,388,236 )
( 2,435,969 )
( 9,058,649 )
( 7,735,975 )
Other expense
-
( 148,084 )
-
( 148,084 )
Interest income
626
7,266
1,773
32,707
Net loss
( 4,387,610 )
( 2,576,787 )
( 9,056,876 )
( 7,851,352 )
Less: Net loss attributable to noncontrolling interest
( 53,621 )
( 15,103 )
( 115,745 )
( 57,032 )
Net loss attributable to common shareholders
$ ( 4,333,989 )
$ ( 2,561,684 )
$ ( 8,941,131 )
$ ( 7,794,320 )
Net loss per common share attributable to common shareholders:
Net loss per common share attributable to common shareholders: Basic and
diluted
$ ( 0.14 )
$ ( 0.11 )
$ ( 0.32 )
$ ( 0.36 )
Weighted average common shares outstanding:
Weighted average common shares outstanding: Basic and diluted
30,455,340
23,165,066
28,090,163
21,678,608
The
accompanying notes are an integral part of these condensed consolidated financial statements.
2
ANIXA
BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY (UNAUDITED )
FOR
THE THREE MONTHS ENDED JULY 31, 2021
Shares
Par Value
Paid-in Capital
Accumulated Deficit
Shareholders’ Equity
controlling Interest
Total Equity
Common Stock
Additional
Total
Non-
Shares
Par Value
Paid-in Capital
Accumulated Deficit
Shareholders’ Equity
controlling Interest
Total Equity
Balance, April 30, 2021
31,449,905
$ 314,499
$ 233,742,019
$ ( 196,442,760 )
$ 37,613,758
$ ( 559,107 )
$ 37,054,651
Stock option compensation to employees and directors
-
-
3,047,877
-
3,047,877
-
3,047,877
Stock options issued to consultants
Common stock issued upon exercise of stock options
Common stock issued upon exercise of stock options, shares
Common stock issued in at-the-market offering, net of offering expenses
Common stock issued in at-the-market offering, net of offering expenses, shares
Common stock issued pursuant to employee stock purchase plan
Common stock issued pursuant to employee stock purchase plan, shares
Common stock issued in a public offering, net of offering expenses
Common stock issued in a public offering, net of offering expenses, shares
Expired restricted stock award to employee
( 1,500,000 )
( 15,000 )
15,000
-
-
-
Stock options and warrants issued to consultants
-
-
139,449
-
139,449
-
139,449
Net loss
-
-
-
( 4,333,989 )
( 4,333,989 )
( 53,621 )
( 4,387,610 )
Balance, July 31, 2021
29,949,905
$ 299,499
$ 236,944,345
$ ( 200,776,749 )
$ 36,467,095
$ ( 612,728 )
$ 35,854,367
FOR
THE THREE MONTHS ENDED July 31, 2020
Common Stock
Additional
Total
Non-
Shares
Par Value
Paid-in Capital
Accumulated Deficit
Shareholders’ Equity
controlling Interest
Total Equity
Balance, April 30, 2020
21,479,335
$ 214,793
$ 192,122,260
$ ( 187,049,899 )
$ 5,287,154
$ ( 464,904 )
$ 4,822,250
Stock option compensation to employees and directors
-
-
997,094
-
997,094
-
997,094
Stock options issued to consultants
-
-
44,705
-
44,705
-
44,705
Common stock issued upon exercise of stock options
7,200
72
18,468
-
18,540
-
18,540
Common stock issued in at-the-market offering, net of offering expenses of $ 155,776
2,167,219
21,672
4,810,533
-
4,832,205
-
4,832,205
Net loss
-
-
-
( 2,561,684 )
( 2,561,684 )
( 15,103 )
( 2,576,787 )
Balance, July 31, 2020
23,653,754
$ 236,537
$ 197,993,060
$ ( 189,611,583 )
$ 8,618,014
$ ( 480,007 )
$ 8,138,007
The
accompanying notes are an integral part of these condensed consolidated financial statements.
3
ANIXA
BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY (UNAUDITED )
FOR
THE NINE MONTHS ENDED JULY 31, 2021
Common Stock
Additional
Total
Non-
Shares
Par Value
Paid-in Capital
Accumulated Deficit
Shareholders’ Equity
controlling Interest
Total Equity
Balance, October 31, 2020
24,248,695
$ 242,486
$ 200,354,488
$ ( 191,835,618 )
$ 8,761,356
$ ( 496,983 )
$ 8,264,373
Stock option compensation to employees and directors
-
-
4,803,515
-
4,803,515
-
4,803,515
Expired restricted stock award to employee
( 1,500,000 )
( 15,000 )
15,000
-
-
-
Stock options and warrants issued to consultants
-
-
421,182
-
421,182
-
421,182
Common stock issued upon exercise of stock options
107,451
1,075
292,529
-
293,604
-
293,604
Common stock issued pursuant to employee stock purchase plan
1,634
16
2,984
-
3,000
-
3,000
Common stock issued in a public offering, net of
offering expenses of $ 2,208,150
4,285,715
42,858
20,248,996
-
20,291,854
-
20,291,854
Common stock issued in at-the-market offering, net of offering expenses of $ 340,775
2,806,410
28,064
10,805,651
-
10,833,715
-
10,833,715
Net loss
-
-
-
( 8,941,131 )
( 8,941,131 )
( 115,745 )
( 9,056,876 )
Balance, July 31, 2021
29,949,905
$ 299,499
$ 236,944,345
$ ( 200,776,749 )
$ 36,467,095
$ ( 612,728 )
$ 35,854,367
FOR
THE NINE MONTHS ENDED JULY 31, 2020
Common Stock
Additional
Total
Non-
Shares
Par Value
Paid-in Capital
Accumulated Deficit
Shareholders’ Equity
controlling Interest
Total Equity
Balance, October 31, 2019
20,331,754
$ 203,317
$ 186,849,299
$ ( 181,817,263 )
$ 5,235,353
$ ( 422,975 )
$ 4,812,378
Stock option compensation to employees and directors
-
-
3,016,305
-
3,016,305
-
3,016,305
Stock options issued to consultants
-
-
156,914
-
156,914
-
156,914
Common stock issued upon exercise of stock options
51,100
511
121,759
-
122,270
-
122,270
Common stock issued pursuant to employee stock purchase plan
9,618
96
15,356
-
15,452
-
15,452
Common stock issued in at-the-market offering, net of offering expenses of $ 314,072
3,261,282
32,613
7,833,427
-
7,866,040
-
7,866,040
Common stock issued in at-the-market offering, net of offering expenses
3,261,282
32,613
7,833,427
-
7,866,040
-
7,866,040
Net loss
-
-
-
( 7,794,320 )
( 7,794,320 )
( 57,032 )
( 7,851,352 )
Balance, July 31, 2020
23,653,754
$ 236,537
$ 197,993,060
$ ( 189,611,583 )
$ 8,618,014
$ ( 480,007 )
$ 8,138,007
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)
2021
2020
For the nine months ended July 31,
2021
2020
Cash flows from operating activities:
Reconciliation of net loss to net cash used in operating activities:
Net loss
$ ( 9,056,876 )
$ ( 7,851,352 )
Stock option compensation to employees and directors
4,803,515
3,016,305
Stock options and warrants issued to consultants
421,182
156,914
Depreciation of property and equipment
-
38,276
Loss on disposal of property and equipment
-
148,084
Gain on sale of equipment
( 5,447 )
-
Amortization of operating lease right-of-use asset
43,929
38,317
Change in operating assets and liabilities:
Receivables
-
60,577
Prepaid expenses and other current assets
( 118,443 )
( 4,870 )
Accounts payable
( 24,635 )
( 246,522 )
Accrued expenses
88,699
( 79,781 )
Operating lease liability
( 44,631 )
( 37,537 )
Net cash used in operating activities
( 3,892,707 )
( 4,761,589 )
Cash flows from investing activities:
Disbursements to acquire short-term investments
( 10,399,784 )
( 5,510,000 )
Proceeds from maturities of short-term investments
3,640,000
4,720,000
Purchase of property and equipment
-
( 15,791 )
Proceeds from sale of equipment
35,447
-
Net cash used in investing activities
( 6,724,337 )
( 805,791 )
Cash flows from financing activities:
Gross proceeds from sale of common stock in a public offering
22,500,004
-
Expenses of the public offering
( 2,208,150 )
-
Gross proceeds from sale of common stock in an at-the-market offering
11,174,490
8,180,112
Expenses of the at-the-market offering
( 340,775 )
( 314,072 )
Proceeds from sale of common stock pursuant to employee stock purchase plan
3,000
15,452
Proceeds from exercise of stock options
293,604
122,270
Net cash provided by financing activities
31,422,173
8,003,762
Net increase in cash and cash equivalents
20,805,129
2,436,382
Cash and cash equivalents at beginning of period
6,417,061
3,491,625
Cash and cash equivalents at end of period
$ 27,222,190
$ 5,928,007
Supplemental cash flow information:
Cash proceeds from interest income
$ 1,675
$ 38,930
Supplemental disclosure of non-cash financing activity:
Fair value of warrants issued in connection with the public offering
$ 1,040,700
$ -
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. Our primary operations involve developing therapies and vaccines that are focused on critical
unmet needs in oncology and infectious disease. Our therapeutics programs include the development of a chimeric endocrine receptor T-cell
technology, a novel form of chimeric antigen receptor T-cell (“CAR-T”) technology, initially focused on treating ovarian
cancer, and discovery and ultimately development of anti-viral drug candidates for the treatment of COVID-19 focused on inhibiting certain
protein functions of the virus. Our vaccine programs include the development of a vaccine against breast cancer, specifically triple
negative breast cancer (“TNBC”), the most lethal form of the disease, and a vaccine against ovarian cancer.
Our
subsidiary, Certainty Therapeutics, Inc. (“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”)
relating to Wistar’s CAR-T technology. We have initially focused on the development of a treatment for ovarian cancer, but we may
also 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.
Certainty,
in collaboration with the H. Lee Moffitt Cancer Center and Research Institute, Inc. (“Moffitt”), is advancing toward human
clinical testing its CAR-T technology for treating ovarian cancer. We submitted an Investigational New Drug (“IND”) application
to the U.S. Food and Drug Administration (“FDA”) in March 2021. In April 2021, the FDA informed us that they needed additional
information before allowing us to proceed with the clinical trial. In May 2021, the FDA provided us with the details of their information
request. Through an iterative process with the FDA, we responded to their information requests and in August 2021, we received authorization
from the FDA to commence enrollment and treatment of patients in a Phase 1 clinical trial. We are performing the activities necessary
to prepare for treatment of patients in the Phase 1 clinical trial, and we anticipate treating the first enrolled patient in early 2022.
In
April 2020, we entered into a collaboration with OntoChem GmbH (“OntoChem”), to discover and ultimately develop anti-viral
drug candidates against COVID-19. Through this collaboration, we utilized advanced computational methods, machine learning, and molecular
modeling techniques to perform in silico screening of over 1.2 billion compounds in chemical libraries (including publicly available
compounds and OntoChem’s proprietary libraries) to evaluate if any of these compounds could disrupt one of two key enzymes of SARS-CoV-2,
the virus that causes the disease COVID-19.
The
screening process resulted in the identification of multiple compounds that could potentially disrupt critical enzymes of the virus.
Several of these compounds were synthesized and tested in in vitro biological assays. Upon completion of these biological assays,
we identified two of the most promising compounds and tested them in animal models. In these animal studies, the two compounds were compared
to Remdesivir, which is the only anti-viral drug authorized by the FDA for COVID-19. The data showed that administration of the
drugs to infected hamsters did not cause any noticeable adverse effects, and monitoring of weight and general animal behavior demonstrated
comparable efficacy of both compounds as well as Remdesivir. Based on this promising data in the animal study, we proceeded to the next
stage of drug development and selected one of the compounds around which we are currently performing combinatorial synthetic medicinal
chemistry to evaluate whether we can increase potency and optimize pharmacokinetics. In addition, we have added chemical structures
which we feel, based on our data and recently published data, could be potent anti-virals.
6
In
May 2021, after completion of the aforementioned animal studies, OntoChem assigned its rights and obligations related to this collaboration
to MolGenie GmbH (“MolGenie”), a company spun-out from OntoChem focused on drug discovery and development.
In
August 2021, in an attempt to evaluate whether our compounds might be effective against the Delta variant of SARS-CoV-2, we undertook
an analysis of certain enzyme mutations in the Delta variant. We note that the Delta variant is characterized by mutations in the
spike protein of the virus. Corresponding to the mutations in the spike protein, we found some of the Delta variants exhibited a mutation
in the enzyme that is our target. Sequence analysis of several Delta variant samples demonstrated that the resultant enzyme mutation
indicates that our novel compounds could be stronger inhibitors of the Delta variant that the original version of the virus.
We
hold an exclusive worldwide, royalty-bearing license to use certain intellectual property owned or controlled by The Cleveland Clinic
Foundation (“Cleveland Clinic”) relating to certain breast cancer vaccine technology developed at Cleveland Clinic. We are
working in collaboration with Cleveland Clinic to develop a method to vaccinate women against contracting breast cancer, focused specifically
on TNBC. A specific protein, alpha-lactalbumin, has been identified 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 December 2020, we received authorization
from the FDA to commence enrollment and treatment of patients in a Phase 1a clinical trial. We are performing the activities necessary
to prepare for treatment of patients in the Phase 1a clinical trial, and we anticipate treating the first enrolled patient in September
2021.
In
November 2020, we executed a license agreement with Cleveland Clinic pursuant to which the Company was granted an exclusive worldwide,
royalty-bearing license to use certain intellectual property owned or controlled by Cleveland Clinic relating to certain ovarian cancer
vaccine technology. This technology pertains to the use of vaccines for the treatment or prevention of ovarian cancers which express
the anti-Mullerian hormone receptor II 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
after 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. We entered into a joint development
agreement with Cleveland Clinic, to advance this vaccine technology toward human clinical testing.
In
May 2021, Cleveland Clinic was granted an award for our ovarian cancer vaccine technology by the National Cancer Institute’s (“NCI”)
PREVENT program. The NCI is a part of the National Institutes of Health. The PREVENT program is a peer-reviewed agent development program
designed to support preclinical development of innovative interventions and biomarkers for cancer prevention and interception towards
clinical trials. The scientific and financial resources of the PREVENT program will be used for our ovarian cancer vaccine technology
to perform virtually all pre-clinical research and development, manufacturing and IND-enabling studies. This work will be performed at
NCI facilities, by NCI scientific staff and with NCI financial resources and will require no material financial expenditures by the Company,
nor the transfer of any rights to the Company’s assets.
Over
the next several quarters, we expect the development of our breast and ovarian cancer vaccines, our COVID-19 therapeutic program and
Certainty’s CAR-T technology to be the primary focus of the Company. As part of our legacy operations, the Company remains engaged
in limited patent licensing activities regarding the Cchek™ liquid biopsy platform (operations for which were suspended in July
2020), as well as in the area of encrypted audio/video conference calling. We do not expect these activities to be a significant part
of the Company’s ongoing operations, nor do we expect these activities to require material financial resources or attention of
senior management.
7
Over
the past several years, our revenue, if any, was derived from technology licensing and the sale of patented technologies, including revenue
from the settlement of litigation. 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.
Funding
and Management’s Plans
Based
on currently available information as of September 1, 2021, 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 nine months ended July 31, 2021, we raised approximately $ 20,292,000 , net of expenses, through
a public offering in which we sold an aggregate of 4,285,715 shares of common stock and approximately $ 10,834,000 , net of expenses, through
our at-the-market equity program in which we sold an aggregate of 2,806,410 shares of common stock. Our at-the-market equity program
was terminated on June 16, 2021. We may seek to obtain working capital during our fiscal year 2021 or thereafter through sales of our
equity securities or through bank credit facilities or public or private debt from various financial institutions where possible. We
cannot be certain that additional funding will be available on acceptable terms, or at all. If we do identify sources for additional
funding, the sale of additional equity securities or convertible debt will result in dilution to our stockholders. We can give no assurance
that we will generate sufficient cash flows in the future to satisfy our liquidity requirements or sustain future operations, or that
other sources of funding, such as sales of equity or debt, would be available or would be approved by our security holders, if needed,
on favorable terms or at all. If we fail to obtain additional working capital as and when needed, such failure could have a material
adverse impact on our business, results of operations and financial condition. Furthermore, such lack of funds may inhibit our ability
to respond to competitive pressures or unanticipated capital needs, or may force us to reduce operating expenses, which would significantly
harm the business and development of operations.
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 generally accepted accounting principles
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 year ended October 31, 2020. The accompanying October 31, 2020 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, 2021, and results of operations and cash flows for the interim periods represented. The results of operations
for the nine months ended July 31, 2021 are not necessarily indicative of the results to be expected for the entire year.
8
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, 2021:
SCHEDULE
OF CHANGES IN NONCONTROLLING INTEREST
Balance, October 31, 2020
$ ( 496,983 )
Net loss attributable to noncontrolling interest
( 115,745 )
Balance, July 31, 2021
$ ( 612,728 )
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.
We
follow the accounting guidance of Accounting Standards Codification 606 (“ASC 606”), Revenue from Contracts with Customers.
In accordance with ASC 606 we are required to make certain judgments and estimates in connection with the accounting for revenue. Such
judgments and estimates 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 and licensing and enforcement related research, 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, consisting primarily of employee compensation, payments to third parties for research and development activities
and other direct costs associated with developing immuno-therapy drugs against cancer, preventative cancer vaccines and anti-viral drug
candidates for COVID-19, are expensed in the accompanying condensed consolidated financial statements in the period incurred.
2. PUBLIC
OFFERING
On
March 25, 2021, the Company completed a public offering in which we sold an aggregate of 4,285,715 shares of its common stock, which
represented 15.8 % of the Company’s outstanding shares at the time of the offering, at a public offering price of $ 5.25 per share.
The Company realized net proceeds of approximately $ 20,292,000 from the public offering, after deducting underwriting discounts and deal
expenses. In connection with the public offering, the Company issued to certain designees of the underwriter, as compensation, warrants
expiring on March 22, 2026 , to purchase 300,000 shares of common stock at $ 6.5625 per share.
3. STOCK
BASED COMPENSATION
The
Company maintains stock equity incentive plans under which the Company grants 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
The
compensation cost for service-based stock options granted to employees and directors 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 four years . We recorded stock-based compensation expense related to service-based
stock options granted to employees and directors of approximately $ 1,066,000 and $ 997,000 during the three months ended July 31, 2021
and 2020, respectively, and approximately $ 2,822,000 and $ 3,016,000 during the nine months ended July 31, 2021 and 2020, respectively.
For
stock options granted to employees and directors that vest based on market conditions, such as the trading price of the Company’s
common stock exceeding certain price targets, we use a Monte Carlo Simulation in estimating the fair value at grant date and recognize
compensation cost over the implied service period (median time to vest). On May 8, 2018, we issued market condition options to purchase
1,500,000 shares of common stock, to our Chairman, President and Chief Executive Officer, vesting at target trading prices of $ 5.00 to
$ 8.00 per share before May 31, 2021 , with implied service periods of three to seven months. In October 2018, the first tranche of 500,000
shares of market condition options became exercisable upon achieving an average closing price above $ 5.00 per share for twenty consecutive
trading days. The remaining tranches did not vest as of May 31, 2021 and expired.
On
June 1, 2021, our Chairman, President and Chief Executive Officer and our Chief Operating Officer and Chief Financial Officer were awarded
options for 2,000,000
shares and 100,000
shares of common stock, respectively, that vest
in four equal installments upon the Company’s share price achieving targets ranging from $ 5.00
to $ 8.00
per share, with implied service periods of three
to fifteen months. The assumptions used in the Monte Carlo Simulation for the June 1, 2021 grants were stock price on date of grant of
$ 4.02 ,
contract term of 10
years, expected volatility of 75 %
and risk-free interest rate of 1.62 %.
We recorded stock-based compensation expense related to market condition stock options of approximately $ 1,981,000
for both the three and nine month periods
ended July 31, 2021. We did not record any market condition stock-based compensation expense for these grants during the three and nine
month periods ended July 31, 2020. As of July 31, 2021, the unrecognized compensation cost related to market condition stock options
was approximately $ 4,528,000
which will be recognized over future periods
through the fourth quarter of fiscal 2022.
10
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 $ 139,000 and $ 45,000 during the three months ended July 31, 2021 and 2020, respectively, and approximately
$ 326,000 and $ 157,000 during the nine months ended July 31, 2021 and 2020, respectively.
Stock
Option Plans
During
the nine months ended July 31, 2021, 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. Further, we had an additional stock option plan: the Anixa Biosciences, Inc. 2003 Share Incentive Plan (the “2003
Share Plan”), under which all outstanding options expired during the nine months ended July 31, 2020.
Stock
Option Activity
During
the three months ended July 31, 2021 and 2020, we granted options to purchase 2,990,000 shares and - 0 - shares of common stock, respectively,
and during the nine months ended July 31, 2021 and 2020, we granted options to purchase 4,370,000 shares and 800,000 shares of common
stock, respectively, to employees and consultants, with exercise prices ranging from $ 2.83 to $ 5.30 per share, pursuant to the 2018 Share
Plan. During the three months ended July 31, 2021 and 2020, stock options to purchase - 0 - shares and 7,200 shares of common stock, respectively,
were exercised with aggregate proceeds of approximately $- 0 - and $ 19,000 , respectively. During the nine months ended July 31, 2021 and
2020, stock options to purchase 107,451 shares, net of 7,937 shares withheld on a cashless exercise, and 51,100 shares of common stock,
respectively, were exercised with aggregate proceeds of approximately $ 294,000 and $ 122,000 , respectively.
2003
Share Plan
The
2003 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 2003 Share Plan, the plan terminated with
respect to the ability to grant future awards on April 21, 2013.
Information
regarding the 2003 Plan for the nine months ended July 31, 2020 is as follows:
SCHEDULE OF OPTION ACTIVITY
Shares
Weighted
Average Exercise
Price Per Share
Aggregate
Intrinsic
Value
Options outstanding at October 31, 2019
400
$ 17.00
Granted
-
$
-
Exercised
-
$ -
Forfeited/Expired
( 400 )
$ 17.00
Options outstanding and exercisable at
July 31, 2020
-
$ - 0 -
$ - 0 -
Options outstanding at July 31, 2020
-
$ -
$ -
Options exercisable at July 31, 2020
-
$ -
$ -
11
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, 2021 is as follows:
SCHEDULE OF OPTION ACTIVITY
Shares
Weighted
Average Exercise
Price Per Share
Aggregate
Intrinsic
Value
Options outstanding at October 31, 2020
1,907,534
$ 2.82
Exercised
( 37,500 )
$ 2.40
Forfeited/Expired
( 10,400 )
$ 4.57
Options outstanding and exercisable at July 31, 2021
1,859,634
$ 2.82
$ 3,138,347
The
following table summarizes information about stock options outstanding and exercisable under the 2010 Share Plan as of July 31, 2021:
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 - $ 2.30
527,500
4.80
$ 1.54
$ 2.58
- $ 3.13
818,000
2.65
$ 2.80
$ 3.46
- $ 5.30
514,134
6.75
$ 4.16
Information
regarding the 2010 Share Plan for the nine months ended July 31, 2020 is as follows:
Shares
Weighted Average Exercise Price Per Share
Aggregate
Intrinsic
Value
Options outstanding at October 31, 2019
1,998,668
$ 2.80
Exercised
( 51,100 )
$ 2.39
Forfeited/Expired
( 20,534 )
$ 1.72
Options outstanding at July 31, 2020
1,927,034
$ 2.82
$ 731,670
Options exercisable at July 31, 2020
1,772,034
$ 2.84
$ 630,120
12
The following table summarizes
information about stock options outstanding and exercisable under the 2010 Share Plan as of July 31, 2020:
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
$
0.67 - $ 2.30
549,000
5.70
$
1.57
494,000
5.56
$
1.64
$
2.58 - $ 3.13
846,000
3.05
$
2.79
846,000
3.41
$
2.79
$
3.46 - $ 5.75
532,034
7.45
$
4.16
432,034
7.33
$
4.33
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, 2021, the 2018 Share Plan had 1,257,937
shares available for future grants.
Information regarding the 2018
Share Plan for the nine months ended July 31, 2021 is as follows:
SCHEDULE OF OPTION ACTIVITY
Shares
Weighted
Average Exercise
Price Per Share
Aggregate Intrinsic Value
Options outstanding at October 31, 2020
4,346,661
$
3.69
Granted
4,370,000
$
3.79
Exercised
( 33,888
)
$
3.81
Forfeited/Expired
( 1,392,781
)
$
3.70
Options outstanding at July 31, 2021
7,289,992
$
3.74
$
5,164,696
Options exercisable at July 31, 2021
2,914,586
$
3.64
$
2,328,335
The following table summarizes
information about stock options outstanding and exercisable under the 2018 Share Plan as of July 31, 2021:
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 - $ 3.70
2,975,000
7.90
$
3.28
2,047,360
7.25
$
3.49
$
3.84 - $ 5.30
4,314,992
8.95
$
4.06
867,226
7.33
$
3.99
13
Information regarding the 2018
Share Plan for the nine months ended July, 2020 is as follows:
SCHEDULE OF OPTION ACTIVITY
Shares
Weighted
Average Exercise
Price Per Share
Aggregate Intrinsic Value
Options outstanding at October 31, 2019
3,935,000
$
3.74
Granted
800,000
$
3.85
Forfeited/Expired
( 258,376
)
$
3.86
Options outstanding at July 31, 2020
4,476,624
$
3.76
$
- 0 -
Options exercisable at July 31, 2020
2,403,014
$
3.76
$
- 0 -
The following table summarizes
information about stock options outstanding and exercisable under the 2018 Share Plan as of July 31, 2020:
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
$
3.70
3,100,000
7.78
$
3.70
1,700,000
7.78
$
3.70
$
3.84 - $ 4.61
1,376,624
7.55
$
3.89
703,014
6.15
$
3.90
Non-Plan Options
In addition to options granted
under stock option plans, during the years ended October 31, 2012 and 2013, the Board of Directors approved the grant of stock options
to certain employees and directors (the “Non-Plan Options”).
Information regarding Non-Plan
Options for the nine months ended July 31, 2021 is as follows:
SCHEDULE
OF OPTION ACTIVITY
Shares
Weighted
Average Exercise
Price Per Share
Aggregate
Intrinsic
Value
Options outstanding at October 31, 2020
1,698,000
$
2.58
Exercised
( 44,000
)
$
2.58
Options outstanding and exercisable at
July 31, 2021
1,654,000
$
2.58
$
3,051,630
The following table summarizes
information about Non-Plan Options outstanding and exercisable as of July 31, 2021:
SCHEDULE
OF OUTSTANDING AND EXERCISABLE
Range of
Exercise Prices
Number
Outstanding
and
Exercisable
Weighted Average Remaining Contractual Life
(in years)
Weighted
Average
Exercise Price
$
2.58
1,654,000
1.06
$
2.58
14
Information regarding Non-Plan
Options for the nine months ended July 31, 2020 is as follows:
Shares
Weighted
Average Exercise
Price Per Share
Aggregate Intrinsic Value
Options outstanding at October 31, 2019
1,698,000
$
2.58
Options outstanding and exercisable at
July 31, 2020
1,698,000
$
2.58
$
348,000
The following table summarizes
information about Non-Plan Options outstanding and exercisable as of July 31, 2020:
Range of
Exercise Prices
Number
Outstanding
and
Exercisable
Weighted Average
Remaining
Contractual Life
(in years)
Weighted
Average
Exercise Price
$
2.58
1,698,000
2.00
$
2.58
Stock Awards
On May 8, 2018, a restricted
stock award of 1,500,000 shares of common stock was granted under the 2018 Share Plan to our Chairman, President and Chief Executive Officer.
The restricted stock award was to vest in its entirety upon achievement of a target trading price of $ 11.00 per share of the Company’s
common stock before May 31, 2021 . The restricted stock award did not vest as of May 31, 2021 and expired. 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). We did not record any compensation expense related
to the restricted stock award during the nine months ended July 31, 2021 and 2020.
Employee Stock Purchase Plan
The Company maintains the Anixa
Biosciences, Inc. Employee Stock Purchase Plan which permits eligible employees to purchase shares at not less than 85 % of the market
value of the Company’s common stock on the offering date or the purchase date of the applicable offering period, whichever is lower.
The plan was adopted by our Board of Directors on August 13, 2018 and approved by our shareholders on September 27, 2018. During the nine
months ended July 31, 2021 and 2020, employees purchased 1,634 and 9,618 shares, respectively, with aggregate proceeds of approximately
$ 3,000 and $ 15,000 , respectively.
Warrants
On October 30, 2020 we issued
a warrant, expiring on October
30, 2025 , to purchase 60,000
shares of common stock at $ 2.06
per share, vesting over five
months, to a consultant for investor relations services. We recorded consulting expense of approximately $ -0-
and $ 96,000 ,
respectively, during the three and nine months ended July 31, 2021, based on the fair value of the warrant on the date of grant recognized
on a straight-line basis over the vesting period. We did no t
record any consulting expense related to warrants during the three and nine months ended July 31, 2020.
As discussed in Note 2, in connection
with the March 25, 2021 public offering 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 . No warrants were issued during the nine month period ended July
31, 2020.
15
As of July 31, 2021, we also
had warrants outstanding to purchase 500,000 shares of common stock at $ 5.03 per share, issued during fiscal year 2017 and expiring on
November 30, 2021 .
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 assets and
liabilities 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 assets and
liabilities 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 assets
and liabilities 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 asset and liabilities.
The following table presents
the hierarchy for our financial assets measured at fair value on a recurring basis as of July 31, 2021:
SCHEDULE
OF FAIR VALUE MEASUREMENTS
Level 1
Level 2
Level 3
Total
Money market funds:
Cash and cash equivalents
$
26,807,696
$
-
$
-
$
26,807,696
Certificates of deposit:
Cash and cash equivalents
250,000
-
-
250,000
Short-term investments
-
1,000,000
-
1,000,000
Treasury bills and bonds:
Short-term investments
-
8,399,784
-
8,399,784
Total financial assets
$
27,057,696
$
9,399,784
$
-
$
36,457,480
The following table presents
the hierarchy for our financial assets measured at fair value on a recurring basis as of October 31, 2020:
Level 1
Level 2
Level 3
Total
Money market funds:
Cash and cash equivalents
$
3,902,292
$
-
$
-
$
3,902,292
Certificates of deposit:
Cash and cash equivalents
2,250,000
-
-
2,250,000
Short-term investments
-
2,640,000
-
2,640,000
Total financial assets
$
6,152,292
$
2,640,000
$
-
$
8,792,292
16
Our non-financial assets that
are measured on a non-recurring basis include our 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 and
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, 2021
October 31, 2020
Payroll and related expenses
$
392,376
$
415,331
Accrued royalty and contingent legal fees
577,190
449,691
Accrued collaborative research and license expense
-
30,000
Accrued other
20,158
6,003
Accrued
expenses
$
989,724
$
901,025
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, 2021 and 2020, were stock options to purchase 10,303,626 and 8,101,658 shares,
respectively, and warrants to purchase 860,000 and 500,000 shares, respectively.
7.
EFFECT OF RECENTLY ADOPTED AND ISSUED PRONOUNCEMENTS
In February 2016, the Financial
Accounting Standards Board (FASB) issued Accounting Standards Update 2016-02 (“ASU 2016-02”) Accounting Standards Codification
Topic 842, Leases (“ASC 842”), which supersedes Topic 840, Leases, and which requires lessees to recognize most leases on
the balance sheet. The new lease standard does not substantially change lessor accounting. For public companies, the standard was effective
for the first interim reporting period within annual periods beginning after December 15, 2018, although early adoption was permitted.
Lessees and lessors were required to apply the new standard at the beginning of the earliest period presented in the financial statements
in which they first apply the new guidance. In July 2018, FASB issued ASU 2018-11, Leases, which provides an additional transition option
for an entity to apply the provisions of ASC 842 by recognizing a cumulative effect adjustment at the effective date of adoption without
adjusting the prior comparative periods presented. The requirements of this standard include a significant increase in required disclosures.
The Company adopted ASU 2016-02 on November 1, 2019. The adoption of this standard did not have a material impact on our condensed consolidated
financial statements. See Note 9 regarding the accounting and disclosures related to our office lease.
In January 2020, the FASB issued
Accounting Standards Update 2020-01 (“ASU 2020-01”) Investments-Equity Securities (Topic 321), Investments-Equity Method and
Joint Ventures (Topic 323), and Derivatives and Hedging (Topic 815). The amendments in ASU 2020-01 clarify certain interactions between
the guidance to account for certain equity securities under Topic 321, the guidance to account for investments under the equity method
of accounting in Topic 323, and the guidance in Topic 815, which could change how an entity accounts for an equity security under the
measurement alternative or a forward contract or purchased option to purchase securities that, upon settlement of the forward contract
or exercise of the purchased option, would be accounted for under the equity method of accounting or the fair value option in accordance
with Topic 825, Financial Instruments. These amendments improve current GAAP by reducing diversity in practice and increasing comparability
of the accounting for these interactions. The amendments in this update are effective for fiscal years beginning after December 15, 2020,
and interim periods within those fiscal years. The adoption of this standard will not have a material impact on our disclosures or consolidated
financial statements.
17
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. We have no unrecognized income tax benefits as of July 31, 2021 and October 31, 2020 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 expires September 30, 2021 . Our base rent is approximately $ 5,000 per month and the lease provides
for annual increases of approximately 3 % and an escalation clause for increases in certain operating costs. Rent expense was approximately
$ 16,000 and $ 16,000 , respectively, for the three months ended July 31, 2021 and 2020, and approximately $ 48,000 and $ 48,000 , respectively,
for the nine months ended July 31, 2021 and 2020.
On November 1, 2019, the Company
adopted ASC 842, which increases transparency and comparability by recognizing a lessee’s rights and obligations resulting from
leases by recording them on the balance sheet as lease assets and lease liabilities. The new guidance requires the recognition of the
right-of-use (“ROU”) assets and related operating lease liabilities on the balance sheet. The Company adopted the new guidance
using the modified retrospective approach on November 1, 2019.
For operating leases, the lease
liability is initially and subsequently measured at the present value of the unpaid lease payments. The remaining 2 -month lease term as
of July 31, 2021 for the Company’s lease includes the noncancelable period of the lease. The lease does not contain a Company option
to extend the lease or an option to extend the lease controlled by the lessor. All ROU assets are reviewed for impairment.
18
Balance sheet information related
to the Company’s lease is presented below:
SCHEDULE
OF OPERATING LEASE
Balance Sheet Location
July 31, 2021
October 31, 2020
Operating Lease:
Right-of-use asset
Operating lease right-of-use asset
$
10,411
$
54,340
Right-of-use liability, current
Operating lease liability
10,567
55,198
As of July 31, 2021, the annual
minimum lease payments of our operating lease liabilities were as follows:
SCHEDULE
OF MINIMUM LEASE PAYMENTS
Operating Leases
2021 future minimum payments, undiscounted
$
10,752
Less: Imputed interest
( 185
)
Present value of future minimum lease payments
$
10,567
In August 2021 the lease was extended
until September 30, 2024 under substantially the same terms as the existing lease.
10.
COMMITMENTS AND CONTINGENCES
Litigation Matters
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.
Impact of Coronavirus Pandemic
On March 10, 2020, the World
Health Organization declared the COVID-19 outbreak a pandemic. The virus and actions taken to mitigate its spread have had and are expected
to continue to have a broad adverse impact on the economies and financial markets of many countries, including the geographical areas
in which the Company operates and conducts its business, and which the Company’s partners operate and conduct their business. We
are currently following the recommendations of local health authorities to minimize exposure risk for our team members and visitors. However,
while the outlook is improving, and there has been a loosening of restrictions in many of the areas in which we and our partners operate
and conduct our business, the scale and scope of this pandemic is unknown, and the duration of the business disruption and related financial
impact cannot be reasonably estimated at this time. While we have implemented specific business continuity plans to reduce the potential
impact of COVID-19, there is no guarantee that our continuity plans will be successful.
We have experienced certain disruptions
to our business such as temporary closure of our offices and similar disruptions have occurred for our partners. Specifically, the outbreak
has caused temporary shutdowns of the laboratories and other service providers that we rely on to develop our programs, and those laboratories
and service providers that have been operating or that have begun operating recently have been doing so with more limited capacity due
to social distancing requirements. As a result, our progress has been slowed and there is no assurance that we will be able to meet our
previously announced timelines regarding the advancement of our programs.
The extent to which COVID-19
or any other health epidemic may impact our results will depend on future developments, which are highly uncertain and cannot be predicted,
including new information which may emerge concerning the severity of COVID-19 and the actions to contain COVID-19 or treat its impact,
among others. Accordingly, COVID-19 could have a material adverse effect on our business, results of operations, financial condition and
prospects.
19
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 five reportable segments, each with different operating
and potential revenue generating characteristics: (i) CAR-T Therapeutics, (ii) Cancer Vaccines, (iii) Anti-Viral Therapeutics, (iv) Cancer
Diagnostics and (v) Patent Licensing activities. The following represents selected financial information for our segments for the three
and nine months ended July 31, 2021 and 2020 and as of July 31, 2021 and October 31, 2020:
SCHEDULE
OF SEGMENT INFORMATION
2021
2020
2021
2020
For the Three Months Ended
July 31,
For the Nine Months Ended
July 31,
2021
2020
2021
2020
Net Income/(Loss):
CAR-T Therapeutics
$
( 1,618,860
)
$
( 417,502
)
$
( 4,025,354
)
$
( 1,542,865
)
Cancer Vaccines
( 1,464,323
)
( 178,738
)
( 3,033,026
)
( 544,605
)
Anti-Viral Therapeutics
( 1,262,260
)
( 281,098
)
( 2,052,821
)
( 590,602
)
Cancer Diagnostics
( 38,198
)
( 1,693,304
)
( 60,569
)
( 5,162,977
)
Patent Licensing
( 3,969
)
( 6,145
)
114,894
( 10,303
)
Total
$
( 4,387,610
)
$
( 2,576,787
)
$
( 9,056,876
)
$
( 7,851,352
)
Net Income/(Loss)
$
( 4,387,610
)
$
( 2,576,787
)
$
( 9,056,876
)
$
( 7,851,352
)
Total operating costs and expenses
$
4,388,236
$
2,435,969
$
9,571,149
$
7,735,975
Less non-cash share-based compensation
( 3,187,326
)
( 1,041,799
)
( 5,224,697
)
( 3,173,219
)
Operating costs and expenses
excluding non-cash share-based
compensation
$
1,200,910
$
1,394,170
$
4,346,452
$
4,562,756
Operating costs and expenses excluding
non-cash share-based compensation:
CAR-T Therapeutics
$
411,313
$
189,589
$
1,903,707
$
759,752
Cancer Vaccines
348,535
72,968
1,185,060
238,297
Anti-Viral Therapeutics
418,285
155,224
826,716
376,242
Cancer Diagnostics
20,645
971,698
37,368
3,180,511
Patent Licensing
2,132
4,691
393,601
7,954
Total
$
1,200,910
$
1,394,170
4,346,452
$
4,562,756
Operating costs and expenses excluding non-cash share-based compensation
$
1,200,910
$
1,394,170
4,346,452
$
4,562,756
July 31,
2021
October 31,
2020
Total assets:
CAR-T Therapeutics
$
12,709,167
$
2,988,124
Cancer Vaccines
10,706,026
946,923
Anti-Viral Therapeutics
12,849,445
2,464,361
Cancer Diagnostics
682,943
2,869,529
Patent Licensing
114,810
184,027
Total
$
37,062,391
$
9,452,964
Total assets
$
37,062,391
$
9,452,964
Operating costs and expenses
excluding non-cash share-based compensation expense is the measurement the chief operating decision-maker uses in managing the enterprise.
20
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, 2020 and the condensed consolidated
financial statements included in this Report. 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, 2021 compared with three months ended
July 31, 2020
Revenue
Over the past several years,
our revenue, if any, was derived from technology licensing and the sale of patented technologies, including revenue from the settlement
of litigation. 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.
We had no revenue during the
three-month periods ended July 31, 2021 and 2020.
Inventor Royalties, Contingent Legal Fees, Litigation
and Licensing Expenses
We had no inventor royalties,
contingent legal fees, litigation and licensing expenses during the three-month periods ended July 31, 2021 and 2020.
Research and Development Expenses
Research and development expenses
incurred in the three months ended July 31, 2021 associated with each of our development programs consisted of approximately $839,000
for CAR-T therapeutics, approximately $770,000 for cancer vaccines, approximately $558,000 for anti-viral therapeutics
and $-0- for cancer diagnostics.
21
Research and development expenses
are related to the development of our cancer therapeutics, vaccine and diagnostics programs and our anti-viral drug program, and increased
by approximately $913,000 to approximately $2,167,000 in the three months ended July 31, 2021, from approximately $1,254,000
in the three months ended July 31, 2020. The increase in research and development expenses was primarily due to an increase in employee
stock option expense of approximately $1,262,000, an increase in outside research and development related to our development programs,
other than our cancer diagnostics program, of approximately $263,000, an increase in consultant stock option expense of approximately
$86,000, offset by a decrease in outside research and development expense related to our cancer diagnostics program of approximately
$288,000, a decrease in employee compensation and related costs, other than stock option compensation expense, of approximately $200,000
and a decrease in consulting expense of approximately $108,000, all such decreases due to suspension of development of our cancer diagnostics
program on July 2, 2020 and a decrease in professional fees of approximately $38,000.
General and Administrative Expenses
General and administrative expenses
increased by approximately $1,040,000 to approximately $2,222,000 in the three months ended July 31, 2021, from approximately
$1,182,000 in the three months ended July 31, 2020. The increase in general and administrative expenses was primarily due to an increase
in employee stock option expense of approximately $447,000, an increase in director stock option expense of approximately $396,000,
an increase in consulting expense of approximately $123,000, an increase in director cash compensation of approximately $63,000, an increase
in corporate insurance expense of approximately $62,000, an increase in professional fees of approximately $32,000, offset by a decrease
in employee compensation and related costs, other than stock option compensation expense, of approximately $100,000.
Interest Income
Interest income decreased by
approximately $7,000 to less than $1,000 in the three months ended July 31, 2021, from approximately $7,000 in the comparable prior year
period as a result of a decrease in interest rates.
Net Loss Attributable to
Noncontrolling Interest
The net loss attributable to
noncontrolling interest, representing Wistar’s 5% ownership interest in Certainty’s net loss, was approximately $54,000
and $15,000, respectively, in the three months ended July 31, 2021 and 2020.
Nine months ended July 31, 2021 compared with nine months ended July
31, 2020
Revenue
For the nine months ended July
31, 2021, we recorded revenue of approximately $513,000 from one license agreement. The license agreement provided for a one-time, non-recurring,
lump sum payment in exchange for a non-exclusive retroactive and future license, and covenant not to sue. Pursuant to the terms of the
agreement, we have no further obligations with respect to the granted intellectual property rights, including no obligation to maintain
or upgrade the technology, or provide future support or services. Accordingly, the performance obligations from this license agreement
were satisfied and 100% of the revenue was recognized upon execution of the license agreement. As discussed in Note 1 to our condensed
consolidated financial statements, as part of our legacy operations, the Company remains engaged in limited patent licensing activities
which we do not expect to be a significant part of our ongoing operations or revenue.
22
We had no revenue during the
nine-month period ended July 31, 2020.
Inventor Royalties, Contingent Legal Fees, Litigation
and Licensing Expenses
Inventor royalties, contingent
legal fees, litigation and licensing expenses increased to approximately $385,000 in the nine months ended July 31, 2021 from $-0- in
the nine months ended July 31, 2020. The increase was primarily due to the increase in related revenues. Inventor royalties and contingent
legal fees are expensed in the period that the related revenues are recognized. Litigation and licensing expenses related to patent assertion,
other than contingent legal fees, are expensed in the period incurred.
Research and Development
Expenses
Research and development expenses
incurred in the nine months ended July 31, 2021 associated with each of our development programs consisted of approximately $1,753,000
for CAR-T therapeutics, approximately $1,400,000 for cancer vaccines, approximately $861,000 for anti-viral therapeutics
and approximately $2,000 for cancer diagnostics.
Research and development expenses
are related to the development of our cancer therapeutics, vaccine and diagnostics programs and our anti-viral drug program, and increased
by approximately $42,000 to approximately $4,016,000 in the nine months ended July 31, 2021, from approximately $3,974,000
in the nine months ended July 31, 2020. The increase in research and development expenses was primarily due to an increase in employee
stock option expense of approximately $1,013,000, an increase in outside research and development related to our development programs,
other than our cancer diagnostics program, of approximately $691,000, an increase in consultant stock option expense of approximately
$161,000, offset by a decrease in outside research and development expense related to our cancer diagnostics program of approximately
$1,104,000, a decrease in employee compensation and related costs, other than stock option compensation expense, of approximately $594,000
and a decrease in consulting expense of approximately $133,000, all such decreases due to suspension of development of our cancer diagnostics
program.
General and Administrative Expenses
General and administrative expenses
increased by approximately $1,408,000 to approximately $5,170,000 in the nine months ended July 31, 2021, from approximately
$3,762,000 in the nine months ended July 31, 2020. The increase in general and administrative expenses was primarily due to an increase
in director compensation of approximately $502,000, an increase in employee stock option expense of approximately $460,000, non-recurring
income in the prior year period resulting from the discharge in January 2020 of a disputed liability of approximately $337,000 upon the
expiration of the vendor’s statutory right to pursue collection of the disputed liability, an increase in patent expense of approximately
$194,000, an increase in corporate insurance expense of approximately $109,000, an increase in consultant stock option and warrant expense
of approximately $103,000, offset by a decrease in employee compensation and related costs, other than stock option compensation expense,
of approximately $347,000.
Interest Income
Interest income decreased by
approximately $31,000 to approximately $2,000 in the nine months ended July 31, 2021, from approximately $33,000 in the comparable prior
year period as a result of a decrease in interest rates.
23
Net Loss Attributable to
Noncontrolling Interest
The net loss attributable to
noncontrolling interest, representing Wistar’s 5% ownership interest in Certainty’s net loss, was approximately $116,000
and $57,000, respectively, in the nine months ended July 31, 2021 and 2020.
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 1, 2021, 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 nine months ended July 31, 2021, we raised approximately $20,292,000, net of expenses, through
a public offering in which we sold an aggregate of 4,285,715 shares of common stock and approximately $10,834,000, net of expenses, through
our at-the-market equity program in which we sold an aggregate of 2,806,410 shares of common stock. Our at-the-market equity program was
terminated on June 16, 2021. We may seek to obtain working capital during our fiscal year 2021 or thereafter through sales of our equity
securities or through bank credit facilities or public or private debt from various financial institutions where possible. We cannot be
certain that additional funding will be available on acceptable terms, or at all. If we do identify sources for additional funding, the
sale of additional equity securities or convertible debt will result in dilution to our stockholders. We can give no assurance that we
will generate sufficient cash flows in the future to satisfy our liquidity requirements or sustain future operations, or that other sources
of funding, such as sales of equity or debt, would be available or would be approved by our security holders, if needed, on favorable
terms or at all. If we fail to obtain additional working capital as and when needed, such failure could have a material adverse impact
on our business, results of operations and financial condition. Furthermore, such lack of funds may inhibit our ability to respond to
competitive pressures or unanticipated capital needs, or may force us to reduce operating expenses, which would significantly harm the
business and development of operations.
During
the nine months ended July 31, 2021, cash used in operating activities was approximately $3,893,000. Cash used in investing activities
was approximately $6,724,000, resulting from the purchase of short-term investments of approximately $10,400,000, which was offset by
the proceeds on maturities of short-term investments of approximately $3,640,000 and the proceeds from the sale of equipment of approximately
$35,000. Cash provided by financing activities was approximately $31,422,000, resulting from net proceeds of approximately $20,292,000
from a public offering of 4,285,715 shares of common stock, the sale of 2,806,410 shares of common stock in an at-the-market equity offering
of approximately $10,834,000, proceeds from exercise of stock options of approximately $294,000 and proceeds from the sale of common stock
pursuant to employee stock purchase plan of approximately $3,000. As a result, our cash, cash equivalents, and short-term investments
at July 31, 2021 increased approximately $27,565,000 to approximately $36,622,000 from approximately $9,057,000 at the end of fiscal year
2020.
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.
24
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, 2020, the following accounting policies require our most difficult, subjective or complex judgments:
●
Revenue Recognition; and
●
Stock-Based Compensation
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.
We follow the accounting guidance
of Accounting Standards Codification 606 (“ASC 606”), Revenue from Contracts with Customers. In accordance with ASC 606 we
are required to make certain judgments and estimates in connection with the accounting for revenue. Such judgments and estimates 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 achieves 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 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).
25
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.
EFFECT OF RECENTLY ISSUED PRONOUNCEMENTS
We discuss the effect of recently
issued pronouncements in the Notes to our Condensed Consolidated Financial Statements.
Item 3. Quantitative and Qualitative Disclosures
About Market Risk.
As of July 31, 2021, we had investments
in short-term, fixed rate and highly liquid instruments that have historically been reinvested when they mature throughout the year. Although
our existing instruments are not considered at risk with respect to changes in interest rates or markets for these instruments, our rate
of return on these securities could be affected at the time of reinvestment, if any.
Item 4. Controls and Procedures.
We carried out an evaluation,
under the supervision and with the participation of our management including our President and Chief Executive Officer and our Chief Operating
Officer and 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 President and Chief Executive Officer and our Chief Operating
Officer and 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 third quarter of fiscal year 2021 that has materially affected, or is reasonably likely to
materially affect, our internal control over financial reporting.
26
PART II. OTHER INFORMATION
Item 1. Legal Proceedings.
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.
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, 2020.
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 1, 2021.
31.2
Certification of Chief Financial Officer, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, dated September 1, 2021.
32.1
Statement of Chief Executive Officer, pursuant to Section 1350 of Title 18 of the United States Code, dated September 1, 2021.
32.2
Statement of Chief Financial Officer, pursuant to Section 1350 of Title 18 of the United States Code, dated September 1, 2021.
101.INS
Inline XBRL Instance Document
101.SCH
Inline XBRL Taxonomy Extension Schema Document
101.CAL
Inline XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF
Inline XBRL Taxonomy Extension Definition Linkbase Document
101.LAB
Inline XBRL Taxonomy Extension Label Linkbase Document
101.PRE
Inline XBRL Taxonomy Extension Presentation Linkbase Document
104
Cover Page Interactive Data File (embedded within the Inline XBRL document)
27
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, President and
Chief Executive Officer
September 1, 2021
(Principal Executive Officer)
By:
/s/ Michael J. Catelani
Michael J. Catelani
Chief Operating Officer and
Chief Financial Officer
(Principal Financial and
September 1, 2021
Accounting Officer)
28
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.