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 January 31, 2022
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
March 11, 2022 the registrant had outstanding 30,152,319 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 as of January 31, 2022 (Unaudited) and October 31, 2021
1
Condensed
Consolidated Statements of Operations (Unaudited) for the three months ended January 31, 2022 and 2021
2
Condensed
Consolidated Statements of Shareholders’ Equity (Unaudited) for the three months ended January 31, 2022 and 2021
3
Condensed
Consolidated Statements of Cash Flows (Unaudited) for the three months ended January 31, 2022 and 2021
4
Notes
to Condensed Consolidated Financial Statements (Unaudited)
5
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
19
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
23
Item 4. Controls and Procedures.
23
PART II. OTHER INFORMATION
Item 1. Legal Proceedings.
24
Item 1A. Risk Factors.
24
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
24
Item 3. Defaults Upon Senior Securities.
24
Item 4. Mine Safety Disclosures.
24
Item 5. Other Information.
24
Item 6. Exhibits
24
SIGNATURES
25
PART
I. FINANCIAL INFORMATION
Item
1. Financial Statements.
ANIXA
BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED BALANCE SHEETS
(in
thousands, except share and per share data)
(Unaudited)
January
31, 2022
October
31, 2021
ASSETS
Current assets:
Cash and cash
equivalents
$ 29,781
$ 29,128
Short-term investments
4,749
6,599
Prepaid
expenses and other current assets
464
276
Total current assets
34,994
36,003
Operating lease right-of-use
asset
244
254
Total
assets
$ 35,238
$ 36,257
LIABILITIES AND
EQUITY
Current liabilities:
Accounts payable
$ 504
$ 136
Accrued expenses
1,242
1,095
Operating
lease liability
41
39
Total
current liabilities
1,787
1,270
Operating lease liability,
non-current
209
220
Total
liabilities
1,996
1,490
Commitments and contingencies (Note 9)
-
-
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
-
-
Common stock, par value $ .01 per share; 100,000,000
shares authorized; 30,132,319 and 30,050,894 shares issued and outstanding as of January 31, 2022 and October 31, 2021, respectively
301
301
Additional paid-in capital
242,281
239,927
Accumulated
deficit
( 208,619 )
( 204,790 )
Total shareholders’
equity
33,963
35,438
Noncontrolling
interest (Note 1)
( 721 )
( 671 )
Total
equity
33,242
34,767
Total
liabilities and equity
$ 35,238
$ 36,257
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)
For
the Three Months Ended January 31,
2022
2021
Revenue
$ -
$ 513
Operating costs and expenses:
Inventor royalties, contingent
legal fees, litigation and licensing expenses
-
385
Research and development
expenses (including non-cash share-based compensation expenses of $ 1,276 and $ 290 , respectively)
1,838
828
General
and administrative expenses (including non-cash share-based compensation expenses of $ 1,078 and $ 696 , respectively)
2,042
1,533
Total
operating costs and expenses
3,880
2,746
Loss from operations
( 3,880 )
( 2,233 )
Interest income
1
1
Net loss
( 3,879 )
( 2,232 )
Less: Net loss attributable
to noncontrolling interest
( 50 )
( 24 )
Net loss attributable
to common shareholders
( 3,829 )
( 2,208 )
Net loss per common share attributable to common
shareholders:
Basic
and diluted
$ ( 0.13 )
$ ( 0.09 )
Weighted average common shares outstanding:
Basic
and diluted
30,125
25,165
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
(in
thousands)
FOR
THE THREE MONTHS ENDED JANUARY 31, 2022 (UNAUDITED )
Additional
Total
Non-
Common
Stock
Paid-in
Accumulated
Shareholders’
controlling
Total
Shares
Par
Value
Capital
Deficit
Equity
Interest
Equity
Balance, October 31, 2021
30,051
$ 301
$ 239,927
$ ( 204,790 )
$ 35,438
$ ( 671 )
$ 34,767
Stock option compensation to employees and
directors
-
-
2,135
-
2,135
-
2,135
Stock options and warrants issued to consultants
-
-
219
-
219
-
219
Common stock issued upon exercise of stock
options and warrants
81
-
-
-
-
-
-
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
Net loss
-
-
-
( 3,829 )
( 3,829 )
( 50 )
( 3,879 )
Balance, January 31, 2022
30,132
$ 301
$ 242,281
$ ( 208,619 )
$ 33,963
$ ( 721 )
$ 33,242
FOR
THE THREE MONTHS ENDED JANUARY 31, 2021 (UNAUDITED )
Additional
Total
Non-
Common
Stock
Paid-in
Accumulated
Shareholders’
controlling
Total
Shares
Par
Value
Capital
Deficit
Equity
Interest
Equity
Balance, October 31, 2020
24,249
$ 242
$ 200,355
$ ( 191,836 )
$ 8,761
$ ( 497 )
$ 8,264
Stock option compensation to employees and
directors
-
-
875
-
875
-
875
Stock options and warrants issued to consultants
-
-
111
-
111
-
111
Common stock issued upon exercise of stock
options
30
-
104
-
104
-
104
Common stock issued in at-the-market offering,
net of offering expenses of $ 185
1,900
20
5,937
-
5,957
-
5,957
Net loss
-
-
-
( 2,208 )
( 2,208 )
( 24 )
( 2,232 )
Balance, January 31, 2021
26,179
$ 262
$ 207,382
$ ( 194,044 )
$ 13,600
$ ( 521 )
$ 13,079
The
accompanying notes are an integral part of these condensed consolidated financial statements.
3
ANIXA
BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
(in
thousands)
For
the three months ended January 31,
2022
2021
Cash flows from operating activities:
Reconciliation
of net loss to net cash used in operating activities:
Net
loss
$ ( 3,879 )
$ ( 2,232 )
Stock
option compensation to employees and directors
2,135
875
Stock
options and warrants issued to consultants
219
111
Gain
on sale of equipment
-
( 5 )
Amortization
of operating lease right-to-use asset
10
14
Change
in operating assets and liabilities:
Prepaid
expenses and other current assets
( 188 )
( 270 )
Accounts
payable
368
279
Accrued
expenses
147
72
Operating
lease liability
( 9 )
( 14 )
Net
cash used in operating activities
( 1,197 )
( 1,170 )
Cash flows from investing activities:
Disbursements
to acquire short-term investments
( 3,499 )
( 1,000 )
Proceeds
from maturities of short-term investments
5,349
1,640
Proceeds
from sale of equipment
-
35
Net
cash provided by investing activities
1,850
675
Cash flows from financing activities:
Net
proceeds from sale of common stock in an at-the-market offering
-
5,957
Proceeds
from exercise of stock options
-
104
Net
cash provided by financing activities
-
6,061
Net increase in cash and cash equivalents
653
5,566
Cash and cash equivalents
at beginning of period
29,128
6,417
Cash and cash equivalents
at end of period
29,781
11,983
The
accompanying notes are an integral part of these condensed consolidated financial statements.
4
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 (i) the development of a chimeric endocrine receptor
T-cell therapy, a novel form of chimeric antigen receptor T-cell (“CAR-T”) technology, initially focused on treating ovarian
cancer, which is being developed at our subsidiary, Certainty Therapeutics, Inc. (“Certainty”), and (ii) the 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 (i) the development of a preventative vaccine against triple negative breast cancer (“TNBC”),
the most lethal form of breast cancer, as well other forms of breast cancer and (ii) a preventative vaccine against ovarian cancer.
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 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.
Certainty,
in collaboration with the H. Lee Moffitt Cancer Center and Research Institute, Inc. (“Moffitt”), is advancing toward human
clinical testing of the CAR-T technology licensed by Certainty from Wistar aimed initially at treating ovarian cancer. We submitted an
Investigational New Drug (“IND”) application to the U.S. Food and Drug Administration (“FDA”) in March 2021 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 initiating
the trial in the first calendar quarter of 2022. This study is a dose-escalation trial with two arms based on injection method—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 24 to 48 patients who have
received at least two prior lines of chemotherapy. The study is estimated to be completed in two to four years depending on multiple
factors including when maximum tolerated dose is reached and the rate of patient recruitment.
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.
5
The
screening process resulted in the identification of multiple compounds that could potentially disrupt critical enzymes of the virus,
including the virus’ main protease, M pro . 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 at the time the assays were performed was the only
anti-viral drug authorized by the FDA for the treatment of 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
between each of our compounds and Remdesivir. Based on this promising data in the animal study, we directed our team to proceed to the
next stage of drug development and we selected one of the compounds around which our team is performing combinatorial synthetic medicinal
chemistry to evaluate whether potency can be increased and pharmacokinetics optimized.
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. As a result of
the MolGenie spin-out, there was no change in the personnel working on our project, and the assignment caused no interruptions to the
program’s development.
While
use of preventative vaccines is widespread throughout much of the developed world, we believe that there is and will continue to be a
need for effective treatments for COVID-19. We believe that there are a number of factors that have limited the effectiveness, both in
the near and long term, of the vaccines currently in use, including, but not limited to, vaccine persistence, viral escape and perceptions
of long-term safety resulting in vaccine resistance. Furthermore, there are currently two new anti-viral treatments, Pfizer’s Paxlovid,
which is a combination therapy consisting of the protease-inhibitor nirmatrelvir and the antiretroviral ritonavir and Merck’s polymerase-inhibitor
molnupiravir, that have recently been authorized for emergency use in the U.S. These treatments use oral formulations, while all other
currently authorized or approved treatments require intravenous administration. As the main component of Pfizer’s treatment is
a protease-inhibitor targeting M pro , it is most similar to our compounds, and we therefore conducted a head-to-head analysis
via a Fluorescence Resonance Energy Transfer (FRET) assay that tested the ability of the compounds to inhibit the function of M pro .
The results of this head-to-head in vitro analysis suggest that our compounds may be five times more effective at inhibiting M pro
than Pfizer’s nirmatrelvir. Whereas we believe Pfizer’s Paxlovid is a repurposed drug based on research done
on other viruses and not designed specifically for SARS-CoV-2, our compounds were designed specifically against the main protease
of SARS-CoV-2 and at the current time we do not anticipate the need for a combination therapy.
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. Utilizing
this technology, we are working in collaboration with Cleveland Clinic to develop a method to vaccinate women against contracting breast
cancer, focused specifically on TNBC. The focus of this vaccine is a specific protein, α-lactalbumin, that is only expressed during
lactation in a healthy mother’s mammary tissue. This protein disappears when the mother 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.
Following
submission of an IND application with the FDA in November 2020, and the FDA’s subsequent authorization to proceed with clinical
trials in December 2020, in October 2021, we commenced dosing patients in a Phase 1 clinical trial of our breast cancer vaccine. Funded
by a U.S. Department of Defense grant, this study is a multiple-ascending dose Phase 1 trial to determine the maximum tolerated dose
of the vaccine in patients with early-stage, triple-negative breast cancer as well as monitor immune response. The study is being conducted
at Cleveland Clinic and will consist of 18 to 24 patients who have completed treatment for early-stage, triple-negative breast cancer
within the past three years and are currently tumor-free but at high risk for recurrence. During the course of the study, participants
will receive three vaccinations, each two weeks apart, and will be closely monitored for side effects and immune response. The study
is estimated to be completed in the third calendar quarter of 2022.
6
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 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 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 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 discovery 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 its liquid biopsy platform, 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.
Over
the past several years, our revenue was derived from technology licensing and the sale of patented technologies, including revenue from
the settlement of litigation. We have not generated any revenue to date from our therapeutics or vaccine programs. In addition, while
we pursue our therapeutics and vaccine programs, we may also make investments in and form new companies to develop additional emerging
technologies. We do not expect to begin generating revenue with respect to any of our current 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 March 11, 2022, 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. We may seek to obtain working capital during our fiscal year 2022 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.
7
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, 2021. The accompanying October 31, 2021 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 January 31, 2022, and results of operations and cash flows for the interim periods represented. The results of operations
for the three months ended January 31, 2022 are not necessarily indicative of the results to be expected for the entire 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 three months ended January 31, 2022 (in thousands):
SCHEDULE
OF NONCONTROLLING INTEREST AS A COMPONENT OF EQUITY
Balance, October 31, 2021
$ ( 671 )
Net loss attributable
to noncontrolling interest
( 50 )
Balance, January 31, 2022
$ ( 721 )
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.
8
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.
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, developing anti-viral drug candidates for COVID-19,
developing our breast cancer vaccine, and developing our ovarian cancer vaccine, are expensed in the consolidated financial statements
in the period incurred.
2.
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 $ 730,000 and $ 875,000 during the three months ended January 31, 2022
and 2021.
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 June 1, 2021, our Chairman, President and Chief Executive
Officer and our Chief Operating Officer and Chief Financial Officer were awarded market condition stock 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. We recorded market condition
stock-based compensation expense during the three months ended January 31, 2022 and 2021 of approximately $ 1,405,000 and $ 0 , respectively.
9
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 $ 109,000 and $ 54,000 during the three months ended January 31, 2022 and 2021, respectively.
Stock
Option Plans
During
the three months ended January 31, 2022, 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.
Stock
Option Activity
During
the three months ended January 31, 2022 and 2021, we granted options to purchase 30,000 shares and 1,130,000 shares of common stock,
respectively, to employees and consultants, with exercise prices ranging from $ 2.83 to $ 3.24 per share, pursuant to the 2018 Share Plan.
During the three months ended January 31, 2022 and 2021, stock options to purchase 100,000 shares of common stock, net of 53,091 shares
withheld on a cashless exercise, and 29,880 shares of common stock, respectively, were exercised with aggregate proceeds of $ 0 and approximately
$ 104,000 , respectively.
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 three months ended
January 31, 2022 is as follows:
SCHEDULE OF OPTION ACTIVITY
Shares
Weighted
Average Exercise
Price Per Share
Aggregate
Intrinsic Value
(in thousands)
Options outstanding at October 31, 2021
1,718,634
$ 2.82
Granted
-
$ -
Exercised
( 100,000 )
$ 2.92
Forfeited/Expired
-
$ -
Options outstanding
and exercisable at
January 31, 2022
1,618,634
$ 2.81
$ 1,216
Options
Outstanding
-
$ -
$ -
Options
Exercisable
-
$ -
$ -
The
following table summarizes information about stock options outstanding and exercisable under the 2010 Share Plan as of January 31, 2022:
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
4.3
$ 1.54
$ 2.58
- $ 3.13
577,000
2.9
$ 2.76
$ 3.46
- $ 5.30
514,134
6.2
$ 4.16
10
Information
regarding the 2010 Share Plan for the three months ended January 31, 2021 is as follows:
Shares
Weighted
Average Exercise
Price Per Share
Aggregate
Intrinsic Value
(in thousands)
Options Outstanding
at October 31, 2020
1,907,534
$ 2.82
Exercised
( 6,000 )
$ 2.32
Forfeited/Expired
( 400 )
$ 5.75
Options
Outstanding at January 31, 2021
1,901,134
$ 2.82
$ 1,906
Options
Exercisable at January 31, 2021
1,823,634
$ 2.83
$ 1,822
The
following table summarizes information about stock options outstanding and exercisable under the 2010 Share Plan as of January 31, 2021:
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
544,000
5.2
$ 1.56
516,500
5.2
$
1.60
$
2.58
- $ 3.13
833,000
3.1
$ 2.79
833,000
3.5
$
2.79
$
3.46
- $ 5.30
524,134
7.1
$ 4.17
474,134
7.1
$
4.25
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 January 31, 2022, the 2018 Share Plan had 2,000,000
shares available for future grants. Information regarding the 2018 Share Plan for the three months ended January 31, 2022 is as follows:
SCHEDULE OF OPTION ACTIVITY
Shares
Weighted
Average Exercise
Price Per Share
Aggregate
Intrinsic
Value
(in thousands)
Options outstanding
at October 31, 2021
7,409,992
$ 3.76
Granted
30,000
$ 3.24
Options
outstanding at January 31, 2022
7,439,992
$ 3.76
$ 676
Options
exercisable at January 31, 2022
3,986,659
$ 3.66
$ 347
11
The
following table summarizes information about stock options outstanding and exercisable under the 2018 Share Plan as of January 31, 2022:
SCHEDULE OF OUTSTANDING AND EXERCISABLE
Options
Outstanding
Options
Exercisable
Range
of
Exercise Prices
Number
Outstanding
Weighted
Average
Remaining
Contractual Life
(in
years)
Weighted
Average
Exercise Price
Number
Exercisable
Weighted
Average
Remaining
Contractual Life
(in
years)
Weighted
Average
Exercise
Price
$ 2.09
- $ 3.87
3,969,992
7.5
$ 3.42
3,030,548
7.1
$ 3.53
$ 3.96
- $ 5.30
3,470,000
8.7
$ 4.16
956,111
7.8
$ 4.08
Information
regarding the 2018 Share Plan for the three months ended January 31, 2021 is as follows:
Shares
Weighted
Average Exercise
Price Per Share
Aggregate
Intrinsic
Value
(in thousands)
Options outstanding
at October 31, 2020
4,346,661
$ 3.69
Granted
1,130,000
$ 2.83
Exercised
( 23,880 )
$ 3.78
Forfeited/Expired
( 392,781 )
$ 3.70
Options
outstanding at January 31, 2021
5,060,000
$ 3.49
$ 1,185
Options
exercisable at January 31, 2021
2,312,640
$ 3.69
$ 148
The
following table summarizes information about stock options outstanding and exercisable under the 2018 Share Plan as of January 31, 2021:
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
3,975,000
8.1
$ 3.38
1,664,862
7.5
$ 3.61
$ 3.84
- $ 4.61
1,085,000
8.0
$ 3.90
647,778
7.7
$ 3.92
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. Information regarding stock options that were granted outside of share
plans for the three months ended January 31, 2022 is as follows:
SCHEDULE OF OPTION ACTIVITY
Shares
Weighted
Average
Exercise
Price Per Share
Aggregate
Intrinsic
Value
(in thousands)
Options outstanding at October
31, 2021
1,642,000
$ 2.58
Options outstanding
and exercisable at
January 31, 2022
1,642,000
$ 2.58
$ 1,158
12
The
following table summarizes information about stock options outstanding and exercisable that were granted outside of share plans as of
January 31, 2022:
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
1,642,000
0.6
$ 2.58
Information
regarding stock options that were granted outside of share plans for the three months ended January 31, 2021 is as follows:
Shares
Weighted
Average Exercise
Price Per Share
Aggregate
Intrinsic
Value
(in thousands)
Options outstanding at October
31, 2020
1,698,000
$ 2.58
Options outstanding
and exercisable at
January 31, 2021
1,698,000
$ 2.58
$ 1,825
The
following table summarizes information about stock options outstanding and exercisable that were granted outside of share plans as of
January 31, 2021:
Range
of
Exercise Prices
Number
Outstanding
and
Exercisable
Weighted
Average
Remaining
Contractual Life
(in
years)
Weighted
Average
Exercise Price
$ 2.58
1,698,000
1.6
$ 2.58
Stock
Awards
For
stock awards granted to employees, directors and consultants that vest upon grant we recognize expense at the date of grant based on
the grant date market price of the underlying common stock. We did not grant any stock awards that vested upon grant during the three
months ended January 31, 2022 or 2021.
Employee
Stock Purchase Plan
The
Company maintains the Anixa Biosciences, Inc. Employee Stock Purchase Plan (the “ESPP”) which permits eligible employees
to purchase shares at not less than 85 % of the market value of the Company’s common stock on the offering date or the purchase
date of the applicable offering period, whichever is lower. The plan was adopted by our Board of Directors on August 13, 2018 and approved
by our shareholders on September 27, 2018. During the three months ended January 31, 2022 and 2021, no shares were purchased under the
ESPP.
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 $ 57,000 during the
three months ended January 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. On November 16, 2021, the warrant was exercised on a cashless basis and 25,484 shares were withheld as payment.
13
On
November 1, 2021 we issued a warrant, expiring on October 30, 2026 , to purchase 60,000 shares of common stock at $ 4.77 per share, vesting
over five months , to a consultant for investor relations services. We recorded consulting expense of approximately $ 110,000 during the
three months ended January 31, 2022, based on the fair value of the warrant on the date of grant recognized on a straight-line basis
over the vesting period.
As
of January 31, 2022, we also 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 .
3.
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 January 31, 2022:
SCHEDULE
OF FAIR VALUE MEASUREMENTS
Level
1
Level
2
Level
3
Total
(in thousands)
Money market funds:
Cash and cash
equivalents
$ 28,312
$ -
$ -
$ 28,312
Certificates of deposit:
Cash and cash equivalents
1,000
-
-
1,000
Short-term investments
-
1,450
-
1,450
U. S. treasury bills
Short-term
investments
-
3,299
-
3,299
Total financial assets
$ 29,312
$ 4,749
$ -
$ 34,061
14
The
following table presents the hierarchy for our financial assets measured at fair value on a recurring basis as of October 31, 2021:
Level
1
Level
2
Level
3
Total
(in thousands)
Money market funds:
Cash and cash
equivalents
$ 28,949
$ -
$ -
$ 28,949
Certificates of deposit:
Short term investments
-
2,000
-
2,000
U. S. treasury bills
Short-term
investments
-
4,599
-
4,599
Total financial assets
$ 28,949
$ 6,599
$ -
$ 35,548
The
estimated fair value of prepaid expenses and other current assets and accounts payable approximates their individual carrying
amounts due to the short-term nature of these instruments. Cash and cash equivalents are stated at carrying value which approximates
fair value.
4.
ACCRUED
EXPENSES
Accrued
expenses consist of the following as of:
SCHEDULE
of ACCRUED EXPENSES
January
31, 2022
October
31, 2021
(in thousands)
Payroll and related expenses
$ 603
$ 492
Accrued royalty and contingent legal fees
577
577
Accrued other
62
26
Accrued expenses
$ 1,242
$ 1,095
5.
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 three months ended January 31, 2022 and 2021, were stock options to purchase
10,700,626 and 8,659,134 shares, respectively, and warrants to purchase 360,000 and 560,000 shares, respectively.
6.
EFFECT
OF RECENTLY ADOPTED AND ISSUED PRONOUNCEMENTS
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 did not have a material impact
on our condensed consolidated financial statements and related disclosures.
15
In
August 2020, the FASB issued Accounting Standards Update 2020-06 (“ASU 2020-06”), Accounting for Convertible Instruments
and Contracts in an Entity’s Own Equity. The amendments in ASU 2020-06 include guidance on convertible instruments and the derivative
scope exception for contracts in an entity’s own equity and simplifies the accounting for convertible instruments which include
beneficial conversion features or cash conversion features by removing certain separation models in Subtopic 470-20. Additionally, ASU
2020-06 will require entities to use the “if-converted” method when calculating diluted earnings per share for convertible
instruments. The amendments in this update are effective for fiscal years beginning after December 15, 2021, including interim periods
within those fiscal years. We do not expect the adoption of this standard to have a material impact on our condensed consolidated financial
statements and related disclosures.
In
May 2021, the FASB issued Accounting Standards Update 2021-04 (“ASU No. 2021-04”), Issuer’s Accounting for Certain
Modifications or Exchanges of Freestanding Equity-Classified Written Call Options. The guidance in ASU 2021-04 requires the issuer to
treat a modification of an equity-classified written call option (the “option”) that does not cause the option to become
liability-classified as an exchange of the original option for a new option. This guidance applies whether the modification is structured
as an amendment to the terms and conditions of the option or as termination of the original option and issuance of a new option. The
amendments in this update are effective for fiscal years beginning after December 15, 2021, including interim periods within those fiscal
years. We do not expect the adoption of this standard to have a material impact on our condensed consolidated financial statements and
related disclosures.
In
October 2021, the FASB issued Accounting Standards Update 2021-08 (“ASU No. 2021-08”), Business Combinations (Topic 805):
Accounting for Contract Assets and Contract Liabilities from Contracts with Customers, to require that an acquirer recognize and measure
contract assets and contract liabilities acquired in a business combination in accordance with Topic 606, Revenue from Contracts with
Customers. At the acquisition date, an acquirer should account for the related revenue contracts in accordance with Topic 606 as if it
had originated the contracts. The amendments in this update should be applied prospectively and are effective for fiscal years beginning
after December 15, 2022, including interim periods within those fiscal years. We do not expect the adoption of this standard to have
a material impact on our condensed consolidated financial statements and related disclosures.
7.
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 January 31,
2022 and October 31, 2021 and we account for interest and penalties related to income tax matters, if any, in general and administrative
expenses.
8.
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 was to expire
on September
30, 2021 . Effective August 17, 2021, the lease
was amended to extend the expiration date to September 30, 2024, with an option to extend the lease an additional two years. Our base
rent is approximately $ 5,000
per month and the lease provides for annual increases
of approximately 3 %
and an escalation clause for increases in certain operating costs. The amendment to the lease resulted in a right-of-use asset and lease
liability of approximately $ 260,000
with a discount rate of 10 %.
Rent expense was approximately $ 17,000
and $ 16,000 ,
respectively, for the three months ended January 31, 2022 and 2021.
16
For
operating leases, the lease liability is initially measured at the present value of the unpaid lease payments. The remaining 56 -month
lease term as of January 31, 2022 for the Company’s lease includes the noncancelable period of the lease and the additional two-year
option period that the Company expects to exercise. All right-of-use assets are reviewed for impairment.
Balance
sheet information related to the Company’s lease is presented below:
SCHEDULE
of OPERATING LEASE
Balance
Sheet
Location
January
31, 2022
October
31,2021
(in
thousands)
Operating Lease:
Right-of-use
asset
Operating lease right-of-use asset
$ 244
$ 254
Right-of-use liability,
current
Operating lease liability
41
39
Right-of-use
liability,
non-current
Operating lease liability,
non-current
209
220
As
of January 31, 2022, the annual minimum lease payments of our operating lease liabilities were as follows:
SCHEDULE
of MINIMUM LEASE PAYMENTS
For years
Ended October 31,
Operating
Leases
(in thousands)
2022
$ 48
2023
66
2024
67
2025
70
2026
65
Total
future minimum lease payments, undiscounted
316
Less:
Imputed interest
66
Present
value of future minimum lease payments
$ 250
9.
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.
Collaborative
Research and License Commitments
As
of January 31, 2022, our commitments under the collaborative and license agreements with Moffitt, Wistar, Cleveland Clinic and MolGenie
for the year ending October 31, 2022 were approximately $ 320,000 .
17
Impact
of Coronavirus Pandemic
The
ongoing global outbreak of COVID-19 has resulted in significant governmental measures being implemented to control the spread of the
virus, and while the breadth of these measures has been reduced recently, the Company cannot predict their scope or the severity of the
outbreak in the future, and these developments and measures could materially and adversely affect the Company’s business, the operations
of the Company’s collaboration partners, and the Company’s results of operations and financial condition. The Company is
closely monitoring the impact of the COVID-19 pandemic on all aspects of its business and has taken steps to minimize its impact on the
Company’s business. Although COVID-19 has not had a material adverse impact on the Company’s operations and its clinical
and preclinical programs, the extent to which COVID-19 ultimately impacts the Company’s business, results of operations or financial
condition will depend on future developments which are highly uncertain and cannot be predicted with confidence, such as the duration
of the outbreak, the occurrence of new mutations of the SARS-CoV-2 virus, new information that may emerge concerning the severity of
COVID-19 or the effectiveness of actions taken to contain the pandemic or mitigate its impact, among others. Certain of the Company’s
collaboration partners have experienced shutdowns or other business disruptions. As a result, the Company’s ability to conduct
its business in the manner and on the timelines presently planned could be materially or negatively affected, which could have a material
adverse impact on the Company’s business, results of operations and financial condition.
10.
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 four reportable
segments, each with different operating and potential revenue generating characteristics: (i) CAR-T Therapeutics, (ii) Cancer Vaccines,
(iii) Anti-Viral Therapeutics and (iv) Other. The following represents selected financial information for our segments for the three
months ended January 31, 2022 and 2021 and as of January 31, 2022 and October 31, 2021:
SCHEDULE
of SEGMENT INFORMATION
2022
2021
For the Three Months Ended January
31,
2022
2021
(in thousands)
Net loss:
CAR-T Therapeutics
$ ( 1,611 )
$ ( 960 )
Cancer Vaccines
( 1,357 )
( 906 )
Anti-Viral Therapeutics
( 904 )
( 481 )
Other
( 7 )
115
Total
$ ( 3,879 )
$ ( 2,232 )
Net loss
$ ( 3,879 )
$ ( 2,232 )
Total operating costs and expenses
$ 3,880
$ 2,746
Less
non-cash share-based compensation
( 2,354 )
( 986 )
Operating
costs and expenses excluding
non-cash share-based compensation
$ 1,526
$ 1,760
Operating costs and expenses excluding non-cash
share based compensation expense:
CAR-T Therapeutics
$ 669
$ 558
Cancer Vaccines
480
538
Anti-Viral Therapeutics
372
271
Other
5
393
Total
$ 1,526
$ 1,760
Operating costs and expenses excluding non-cash
share based compensation expense
$ 1,526
$ 1,760
January
31, 2022
October
31, 2021
(in thousands)
Total assets:
CAR-T Therapeutics
$ 15,412
$ 15,068
Cancer Vaccines
11,052
13,276
Anti-Viral Therapeutics
8,562
7,368
Other
212
545
Total
$ 35,238
$ 36,257
Total Asset
$ 35,238
$ 36,257
Operating
costs and expenses excluding non-cash share-based compensation is the measurement the chief operating decision-maker uses in managing
the enterprise.
The
Company’s consolidated revenue of $ 513,000 and inventor royalties, contingent legal fees, litigation and licensing expense of $ 385,000
for the three months ended January 31, 2021 were solely related to our encrypted audio/video conference calling technology, which is
included in our other segment. All our revenue is generated domestically (United States) based on the country in which the licensee is
located.
18
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, 2021 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 January 31, 2022 compared with three months ended January 31, 2021
Revenue
We
had no revenue during the three-month period ended January 31, 2022.
For
the three months ended January 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, nor do we
expect these activities to require material financial resources or attention of senior management.
We
have not generated any revenue to date from our therapeutics or vaccine programs. In addition, while we pursue our therapeutics and vaccine
programs, we may also make investments in and form new companies to develop additional emerging technologies. We do not expect to begin
generating revenue with respect to any of our current therapy or vaccine programs in the near term. 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.
19
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 period ended January 31, 2022.
Inventor
royalties, contingent legal fees, litigation and licensing expenses for the three months ended January 31, 2021 were approximately $385,000.
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 are related to the development of our cancer therapeutics and vaccine programs and our anti-viral drug program,
and increased by approximately $1,010,000 to approximately $1,838,000 in the three months ended January 31, 2022, from approximately
$828,000 in the three months ended January 31, 2021. The increase in research and development expenses was primarily due to an increase
in employee stock option compensation expense of approximately $918,000, an increase in employee compensation and related costs, other
than stock option compensation expense, of approximately $86,000, an increase in outside research and development expense related to
our ovarian cancer vaccine program of approximately $71,000 and an increase in consultant stock option expense of approximately $68,000,
offset by a decrease in license fees of approximately $130,000.
Research
and development expenses incurred in the three months ended January 31, 2022 associated with each of our development programs consisted
of approximately $743,000 for CAR-T therapeutics, approximately $708,000 for cancer vaccines and approximately $387,000 for anti-viral
therapeutics.
General
and Administrative Expenses
General
and administrative expenses increased by approximately $509,000 to approximately $2,042,000 in the three months ended January 31, 2022,
from approximately $1,533,000 in the three months ended January 31, 2021. The increase in general and administrative expenses was primarily
due to an increase in employee stock option compensation expense of approximately $496,000, an increase in investor and public relations
expense, excluding warrant expense, of approximately $123,000 and an increase in warrant expense of approximately $53,000, offset by
a decrease in director compensation of approximately $177,000.
Interest
Income
Interest
income was approximately $1,000 in each of the three month periods ended January 31, 2022 and 2021.
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 $50,000 and $24,000, respectively, in the three months ended January 31, 2022 and 2021.
20
LIQUIDITY
AND CAPITAL RESOURCES
Our
primary sources of liquidity are cash, cash equivalents and short-term investments.
Based
on currently available information as of March 11, 2022, 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. We may seek to obtain working capital during our fiscal year 2022 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 three months ended January 31, 2022, cash used in operating activities was approximately $1,197,000. Cash provided by investing activities
was approximately $1,850,000, resulting from the proceeds on maturities of short term investments of approximately $5,349,000, which
was offset by the purchase of short term investments totaling approximately $3,499,000. As a result, our cash, cash equivalents, and
short-term investments at January 31, 2022 decreased approximately $1,197,000 to approximately $34,530,000 from approximately $35,727,000
at the end of fiscal year 2021.
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, 2021, 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.
21
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).
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.
22
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
do not believe that any of the recently issued accounting pronouncements will have a material effect on the Company’s consolidated
financial statements.
Item
3. Quantitative and Qualitative Disclosures About Market Risk.
As
of January 31, 2022, 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 first quarter of fiscal year 2022 that has materially affected,
or is reasonably likely to materially affect, our internal control over financial reporting.
23
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, 2021.
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.
On
March 10, 2022, the compensation committee (the “Committee”) of the Board of Directors of the Company approved compensation
packages for each of Dr. Amit Kumar, the President, Chief Executive Officer and Chairman of the Board of Directors of the Company, and
Michael Catelani, the Chief Operating Officer and Chief Financial Officer of the Company. Dr. Kumar’s base salary will be increased
to $640,295 per year and he will receive a cash bonus of $200,000 and Mr. Catelani’s base salary will be increased to $384,611
per year and he will receive a cash bonus of $50,000. The cash bonuses earned by each of Dr. Kumar and Mr. Catelani are in addition to
cash bonuses of $200,000 and $100,000, respectively, approved by the Committee and received by Dr. Kumar and Mr. Catelani in January
2022. In addition, Dr. Kumar and Mr. Catelani each received a stock option to purchase 500,000 shares of the Company’s common stock
pursuant to the 2018 Share Plan. The stock options are exercisable at an exercise price of $2.74 per share (the closing price of the
Common Stock on the Nasdaq Capital Market on March 10, 2022), have a 10 year term and vest on a monthly basis over three years beginning
on March 31, 2022. If either Dr. Kumar or Mr. Catelani is terminated for any reason, the stock option will cease vesting, and they will
have five (5) years to exercise the vested portion of such grant.
Item
6. Exhibits.
31.1
Certification of Chief Executive Officer, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, dated March 11, 2022.
31.2
Certification of Chief Financial Officer, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, dated March 11, 2022.
32.1
Statement of Chief Executive Officer, pursuant to Section 1350 of Title 18 of the United States Code, dated March 11, 2022.
32.2
Statement of Chief Financial Officer, pursuant to Section 1350 of Title 18 of the United States Code, dated March 11, 2022.
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
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24
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
March
11, 2022
(Principal
Executive Officer)
By:
/s/
Michael J. Catelani
Michael
J. Catelani
Chief
Operating Officer and
Chief
Financial Officer
(Principal
Financial and
March
11, 2022
Accounting
Officer)
25
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