NOTES
TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
1.
NATURE OF OPERATIONS
Advaxis,
Inc. (“Advaxis” or the “Company”) is a clinical-stage biotechnology company focused on the development and commercialization
of proprietary Listeria monocytogenes (“Lm”)-based antigen delivery products. The Company is using its Lm
platform directed against tumor-specific targets in order to engage the patient’s immune system to destroy tumor cells. Through
a license from the University of Pennsylvania, Advaxis has exclusive access to this proprietary formulation of attenuated Lm called
Lm TechnologyTM. Advaxis’ proprietary approach is designed to deploy a unique mechanism of action that redirects
the immune system to attack cancer in three distinct ways:
|
● |
Alerting
and training the immune system by activating multiple pathways in Antigen-Presenting Cells (“APCs”) with the equivalent
of multiple adjuvants; |
|
|
|
|
● |
Attacking
the tumor by generating a strong, cancer-specific T cell response; and |
|
|
|
|
● |
Breaking
down tumor protection through suppression of the protective cells in the tumor microenvironment (“TME”) that shields
the tumor from the immune system. This enables the activated T cells to begin working to attack the tumor cells. |
Advaxis’
proprietary Lm platform technology has demonstrated clinical activity in several of its programs and has been dosed in over 470
patients across multiple clinical trials and in various tumor types. The Company believes that Lm Technology immunotherapies can
complement and address significant unmet needs in the current oncology treatment landscape. Specifically, its product candidates have
the potential to work synergistically with other immunotherapies, including checkpoint inhibitors, while having a generally well-tolerated
safety profile.
COVID-19
On
March 11, 2020, the World Health Organization characterized the outbreak of the novel coronavirus (“COVID-19”) as a global
pandemic and recommended containment and mitigation measures. Since then, extraordinary actions have been taken by international, federal,
state, and local public health and governmental authorities to contain and combat the outbreak and spread of COVID-19 in regions throughout
the world. The continued impact of the COVID-19 pandemic cannot be predicted at this time.
Liquidity
and Capital Resources
Liquidity
and Management’s Plans
Similar
to other development stage biotechnology companies, the Company’s products that are being developed have not generated significant
revenue. As a result, the Company has suffered recurring losses and requires significant cash resources to execute its business plans.
These losses are expected to continue for the foreseeable future.
As
of July 31, 2022, the Company had approximately $28.2 million in cash and cash equivalents. Although the Company expects to have sufficient
capital to fund its obligations, as they become due, in the ordinary course of business until at least one year from the issuance of
these consolidated financial statements, the actual amount of cash that it will need to operate is subject to many factors.
The
Company recognizes it will need to raise additional capital in order to continue to execute its business plan in the future. There is
no assurance that additional financing will be available when needed or that management will be able to obtain financing on terms acceptable
to the Company or whether the Company will become profitable and generate positive operating cash flow. If the Company is unable to raise
sufficient additional funds, it will have to further scale back its operations.
2.
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND BASIS OF PRESENTATION
Basis
of Presentation/Estimates
The
accompanying unaudited interim condensed consolidated financial statements and related notes have been prepared in accordance with accounting
principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information, and in accordance
with the rules and regulations of the Securities and Exchange Commission (“SEC”) with respect to Form 10-Q and Rule 10-01
of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial
statements and the accompanying unaudited interim condensed consolidated balance sheet as of July 31, 2022 has been derived from the
Company’s October 31, 2021 audited financial statements. In the opinion of management, the unaudited interim condensed consolidated
financial statements furnished include all adjustments (consisting of normal recurring accruals) necessary for a fair statement of the
results for the interim periods presented.
Operating
results for interim periods are not necessarily indicative of the results to be expected for the full year. The preparation of financial
statements in accordance with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets,
liabilities, revenues, expenses, and the related disclosures at the date of the financial statements and during the reporting period.
Significant estimates include the timelines associated with revenue recognition on upfront payments received, fair value and recoverability
of the carrying value of property and equipment and intangible assets, fair value of warrant liability, grant date fair value of options,
deferred tax assets and any related valuation allowance and related disclosure of contingent assets and liabilities. On an on-going basis,
the Company evaluates its estimates, based on historical experience and on various other assumptions that it believes to be reasonable
under the circumstances. Actual results could materially differ from these estimates.
These
unaudited interim condensed consolidated financial statements should be read in conjunction with the financial statements of the Company
as of and for the fiscal year ended October 31, 2021 and notes thereto contained in the Company’s 2021 Annual Report on Form 10-K,
as filed with the SEC on February 14, 2022.
Principles
of Consolidation
The
consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary. All significant intercompany accounts
and transactions have been eliminated.
Restricted
Cash
On
January 31, 2022, the Company transferred $5,250,000 into an escrow fund to fund a potential Series D preferred stock redemption. On
April 6, 2022, the Series D convertible preferred stock was redeemed utilizing the entire amount held in the escrow fund.
Convertible
Preferred Stock
Preferred
shares subject to mandatory redemption are classified as liability instruments and are measured at fair value. The Company classifies
conditionally redeemable preferred shares, which includes preferred shares that feature redemption rights that are either within the
control of the holder or subject to redemption upon the occurrence of uncertain events not solely within the Company’s control,
as temporary equity (“mezzanine”) until such time as the conditions are removed or lapse.
Derivative
Financial Instruments
The
Company does not use derivative instruments to hedge exposures to cash flow, market or foreign currency risks. The Company evaluates
all of its financial instruments to determine if such instruments are derivatives or contain features that qualify as embedded derivatives.
For derivative financial instruments that are accounted for as liabilities, the derivative instrument is initially recorded at its fair
value and is then re-valued at each reporting date, with changes in the fair value reported in the statements of operations. For share-based
derivative financial instruments, the Company used the Monte Carlo simulation model, the Black Scholes model and a binomial model to
value the derivative instruments at inception and on subsequent valuation dates. The classification of derivative instruments, including
whether such instruments should be recorded as liabilities or as equity, is evaluated at the end of each reporting period. Derivative
liabilities are classified in the consolidated balance sheet as current or non-current based on whether or not net-cash settlement of
the instrument could be required within 12 months after the balance sheet date.
Net
Income (Loss) per Share
Basic
net income or loss per common share is computed by dividing net income or loss available to common stockholders by the weighted average
number of common shares outstanding during the period. Diluted earnings per share give effect to dilutive options, warrants, restricted
stock units and other potential common stock outstanding during the period. In the case of a net loss, the impact of the potential common
stock resulting from warrants, outstanding stock options and convertible debt are not included in the computation of diluted loss per
share, as the effect would be anti-dilutive. In the case of net income, the impact of the potential common stock resulting from these
instruments that have intrinsic value are included in the diluted earnings per share. The table below sets forth the number of potential
shares of common stock that have been excluded from diluted net loss per share:
SCHEDULE
OF ANTI -DILUTED SECURITIES EXCLUDED FROM DILUTED NET LOSS PER SHARE
| |
2022 | | |
2021 | |
| |
As
of July 31, | |
| |
2022 | | |
2021 | |
Warrants | |
| 377,818 | | |
| 377,818 | |
Stock options | |
| 11,118 | | |
| 12,892 | |
Total | |
| 388,936 | | |
| 390,710 | |
Reverse Stock
Split
On March
31, 2022, the Company’s stockholders voted to approve an amendment to allow the Company to execute a reverse stock split of common
stock within a range of 1 for 20 to 1 for 80, without reducing the authorized number of shares of the common stock, at the discretion
of the Board of Directors. On June 3, 2022, the Board of Directors approved a 1 for 80 reverse stock split, which became effective on
June 6, 2022. All references in this Report to number of shares, price per share and weighted average number of shares of common stock
outstanding prior to this reverse stock split have been adjusted to reflect the reverse stock split on a retroactive basis, unless otherwise
noted.
Recent
Accounting Standards
In
December 2019, the FASB issued ASU 2019-12, Simplification of Income Taxes (Topic 740) Income Taxes (“ASU 2019-12”). ASU
2019-12 simplifies the accounting for income taxes by removing certain exceptions to the general principles in Topic 740. The amendments
also improve consistent application of and simplify U.S. GAAP for other areas of Topic 740 by clarifying and amending existing guidance.
ASU 2019-12 is effective for public companies for annual periods beginning after December 15, 2020, including interim periods within
those fiscal years. The Company adopted this standard effective November 1, 2021 and it is not material to the financial results of the
Company.
In
August 2020, the FASB issued ASU 2020-06, Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity, which
simplifies the accounting for certain convertible instruments, amends guidance on derivative scope exceptions for contracts in an entity’s
own equity, and modifies the guidance on diluted earnings per share (“EPS”) calculations as a result of these changes. The
standard will be effective for the Company for fiscal years beginning after December 15, 2023 and can be applied on either a fully retrospective
or modified retrospective basis. Early adoption is permitted for fiscal years beginning after December 15, 2020. The Company adopted
this standard effective November 1, 2021 and it is not material to the financial results of the Company.
Management
does not believe that any recently issued, but not yet effective accounting pronouncements, if adopted, would have a material impact
on the accompanying condensed consolidated financial statements.
3.
PROPERTY AND EQUIPMENT
Property
and equipment, net consisted of the following (in thousands):
SCHEDULE
OF PROPERTY AND EQUIPMENT
| |
July
31, 2022 | | |
October
31, 2021 | |
Laboratory equipment | |
$ | 179 | | |
$ | 179 | |
Computer equipment | |
| 241 | | |
| 241 | |
Total property and equipment | |
| 420 | | |
| 420 | |
Accumulated depreciation | |
| (347 | ) | |
| (302 | ) |
Net property and equipment | |
$ | 73 | | |
$ | 118 | |
Depreciation
expense for the three months ended July 31, 2022 and 2021 was approximately $13,000 and $50,000, respectively. Depreciation expense for
the nine months ended July 31, 2022 and 2021 was approximately $45,000 and $366,000, respectively. During the nine months ended July
31, 2021, the Company incurred a loss on disposal of equipment of approximately $1,530,000, $968,000 of which is reflected in the research
and development expenses and $562,000 of which is reflected in the general and administrative expenses in the condensed consolidated
statement of operations.
4.
INTANGIBLE ASSETS
Intangible
assets, net consisted of the following (in thousands):
SUMMARY
OF INTANGIBLE ASSETS
| |
July
31, 2022 | | |
October
31, 2021 | |
| |
| | |
| |
Patents | |
$ | 275 | | |
$ | 4,836 | |
License | |
| 44 | | |
| 777 | |
Software | |
| 98 | | |
| 98 | |
Total intangibles | |
| 417 | | |
| 5,711 | |
Accumulated amortization | |
| (236 | ) | |
| (2,357 | ) |
Intangible assets | |
$ | 181 | | |
$ | 3,354 | |
The
expiration dates of the existing patents range from 2022 to 2039 but the expiration dates can be extended based on market approval if
granted and/or based on existing laws and regulations. Capitalized costs associated with patent applications that are abandoned without
future value are charged to expense when the determination is made not to further pursue the application. Patent applications having
a net book value of approximately $29,000 and $21,000 were abandoned and were charged to general and administrative expenses in the condensed
consolidated statement of operations for the three months ended July 31, 2022 and 2021, respectively. Patent applications having a net
book value of approximately $159,000 and $90,000 were abandoned and were charged to general and administrative expenses in the condensed
consolidated statement of operations for the nine months ended July 31, 2022 and 2021, respectively. Amortization expense for intangible
assets that was charged to general and administrative expense in the condensed consolidated statement of operations aggregated approximately
$70,000 and $68,000 for the three months ended July 31, 2022 and 2021, respectively. Amortization expense for intangible assets that
was charged to general and administrative expense in the condensed consolidated statement of operations aggregated approximately $210,000
and $203,000 for the nine months ended July 31, 2022 and 2021, respectively.
Management
reviews its long-lived assets for impairment whenever events and circumstances indicate that the carrying value of an asset might not
be recoverable. Net assets are recorded on the balance sheet for patents related to ADXS-HPV (AXAL), ADXS-HOT, ADXS-PSA,
ADXS-HER2 and other products that are in development, and the Lm technology licensed from the University of Pennsylvania. There
are various scenarios under which an impairment charge may be recorded, which include if a competitor were to gain FDA approval for a
similar treatment before the Company, if future clinical trials fail to meet the targeted endpoints, or if a drug application is rejected
or fails to be issued. Lastly, if the Company is unable to raise enough capital to continue funding its studies and developing its intellectual
property, the Company would likely record an impairment to these assets.
During
the three months ended July 31, 2022, the Company identified the following indicators of impairment under ASC 360 indicating that the
patents and license carrying amounts might not be recoverable:
|
● |
Adverse
changes in the business climate for biotechnology companies, particularly raising capital; and |
|
● |
A
significant reduction in the Company’s market capitalization during the nine months ended July 31, 2022. |
The
Company performed an impairment test under ASC 350 on its patents owned and in-licensed intellectual property. Under this test a fair value of the relevant asset is
compared with the carrying amount of such asset. Fair value is calculated using a discounted cash flow analysis. Cash flows are discounted
using a weighted average cost of capital derived from comparable companies, which reflects the costs of borrowing as well as the associated
risk. The results of the impairment test indicated that the carrying value of the patents owned and in-licensed intellectual property exceeded the fair value. During
the three months ended July 31, 2022, the Company recorded an impairment charge for patents owned and in-licensed intellectual property of approximately $3,005,000
in its condensed consolidated statement of operations.
As
of July 31, 2022, the estimated amortization expense by fiscal year based on the current carrying value of intangible assets is as follows
(in thousands):
SCHEDULE
OF CARRYING VALUE OF INTANGIBLE ASSETS
| | |
Fiscal year ending October 31, | |
| | |
| |
2022 (Remaining) | | |
$ | 24 | |
2023 | | |
| 94 | |
2024 | | |
| 63 | |
Total | | |
$ | 181 | |
5.
ACCRUED EXPENSES:
The
following table summarizes accrued expenses included in the condensed consolidated balance sheets (in thousands):
SUMMARY OF ACCRUED EXPENSES
| |
July
31, 2022 | | |
October
31, 2021 | |
| |
| | |
| |
Salaries and other compensation | |
$ | 116 | | |
$ | 55 | |
Vendors | |
| 851 | | |
| 1,968 | |
Professional fees | |
| 343 | | |
| 613 | |
Other | |
| 200 | | |
| 200 | |
Total accrued expenses | |
$ | 1,510 | | |
$ | 2,836 | |
6.
LEASES
Operating
Leases
The
Company previously leased a corporate office and manufacturing facility in Princeton, New Jersey under an operating lease that was set
to expire in November 2025. On March 26, 2021, the Company entered into a Lease Termination and Surrender Agreement with respect to this
lease agreement. The Lease Termination and Surrender Agreement provides for the early termination of the lease, which became effective
on March 31, 2021. In connection with the early termination of the lease, the Company was required to pay a $1,000,000 termination payment.
The unapplied security deposit totaling approximately $182,000 was credited against the termination fee for a net payment of approximately
$818,000. The Company wrote off of the remaining right-of-use asset of approximately $4,512,000 and lease liability of approximately
$5,628,000. After consideration of the termination payment and write off of the remaining right-of-use asset and lease liability, the
Company recorded a net gain of approximately $116,000.
On
March 25, 2021, the Company entered into a new one-year lease agreement for its corporate office/lab with base rent of approximately
$29,000 per year, plus other expenses. This lease was accounted for as a short-term lease at inception, and the Company elected not to
recognize a right-of-use asset and lease liability. In September 2021, the Company exercised its option to renew the lease, extending
the lease term until March 25, 2023. Since the renewed lease term exceeded one-year, the lease no longer qualified for the short-term
lease exception, resulting in the recognition of a right-of-use asset and operating lease liability of approximately $43,000.
Supplemental
balance sheet information related to leases was as follows (in thousands):
SCHEDULE OF SUPPLEMENTAL BALANCE SHEET RELATED TO LEASES
| |
July
31, 2022 | | |
October
31, 2021 | |
Operating leases: | |
| | | |
| | |
Operating
lease right-of-use assets | |
$ | 19 | | |
$ | 40 | |
| |
| | | |
| | |
Operating lease liability | |
$ | 19 | | |
$ | 28 | |
Operating lease liability,
net of current portion | |
| - | | |
| 12 | |
Total operating lease
liabilities | |
$ | 19 | | |
$ | 40 | |
Supplemental
lease expense related to leases was as follows (in thousands):
SCHEDULE OF LEASE EXPENSES
Lease Cost
(in thousands) | |
Statements
of Operations Classification | |
For the Three
Months Ended
July 31, 2022 | | |
For the Nine
Months
Ended
July 31, 2022 | |
Operating lease cost | |
General and administrative | |
$ | 7 | | |
$ | 22 | |
Variable lease cost | |
General and administrative | |
| 17 | | |
| 36 | |
Total
lease expense | |
| |
$ | 24 | | |
$ | 58 | |
Lease Cost
(in thousands) | |
Statements
of Operations Classification | |
For the Three
Months Ended
July 31, 2021 | | |
For the nine
Months Ended
July 31, 2021 | |
Operating lease cost | |
General and administrative | |
$ | - | | |
$ | 1,301 | |
Short-term lease cost | |
General and administrative | |
| 12 | | |
| 16 | |
Variable lease cost | |
General and administrative | |
| 4 | | |
| 165 | |
Total
lease expense | |
| |
$ | 16 | | |
$ | 1,482 | |
Other
information related to leases where the Company is the lessee is as follows:
SCHEDULE OF OTHER INFORMATION RELATED TO LEASES
| |
July
31, 2022 | | |
October
31, 2021 | |
Weighted-average remaining lease term | |
0.7 years | | |
1.4 years | |
Weighted-average discount rate | |
| 3.79 | % | |
| 3.79 | % |
Supplemental
cash flow information related to operating leases was as follows:
SCHEDULE OF CASH FLOW INFORMATION RELATED TO LEASES
| |
For the Nine
Months Ended
July 31, 2022 | | |
For the Nine
Months Ended
July 31, 2021 | |
Cash paid
for operating lease liabilities | |
$ | 22 | | |
$ | 1,363 | |
Future
minimum lease payments under non-cancellable leases as of July 31, 2022 were as follows:
SCHEDULE OF FUTURE MINIMUM LEASE PAYMENTS UNDER NON-CANCELLABLE LEASES
| |
| | |
Fiscal Year ending October
31, | |
| |
2022 (Remaining) | |
$ | 7 | |
2023 | |
| 13 | |
Total minimum lease payments | |
| 20 | |
Less: Imputed interest | |
| 1 | |
Total | |
$ | 19 | |
7.
COMMON STOCK PURCHASE WARRANTS AND WARRANT LIABILITY
Warrants
As
of July 31, 2022 and October 31, 2021, there were outstanding and exercisable warrants to purchase 377,818 shares of our common stock
with exercise prices ranging from $20.00 to $224.00 per share. Information on the outstanding warrants is as follows:
SCHEDULE
OF COMMON STOCK PURCHASE WARRANTS AND WARRANT LIABILITY
Exercise
Price | | |
Number of
Shares
Underlying
Warrants | | |
Expiration
Date | |
Type of
Financing |
$ | 20.00 | | |
| 879 | | |
September 2024 | |
September 2018 Public Offering |
$ | 224.00 | | |
| 4,092 | | |
July 2024 | |
July 2019 Public Offering |
$ | 28.00 | | |
| 57,230 | | |
November 2025 | |
November 2020 Public Offering |
$ | 56.00 | | |
| 140,552 | | |
April 2026 | |
April 2021 Registered Direct Offering (Accompanying
Warrants) |
$ | 56.00 | | |
| 175,065 | | |
5 years after the date
such warrants become exercisable, if ever | |
April 2021 Private Placement
(Private Placement Warrants) |
| Grand
Total | | |
| 377,818 | | |
| |
|
As
of July 31, 2022 and October 31, 2021, the Company had 201,874 of its total 377,818 outstanding warrants classified as equity (equity
warrants).
Warrant
Liability
As
of July 31, 2022 and October 31, 2021, the Company had 175,944 of its total 377,818 outstanding warrants from an April 2021 private offering
of common stock and warrants (the “April 2021 Private Placement”) and a September 2018 public offering of common stock and
warrants (the “September 2018 Public Offering”) classified as liabilities (liability warrants).
The
warrants issued in the April 2021 Private Placement will become exercisable only on such day, if ever, that is 14 days after the Company
files an amendment to the Company’s Amended and Restated Certificate of Incorporation to increase the number of authorized shares
of common stock, $0.001 par value per share from 170,000,000 shares to 300,000,000 shares. These warrants expire five years after the
date they become exercisable. As of July 31, 2022, the Company did not have sufficient authorized common stock to allow for the issuance
of common stock underlying these warrants. The Company did not receive stockholder authorization to increase the authorized shares from
170,000,000 to 300,000,000 shares at the stockholder’s meeting commenced on June 3, 2021. The Company was subsequently required
to file a proxy to seek an increase in the number of authorized shares and did not file such a proxy but rather elected to seek a reverse
stock split to, among other things, increase the shares available. Accordingly, based on certain indemnification provisions of the securities
purchase agreement, the Company concluded that liability classification is warranted. The Company utilized the Black Scholes model to
calculate the fair value of these warrants at issuance and at each subsequent reporting date.
In
measuring the warrant liability for the warrants issued in the April 2021 Private Placement at July 31, 2022 and October 31, 2021, the
Company used the following inputs in its Black Scholes model:
SCHEDULE OF ASSUMPTIONS USED IN WARRANT LIABILITY
| |
July
31, 2022 | | |
October
31, 2021 | |
Exercise Price | |
$ | 56.00 | | |
$ | 56.00 | |
Stock Price | |
$ | 3.73 | | |
$ | 38.80 | |
Expected Term | |
| 5.00
years | | |
| 5.00
years | |
Volatility % | |
| 112 | % | |
| 106 | % |
Risk Free Rate | |
| 2.70 | % | |
| 1.18 | % |
The
September 2018 Public Offering warrants contain a down round feature, except for exempt issuances as defined in the warrant agreement,
in which the exercise price would immediately be reduced to match a dilutive issuance of common stock, options, convertible securities
and changes in option price or rate of conversion. As of July 31, 2022, the down round feature was triggered four times and the exercise
price of the warrants were reduced from $1,800.00 to $20.00. The warrants require liability classification as the warrant agreement requires
the Company to maintain an effective registration statement and does not specify any circumstances under which settlement in other than
cash would be permitted or required. As a result, net cash settlement is assumed and liability classification is warranted. For these
liability warrants, the Company utilized the Monte Carlo simulation model to calculate the fair value of these warrants at issuance and
at each subsequent reporting date.
In
measuring the warrant liability for the September 2018 Public Offering warrants at July 31, 2022 and October 31, 2021, the Company used
the following inputs in its Monte Carlo simulation model:
SCHEDULE OF ASSUMPTIONS USED IN WARRANT LIABILITY
| |
July
31, 2022 | | |
October
31, 2021 | |
Exercise Price | |
$ | 20.00 | | |
$ | 24.00 | |
Stock Price | |
$ | 3.73 | | |
$ | 38.80 | |
Expected Term | |
| 2.12
years | | |
| 2.87
years | |
Volatility % | |
| 104 | % | |
| 123 | % |
Risk Free Rate | |
| 2.89 | % | |
| 0.77 | % |
At
July 31, 2022 and October 31, 2021, the fair value of the warrant liability was approximately $287,000 and $4,929,000, respectively.
For the three months ended July 31, 2022 and 2021, the Company reported income of approximately $276,000 and $846,000, respectively,
due to changes in the fair value of the warrant liability. For the nine months ended July 31, 2022 and 2021, the Company reported income
of approximately $4,642,000 and $1,814,000, respectively, due to changes in the fair value of the warrant liability.
8.
COMMITMENTS AND CONTINGENCIES
Atachbarian
On
November 15, 2021, a purported stockholder of the Company commenced an action against the Company and certain of its directors in the
U.S. District Court for the District of New Jersey, entitled Atachbarian v. Advaxis, Inc., et al., No. 3:21-cv-20006. The plaintiff alleges
that the defendants breached their fiduciary duties and violated Section 14(a) and Rule 20(a) of the Securities Exchange Act of 1934
and Rule 14a-9 promulgated thereunder by allegedly failing to disclose certain matters in its Registration Statement on Form S-4 (Commission
File No. 333-259065 (the “Registration Statement”) filed in connection with a proposed merger with Biosight Ltd. (the “Previously
Proposed Merger”). On December 15, 2021, pursuant to an understanding reached with the plaintiff, the Company made certain other
additional disclosures that mooted the demands asserted in the complaint. On December 17, 2021, the plaintiff filed a notice of voluntary
dismissal with prejudice. On February 7, 2022, the Company and the plaintiff reached a settlement agreement, which is recorded in general
and administrative expenses in the condensed consolidated statement of operations.
Purported
Stockholder Claims Related to Biosight Transaction
Between
September 16, 2021, and November 4, 2021, the Company received demand letters on behalf of six purported stockholders of the Company,
alleging that the Company failed to disclose certain matters in the Registration Statement, and demanding that the Company disclose such
information in a supplemental disclosure filed with the SEC. On October 14, 2021, the Company filed an amendment to the Registration
Statement and on November 8, 2021, the Company made certain other additional disclosures that mooted the demands asserted in the above-referenced
letters. The six plaintiffs have made settlement demands. On May 20, 2022, the Company and one of the plaintiffs have reached a settlement
agreement, which is recorded in general and administrative expenses in the condensed consolidated statement of operations. The Company
believes it has adequately accrued for settlements with the other five shareholders, which is recorded in accrued expenses in the condensed
consolidated balance sheet.
In
addition, the Company received certain additional demands from stockholders asserting that the proxy materials filed by the Company in
connection with the Previously Proposed Merger contained alleged material misstatements and/or omissions. Certain stockholders also demanded
books and records of the Company pursuant to Delaware law. In response to these demands, the Company agreed to make, and did make, certain
supplemental disclosures to the proxy materials. The stockholders have made settlement demands. On July 18, 2022, the Company and the
plaintiffs reached settlement agreements, which is recorded in general and administrative expenses in the condensed consolidated statement
of operations.
Purported
Stockholder Claims Related to Series D Convertible Preferred Stock Offering
On
February 17, 2022, the Company received a letter on behalf of purported stockholders of the Company, demanding certain books and records
pursuant to Delaware law regarding the proposed issuance of super voting preferred stock. The Company agreed to provide certain books
and records to the stockholders and agreed to make, and did make, a supplemental disclosure to the proxy materials. The stockholders
have made settlement demands. On July 18, 2022, the Company and the plaintiffs reached settlement agreements, which is recorded in general
and administrative expenses in the condensed consolidated statement of operations.
9.
TEMPORARY EQUITY
Series
D Convertible Preferred Stock Offering
On
January 31, 2022, the Company consummated an offering with certain institutional investors for the private placement of 1,000,000 shares
of Series D convertible redeemable preferred stock (the “Series D Preferred Stock”). The shares, which have since been redeemed
in accordance with their terms as described below, and are thus no longer outstanding as of July 31, 2022, had an aggregate stated value
of $5,000,000. Each share of the Series D preferred stock had a purchase price of $4.75, representing an original issue discount of 5%
of the stated value. The shares of Series D Preferred Stock were convertible into shares of the Company’s common stock, upon the
occurrence of certain events, at a conversion price of $20.00 per share. The conversion, at the option of the stockholder, could occur
at any time following the receipt of the stockholders’ approval for a reverse stock split. The Company was permitted to compel
conversion of the Series D Preferred Stock after the fulfillment of certain conditions and subject to certain limitations. The Series
D Preferred Stock also had a liquidation preference over the shares of common stock, and could be redeemed by the investors, in accordance
with certain terms, for a redemption price equal to 105% of the stated value, or in certain circumstances, 110% of the stated value.
Total net proceeds from the offering, after deducting the financial advisor’s fees and other estimated offering expenses, were
approximately $4.3 million.
Since
the Series D preferred stock had a redemption feature at the option of the holder, it was classified as temporary equity. At the January
31, 2022 issuance date, the Series D preferred stock was recorded on the balance sheet at approximately $4,225,000, which is the $4,312,000
net proceeds less the $87,000 value of the bifurcated preferred stock redemption liability (see below).
On
April 6, 2022, the holders of all 1,000,000 outstanding shares of the Series D Preferred Stock exercised their right to cause the Company
to redeem all of such shares at a price per share equal to 105% of the stated value per share of $5.00, and such shares were redeemed
accordingly. The $1,025,000 accretion of the Series D convertible preferred stock to its redemption value was recorded as a reduction
in additional paid-in capital (see Note 10).
Preferred
Stock Redemption Liability
The
Company evaluated the preferred stock redemption feature under ASC 815. Since the preferred stock redemption feature is not considered
to be clearly and closely related to the preferred stock host and the redemption feature meets the four characteristics of a derivative
under ASC 815, the preferred stock redemption feature is required to be bifurcated from the preferred stock host and valued as a liability.
The Company utilized a binomial model to calculate the fair value of the preferred stock redemption feature at issuance.
In
measuring the preferred stock redemption liability at April 6, 2021 (redemption date) and January 31, 2022 (issuance date), the Company
used the following inputs in its binomial model:
SCHEDULE OF PREFERRED STOCK REDEMPTION LIABILITY
| |
April
6, 2022 | | |
January
31, 2022 | |
Exercise Price | |
$ | 20.00 | | |
$ | 20.00 | |
Stock Price | |
$ | 9.04 | | |
$ | 10.88 | |
Volatility % | |
| 96 | % | |
| 105 | % |
Risk Free Rate | |
| 1.25 | % | |
| 1.00 | % |
At
April 6, 2022 and January 31, 2022, the fair value of the preferred stock redemption liability was approximately $44,000 and $87,000,
respectively. On April 6, 2022, the Series D convertible preferred stock was redeemed, and the $44,000 preferred stock redemption liability
was reclassified into other paid-in capital (see Note 10). For the three months and nine months ended July 31, 2022, the Company reported
income of approximately $0 and $44,000, respectively, due to a change in the fair value of the preferred stock redemption liability.
10.
STOCKHOLDERS’ EQUITY
A
summary of the changes in stockholders’ equity for the nine months ended July 31, 2022 and 2021 is presented below (in thousands,
except share data):
SUMMARY OF STOCKHOLDERS EQUITY
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Equity | |
| |
Preferred
Stock | | |
Common
Stock | | |
Additional
Paid-In | | |
Accumulated | | |
Total
Shareholders’ | |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Equity | |
Balance at November 1, 2020 | |
| - | | |
$ | - | | |
| 975,897 | | |
$ | 2 | | |
$ | 440,916 | | |
$ | (410,738 | ) | |
$ | 30,180 | |
Stock-based compensation | |
| - | | |
| - | | |
| - | | |
| - | | |
| 236 | | |
| - | | |
| 236 | |
Advaxis public offerings, net of offering costs | |
| - | | |
| - | | |
| 383,333 | | |
| - | | |
| 8,550 | | |
| - | | |
| 8,550 | |
Warrant exercises | |
| - | | |
| - | | |
| 92,375 | | |
| - | | |
| 2,586 | | |
| - | | |
| 2,586 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (3,977 | ) | |
| (3,977 | ) |
Balance at January 31, 2021 | |
| - | | |
$ | - | | |
| 1,451,605 | | |
$ | 2 | | |
$ | 452,288 | | |
$ | (414,715 | ) | |
$ | 37,575 | |
Stock-based compensation | |
| - | | |
| - | | |
| 69 | | |
| - | | |
| 215 | | |
| - | | |
| 215 | |
Stock option exercises | |
| - | | |
| - | | |
| 4 | | |
| - | | |
| - | | |
| - | | |
| - | |
Advaxis public offerings, net of offering costs | |
| - | | |
| - | | |
| 230,794 | | |
| - | | |
| 13,683 | | |
| - | | |
| 13,683 | |
Warrant exercises | |
| - | | |
| - | | |
| 137,968 | | |
| - | | |
| 1,185 | | |
| - | | |
| 1,185 | |
Issuance of shares to employees under ESPP
Plan | |
| - | | |
| - | | |
| 12 | | |
| - | | |
| - | | |
| - | | |
| - | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (5,107 | ) | |
| (5,107 | ) |
Balance at April 30, 2021 | |
| - | | |
$ | - | | |
| 1,820,452 | | |
$ | 2 | | |
$ | 467,371 | | |
$ | (419,822 | ) | |
$ | 47,551 | |
Stock-based compensation | |
| - | | |
| - | | |
| - | | |
| - | | |
| 60 | | |
| - | | |
| 60 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (3,334 | ) | |
| (3,334 | ) |
Balance at July 31,
2021 | |
| - | | |
$ | - | | |
| 1,820,452 | | |
$ | 2 | | |
$ | 467,431 | | |
$ | (423,156 | ) | |
$ | 44,277 | |
| |
Preferred
Stock | | |
Common
Stock | | |
Additional
Paid-In | | |
Accumulated | | |
Total
Shareholders’ | |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Equity | |
Balance at November 1, 2021 | |
| - | | |
$ | - | | |
| 1,820,452 | | |
$ | 2 | | |
$ | 467,486 | | |
$ | (428,600 | ) | |
$ | 38,888 | |
Stock-based compensation | |
| - | | |
| - | | |
| - | | |
| - | | |
| 26 | | |
| - | | |
| 26 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (365 | ) | |
| (365 | ) |
Balance at January 31, 2022 | |
| - | | |
$ | - | | |
| 1,820,452 | | |
$ | 2 | | |
$ | 467,512 | | |
$ | (428,965 | ) | |
$ | 38,549 | |
Stock-based compensation | |
| - | | |
| - | | |
| - | | |
| - | | |
| 23 | | |
| - | | |
| 23 | |
Accretion of discount and redemption feature
of convertible preferred stock | |
| - | | |
| - | | |
| - | | |
| - | | |
| (1,025 | ) | |
| - | | |
| (1,025 | ) |
Convertible preferred stock redemption | |
| - | | |
| - | | |
| - | | |
| - | | |
| 44 | | |
| - | | |
| 44 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (2,440 | ) | |
| (2,440 | ) |
Balance at April 30, 2022 | |
| - | | |
$ | - | | |
| 1,820,452 | | |
$ | 2 | | |
$ | 466,554 | | |
$ | (431,405 | ) | |
$ | 35,151 | |
Beginning balance | |
| - | | |
$ | - | | |
| 1,820,452 | | |
$ | 2 | | |
$ | 466,554 | | |
$ | (431,405 | ) | |
$ | 35,151 | |
Stock-based compensation | |
| - | | |
| - | | |
| - | | |
| - | | |
| 25 | | |
| - | | |
| 25 | |
Fractional shares cashed out | |
| - | | |
| - | | |
| (4,501 | ) | |
| - | | |
| (18 | ) | |
| - | | |
| (18 | ) |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (6,963 | ) | |
| (6,963 | ) |
Balance at July 31, 2022 | |
| - | | |
| - | | |
| 1,815,951 | | |
| 2 | | |
| 466,561 | | |
| (438,368 | ) | |
| 28,195 | |
Ending
balance | |
| - | | |
| - | | |
| 1,815,951 | | |
| 2 | | |
| 466,561 | | |
| (438,368 | ) | |
| 28,195 | |
11.
SHARE BASED COMPENSATION
The
following table summarizes share-based compensation expense included in the condensed consolidated statements of operations (in thousands):
SUMMARY OF SHARE BASED COMPENSATION EXPENSE
| |
2022 | | |
2021 | | |
2022 | | |
2021 | |
| |
Three Months Ended
July 31, | | |
Nine Months Ended
July 31, | |
| |
2022 | | |
2021 | | |
2022 | | |
2021 | |
Research and development | |
$ | 12 | | |
$ | 29 | | |
$ | 36 | | |
$ | 142 | |
General and administrative | |
| 13 | | |
| 31 | | |
| 38 | | |
| 369 | |
Total | |
$ | 25 | | |
$ | 60 | | |
$ | 74 | | |
$ | 511 | |
Stock
Options
A
summary of changes in the stock option plan for the nine months ended July 31, 2022 is as follows:
SUMMARY OF CHANGES IN STOCK OPTION PLAN
| |
Shares | | |
Weighted
Average Exercise
Price | | |
Weighted
Average Remaining Contractual Life In Years | | |
Aggregate
Intrinsic Value (in thousands) | |
Outstanding as of October 31, 2021 | |
| 11,192 | | |
$ | 1,550.26 | | |
| 7.80 | | |
$ | 34 | |
Cancelled or expired | |
| (74 | ) | |
| 22,200.00 | | |
| | | |
| | |
Outstanding as of July 31, 2022 | |
| 11,118 | | |
$ | 1,412.82 | | |
| 7.06 | | |
$ | - | |
Vested and exercisable
at July 31, 2022 | |
| 7,490 | | |
$ | 2,077.20 | | |
| 6.64 | | |
$ | - | |
The
following table summarizes information about the outstanding and exercisable options at July 31, 2022:
SUMMARY OF OUTSTANDING AND EXERCISABLE OPTIONS
Options
Outstanding | |
Options
Exercisable | |
| |
| | |
Weighted | | |
Weighted | | |
| | |
Weighted | | |
Weighted | |
| |
| | |
Average | | |
Average | | |
| | |
Average | | |
Average | |
Exercise | |
Number | | |
Remaining | | |
Exercise | | |
Number | | |
Remaining | | |
Exercise | |
Price Range | |
Outstanding | | |
Contractual | | |
Price | | |
Exercisable | | |
Contractual | | |
Price | |
$ 24.00-$50.00 | |
| 4,241 | | |
| 7.86 | | |
$ | 32.53 | | |
| 1,964 | | |
| 7.69 | | |
$ | 30.40 | |
$ 50.01-$100.00 | |
| 4,174 | | |
| 7.74 | | |
$ | 53.33 | | |
| 2,824 | | |
| 7.73 | | |
$ | 53.58 | |
$ 100.01-20,664.00 | |
| 2,703 | | |
| 4.75 | | |
$ | 5,677.84 | | |
| 2,703 | | |
| 4.75 | | |
$ | 5,677.84 | |
As
of July 31, 2022, there was approximately $77,000 of unrecognized compensation cost related to non-vested stock option awards, which
is expected to be recognized over a remaining weighted average vesting period of 0.94 years.
Potential
Acceleration of Stock Options
In
the event of a merger transaction, similar to the Previously Proposed Merger Agreement, all of the Chief Executive Officer’s 624
unvested stock options as of July 31, 2022, pursuant to his employment agreement, would accelerate.
12.
LICENSING AGREEMENTS
OS
Therapies LLC
On
September 4, 2018, the Company entered into a development, license and supply agreement with OS Therapies (“OST”) for the
use of ADXS31-164, also known as ADXS-HER2, for evaluation in the treatment of osteosarcoma in humans. Under the terms of the license
agreement, as amended, OST will be responsible for the conduct and funding of a clinical study evaluating ADXS-HER2 in recurrent, completely
resected osteosarcoma. Under the most recent amendment to the licensing agreement, OST agreed to pay Advaxis $25,000 per month (“Monthly
Payment”) starting on April 30, 2020 until it achieved its funding milestone of $2,337,500. Upon receipt of the first Monthly Payment,
Advaxis initiated the transfer of the intellectual property and licensing rights of ADXS31-164, which were licensed pursuant to the Penn
Agreement, back to the University of Pennsylvania. Contemporaneously, OST will enter negotiations with the University of Pennsylvania
to establish a licensing agreement for ADXS31-164 to OST for clinical and commercial development of the ADXS31-164 technology.
In
December 2020 and January 2021, the Company received
an aggregate of $1,615,000 from OS Therapies upon achievement of the funding milestone set forth in the license agreement and recorded
$1,615,000 in revenue. The Company therefore transferred, and OST took full ownership of, the IND application for ADXS31-164 in its entirety
along with agreements and promises contained therein, as well as all obligations associated with this IND or any HER2 product/program
development.
In
April 2021, the Company achieved the second milestone set forth in the license agreement for evaluation in the treatment of osteosarcoma
in humans and recorded $1,375,000 in revenue. The Company
received the amount due from OS Therapies of $1,375,000 in May 2021.
Global
BioPharma Inc.
On
December 9, 2013, the Company entered into an exclusive licensing agreement for the development and commercialization of axalimogene
filolisbac with Global BioPharma, Inc. (“GBP”), a Taiwanese based biotech company funded by a group of investors led by Taiwan
Biotech Co., Ltd (TBC). During each of the nine months ended July 31, 2022 and 2021, the Company recorded $250,000 in revenue for the
annual license fee renewal. Since Advaxis has no significant obligation to perform after the license transfer and has provided GBP with
the right to use its intellectual property, performance is satisfied when the license renews.
13.
FAIR VALUE
The
authoritative guidance for fair value measurements defines fair value as the exchange price that would be received for an asset or paid
to transfer a liability (an exit price) in the principal or the most advantageous market for the asset or liability in an orderly transaction
between market participants on the measurement date. Market participants are buyers and sellers in the principal market that are (i)
independent, (ii) knowledgeable, (iii) able to transact, and (iv) willing to transact. The guidance describes a fair value hierarchy
based on the levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure
fair value which are the following:
●
Level 1 — Quoted prices in active markets for identical assets or liabilities.
●
Level 2— Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets
or liabilities; quoted prices in markets that are not active; or other inputs that are observable or corroborated by observable market
data or substantially the full term of the assets or liabilities.
●
Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to the value of the assets
or liabilities.
The
following table provides the assets and liabilities carried at fair value measured on a recurring basis as of July 31, 2022 and October
31, 2021 (in thousands):
SCHEDULE OF FAIR VALUE, ASSETS AND LIABILITIES MEASURED ON RECURRING BASIS
| |
Level
1 | | |
Level
2 | | |
Level
3 | | |
Total | |
Fair
Value Measured at July 31, 2022 |
| |
Level
1 | | |
Level
2 | | |
Level
3 | | |
Total | |
Financial
assets at fair value: | |
| | | |
| | | |
| | | |
| | |
Cash equivalents
(money market funds) | |
$ | 17,183 | | |
$ | - | | |
$ | - | | |
$ | 17,183 | |
Total
Financial Assets at Fair Value | |
$ | 17,183 | | |
$ | - | | |
$ | - | | |
$ | 17,183 | |
| |
| | | |
| | | |
| | | |
| | |
Financial
liabilities at fair value: | |
| | | |
| | | |
| | | |
| | |
Common stock warrant liability, warrants exercisable
at $20.00 through September 2024 | |
$ | - | | |
$ | - | | |
$ | 2 | | |
$ | 2 | |
Common stock warrant
liability, warrants exercisable at $56.00 through 5 years after the date such warrants become exercisable, if ever (Private Placement
Warrants) | |
| - | | |
| - | | |
| 285 | | |
| 285 | |
Total
financial liabilities at fair value | |
$ | - | | |
$ | - | | |
$ | 287 | | |
$ | 287 | |
| |
Level
1 | | |
Level
2 | | |
Level
3 | | |
Total | |
Fair
Value Measured at October 31, 2021 |
| |
Level
1 | | |
Level
2 | | |
Level
3 | | |
Total | |
Financial
assets at fair value: | |
| | | |
| | | |
| | | |
| | |
Cash equivalents
(money market funds) | |
$ | 17,153 | | |
$ | - | | |
$ | - | | |
$ | 17,153 | |
Total
Financial Assets at Fair Value | |
$ | 17,153 | | |
$ | - | | |
$ | - | | |
$ | 17,153 | |
| |
| | | |
| | | |
| | | |
| | |
Financial
liabilities at fair value: | |
| | | |
| | | |
| | | |
| | |
Common stock warrant liability, warrants exercisable
at $24.00 through September 2024 | |
$ | - | | |
$ | - | | |
$ | 27 | | |
$ | 27 | |
Common stock warrant liability, warrants exercisable | |
$ | - | | |
$ | - | | |
$ | 27 | | |
$ | 27 | |
Common stock warrant
liability, warrants exercisable at $56.00 through 5 years after the date such warrants become exercisable, if ever (Private Placement
Warrants) | |
| - | | |
| - | | |
| 4,902 | | |
| 4,902 | |
Total
financial liabilities at fair value | |
$ | - | | |
$ | - | | |
$ | 4,929 | | |
$ | 4,929 | |
The
following table presents changes in Level 3 liabilities measured at fair value (in thousands) for the nine months ended July 31, 2022.
Unobservable inputs were used to determine the fair value of positions that the Company has classified within the Level 3 category.
SCHEDULE
OF FAIR VALUE MEASURING UNOBSERVABLE INPUTS
| |
| | |
| | |
| |
| |
Preferred
Stock
Redemption
Liability | | |
Warrant
Liabilities | | |
Total | |
Fair value at October 31, 2021 | |
$ | - | | |
$ | 4,929 | | |
$ | 4,929 | |
Additions | |
| 87 | | |
| - | | |
| 87 | |
Change in fair value | |
| (43 | ) | |
| (4,642 | ) | |
| (4,685 | ) |
Redemption | |
| (44 | ) | |
| - | | |
| (44 | ) |
Fair value at July
31, 2022 | |
$ | - | | |
$ | 287 | | |
$ | 287 | |